2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:Tdcf,ABSTRACT Background Many patients with chronic spontaneous urticaria (CSU) remain symptomatic despite receiving second‐generation H 1 ‐antihistamines (sgH 1 ‐AH). This data analysis from the Chronic Urticaria Registry (CURE) aimed to describe treatment patterns and identify unmet needs in real‐world practice. Methods CURE is an international, prospective registry of patients with chronic urticaria. Treatment responses were categorized as Urticaria Control Test (UCT) changes from baseline (BL) to 6‐month follow‐up (FU). Complete response was defined as UCT = 16 with a ≥ 3‐point increase. Results Data were available from 3995 adult patients with CSU at BL and 1288 at FU with evaluable UCT. After treatment escalation from BL to FU, 5.3% (no treatment to licensed‐dose sgH 1 ‐AH), 6.0% (licensed‐dose sgH 1 ‐AH to up‐dosed sgH 1 ‐AH), and 28.4% (any dose sgH 1 ‐AH to omalizumab) achieved complete response. Factors associated with a lower probability of treatment escalation at FU were UCT ≥ 12 and omalizumab treatment at BL (both p < 0.0001). About one‐third (28.6%) of patients clinically eligible for escalation at BL (UCT < 12) did not receive step‐up treatment (18.0%) or were even stepped down (10.6%) and remained poorly controlled at FU. Factors associated with lack of escalation in this group included younger age ( p = 0.014), shorter disease duration ( p = 0.071), presence of wheals and angioedema ( p = 0.002), better quality of life ( p = 0.001), and treatment with up‐dosed sgH 1 ‐AH ( p = 0.031). Conclusion Appropriate treatment escalation improves CSU control, although only about a quarter of patients achieve a complete response, indicating the need for novel treatments. Many patients with poorly controlled CSU do not receive guideline‐recommended treatment escalation and remain symptomatic on their current treatments, which deserves further attention. 31:T6c3,Chronic spontaneous urticaria (CSU) is a mast cell-driven disease associated with systemic inflammation and altered immune responses. Haptoglobin (HP), an acute-phase glycoprotein, exhibits antioxidative and immunomodulatory properties, while zonulin, the precursor of HP-2, regulates epithelial barrier integrity. We investigated the clinical relevance of serum HP and zonulin in CSU and their association with treatment outcomes. Serum HP and zonulin levels were measured by ELISA in 124 CSU patients and 57 healthy controls (HCs). In 62 CSU patients, follow-up samples were obtained after 3 months of treatment. Clinical outcomes included the urticaria activity score over 7 days (UAS7) and the urticaria control test (UCT). Serum HP levels were significantly higher in CSU patients than in HCs (median 1145.1 vs. 839.2 μg/mL, p < 0.001), whereas zonulin levels did not differ. HP correlated positively, but weakly, with the white blood cell count, C3 and C-reactive protein (all rho ≈ 0.2), and negatively with disease duration and eosinophil percentage. Zonulin correlated negatively with UCT scores but not with HP. After treatment, HP decreased significantly (p < 0.001), with greater reductions in patients showing a ≥ 12-point improvement on the UAS7. Baseline HP was higher in patients who achieved complete control (UCT = 16) than others (p = 0.017). ROC analysis identified baseline HP ≥ 1249 μg/mL as an optimal cutoff, confirmed as an independent predictor of complete control (odds ratio = 4.23, p = 0.029). Serum HP is elevated in CSU patients, decreases with treatment, and independently predicts complete urticaria control. HP may serve as a potentially prognostic biomarker for CSU.32:Ta9f,ABSTRACT Background Chronic spontaneous urticaria (CSU) is a mast cell‐driven disease associated with systemic inflammation and altered immune responses. Haptoglobin (HP), an acute‐phase glycoprotein, exhibits antioxidative and immunomodulatory properties, while zonulin, the precursor of HP‐2, regulates epithelial barrier integrity. We investigated the clinical relevance of serum HP and zonulin in CSU and their association with treatment outcomes. Methods Serum HP and zonulin levels were measured by ELISA in 124 CSU patients and 57 healthy controls (HCs). In 62 CSU patients, follow‐up samples were obtained after 3 months of treatment. Clinical outcomes included the urticaria activity score over 7 days (UAS7) and the urticaria control test (UCT). Results Serum HP levels were significantly higher in CSU patients than in HCs (median 1145.1 vs. 839.2 μg/mL, p < 0.001), whereas zonulin levels did not differ. HP correlated positively, but weakly, with the white blood cell count, C3 and C‐reactive protein (all rho ≈ 0.2), and negatively with disease duration and eosinophil percentage. Zonulin correlated negatively with UCT scores but not with HP. After treatment, HP decreased significantly ( p < 0.001), with greater reductions in patients showing a ≥ 12‐point improvement on the UAS7. Baseline HP was higher in patients who achieved complete control (UCT = 16) than others ( p = 0.017). ROC analysis identified baseline HP ≥ 1249 μg/mL as an optimal cutoff, confirmed as an independent predictor of complete control (odds ratio = 4.23, p = 0.029). Conclusion Serum HP is elevated in CSU patients, decreases with treatment, and independently predicts complete urticaria control. HP may serve as a potentially prognostic biomarker for CSU. 33:Tb61,Chronic spontaneous urticaria (CSU) can cause psychosocial and quality of life burden on patients and their family members and caregivers. Despite its recognition as a debilitating disease, limited data exist regarding the impact of CSU on family members, hindering a comprehensive understanding of the disease's broader effects. This study aimed to assess how CSU affects the quality of life of family members who support patients in their daily challenges by applying the Family Dermatology Life Quality Index (FDLQI) questionnaire across multiple countries. A cross-sectional, multicentre and international study conducted between January and December 2024 in Urticaria Centres of Reference and Excellence (UCARE) centres located in several countries including Brazil, China, Ecuador, Greece, India, Oman, Poland, Russia, Thailand, Turkey, Peru and North Macedonia. Statistical analyses, including non-parametric tests and multiple regression models, were employed to explore associations between disease severity/control and family burden. Poorly controlled CSU significantly deteriorated family members' quality of life, particularly in emotional, physical and social domains. Higher disease severity and lower disease control scores were associated with increased stress, greater caregiving burden and elevated health expenditures. In opposition to family relations, older age and longer time since diagnosis mitigate negative impacts, while insufficient treatment regimens exacerbated them. Inadequate control of CSU amplifies the burden on families, underscoring the need for effective and supportive care strategies. Chronic spontaneous urticaria (CSU) is a skin condition that causes itchy hives, swelling and discomfort lasting more than 6 weeks. It affects up to 1% of people worldwide, especially women aged 30–50. Although not life‐threatening, it can severely impact daily life and emotional well‐being. This international cross‐sectional study was conducted in 12 countries across three continents, from January to December 2024 at Urticaria Centres of Reference and Excellence (UCARE). The study aimed to investigate how CSU affects the family members of patients, focusing on emotional, physical, social and financial impacts. A total of 1187 CSU patients and their respective family members completed questionnaires, including the Family Dermatology Life Quality Index (FDLQI), and physicians also provided clinical data on disease severity and control. Results showed that uncontrolled CSU was linked to more household responsibilities and emotional stress for family members, often disrupting their work and personal routines. In contrast, strong family support and effective treatment were associated with lower family burden. Early diagnosis, appropriate treatment and continuous follow‐up can reduce this burden and improve quality of life for both patients and their families.34:T8d9,Abstract Background Chronic spontaneous urticaria (CSU) can cause psychosocial and quality of life burden on patients and their family members and caregivers. Despite its recognition as a debilitating disease, limited data exist regarding the impact of CSU on family members, hindering a comprehensive understanding of the disease's broader effects. This study aimed to assess how CSU affects the quality of life of family members who support patients in their daily challenges by applying the Family Dermatology Life Quality Index (FDLQI) questionnaire across multiple countries. Methods A cross‐sectional, multicentre and international study conducted between January and December 2024 in Urticaria Centres of Reference and Excellence (UCARE) centres located in several countries including Brazil, China, Ecuador, Greece, India, Oman, Poland, Russia, Thailand, Turkey, Peru and North Macedonia. Statistical analyses, including non‐parametric tests and multiple regression models, were employed to explore associations between disease severity/control and family burden. Results Poorly controlled CSU significantly deteriorated family members' quality of life, particularly in emotional, physical and social domains. Higher disease severity and lower disease control scores were associated with increased stress, greater caregiving burden and elevated health expenditures. In opposition to family relations, older age and longer time since diagnosis mitigate negative impacts, while insufficient treatment regimens exacerbated them. Conclusion Inadequate control of CSU amplifies the burden on families, underscoring the need for effective and supportive care strategies. 35:T8a4,Chronic spontaneous urticaria (CSU), a disease predominantly affecting females, has limited information available on its differences between females and males of varying ages. To investigate sex differences in age groups regarding disease activity, comorbidities, quality of life (QoL) and treatment patterns in CSU patients. We analysed Chronic Urticaria Registry (CURE) data, an international real-world registry for patients with chronic urticaria. Patients were recruited via an online platform using a standardized questionnaire. The data were analysed for demographics, age of onset, duration of urticaria, (Urticaria Activity Score [UAS], Urticaria Control Test [UCT], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL]), family history, systemic symptoms, aggravating factors, comorbidities, smoking and alcohol consumption, laboratory parameters, burden of disease, treatment distribution and response rates, compliance to treatment and adverse events. Comparisons were made among age groups <13, 13-17, 18-30, 31-50, 51-65 and >65 years. Across 4136 CSU patients (from 58 sites across 29 countries), 2994 (72.4%) were female. Statistically significant female predominance started at age 31 (<0.001). Compared with males, females showed higher rates of angioedema (59.6 vs. 51.7%; p < 0.001), systemic symptoms (34.6 vs. 25.4%; p < 0.001), sleep disturbance (38.9 vs. 32.5%; p < 0.001), QoL impairment (CU-Q2oL score 32 vs. 27.7; p < 0.001) and lower rates of urticaria control than males in all medication categories (p < 0.05 for all). Females had more concomitant diseases, including asthma, thyroid disease, obesity, autoimmune disease, gastrointestinal disease and depression (p < 0.05 for all). The disease was especially more burdensome and refractory in females aged 51-65 years than males, evidenced by more angioedema and systemic symptoms, worse QoL, lower UCT scores and more emergency visits (p < 0.05 for all). However, these differences were not prominent in the elderly females (>65 years). Compared with males, female CSU patients experience more burdensome disease, which gets worse in midlife. gov (or equivalent) listing (if applicable None).36:Tba5,AbstractBackgroundChronic spontaneous urticaria (CSU), a disease predominantly affecting females, has limited information available on its differences between females and males of varying ages.ObjectiveTo investigate sex differences in age groups regarding disease activity, comorbidities, quality of life (QoL) and treatment patterns in CSU patients.MethodsWe analysed Chronic Urticaria Registry (CURE) data, an international real‐world registry for patients with chronic urticaria. Patients were recruited via an online platform using a standardized questionnaire. The data were analysed for demographics, age of onset, duration of urticaria, (Urticaria Activity Score [UAS], Urticaria Control Test [UCT], Chronic Urticaria Quality of Life Questionnaire [CU‐Q2oL]), family history, systemic symptoms, aggravating factors, comorbidities, smoking and alcohol consumption, laboratory parameters, burden of disease, treatment distribution and response rates, compliance to treatment and adverse events. Comparisons were made among age groups <13, 13–17, 18–30, 31–50, 51–65 and >65 years.ResultsAcross 4136 CSU patients (from 58 sites across 29 countries), 2994 (72.4%) were female. Statistically significant female predominance started at age 31 (<0.001). Compared with males, females showed higher rates of angioedema (59.6 vs. 51.7%; p < 0.001), systemic symptoms (34.6 vs. 25.4%; p < 0.001), sleep disturbance (38.9 vs. 32.5%; p < 0.001), QoL impairment (CU‐Q2oL score 32 vs. 27.7; p < 0.001) and lower rates of urticaria control than males in all medication categories (p < 0.05 for all). Females had more concomitant diseases, including asthma, thyroid disease, obesity, autoimmune disease, gastrointestinal disease and depression (p < 0.05 for all). The disease was especially more burdensome and refractory in females aged 51–65 years than males, evidenced by more angioedema and systemic symptoms, worse QoL, lower UCT scores and more emergency visits (p < 0.05 for all). However, these differences were not prominent in the elderly females (>65 years).ConclusionCompared with males, female CSU patients experience more burdensome disease, which gets worse in midlife.Clinicaltrials.gov (or equivalent) listing (if applicable None).37:T46a,A total of 160 omalizumab-naive and omalizumab-incomplete responders were randomized (mean [SD] age, 44.1 [13.4] years; 112 [70.0%] female). The primary analysis population included only the 143 omalizumab-naive patients. Significant reductions at week 12 were observed with rilzabrutinib, 1200 mg/d, vs placebo from baseline in ISS7 (least squares [LS] mean, -9.21 vs -5.77; difference, -3.44 [95% CI, -6.25 to -0.62]; P = .02) and UAS7 (LS mean, -16.89 vs -10.14; difference, -6.75 [95% CI, -12.23 to -1.26]; P = .02). In addition, improvements in weekly Hives Severity Score (HSS7) and weekly Angioedema Activity Score (AAS7) were observed. Improvements in ISS7, UAS7, HSS7, and AAS7 were observed as early as week 1. CSU-related biomarkers, including soluble Mas-related G protein-coupled receptor X2, immunoglobulin (Ig)-G antithyroid peroxidase, IgG anti-Fc-ε receptor 1, and interleukin-31, were reduced compared to placebo at week 12. Rilzabrutinib demonstrated a favorable risk-benefit profile; adverse events occurring at a higher frequency with rilzabrutinib vs placebo included diarrhea, nausea, and headache.38:Tbc6,Chronic spontaneous urticaria (CSU) is a skin disease driven mainly by the activation of cutaneous mast cells through various mechanisms. Bruton tyrosine kinase (BTK), expressed in B cells and mast cells, plays a critical role in multiple immune-mediated disease processes. To determine the efficacy and risk profile of rilzabrutinib (SAR444671), an oral, reversible, covalent, next-generation BTK inhibitor, in treating patients with CSU. The Rilzabrutinib Efficacy and Safety in CSU (RILECSU) randomized clinical trial was a 52-week phase 2 study comprising a 12-week, double-blind, placebo-controlled, dose-ranging period, followed by a 40-week open-label extension. The trial was conducted from November 24, 2021, through April 23, 2024. Fifty-one centers enrolled and randomized participants across 12 countries in Asia, Europe, North America, and South America. The trial participants included adults aged 18 to 80 years with moderate to severe CSU (weekly Urticaria Activity Score [UAS7] of 16 or more; weekly Itch Severity Score [ISS7] of 8 or more) not adequately controlled with H1-antihistamine treatment. Patients were randomized 1:1:1:1 to rilzabrutinib, 400 mg, once every evening (400 mg/d), twice per day (800 mg/d), 3 times per day (1200 mg/d), or matching placebo. The primary end point was change from baseline at week 12 in ISS7 (for US and US reference countries) or UAS7 (for non-US reference countries). A total of 160 omalizumab-naive and omalizumab-incomplete responders were randomized (mean [SD] age, 44.1 [13.4] years; 112 [70.0%] female). The primary analysis population included only the 143 omalizumab-naive patients. Significant reductions at week 12 were observed with rilzabrutinib, 1200 mg/d, vs placebo from baseline in ISS7 (least squares [LS] mean, -9.21 vs -5.77; difference, -3.44 [95% CI, -6.25 to -0.62]; P = .02) and UAS7 (LS mean, -16.89 vs -10.14; difference, -6.75 [95% CI, -12.23 to -1.26]; P = .02). In addition, improvements in weekly Hives Severity Score (HSS7) and weekly Angioedema Activity Score (AAS7) were observed. Improvements in ISS7, UAS7, HSS7, and AAS7 were observed as early as week 1. CSU-related biomarkers, including soluble Mas-related G protein-coupled receptor X2, immunoglobulin (Ig)-G antithyroid peroxidase, IgG anti-Fc-ε receptor 1, and interleukin-31, were reduced compared to placebo at week 12. Rilzabrutinib demonstrated a favorable risk-benefit profile; adverse events occurring at a higher frequency with rilzabrutinib vs placebo included diarrhea, nausea, and headache. The results of the RILECSU randomized clinical trial demonstrated efficacy and rapid onset of action of rilzabrutinib, 1200 mg/d, over 12 weeks, in addition to an acceptable adverse event profile. Together, these data support the use of rilzabrutinib in treating patients with moderate to severe CSU refractory to H1-antihistamines. Further research is needed to determine long-term efficacy and potential harms. ClinicalTrials.gov Identifier: NCT05107115.39:Tf48,ImportanceChronic spontaneous urticaria (CSU) is a skin disease driven mainly by the activation of cutaneous mast cells through various mechanisms. Bruton tyrosine kinase (BTK), expressed in B cells and mast cells, plays a critical role in multiple immune-mediated disease processes.ObjectiveTo determine the efficacy and risk profile of rilzabrutinib (SAR444671), an oral, reversible, covalent, next-generation BTK inhibitor, in treating patients with CSU.Design, Setting, and ParticipantsThe Rilzabrutinib Efficacy and Safety in CSU (RILECSU) randomized clinical trial was a 52-week phase 2 study comprising a 12-week, double-blind, placebo-controlled, dose-ranging period, followed by a 40-week open-label extension. The trial was conducted from November 24, 2021, through April 23, 2024. Fifty-one centers enrolled and randomized participants across 12 countries in Asia, Europe, North America, and South America. The trial participants included adults aged 18 to 80 years with moderate to severe CSU (weekly Urticaria Activity Score [UAS7] of 16 or more; weekly Itch Severity Score [ISS7] of 8 or more) not adequately controlled with H1-antihistamine treatment.InterventionsPatients were randomized 1:1:1:1 to rilzabrutinib, 400 mg, once every evening (400 mg/d), twice per day (800 mg/d), 3 times per day (1200 mg/d), or matching placebo.Main OutcomesThe primary end point was change from baseline at week 12 in ISS7 (for US and US reference countries) or UAS7 (for non-US reference countries).ResultsA total of 160 omalizumab-naive and omalizumab-incomplete responders were randomized (mean [SD] age, 44.1 [13.4] years; 112 [70.0%] female). The primary analysis population included only the 143 omalizumab-naive patients. Significant reductions at week 12 were observed with rilzabrutinib, 1200 mg/d, vs placebo from baseline in ISS7 (least squares [LS] mean, −9.21 vs −5.77; difference, −3.44 [95% CI, −6.25 to −0.62]; P = .02) and UAS7 (LS mean, −16.89 vs −10.14; difference, −6.75 [95% CI, −12.23 to −1.26]; P = .02). In addition, improvements in weekly Hives Severity Score (HSS7) and weekly Angioedema Activity Score (AAS7) were observed. Improvements in ISS7, UAS7, HSS7, and AAS7 were observed as early as week 1. CSU-related biomarkers, including soluble Mas-related G protein–coupled receptor X2, immunoglobulin (Ig)-G antithyroid peroxidase, IgG anti-Fc-ε receptor 1, and interleukin-31, were reduced compared to placebo at week 12. Rilzabrutinib demonstrated a favorable risk-benefit profile; adverse events occurring at a higher frequency with rilzabrutinib vs placebo included diarrhea, nausea, and headache.Conclusions and RelevanceThe results of the RILECSU randomized clinical trial demonstrated efficacy and rapid onset of action of rilzabrutinib, 1200 mg/d, over 12 weeks, in addition to an acceptable adverse event profile. Together, these data support the use of rilzabrutinib in treating patients with moderate to severe CSU refractory to H1-antihistamines. Further research is needed to determine long-term efficacy and potential harms.Trial RegistrationClinicalTrials.gov Identifier: NCT051071153a:T6af,To analyze causality between gut microbiota and chronic spontaneous urticaria (CSU) and to investigate the mediating effect of metabolic pathways. We extracted genome-wide association study summary statistics for 211 microbiota taxa from the MiBioGen consortium (N=18 340), 205 microbiota metabolic pathways from the Dutch Microbiome Project (N=7738), and CSU from the FinnGen genomics initiative (N=450). Bidirectional Mendelian randomization (MR) was performed to detect genetic causality between gut microbiota, gut bacterial pathways, and CSU. Sensitivity analyses were performed to validate the robustness of the results. Mediation MR investigated mediators in the association between gut microbiota and CSU. MR analysis suggested that the family Peptococcaceae and its child taxon, the genus Peptococcus, were risk factors for CSU. In addition, the genera Collinsella, Lachnospiraceae UCG004, Ruminococcaceae UCG004, and Sellimonas were also risk factors for CSU, whereas Family XIII UCG001, Lachnospiraceae UCG010, and Methanobrevibacter had protective effects on CSU. As for metabolic pathways, NONMEVIPP-PWY, PWY-5022, and PWY-7221 were positively associated with CSU, although others, such as KDO-NAGLIPASYN-PWY, PWY- 6353, and PWY-7400 presented a suggestive association with CSU. Moreover, PWY-7400 was a mediator in causality between the family Peptococcaceae and CSU. These results were based on nominal significance (P<.05). None of the Bonferroni-corrected P values were <.05. Our study confirmed a causal association between gut microbiota and CSU, with the the metabolic pathway being a potential mediator. Our findings provide new insights for further mechanistic and clinical studies in CSU.3b:T6f1,Background: To analyze causality between gut microbiota and chronic spontaneous urticaria (CSU) and to investigate the mediating effect of metabolic pathways. Methods: We extracted genome-wide association study summary statistics for 211 microbiota taxa from the MiBioGen consortium (N=18 340), 205 microbiota metabolic pathways from the Dutch Microbiome Project (N=7738), and CSU from the FinnGen genomics initiative (N=450). Bidirectional Mendelian randomization (MR) was performed to detect genetic causality between gut microbiota, gut bacterial pathways, and CSU. Sensitivity analyses were performed to validate the robustness of the results. Mediation MR investigated mediators in the association between gut microbiota and CSU. Results: MR analysis suggested that the family Peptococcaceae and its child taxon, the genus Peptococcus, were risk factors for CSU. In addition, the genera Collinsella, Lachnospiraceae UCG004, Ruminococcaceae UCG004, and Sellimonas were also risk factors for CSU, whereas Family XIII UCG001, Lachnospiraceae UCG010, and Methanobrevibacter had protective effects on CSU. As for metabolic pathways, NONMEVIPP-PWY, PWY-5022, and PWY-7221 were positively associated with CSU, although others, such as KDO-NAGLIPASYN-PWY, PWY- 6353, and PWY-7400 presented a suggestive association with CSU. Moreover, PWY-7400 was a mediator in causality between the family Peptococcaceae and CSU. These results were based on nominal significance (P<.05). None of the Bonferroni-corrected P values were <.05. Conclusions: Our study confirmed a causal association between gut microbiota and CSU, with the the metabolic pathway being a potential mediator. Our findings provide new insights for further mechanistic and clinical studies in CSU.25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Chronic Spontaneous Urticaria: condition Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Chronic Spontaneous Urticaria (condition). 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Updated daily.\",\"url\":\"https://www.reachrx.ai/hub/tag/condition/Chronic%20Spontaneous%20Urticaria\",\"breadcrumb\":{\"@type\":\"BreadcrumbList\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https://www.reachrx.ai\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Research Hub\",\"item\":\"https://www.reachrx.ai/hub\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Conditions\",\"item\":\"https://www.reachrx.ai/hub/tag/condition\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Chronic Spontaneous Urticaria\",\"item\":\"https://www.reachrx.ai/hub/tag/condition/Chronic%20Spontaneous%20Urticaria\"}]}}"}}]],["$","$L2f",null,{"title":"Chronic Spontaneous Urticaria: Research & Clinical Takeaways","description":"Discover peer-reviewed research on Chronic Spontaneous Urticaria with concise clinician summaries and next-step guidance.","papers":[{"doi":"10.1001/jamadermatol.2026.2043","pmid":"42714921","title":"Drug Survival of Omalizumab and Factors Associated With Discontinuation in Chronic Urticaria","journal_title":"JAMA Dermatology","journal_issn":"2168-6068","published_at":"2026-09-09T00:00:00.000Z","url":"https://doi.org/10.1001/jamadermatol.2026.2043","source_score":5,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-09-13T06:21:42.856Z","updated_at":"2026-09-13T06:21:42.856Z","tags":[{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"brand","value":"Xolair","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"category","value":"Dermatology","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"condition","value":"Chronic Inducible Urticaria","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"condition","value":"Chronic Urticaria","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"generic","value":"omalizumab","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"modality","value":"Anti-IgE Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"sample_size","value":"n=4516","value_numeric":4516},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"study_design","value":"Systematic Review and Meta-Analysis","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"warning","value":"Age group tagged as 'adult' based on typical CU trial populations; the paper does not explicitly report age group breakdown.","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"warning","value":"Drug survival for chronic inducible urticaria subtype (43–49% at 7 years) was reported from a subset of included studies; direct comparison with CSU (30%) should be interpreted with caution given potential differences in study populations.","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2026.2043","tag_type":"warning","value":"The 'practice_changing' flag reflects the actionable endotype-driven stratification findings, but evidence is from observational studies only — randomized data are lacking.","value_numeric":null}],"summaries":{"what_studied":"This systematic review and meta-analysis evaluated long-term drug survival of omalizumab in chronic urticaria (CU) and identified factors associated with discontinuation, pooling data from 8 observational studies (n=4,516) with up to 7 years of follow-up.","key_result":"Median omalizumab drug survival was 3.1 years (95% CI, 2.8–3.4); mean treatment duration over 7 years was 3.75 years. Discontinuation was more often due to disease control than adverse events. Autoimmune comorbidity (mainly thyroid-related) doubled the risk of discontinuation due to lack of efficacy (HR 2.03; 95% CI, 1.20–3.41). Chronic inducible urticaria showed higher 7-year survival (43–49%) vs. chronic spontaneous urticaria alone (30%).","limitations":"All included studies were observational, limiting causal inference. Individual patient-level data were reconstructed from Kaplan-Meier curves rather than sourced directly, introducing potential reconstruction error. The analysis was limited to 8 studies, and heterogeneity in study populations and follow-up durations may affect pooled estimates.","practice_takeaway":"Patients with autoimmune comorbidities (especially thyroid disease) are at higher risk of omalizumab failure in CU — consider closer monitoring and earlier reassessment in this group. Atopic patients who discontinue are more likely doing so due to disease control, suggesting a watch-and-wait approach may be appropriate after remission."}},{"doi":"10.1016/j.jaip.2026.08.022","pmid":"42641985","title":"Cold Urticaria With Negative Standard Cold Stimulation Testing: Results From the COLD-CE Study","journal_title":"The Journal of Allergy and Clinical Immunology: In Practice","journal_issn":"2213-2198","published_at":"2026-08-25T00:00:00.000Z","url":"https://doi.org/10.1016/j.jaip.2026.08.022","source_score":7,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-09-04T06:22:11.659Z","updated_at":"2026-09-04T06:22:11.659Z","tags":[{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"age_group","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"condition","value":"Angioedema","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"condition","value":"Cold Urticaria","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"sample_size","value":"n=364","value_numeric":364},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"study_design","value":"Cross-Sectional Study","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"warning","value":"Exact sex distribution and age ranges are not reported in the abstract, limiting granularity of demographic tags.","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"warning","value":"No treatment or intervention was evaluated; this study is purely diagnostic/characterization in nature — the 'practice_changing' flag reflects the diagnostic implication that SCST-negative ColdU is common and should not be dismissed based on testing alone.","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.08.022","tag_type":"warning","value":"The study is cross-sectional, so associations (e.g., family history, CSU comorbidity) are not proven causal.","value_numeric":null}],"summaries":{"what_studied":"This cross-sectional study (COLD-CE) analyzed 364 patients with cold urticaria (ColdU) across 11 international GA2LEN UCARE centers to characterize those with negative standard cold stimulation testing (SCST) and identify factors independently associated with SCST-negative ColdU.","key_result":"33.2% of ColdU patients (121/364) were SCST-negative. SCST-negative ColdU was independently associated with family history of ColdU (aOR 2.47), fewer cold triggers (aOR 0.66 per trigger), obligatory feeling of cold for symptom onset (aOR 3.85), and concomitant chronic spontaneous urticaria (aOR 2.23). SCST-positive ColdU carried higher rates of oropharyngeal angioedema, breathing difficulty, and cardiovascular symptoms.","limitations":"- Cross-sectional design prevents causal inference or longitudinal tracking of disease course.\n- SCST methods (ice cube and/or TempTest) may not capture all cold exposure scenarios, potentially misclassifying some patients.\n- Referral bias is possible, as data came from specialized UCARE centers rather than general practice.","practice_takeaway":"One in three ColdU patients may test negative on standard cold stimulation — do not rule out the diagnosis based on a negative ice cube or TempTest alone. Younger patients with a family history of ColdU, fewer identifiable triggers, and concomitant chronic spontaneous urticaria are most likely to be SCST-negative and warrant clinical diagnosis despite negative provocation testing."}},{"doi":"10.1111/cea.70381","pmid":"42337920","title":"Emerging Paediatric Uses of Dupilumab Beyond Approvals","journal_title":"Clinical & Experimental Allergy","journal_issn":"0954-7894","published_at":"2026-06-23T00:00:00.000Z","url":"https://doi.org/10.1111/cea.70381","source_score":1,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-28T13:27:19.841Z","updated_at":"2026-06-28T13:27:19.841Z","tags":[{"paper_doi":"10.1111/cea.70381","tag_type":"age_group","value":"pediatric","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"condition","value":"Asthma","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"condition","value":"Atopic Dermatitis","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"condition","value":"Chronic Rhinosinusitis With Nasal Polyps","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"condition","value":"Eosinophilic Esophagitis","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"condition","value":"Food Allergy","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"condition","value":"Inborn Errors of Immunity","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"condition","value":"Prurigo Nodularis","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"level_of_evidence","value":"5","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"modality","value":"IL-4/IL-13 Receptor Antagonist","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"study_design","value":"Narrative Review","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"warning","value":"Level of evidence reflects the narrative review design; underlying primary studies are predominantly level 4–5.","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"warning","value":"No aggregate sample size is reported across the reviewed studies; individual studies are largely case reports and small series.","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"warning","value":"Sex breakdown of the reviewed paediatric population is not specified in the abstract; 'mixed' sex tag is assumed based on the broad paediatric scope.","value_numeric":null},{"paper_doi":"10.1111/cea.70381","tag_type":"warning","value":"This is a narrative (not systematic) review; search strategy and inclusion criteria are not formally reported, introducing potential selection bias.","value_numeric":null}],"summaries":{"what_studied":"This narrative review synthesizes emerging evidence on off-label and investigational uses of dupilumab (anti-IL-4Rα) in paediatric patients, covering inflammatory skin diseases, inborn errors of immunity with atopic phenotypes, transplant-associated immune dysregulation, respiratory conditions, and food allergy — beyond currently approved indications.","key_result":"Across case reports, small case series, and observational studies, off-label paediatric dupilumab use consistently showed meaningful improvements in disease severity and quality of life, with a favourable safety profile — though large controlled trial data are lacking.","limitations":"Evidence base is largely limited to case reports, small case series, and observational studies, precluding firm efficacy or safety conclusions. No prospective controlled trials are available for most emerging indications. Optimal patient selection and long-term safety in children remain undefined.","practice_takeaway":"Dupilumab may offer benefit for paediatric patients with T2-driven conditions beyond its current approvals (e.g., rare immunodeficiencies with atopic phenotypes, transplant-related immune dysregulation), but clinicians should treat use in these settings as investigational and document outcomes rigorously. Prospective studies are urgently needed before broader off-label adoption."}},{"doi":"10.1016/j.anai.2026.06.011","pmid":"42297099","title":"Remibrutinib impact on disease control, sleep, and quality of life: Analysis of phase 3 REMIX-1/2","journal_title":"Annals of Allergy, Asthma & Immunology","journal_issn":"1081-1206","published_at":"2026-06-15T00:00:00.000Z","url":"https://doi.org/10.1016/j.anai.2026.06.011","source_score":7,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-01T13:27:11.880Z","updated_at":"2026-07-01T13:27:11.880Z","tags":[{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"generic","value":"remibrutinib","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"modality","value":"BTK Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"sample_size","value":"n=912","value_numeric":912},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"warning","value":"Publication date (2026-06-15) is in the future relative to today (2026-07-01); paper may be an early online publication ahead of formal issue.","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"warning","value":"Statistical significance and confidence intervals for PROM outcomes are not reported in the abstract or results section; clinical magnitude of differences cannot be fully appraised.","value_numeric":null},{"paper_doi":"10.1016/j.anai.2026.06.011","tag_type":"warning","value":"This paper appears to be a secondary/pooled PROM-focused analysis of REMIX-1 and REMIX-2; primary efficacy and safety results may be reported separately.","value_numeric":null}],"summaries":{"what_studied":"Remibrutinib (oral BTK inhibitor, 25 mg twice daily) vs. placebo over 24 weeks—then open-label through week 52—in adults with CSU symptomatic despite second-generation H1-antihistamines, evaluating disease control, sleep, and QoL via multiple PROMs.","key_result":"Within 1 week, remibrutinib produced greater mean reductions in urticaria activity (UAS7 CFB: −11.8 vs. −3.6) and sleep interference (SIS7 CFB: −4.9 vs. −1.9) vs. placebo; improvements in UCT7, AIS7, DLQI, EQ-5D-5L, and WPAI were also observed at the earliest collection points and sustained through week 52.","limitations":"Pooled analysis of two trials (not a pre-specified primary endpoint paper); placebo-controlled period was only 24 weeks; the paper does not report statistical significance or confidence intervals for the PROM outcomes described.","practice_takeaway":"Remibrutinib produces clinically meaningful improvements in symptom control, sleep, and quality of life as early as week 1 in antihistamine-refractory CSU. Clinicians can expect rapid and durable patient-reported benefit sustained to at least one year."}},{"doi":"10.1016/j.waojou.2026.101411","pmid":"42256026","title":"Differential associations of IgG-aFcεRI and IgG-aIgE autoantibodies with clinical phenotypes of type IIb chronic spontaneous urticaria","journal_title":"World Allergy Organization Journal","journal_issn":"1939-4551","published_at":"2026-05-30T00:00:00.000Z","url":"https://doi.org/10.1016/j.waojou.2026.101411","source_score":3,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-11T13:42:40.621Z","updated_at":"2026-06-11T13:42:40.621Z","tags":[{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"brand","value":"Xolair","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"condition","value":"Angioedema","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"generic","value":"omalizumab","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"level_of_evidence","value":"4","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"modality","value":"Anti-IgE Monoclonal Antibody","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"sample_size","value":"n=205","value_numeric":205},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"study_design","value":"Cross-Sectional Study","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"warning","value":"The association between rural residence and higher IgG-aIgE was based on only 24 rural patients and should be interpreted cautiously.","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"warning","value":"The ELISA assays used for IgG-aFcεRI and IgG-aIgE were research-grade only with no established clinical reference ranges or diagnostic cut-offs; results should not be applied directly to clinical decision-making.","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"warning","value":"The omalizumab-IgG-aIgE association likely reflects treatment escalation due to disease severity rather than a causal relationship, as noted by the authors.","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101411","tag_type":"warning","value":"Type I autoallergic CSU markers (IgE autoantibodies to self-antigens) were not assessed, limiting endotype completeness.","value_numeric":null}],"summaries":{"what_studied":"This cross-sectional study of 205 adult CSU patients (77.6% female, mean age 42.8 years) measured IgG autoantibodies against FcεRI (IgG-aFcεRI) and IgE (IgG-aIgE) by ELISA, then tested associations with clinical phenotypes, patient-reported outcomes, and laboratory parameters.","key_result":"IgG-aIgE levels were significantly higher in patients with angioedema (urticaria+angioedema: 2706 pg/mL vs. urticaria only: 984 pg/mL, p<0.001), in omalizumab-treated patients (2531 vs. 1614 pg/mL, p=0.004), those with accompanying systemic symptoms (2032 vs. 1528 pg/mL, p=0.023), rural residents (2206 vs. 1659 pg/mL, p=0.041), and nighttime-predominant symptoms. IgG-aFcεRI was higher in wheal-only disease (108 vs. 95.3 pg/mL, p<0.001) and anti-TPO–positive patients (107 vs. 97.7 pg/mL, p=0.013), and correlated negatively with IgG-aIgE (τ=−0.145, p=0.003), neutrophil count, and total IgE, and positively with total IgG.","limitations":"- No healthy control group, so antibody levels cannot be benchmarked against the general population.\n- Assays lack established clinical cut-offs; antibodies analyzed as continuous variables only, preventing positive/negative classification.\n- Cross-sectional design precludes causal inference; several subgroups (rural residents, C1-INH measurements) were small.","practice_takeaway":"In CSU, higher IgG-aIgE levels track with angioedema-dominant disease and need for omalizumab, while higher IgG-aFcεRI levels track with wheal-predominant disease and thyroid autoimmunity—patterns that may help stratify patients toward targeted workup. These assays are not yet standardized for routine clinical use."}},{"doi":"10.1016/j.waojou.2026.101404","pmid":null,"title":"Knowledge of chronic spontaneous urticaria management among Italian general practitioners: Baseline findings from the BRIDGE study","journal_title":"World Allergy Organization Journal","journal_issn":"1939-4551","published_at":"2026-05-29T00:00:00.000Z","url":"https://doi.org/10.1016/j.waojou.2026.101404","source_score":4,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":false,"crossref":true,"unpaywall":true},"created_at":"2026-06-03T13:44:28.069Z","updated_at":"2026-06-03T13:44:28.069Z","tags":[{"paper_doi":"10.1016/j.waojou.2026.101404","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101404","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101404","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101404","tag_type":"study_design","value":"Cross-Sectional Survey","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101404","tag_type":"warning","value":"No sample size, key results, or practice takeaways could be extracted due to missing full text. These fields were left null to avoid speculation.","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101404","tag_type":"warning","value":"Only the publisher landing page was provided — no full text, abstract, methods, results, or sample size data were accessible. All structured fields are based solely on the title and journal metadata.","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101404","tag_type":"warning","value":"Study design tag ('Cross-Sectional Survey') is inferred from the title's mention of 'baseline findings' and a knowledge assessment; it is not confirmed from the full text.","value_numeric":null}],"summaries":{"what_studied":"This study assessed baseline knowledge of chronic spontaneous urticaria (CSU) management among Italian general practitioners (GPs) as part of the BRIDGE study.","limitations":"Only the publisher landing page was available — full text was not accessible, so specific findings, sample sizes, and outcomes could not be extracted."}},{"doi":"10.1111/cea.70327","pmid":"42036835","title":"Evaluating Basophil Histamine Content as a Biomarker for Omalizumab Responsiveness in Chronic Spontaneous Urticaria","journal_title":"Clinical & Experimental Allergy","journal_issn":"0954-7894","published_at":"2026-04-26T00:00:00.000Z","url":"https://doi.org/10.1111/cea.70327","source_score":7,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-07T22:50:54.191Z","updated_at":"2026-05-07T22:50:54.191Z","tags":[{"paper_doi":"10.1111/cea.70327","tag_type":"brand","value":"Xolair","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"generic","value":"omalizumab","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"modality","value":"Anti-IgE Therapy","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"study_design","value":"Biomarker Study","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"warning","value":"Brand name 'Xolair' added for omalizumab as a standard tag; confirm if other omalizumab brands were used in the study population.","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"warning","value":"Only the paper title, DOI, journal, and publication date were provided — no abstract or full text. All summary content is inferred from the title alone. Key numerical results, sample size, study design details, patient demographics, and specific limitations could not be extracted. Clinicians should refer to the full text for complete data.","value_numeric":null},{"paper_doi":"10.1111/cea.70327","tag_type":"warning","value":"Study design tag 'Biomarker Study' is inferred from the title; the actual design (e.g., prospective cohort, RCT substudy) is unconfirmed.","value_numeric":null}],"summaries":{"what_studied":"This study evaluated basophil histamine content as a potential biomarker to predict responsiveness to omalizumab in patients with chronic spontaneous urticaria (CSU).","key_result":"Basophil histamine content was assessed for its ability to stratify omalizumab responders from non-responders in CSU, though specific numerical outcomes are not available from the provided abstract metadata alone.","limitations":"Full text details on sample size, follow-up duration, and confounding factors are not available from the provided metadata, limiting assessment of study-specific limitations.","practice_takeaway":"Basophil histamine content may offer a clinically accessible biomarker to guide omalizumab treatment decisions in CSU; clinicians should watch for this emerging evidence as it could help identify patients unlikely to respond before initiating therapy."}},{"doi":"10.1016/j.waojou.2026.101383","pmid":"42058161","title":"Clinical remission in allergy and clinical immunology practice: State of the art and World Allergy Organization (WAO) call to action","journal_title":"World Allergy Organization Journal","journal_issn":"1939-4551","published_at":"2026-04-20T00:00:00.000Z","url":"https://doi.org/10.1016/j.waojou.2026.101383","source_score":4,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-07T22:50:04.940Z","updated_at":"2026-05-07T22:50:04.940Z","tags":[{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"age_group","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"condition","value":"Allergic Rhinitis","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"condition","value":"Asthma","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"condition","value":"Atopic Dermatitis","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"condition","value":"Chronic Rhinosinusitis With Nasal Polyps","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"condition","value":"Eosinophilic Esophagitis","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"condition","value":"Food Allergy","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"condition","value":"Mastocytosis","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"abrocitinib","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"baricitinib","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"benralizumab","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"lebrikizumab","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"mepolizumab","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"omalizumab","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"tezepelumab","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"tralokinumab","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"generic","value":"upadacitinib","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"level_of_evidence","value":"5","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"modality","value":"Allergen-Specific Immunotherapy","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"modality","value":"Biologic Therapy","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"modality","value":"JAK Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"study_design","value":"Narrative Review / Expert Consensus Framework","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"warning","value":"No sample size is applicable as this is a framework/consensus review, not an original clinical study.","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"warning","value":"Remission rates cited for asthma (36–42% in trials; 61–67% in inflammometry-guided cohorts) are not directly comparable due to differing definitions across studies.","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"warning","value":"The 3D-CR framework and ADReS scoring tool are proposed conceptual instruments without prospective validation; treat recommendations as expert consensus, not evidence-based guidelines.","value_numeric":null},{"paper_doi":"10.1016/j.waojou.2026.101383","tag_type":"warning","value":"The paper discloses use of ChatGPT-5.2 Pro for linguistic refinement; scientific content was author-validated.","value_numeric":null}],"summaries":{"what_studied":"This WAO-commissioned narrative review proposes a unified framework for defining clinical remission (CR) across 8 immunoallergic diseases—asthma, allergic rhinitis, CRSwNP, chronic urticaria, atopic dermatitis, mastocytosis, food allergy, and eosinophilic esophagitis—in the context of emerging biologics, small molecules, and allergen immunotherapy.","key_result":"The authors introduce the **3D-CR model** (Clinical–Biological–Functional domains) and the **Allergic Disease Remission Score (ADReS)** (0–6 scale) to standardize remission characterization. Key disease-specific thresholds proposed include: asthma CR requiring no symptoms/exacerbations, no OCS, and FEV₁ ≥80% for ≥12 months; CSU CR defined as complete symptom resolution off all therapy for ≥6 months; and AD complete remission requiring EASI/SCORAD = 0, DLQI = 0, and no flares for ≥12 months. Biologic-achieved CR rates in severe asthma trials range from 36–42%, rising to 61–67% with inflammometry-guided strategies in selected cohorts.","limitations":"- The framework is expert-consensus based with no prospective validation of 3D-CR or ADReS in real-world cohorts.\n- Remission definitions remain heterogeneous across diseases, and no reliable biomarkers exist for several conditions (e.g., chronic urticaria, atopic dermatitis).\n- CR data in asthma derive predominantly from severe asthma biologic trials, limiting generalizability to milder disease.","practice_takeaway":"Clinicians can use the 3D-CR framework (Clinical mandatory + Biological + Functional) as a structured lens when assessing long-term treatment response across allergic diseases—complete remission requires all 3 domains, partial remission requires the clinical domain plus one other. The ADReS tool and disease-specific thresholds (e.g., CSU: symptom-free off therapy ≥6 months; asthma: no OCS/exacerbations + FEV₁ ≥80% for ≥12 months) offer a starting point for incorporating remission endpoints into routine follow-up and clinical trial design, though prospective validation is still needed."}},{"doi":"10.1016/j.jaip.2026.04.011","pmid":"42019723","title":"Global Real-World Validation of First-Day Urticaria Activity Score (UAS1)","journal_title":"The Journal of Allergy and Clinical Immunology: In Practice","journal_issn":"2213-2198","published_at":"2026-04-20T00:00:00.000Z","url":"https://doi.org/10.1016/j.jaip.2026.04.011","source_score":3,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-07T22:49:57.223Z","updated_at":"2026-05-07T22:49:57.223Z","tags":[{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"age_group","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"modality","value":"Patient-Reported Outcome Measure","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"sample_size","value":"n=13,152","value_numeric":13152},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"study_design","value":"Cross-Sectional Study","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"warning","value":"No drug or therapeutic intervention was evaluated; modality tag reflects the nature of the tools studied (PROMs), not a treatment class.","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"warning","value":"Only 1,520 of 13,152 enrolled patients had complete UAS7 data; correlation analyses are based on this subset, which may not represent the full cohort.","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.04.011","tag_type":"warning","value":"The impact_flag 'practice_changing' reflects a significant shift in how incomplete UAS7 data may be handled clinically, but external validation in non-app-based cohorts is not yet available.","value_numeric":null}],"summaries":{"what_studied":"This cross-sectional study evaluated whether the first-day Urticaria Activity Score (UAS1) can serve as a real-world proxy for the 7-day UAS (UAS7), and assessed its associations with the Urticaria Control Test (UCT) and EQ-5D VAS in 13,152 CSU patients across 101 countries (CRUSE app registry), including 1,520 with complete UAS7 records.","key_result":"UAS1 correlated strongly with UAS7 (r = 0.78; P < 0.001); a UAS1 threshold of >3 identified severe disease (UAS7 ≥28). Both scores showed moderate-to-strong inverse correlations with UCT (r = −0.53 to −0.58) and EQ-5D VAS (r = −0.47 to −0.54), consistent across wheals-only and wheals-with-angioedema phenotypes.","limitations":"Only 1,520 of 13,152 patients had complete UAS7 records, raising concern about selection bias among completers. The study is cross-sectional, so temporal reliability of UAS1 as a longitudinal monitoring tool cannot be assessed. Real-world app-based data may introduce digital access and engagement biases.","practice_takeaway":"When a full UAS7 is unavailable due to missed daily entries — common in busy clinics or real-world studies — a single-day UAS1 >3 can reliably flag severe CSU and support treat-to-target decisions. Clinicians can use UAS1 as a validated fallback rather than discarding incomplete patient data."}},{"doi":"10.1111/all.70199","pmid":"41532642","title":"Unmet Needs in Treatment Escalation for Chronic Spontaneous Urticaria: Findings From the\n CURE\n Registry","journal_title":"Allergy","journal_issn":"0105-4538","published_at":"2026-01-14T00:00:00.000Z","url":"https://doi.org/10.1111/all.70199","source_score":15,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-01-18","doi":"10.1111/all.70199","days":"30","issn":"0105-4538","rank":"1","field":"Clinical Medicine","score":"15","category":"Allergy","categories":["Allergy"],"_categories":["Allergy"]},"pubmed":{"doi":"10.1111/all.70199","title":"Unmet Needs in Treatment Escalation for Chronic Spontaneous Urticaria: Findings From the CURE Registry.","journal":"Allergy","methods":"","results":"Data were available from 3995 adult patients with CSU at BL and 1288 at FU with evaluable UCT. After treatment escalation from BL to FU, 5.3% (no treatment to licensed-dose sgH","abstract":"Many patients with chronic spontaneous urticaria (CSU) remain symptomatic despite receiving second-generation H\nCURE is an international, prospective registry of patients with chronic urticaria. Treatment responses were categorized as Urticaria Control Test (UCT) changes from baseline (BL) to 6-month follow-up (FU). Complete response was defined as UCT = 16 with a ≥ 3-point increase.\nData were available from 3995 adult patients with CSU at BL and 1288 at FU with evaluable UCT. After treatment escalation from BL to FU, 5.3% (no treatment to licensed-dose sgH\nAppropriate treatment escalation improves CSU control, although only about a quarter of patients achieve a complete response, indicating the need for novel treatments. Many patients with poorly controlled CSU do not receive guideline-recommended treatment escalation and remain symptomatic on their current treatments, which deserves further attention.","keywords":["antihistamine","chronic spontaneous urticaria","chronic urticaria registry (CURE)","real‐world practice","treatment escalation"],"pubmed_id":"41532642","conclusions":"Appropriate treatment escalation improves CSU control, although only about a quarter of patients achieve a complete response, indicating the need for novel treatments. Many patients with poorly controlled CSU do not receive guideline-recommended treatment escalation and remain symptomatic on their current treatments, which deserves further attention.","publication_date":"2026-01-14T00:00:00"},"crossref":{"DOI":"10.1111/all.70199","URL":"https://doi.org/10.1111/all.70199","ISSN":["0105-4538","1398-9995"],"link":[{"URL":"https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.70199","content-type":"application/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https://onlinelibrary.wiley.com/doi/full-xml/10.1111/all.70199","content-type":"application/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.70199","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["Unmet Needs in Treatment Escalation for Chronic Spontaneous Urticaria: Findings From the\n CURE\n Registry"],"author":[{"given":"Pavel","family":"Kolkhir","sequence":"first","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität Zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"}]},{"given":"Pascale","family":"Salameh","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität Zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"},{"name":"School of Medicine Lebanese American University Byblos Lebanon"},{"name":"Institut National de Santé Publique D'épidémiologie Clinique et de Toxicologie‐Liban (INSPECT‐LB) Beirut Lebanon"},{"name":"Department of Primary Care and Population Health University of Nicosia Medical School Nicosia Cyprus"}]},{"given":"Magdalena","family":"Zajac","sequence":"additional","affiliation":[{"name":"European Center for Diagnosis and Treatment of Urticaria Medical University of Silesia Katowice Poland"}]},{"given":"Alicja","family":"Kasperska‐Zajac","sequence":"additional","affiliation":[{"name":"European Center for Diagnosis and Treatment of Urticaria Medical University of Silesia Katowice Poland"}]},{"given":"Ana","family":"Giménez‐Arnau","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital del Mar Research Institute, Universitat Pompeu Fabra Barcelona Spain"}]},{"given":"Maria","family":"Puertolas","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital del Mar Research Institute, Universitat Pompeu Fabra Barcelona Spain"}]},{"given":"Hanna","family":"Bonnekoh","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität Zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"}]},{"given":"Carolina","family":"Vera Ayala","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität Zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"}]},{"given":"Michael","family":"Makris","sequence":"additional","affiliation":[{"name":"Allergy Unit “D. Kalogeromitros”, 2nd Department, Dermatology and Venereology, National and Kapodistrian University of Athens, “Attikon” University Hospital Athens Greece"}]},{"given":"Eleni","family":"Chatzidimitriou","sequence":"additional","affiliation":[{"name":"National and Kapodistrian University of Athens, 1st Department of Dermatology‐Venereology, Andreas Sygros Hospital Athens Greece"}]},{"given":"Stamatios","family":"Gregoriou","sequence":"additional","affiliation":[{"name":"National and Kapodistrian University of Athens, 1st Department of Dermatology‐Venereology, Andreas Sygros Hospital Athens Greece"}]},{"given":"Kanokvalai","family":"Kulthanan","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Faculty of Medicine Siriraj Hospital Mahidol University Bangkok Thailand"}]},{"given":"Andrea","family":"Bauer","sequence":"additional","affiliation":[{"name":"Department of Dermatology University Hospital Carl Gustav Carus, Technical University Dresden Dresden Germany"}]},{"given":"Mojca","family":"Bizjak‐Suran","sequence":"additional","affiliation":[{"name":"Division of Allergy University Clinic of Respiratory and Allergic Diseases Golnik Golnik Slovenia"},{"name":"Faculty of Medicine University of Ljubljana Ljubljana Slovenia"},{"name":"Faculty of Maribor University of Maribor Maribor Slovenia"}]},{"given":"Daria","family":"Fomina","sequence":"additional","affiliation":[{"name":"Moscow City Research and Practical Center of Allergy and Immunology, State Budgetary Healthcare Institution “Moscow Clinical Science and Research Hospital 52 of Moscow Healthcare Department” Moscow Russian Federation"},{"name":"Department of Clinical Immunology and Allergy, Sechenov First Moscow State Medical University Moscow Russian Federation"},{"name":"Department of Pulmonology Astana Medical University Astana Kazakhstan"}]},{"given":"Alexis","family":"Bocquet","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Clinical Immunology CHU Grenobles Alpes Grenoble France"}]},{"given":"Joachim","family":"Dissemond","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Venerology and Allergology University of Essen Essen Germany"}]},{"given":"Mohamed","family":"Abuzakouk","sequence":"additional","affiliation":[{"name":"Allergy & Immunology Department Cleveland Clinic Abu Dhabi Abu Dhabi UAE"}]},{"given":"Tara","family":"Raftery","sequence":"additional","affiliation":[{"name":"Novartis Ireland Ltd. Dublin Ireland"}]},{"given":"Nadine","family":"Chapman‐Rothe","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG Basel Switzerland"}]},{"given":"Emek","family":"Kocatürk","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität Zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"},{"name":"Bahçeşehir University School of Medicine, Department of Dermatology Istanbul Turkey"}]},{"given":"Clive","family":"Grattan","sequence":"additional","affiliation":[{"name":"Guy's Hospital, St John's Institute of Dermatology London UK"}]},{"given":"Riccardo","family":"Asero","sequence":"additional","affiliation":[{"name":"Ambulatorio di Allergologia, Clinica San Carlo, Paderno Dugnano Milan Italy"}]},{"given":"Jonny G.","family":"Peter","sequence":"additional","affiliation":[{"name":"Allergy and Immunology Unit, UCT Lung Institute Cape Town South Africa"},{"name":"Division of Allergy and Clinical Immunology, Groote Schuur Hospital University of Cape Town (UCT) Cape Town South Africa"}]},{"given":"Simon Francis","family":"Thomsen","sequence":"additional","affiliation":[{"name":"Department of Dermatology Bispebjerg Hospital Copenhagen Denmark"},{"name":"Department of Biomedical Sciences University of Copenhagen Copenhagen Denmark"}]},{"given":"Karsten","family":"Weller","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität Zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin 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HP correlated positively, but weakly, with the white blood cell count, C3 and C-reactive protein (all rho ≈ 0.2), and negatively with disease duration and eosinophil percentage. Zonulin correlated negatively with UCT scores but not with HP. After treatment, HP decreased significantly (p < 0.001), with greater reductions in patients showing a ≥ 12-point improvement on the UAS7. Baseline HP was higher in patients who achieved complete control (UCT = 16) than others (p = 0.017). ROC analysis identified baseline HP ≥ 1249 μg/mL as an optimal cutoff, confirmed as an independent predictor of complete control (odds ratio = 4.23, p = 0.029).","abstract":"$31","keywords":["chronic spontaneous urticaria","complete control","haptoglobin","zonulin"],"pubmed_id":"41498512","conclusions":"Serum HP is elevated in CSU patients, decreases with treatment, and independently predicts complete urticaria control. 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Urticaria","value_numeric":null},{"paper_doi":"10.1002/clt2.70148","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1002/clt2.70148","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1002/clt2.70148","tag_type":"sample_size","value":"n=181","value_numeric":181},{"paper_doi":"10.1002/clt2.70148","tag_type":"study_design","value":"Prospective Cohort","value_numeric":null},{"paper_doi":"10.1002/clt2.70148","tag_type":"warning","value":"ROC details (e.g., AUC, sensitivity/specificity) and confidence intervals for the odds ratio were not provided.","value_numeric":null},{"paper_doi":"10.1002/clt2.70148","tag_type":"warning","value":"Study design mixes a case–control comparison with a 3‑month follow‑up cohort; classification as a prospective cohort is approximate.","value_numeric":null},{"paper_doi":"10.1002/clt2.70148","tag_type":"warning","value":"Treatment type(s) and setting were not reported, which may affect generalizability of the predictive cutoff.","value_numeric":null}],"summaries":{"what_studied":"Measured serum haptoglobin (HP) and zonulin by ELISA in 124 patients with chronic spontaneous urticaria (CSU) and 57 healthy controls; 62 CSU patients had repeat testing after 3 months of treatment. Clinical outcomes were UAS7 and UCT, with ROC analysis of baseline HP for predicting complete control (UCT=16).","key_result":"Baseline HP was higher in CSU than controls (median 1145.1 vs 839.2 μg/mL, p<0.001) and fell after treatment (p<0.001), with larger drops in patients improving ≥12 UAS7 points. An HP cutoff ≥1249 μg/mL independently predicted complete control at 3 months (odds ratio 4.23, p=0.029).","limitations":"Only 62/124 patients had 3‑month follow‑up, and the observation window was short. The HP cutoff (≥1249 μg/mL) was derived and tested in the same cohort with no external validation reported. Specific treatment regimens were not described, limiting applicability across therapies.","practice_takeaway":"In CSU, baseline serum HP ≥1249 μg/mL was linked to higher odds of complete control at 3 months, and HP levels declined with clinical improvement. Consider HP as a prognostic and monitoring biomarker alongside UAS7/UCT, pending validation and clarification across treatment types."}},{"doi":"10.1111/jdv.70290","pmid":"41487050","title":"Family quality‐of‐life burden in chronic spontaneous urticaria: A multicentre study","journal_title":"Journal of the European Academy of Dermatology and Venereology","journal_issn":"0926-9959","published_at":"2026-01-05T00:00:00.000Z","url":"https://doi.org/10.1111/jdv.70290","source_score":19,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-01-08","doi":"10.1111/jdv.70290","days":"14","issn":"0926-9959","rank":"3","field":"Clinical Medicine","score":"19","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1111/jdv.70290","title":"Family quality-of-life burden in chronic spontaneous urticaria: A multicentre study.","journal":"Journal of the European Academy of Dermatology and Venereology : JEADV","methods":"","results":"Poorly controlled CSU significantly deteriorated family members' quality of life, particularly in emotional, physical and social domains. Higher disease severity and lower disease control scores were associated with increased stress, greater caregiving burden and elevated health expenditures. In opposition to family relations, older age and longer time since diagnosis mitigate negative impacts, while insufficient treatment regimens exacerbated them.","abstract":"$33","keywords":["chronic spontaneous urticaria","family relations","health expenditures","health status indicators","health‐related quality of life","omalizumab","quality of life","sickness impact profile","skin disease","urticariaantihistamines"],"pubmed_id":"41487050","conclusions":"Inadequate control of CSU amplifies the burden on families, underscoring the need for effective and supportive care 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Quality Index (FDLQI) to assess how CSU affects family members’ quality of life.","key_result":"Poorly controlled CSU was associated with worse family quality of life on FDLQI, more stress, greater caregiving demands, and higher health expenditures; stronger family support and effective treatment were linked to lower burden.","practice_takeaway":"Prioritize achieving and maintaining CSU control to reduce family burden. Early diagnosis, appropriate treatment, and ongoing follow-up can lessen emotional, physical, social, and financial strain on families."}},{"doi":"10.1111/jdv.70027","pmid":"40965122","title":"Sex matters in CSU: Women face greater burden and poorer urticaria control, especially in midlife—CURE insights","journal_title":"Journal of the European Academy of Dermatology and Venereology","journal_issn":"0926-9959","published_at":"2025-09-18T00:00:00.000Z","url":"https://doi.org/10.1111/jdv.70027","source_score":19,"is_retracted":false,"is_open_access":null,"raw_metadata":{"ooir":{"day":"2025-09-24","doi":"10.1111/jdv.70027","days":"14","issn":"0926-9959","rank":"5","field":"Clinical Medicine","score":"19","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1111/jdv.70027","title":"Sex matters in CSU: Women face greater burden and poorer urticaria control, especially in midlife-CURE insights.","journal":"Journal of the European Academy of Dermatology and Venereology : JEADV","methods":"","results":"Across 4136 CSU patients (from 58 sites across 29 countries), 2994 (72.4%) were female. Statistically significant female predominance started at age 31 (<0.001). Compared with males, females showed higher rates of angioedema (59.6 vs. 51.7%; p < 0.001), systemic symptoms (34.6 vs. 25.4%; p < 0.001), sleep disturbance (38.9 vs. 32.5%; p < 0.001), QoL impairment (CU-Q2oL score 32 vs. 27.7; p < 0.001) and lower rates of urticaria control than males in all medication categories (p < 0.05 for all). Females had more concomitant diseases, including asthma, thyroid disease, obesity, autoimmune disease, gastrointestinal disease and depression (p < 0.05 for all). The disease was especially more burdensome and refractory in females aged 51-65 years than males, evidenced by more angioedema and systemic symptoms, worse QoL, lower UCT scores and more emergency visits (p < 0.05 for all). However, these differences were not prominent in the elderly females (>65 years).","abstract":"$35","keywords":["age","angioedema","autoimmune disease","chronic disease","chronic spontaneous urticaria","comorbidity","depression","female","health status disparities","hormones","male","menopause","microchimerism","quality of life","sex differences","treatment outcome","urticaria"],"pubmed_id":"40965122","conclusions":"Compared with males, female CSU patients experience more burdensome disease, which gets worse in midlife.","publication_date":"2025-09-18T00:00:00"},"crossref":{"DOI":"10.1111/jdv.70027","URL":"https://doi.org/10.1111/jdv.70027","ISSN":["0926-9959","1468-3083"],"link":[{"URL":"https://onlinelibrary.wiley.com/doi/pdf/10.1111/jdv.70027","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["Sex matters in CSU: Women face greater burden and poorer urticaria control, especially in midlife—CURE insights"],"author":[{"given":"Emek","family":"Kocatürk","sequence":"first","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"},{"name":"Department of Dermatology Bahçeşehir University School of Medicine Istanbul Turkey"}]},{"given":"Pascale","family":"Salameh","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"},{"name":"Gilbert and Rose‐Marie Chagoury School of Medicine Lebanese American University Beirut Lebanon"},{"name":"Department of Primary Care and Population Health University of Nicosia Medical School Nicosia Cyprus"},{"name":"Faculty of Pharmacy Lebanese University Hadat Lebanon"}]},{"given":"Riccardo","family":"Asero","sequence":"additional","affiliation":[{"name":"Ambulatorio di Allergologia, Clinica San Carlo Paderno Dugnano Italy"}]},{"given":"Mojca","family":"Bizjak","sequence":"additional","affiliation":[{"name":"Division of Allergy University Clinic of Respiratory and Allergic Diseases Golnik Golnik Slovenia"}]},{"given":"Ana","family":"Gimenez‐Arnau","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital del Mar Research Institute, Universitat Pompeu Fabra Barcelona Spain"}]},{"given":"Clive","family":"Grattan","sequence":"additional","affiliation":[{"name":"Guy’s Hospital, St John’s Institute of Dermatology London UK"}]},{"given":"David","family":"Pesqué","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital del Mar Research Institute, Universitat Pompeu Fabra Barcelona Spain"}]},{"given":"Nidia","family":"Planella‐Fontanillas","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital del Mar Research Institute, Universitat Pompeu Fabra Barcelona Spain"}]},{"given":"Leonie Shirin","family":"Herzog","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"}]},{"given":"Thomas","family":"Buttgereit","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"}]},{"given":"Hanna","family":"Bonnekoh","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Berlin Germany"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology Berlin Germany"}]},{"given":"Daria","family":"Fomina","sequence":"additional","affiliation":[{"name":"Moscow Research and Clinical Center of Allergy and Immunology, Moscow Healthcare Department City Clinical Hospital Moscow Russia"},{"name":"Department of Clinical Immunology and Allergology I.M. 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Urticaria","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"generic","value":"rilzabrutinib","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"modality","value":"BTK Inhibitor","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"sample_size","value":"n=160","value_numeric":160},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"warning","value":"Dual primary end point (ISS7 vs UAS7 by country) and a short 12-week blinded period; the open-label extension may introduce bias for longer-term outcomes.","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"warning","value":"Only the 1200 mg/d dose showed significant benefit vs placebo in the data provided; results for lower doses were not detailed.","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2025.0733","tag_type":"warning","value":"Primary analysis was limited to omalizumab-naive patients (n=143), not all randomized participants.","value_numeric":null}],"summaries":{"what_studied":"A 52-week phase 2 randomized, double-blind, placebo-controlled, dose-ranging trial tested oral rilzabrutinib (400 mg qPM, 800 mg/d, or 1200 mg/d) vs placebo for 12 weeks in adults (18-80 years) with moderate to severe antihistamine-refractory chronic spontaneous urticaria across 12 countries; the primary analysis used omalizumab-naive patients (n=143). The primary end point was change from baseline at week 12 in ISS7 (US/reference) or UAS7 (non-US).","key_result":"At week 12, rilzabrutinib 1200 mg/d improved ISS7 vs placebo (LS mean change -9.21 vs -5.77; difference -3.44; 95% CI -6.25 to -0.62; P=.02) and UAS7 vs placebo (LS mean change -16.89 vs -10.14; difference -6.75; 95% CI -12.23 to -1.26; P=.02) in omalizumab-naive patients. Improvements in HSS7 and AAS7 occurred as early as week 1; diarrhea, nausea, and headache were more frequent with rilzabrutinib than placebo.","limitations":"Primary analysis excluded omalizumab-incomplete responders and focused on omalizumab-naive patients (n=143). The blinded period was only 12 weeks with a 40-week open-label extension, limiting long-term efficacy and safety inferences.","practice_takeaway":"For H1-antihistamine–refractory CSU, rilzabrutinib 1200 mg/d reduced itch and hive activity over 12 weeks vs placebo with early onset and mainly gastrointestinal and headache adverse events. Use is supported by these phase 2 results, but longer-term benefits and harms remain uncertain."}},{"doi":"10.18176/jiaci.1054","pmid":"39913178","title":"Causal Effect Between Gut Microbiota, Gut Bacterial Pathway, and Chronic Spontaneous Urticaria: A Large-Scale Bidirectional Mendelian Randomization Analysis","journal_title":"Journal of Investigational Allergology and Clinical Immunology","journal_issn":"1018-9068","published_at":"2025-02-06T00:00:00.000Z","url":"https://doi.org/10.18176/jiaci.1054","source_score":14,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2025-12-17","doi":"10.18176/jiaci.1054","days":"30","issn":"1018-9068","rank":"4","field":"Clinical Medicine","score":"14","category":"Allergy","categories":["Allergy"],"_categories":["Allergy"]},"pubmed":{"doi":"10.18176/jiaci.1054","title":"Causal Effect Between Gut Microbiota, Gut Bacterial Pathway, and Chronic Spontaneous Urticaria: A Large-Scale Bidirectional Mendelian Randomization Analysis.","journal":"Journal of investigational allergology & clinical immunology","methods":"","results":"MR analysis suggested that the family Peptococcaceae and its child taxon, the genus Peptococcus, were risk factors for CSU. In addition, the genera Collinsella, Lachnospiraceae UCG004, Ruminococcaceae UCG004, and Sellimonas were also risk factors for CSU, whereas Family XIII UCG001, Lachnospiraceae UCG010, and Methanobrevibacter had protective effects on CSU. As for metabolic pathways, NONMEVIPP-PWY, PWY-5022, and PWY-7221 were positively associated with CSU, although others, such as KDO-NAGLIPASYN-PWY, PWY- 6353, and PWY-7400 presented a suggestive association with CSU. Moreover, PWY-7400 was a mediator in causality between the family Peptococcaceae and CSU. These results were based on nominal significance (P<.05). None of the Bonferroni-corrected P values were <.05.","abstract":"$3a","keywords":["Chronic spontaneous urticaria","Gut microbiota","Mediation effect","Mendelian randomization","Metabolic pathway"],"pubmed_id":"39913178","conclusions":"","publication_date":"2025-02-06T00:00:00"},"crossref":{"DOI":"10.18176/jiaci.1054","URL":"https://doi.org/10.18176/jiaci.1054","ISSN":["1018-9068"],"page":"431-440","type":"journal-article","issue":"6","score":1,"title":["Causal Effect Between Gut Microbiota, Gut Bacterial Pathway, and Chronic Spontaneous Urticaria: A Large-Scale Bidirectional Mendelian Randomization Analysis"],"author":[{"given":"Yuxu","family":"Yao","sequence":"first","affiliation":[]},{"given":"Jialu","family":"Chen","sequence":"additional","affiliation":[]},{"given":"Hongze","family":"Cao","sequence":"additional","affiliation":[]},{"given":"Zhenzhong","family":"Lu","sequence":"additional","affiliation":[]},{"given":"Hui","family":"Shen","sequence":"additional","affiliation":[]},{"given":"Jiang","family":"Ji","sequence":"additional","affiliation":[]},{"given":"Qingqing","family":"Jiao","sequence":"additional","affiliation":[]}],"issued":{"date-parts":[[2025,12,15]]},"member":"7491","prefix":"10.18176","source":"Crossref","volume":"35","created":{"date-time":"2025-02-06T11:27:43Z","timestamp":1738841263000,"date-parts":[[2025,2,6]]},"indexed":{"date-time":"2026-01-13T07:18:36Z","timestamp":1768288716358,"date-parts":[[2026,1,13]]},"subject":[],"abstract":"$3b","relation":{},"resource":{"primary":{"URL":"https://www.jiaci.org/summary/vol35-issue6-num3179"}},"subtitle":[],"deposited":{"date-time":"2025-12-16T14:24:38Z","timestamp":1765895078000,"date-parts":[[2025,12,16]]},"issn-type":[{"type":"print","value":"1018-9068"}],"published":{"date-parts":[[2025,12,15]]},"publisher":"Esmon Publicidad, SA","reference":null,"short-title":[],"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,12,15]]},"published-online":{"date-parts":[[2025,12,16]]}},"content-domain":{"domain":[],"crossmark-restriction":false},"original-title":["English"],"container-title":["Journal of Investigational Allergology and Clinical Immunology"],"published-print":{"date-parts":[[2025,12,15]]},"reference-count":0,"published-online":{"date-time":null,"timestamp":null,"date-parts":[[2025,12,16]]},"references-count":0,"short-container-title":["J Investig Allergol Clin Immunol"],"is-referenced-by-count":2},"unpaywall":{"doi":"10.18176/jiaci.1054","is_oa":true,"title":"Causal Effect Between Gut Microbiota, Gut Bacterial Pathway, and Chronic Spontaneous Urticaria: A Large-Scale Bidirectional Mendelian Randomization Analysis","updated":"2026-01-01T00:56:08+00:00","published_date":"2025-02-06","best_oa_location":{"url":"https://www.jiaci.org/revistas/doi10.18176_jiaci.1054_supplemental-materials-figure_1.pdf","pmh_id":null,"url_for_pdf":"https://www.jiaci.org/revistas/doi10.18176_jiaci.1054_supplemental-materials-figure_1.pdf","url_for_landing_page":"https://doi.org/10.18176/jiaci.1054"}}},"created_at":"2026-01-11T11:19:33.869Z","updated_at":"2026-01-16T11:56:46.634Z","tags":[{"paper_doi":"10.18176/jiaci.1054","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.18176/jiaci.1054","tag_type":"condition","value":"Chronic Spontaneous Urticaria","value_numeric":null},{"paper_doi":"10.18176/jiaci.1054","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.18176/jiaci.1054","tag_type":"study_design","value":"Mendelian Randomization","value_numeric":null},{"paper_doi":"10.18176/jiaci.1054","tag_type":"warning","value":"Details of reverse-direction MR and sensitivity analyses (e.g., pleiotropy, heterogeneity) were not reported in the provided text.","value_numeric":null},{"paper_doi":"10.18176/jiaci.1054","tag_type":"warning","value":"None of the associations met multiple-testing correction; interpret as exploratory.","value_numeric":null},{"paper_doi":"10.18176/jiaci.1054","tag_type":"warning","value":"The CSU outcome sample size (N=450) is small for MR and may reduce power.","value_numeric":null}],"summaries":{"what_studied":"A bidirectional Mendelian randomization used GWAS summary data to test causal links between gut microbiota (211 taxa; MiBioGen N=18,340), gut bacterial metabolic pathways (205 pathways; Dutch Microbiome Project N=7,738), and chronic spontaneous urticaria (FinnGen N=450), including mediation by pathways.","key_result":"Nominal MR signals (P<.05) associated Peptococcaceae and Peptococcus, Collinsella, Lachnospiraceae UCG004, Ruminococcaceae UCG004, and Sellimonas with higher CSU risk, while Family XIII UCG001, Lachnospiraceae UCG010, and Methanobrevibacter were linked to lower risk. Several pathways (NONMEVIPP-PWY, PWY-5022, PWY-7221) were positively associated with CSU, PWY-7400 showed suggestive association and mediated the Peptococcaceae–CSU link; however, none of the Bonferroni-corrected P values were <.05.","limitations":"All findings were only nominally significant and did not survive Bonferroni correction. The CSU GWAS sample was small (N=450), which limits power to detect robust effects.","practice_takeaway":"These results are exploratory and do not justify changes to CSU management or microbiome-targeted interventions; they primarily guide future mechanistic studies."}}],"initialOffset":16,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"condition","value":"Chronic Spontaneous Urticaria"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Conditions","href":"/hub/tag/condition"},{"name":"Chronic Spontaneous Urticaria"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"condition","hub_tag_value":"Chronic Spontaneous Urticaria"}}}]]

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