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:T83a,Emerging evidence suggests rosacea as a recognizable adverse event during dupilumab therapy. This study aimed to investigate the potential association between dupilumab and rosacea using pharmacovigilance data and to characterize the clinical features of dupilumab-associated rosacea (DAR) through a review of reported cases. We utilized the FDA Adverse Event Reporting System (FAERS) database (2017-2024) to identify disproportionality signals using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayesian Geometric Mean (EBGM). To contextualize these findings, we performed a focused narrative review of 8 publications comprising 10 DAR cases with extractable individual data. A significant disproportionality signal was identified across all four methods (ROR 3.873; PRR 3.872; IC 1.865 with IC025 1.653; EBGM 3.642), with reports predominantly in adults and females. In the case review, a consistent phenotype emerged: papulopustules on persistent centrofacial erythema with frequent burning; facial predominance with occasional extension to neck, scalp, or upper trunk; frequent Demodex detection by scraping, KOH, or in vivo imaging; and occasional granulomatous histology. Onset ranged from approximately 2 weeks to 21 months, including one post-discontinuation case. Most patients improved with rosacea-directed therapy (topical ivermectin or metronidazole; anti-inflammatory-dose doxycycline). However, dechallenge or rechallenge patterns and the need for dose-interval extension, temporary interruption, or switching biologic (e.g., lebrikizumab, upadacitinib) in a subset support a drug-related pattern at the reporting level. DAR represents a distinct clinical entity from dupilumab-associated head and neck dermatitis, which is eczematous and typically responds to antifungals or calcineurin inhibitors. While disproportionality signals indicate association rather than incidence or causality and are subject to reporting bias, clinicians should be aware of this potential adverse event to ensure appropriate management.31:Td87,Dupilumab, a human monoclonal anti-interleukin-4/13 antibody, is approved for treating severe atopic dermatitis (AD) in children aged 6 months-5 years. It received approval for an Early Access Program (EAP) for children by the French Health Authority in October 2022. This EAP aims to evaluate the effectiveness and safety of dupilumab in children (aged 6 months-5 years) with severe AD requiring systemic treatment. Cumulative data from the French EAP were analysed. Children with severe AD were administered dupilumab 200 and 300 mg (children ≥5 to <15 kg and ≥15 to <30 kg, respectively) every 4 weeks via a pre-filled syringe. The Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) 50/75/90, Pruritus-Numerical Rating Scale (P-NRS), Infants' Dermatitis Quality of Life Index (IDQOL; for children aged <4 years) and Children's Dermatology Life Quality Index (CDLQI; for children aged ≥4 years) scores were assessed at baseline and follow-up months (M) 1, 3 and 6. Safety was evaluated. A total of 198 children were enrolled (<2 years old: N = 27 [13.6%]; ≥2 years old: N = 171 [86.4%]). Of the 116 evaluated patients (exposed patients with at least ≥1 follow-up form), 83.7% achieved an IGA score of 0/1, 94.4%/75.0%/44.4% achieved an EASI 50/75/90, respectively, and 67.6% achieved a ≥4-point improvement in the P-NRS scores, at M6. The mean ± SD reduction from treatment initiation to M6 in the IGA, EASI and P-NRS scores was -2.1 ± 1.2, -17.5 ± 11.6 and -4.4 ± 2.8, respectively. The mean ± SD IDQOL and CDLQI scores reduced numerically from treatment initiation to M6 by -6.9 ± 6.6 and -8.8 ± 7.3, respectively. Safety was consistent with the established safety profile of dupilumab. The effectiveness and safety profile of dupilumab in children (aged 6 months-5 years) with severe AD were consistent with those reported in children with moderate-to-severe AD in clinical studies. Atopic dermatitis or eczema is a common skin disease that has a huge impact on the life of children and their family. Dupilumab has been proved to improve skin conditions of children in clinical trials. This EAP was conducted to provide the patients access to dupilumab, before its launch, and see how dupilumab treatment works in real life in children with eczema (especially infants under 2 years). Overall, 198 children with severe atopic dermatitis took part in this programme across 65 sites in France. They received dupilumab injections once every 4 weeks, and the dose of the drug was calculated based on their body weight. The healthcare professionals followed these children closely for any improvement in their eczema symptoms, quality of life and any side effects experienced by children, over 6 months while receiving dupilumab. Throughout this 6 months treatment period, the skin of ~84% of children became clear or almost clear, 75% of children saw the area affected by eczema reduce by at least three quarters, and ~68% of children felt less itchy. The quality of life of children also improved. While some children had minor side effects, these were not new and similar to what the healthcare professionals had seen in clinical trials of dupilumab. This EAP provides real‐world evidence that dupilumab treatment can help children as young as 6 months with severe atopic dermatitis, with results similar to those seen in clinical studies.32:Tbd1,Abstract Background Dupilumab, a human monoclonal anti‐interleukin‐4/13 antibody, is approved for treating severe atopic dermatitis (AD) in children aged 6 months–5 years. It received approval for an Early Access Program (EAP) for children by the French Health Authority in October 2022. Objective This EAP aims to evaluate the effectiveness and safety of dupilumab in children (aged 6 months–5 years) with severe AD requiring systemic treatment. Methods Cumulative data from the French EAP were analysed. Children with severe AD were administered dupilumab 200 and 300 mg (children ≥5 to <15 kg and ≥15 to <30 kg, respectively) every 4 weeks via a pre‐filled syringe. The Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) 50/75/90, Pruritus‐Numerical Rating Scale (P‐NRS), Infants' Dermatitis Quality of Life Index (IDQOL; for children aged <4 years) and Children's Dermatology Life Quality Index (CDLQI; for children aged ≥4 years) scores were assessed at baseline and follow‐up months (M) 1, 3 and 6. Safety was evaluated. Results A total of 198 children were enrolled (<2 years old: N = 27 [13.6%]; ≥2 years old: N = 171 [86.4%]). Of the 116 evaluated patients (exposed patients with at least ≥1 follow‐up form), 83.7% achieved an IGA score of 0/1, 94.4%/75.0%/44.4% achieved an EASI 50/75/90, respectively, and 67.6% achieved a ≥4‐point improvement in the P‐NRS scores, at M6. The mean ± SD reduction from treatment initiation to M6 in the IGA, EASI and P‐NRS scores was −2.1 ± 1.2, −17.5 ± 11.6 and −4.4 ± 2.8, respectively. The mean ± SD IDQOL and CDLQI scores reduced numerically from treatment initiation to M6 by −6.9 ± 6.6 and −8.8 ± 7.3, respectively. Safety was consistent with the established safety profile of dupilumab. Conclusions The effectiveness and safety profile of dupilumab in children (aged 6 months–5 years) with severe AD were consistent with those reported in children with moderate‐to‐severe AD in clinical studies. 33:T71c,Non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD) is characterised by the clinical triad of hypersensitivity to NSAIDs, nasal polyposis, and asthma. The cells and mediators causing acute symptoms when driving the hypersensitivity reaction to acetylsalicylic acid (ASA) ingestion, remain poorly defined. To investigate the dynamics of nasal mediators during ASA provocation in N-ERD patients before and 24 weeks after therapy with the IL-4 receptor alpha-blocking antibody dupilumab (EudraCT (2019-004889-18) and ClinicalTrials.gov (NCT04442256)). Nasal mucosal lining fluids of patients with N-ERD, chronic rhinosinusitis patients with nasal polyp (CRSwNP) and healthy disease controls were collected at selected time points up to 2 h after ASA provocation. Analysis of thirty-three different inflammatory mediators as well as transcriptomic profiling was performed. In N-ERD patients, provocation was repeated after 24 weeks of dupilumab therapy. Sixty minutes after provocation with ASA, N-ERD patients showed a significant increase in type 2 associated cytokines (i.e., TSLP, IL-5 and eotaxin-3) as compared to the other patient groups. This effect was diminished after 24 weeks of dupilumab therapy and was independent of the development of ASA tolerance. Transcriptomics revealed dampened upregulation of type 2 associated pathway genes (i.e., AREG) as well as enhanced downregulation of lipid (i.e., ALOX15) and peroxisome metabolisms (i.e., NOS2) at ASA provocation after dupilumab therapy. Treatment with dupilumab leads to reduced nasal type 2 cytokine secretion and distinct changes in transcriptomic profile during ASA provocation, but changes in type 2 mediators show no association with tolerance development. EudraCT (2019-004889-18) and ClinicalTrials.gov (NCT04442256).34:Td9d,ABSTRACT Background Non‐steroidal anti‐inflammatory drug‐exacerbated respiratory disease (N‐ERD) is characterised by the clinical triad of hypersensitivity to NSAIDs, nasal polyposis, and asthma. The cells and mediators causing acute symptoms when driving the hypersensitivity reaction to acetylsalicylic acid (ASA) ingestion, remain poorly defined. Objective To investigate the dynamics of nasal mediators during ASA provocation in N‐ERD patients before and 24 weeks after therapy with the IL‐4 receptor alpha‐blocking antibody dupilumab (EudraCT (2019‐004889‐18) and ClinicalTrials.gov (NCT04442256)). Methods Nasal mucosal lining fluids of patients with N‐ERD, chronic rhinosinusitis patients with nasal polyp (CRSwNP) and healthy disease controls were collected at selected time points up to 2 h after ASA provocation. Analysis of thirty‐three different inflammatory mediators as well as transcriptomic profiling was performed. In N‐ERD patients, provocation was repeated after 24 weeks of dupilumab therapy. Results Sixty minutes after provocation with ASA, N‐ERD patients showed a significant increase in type 2 associated cytokines (i.e., TSLP, IL‐5 and eotaxin‐3) as compared to the other patient groups. This effect was diminished after 24 weeks of dupilumab therapy and was independent of the development of ASA tolerance. Transcriptomics revealed dampened upregulation of type 2 associated pathway genes (i.e., AREG ) as well as enhanced downregulation of lipid (i.e., ALOX15 ) and peroxisome metabolisms (i.e., NOS2 ) at ASA provocation after dupilumab therapy. Conclusion and Clinical Relevance Treatment with dupilumab leads to reduced nasal type 2 cytokine secretion and distinct changes in transcriptomic profile during ASA provocation, but changes in type 2 mediators show no association with tolerance development. Trial Registration EudraCT (2019‐004889‐18) and ClinicalTrials.gov (NCT04442256) 35:Ta21,Chronic rhinosinusitis with nasal polyps (CRSwNP) is predominantly driven by type 2 inflammation. The biologics dupilumab and omalizumab, which target drivers and mediators of type 2 inflammation (interleukin [IL]-4/IL-13 signaling and immunoglobulin E [IgE], respectively), are efficacious in treating CRSwNP but direct comparisons are few. In EVEREST (EValuating trEatment RESponses of dupilumab versus omalizumab), the first head-to-head trial in respiratory biologics, we aimed to compare the efficacy and safety of dupilumab and omalizumab in patients with severe CRSwNP who had mild, moderate, or severe asthma. EVEREST was an international, randomised, double-blind, phase 4 trial, conducted at 100 hospitals or clinical centres in 17 countries. Sites were selected with otolaryngology, pneumologist, allergist, and immunologist practices; needed to have previously conducted double-blind studies; and were required have nasal endoscopy and electrocardiogram machines. Eligible patients aged 18 years or older with severe uncontrolled CRSwNP (with a nasal polyp score of 5 or more [and ≥2 for each nostril]), symptoms of nasal congestion and loss of smell for at least 8 weeks before screening, and physician-diagnosed asthma. Patients were randomly assigned (1:1) to subcutaneous dupilumab 300 mg every 2 weeks or omalizumab weight-tiered and IgE-tiered dosing every 2 weeks or 4 weeks for 24 weeks, with background mometasone furoate nasal spray. Patients and investigators were masked to the study drugs. Primary endpoints were change from baseline in endoscopic nasal polyp score and University of Pennsylvania Smell Identification Test (UPSIT) at 24 weeks. Efficacy was assessed in the intention-to-treat population and safety was assessed in patients who received at least one dose of study medication. The trial was registered at ClinicalTrials.gov, NCT04998604. Between Sept 27, 2021, and Dec 27, 2024, 819 individuals were screened for study inclusion, 459 were excluded (most common screen failures were: 167 did not meet nasal polyp score ≥5 or did not have ongoing symptoms of nasal congestion and loss of smell, 114 did not meet pre-bronchodilator FEV Dupilumab was superior to omalizumab in patients with severe CRSwNP and coexisting asthma. These findings support the efficacy of dupilumab in patients with type 2 respiratory diseases versus an active biologic comparator, the known safety profiles of dupilumab and omalizumab, and could enable better treatment targeting for patients with CRSwNP and asthma in clinical practice. Sanofi and Regeneron Pharmaceuticals.36:Te28,Atopic dermatitis (AD), a chronic systemic disease, can cause intense skin itching and negatively impact sleep, mood, and quality of life (QoL) for patients and families. PEDISTAD is an ongoing, 10-year, observational registry describing disease characteristics, atopic comorbidities, and treatment patterns in pediatric patients (aged <12 years at enrollment) with moderate-to-severe AD. This 3-year interim analysis evaluates clinician-reported and caregiver-reported/patient-reported outcomes (Eczema Area and Severity Index [EASI], percent body surface area affected, worst itching/scratching, Children's Dermatology Life Quality Index, and Dermatitis Family Impact) in children treated with dupilumab, methotrexate, and/or cyclosporine. Outcomes were assessed as change from therapy start to last observation (either data cutoff date or treatment discontinuation). Mean (±SE) EASI scores at the time of the last 3-year interim observation were consistent with mild disease in the dupilumab cohort and moderate disease in the methotrexate and cyclosporine cohorts. Improvements in pruritus were numerically greater in the dupilumab cohort relative to the methotrexate and cyclosporine cohorts, while improvements in QoL were similar in the dupilumab and methotrexate cohorts, with no significant change in the cyclosporine cohort. Rates of AD exacerbation were numerically lower with dupilumab treatment relative to methotrexate treatment which were numerically lower than cyclosporine treatment. Dupilumab discontinuation rates were numerically lower relative to methotrexate which were numerically lower than cyclosporine. This PEDISTAD 3-year interim analysis of dupilumab, methotrexate, and cyclosporine treatment in children with AD demonstrates numerically greater improvements in AD signs, symptoms and QoL with dupilumab treatment relative to methotrexate and cyclosporine [Video abstract and graphical abstract available]. NCT03687359. Supplementary file1 (MP4 58163 KB). Atopic dermatitis (AD) is a chronic inflammatory skin disease, often diagnosed before 5 years of age. AD causes intense itching and negatively impacts the sleep, mood, and quality of life of affected children and their families. Children may be treated with skin creams and ointments, which are often not enough to treat all AD signs (extent and severity of disease assessed by a clinician) and symptoms (burden of disease reported by a patient and/or caregiver). The drug dupilumab is approved for use in children as young as 6 months with moderate-to-severe AD and has shown improvements in signs and symptoms in clinical trials (sponsored by Regeneron Pharmaceuticals Inc., and Sanofi). We compared the use of dupilumab, methotrexate, and cyclosporine in routine clinical practice in children under the age of 12 years with moderate-to-severe AD using 3-year data from the PEDISTAD study. Compared with children treated with methotrexate and cyclosporine, children treated with dupilumab had greater improvements in the extent and severity of their AD, as assessed by their doctor. Children treated with dupilumab also showed greater improvements in how they described the severity of their symptoms, such as daytime/nighttime itching, and their quality of life. Fewer children using dupilumab stopped treatment and fewer reported side effects compared with those using methotrexate and cyclosporine. In summary, dupilumab-treated children had greater improvements in AD signs, AD symptoms, and quality of life, were more likely to continue treatment, and had fewer reported side effects than those given cyclosporine and methotrexate.37:T112f,Amy S. Paller is an investigator for AbbVie, Applied Pharma Research, Dermavant, Eli Lilly, Incyte, Janssen, Krystal Biotech, Regeneron Pharmaceuticals Inc., and UCB; a consultant for Aegerion Pharmaceuticals, Azitra, BioCryst, Boehringer Ingelheim, BMS, Eli Lilly, Janssen, Johnson & Johnson, Krystal Biotech, LEO Pharma, Novartis, Primus Pharmaceuticals, Regeneron Pharmaceuticals Inc., Sanofi, Seanergy, TWi Biotechnology, and UCB; and participates on data safety monitoring boards for AbbVie, Abeona Therapeutics, Catawba Research, Galderma, and InMed Pharmaceuticals. Amy S. Paller is an Editorial Board member of the American Journal of Clinical Dermatology. Amy Paller was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Danielle Marcoux is an advisory board member for Arcutis Biotherapeutics, Johnson & Johnson, Pierre Fabre, and Sanofi; is a consultant for AbbVie, Novartis, and Sanofi; an investigator for AbbVie, Amgen, Celgene, Eli Lilly, Incyte, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, and UCB; and a speaker for LEO Pharma, Pfizer, and Sanofi. Michele Ramien is a consultant for AbbVie, Eli Lilly, LEO Pharma, Pfizer, and Sanofi; and participates in a registry study for Sanofi. Eulalia Baselga is a speaker for Almirall; an investigator for AbbVie, Eli Lilly, and Pfizer; an investigator and consultant for Pierre Fabre Dermatologie; a consultant for Regeneron Pharmaceuticals Inc. and Sanofi; and a co-founder and consultant for Venthera. Vania Oliveira de Carvalho is a speaker for Expanscience, Galderma, Johnson & Johnson Consumer Health, Mantecorp Skincare, Megalabs, and Royal Canin; and an investigator for Sanofi. Ledit R.F. Ardusso is a consultant and/or advisory board member, and/or speaker for AstraZeneca, GSK, Novartis, and Sanofi. Marlies De Graaf is an investigator for AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi; a consultant for AbbVie, Almirall, Eli Lilly, LEO Pharma, Regeneron Pharmaceuticals Inc., and Sanofi; and a speaker for AbbVie, Eli Lilly, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., and Sanofi. Suzanne Pasmans is an advisor, consultant, speaker, and/or investigator for Boehringer Ingelheim, LEO Pharma, Novartis, Pierre Fabre, Regeneron Pharmaceuticals Inc., and Sanofi; and has received grants from BAP Medical, Boehringer Ingelheim, D&M, DeclaCare (part of BENU Netherlands), Micreos, Ministry of Health Welfare and Sport, Novartis, Pierre Fabre, and Zon MW. Mirna Toledo-Bahena is a speaker for AbbVie, Expanscience, Janssen, LEO Pharma, and Pierre Fabre; and an investigator for Pfizer and Sanofi. Cory Rubin is a speaker for AbbVie, Amgen, Bayer, BMS, Castle Creek Biosciences, Celgene, Cutanea, Dermavant, DermTech, Galderma, Genentech, Helsinn, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Promius Pharma, Regeneron Pharmaceuticals Inc., Sanofi, Sun Pharma, and UCB; a consultant for AbbVie, Allergan, Amgen, Biofrontera, Castle Creek Biosciences, Celgene, Dermavant, DermTech, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Promius Pharma, Regeneron Pharmaceuticals Inc., Sanofi, and UCB; and an investigator for BMS, Cara Therapeutics, Castle Creek Biosciences, DermTech, Janssen, LEO Pharma, and Sanofi. Joel C. Joyce has received consultant fees from Pfizer and Sanofi; speaker fees from Sanofi; and is a study investigator for AbbVie, Aclaris Therapeutics, Amgen, AstraZeneca, Bayer, BMS, Eli Lilly, Galderma, Incyte, Janssen, NFlection Therapeutics, Novartis, Pfizer, Sanofi, and UCB. Lara Wine Lee is an advisory board member for Castle Creek Biosciences, Eli Lilly, Pfizer, and Regeneron Pharmaceuticals Inc; is a consultant for AbbVie, Amryt Pharma, Kimberly-Clark, Krystal Biotech, Novartis, and Pyramid Biosciences; an investigator with AbbVie, Amgen, Amryt Pharma, Arcutis Biotherapeutics, Castle Creek Biosciences, Celgene, Eli Lilly, Galderma, Incyte, Mayne Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, Target Pharma, Trevi Therapeutics, and UCB; and a speaker for Amryt Pharma and Krystal Biotech. Rajan Gupta has served as a consultant for Sanofi. Bryan Adams and Annie Zhang are employees of Sanofi and may hold stock and/or stock options in the company. Marius Ardeleanu is an employee and shareholder of Regeneron Pharmaceuticals Inc.38:T449,After matching, each cohort comprised 9860 patients, with 10 891 female individuals (55.2%), a mean (SD) age of 44.8 (20.3) years, 3582 African American or Black individuals (18.2%), 2004 Asian individuals (10.2%), and 9901 White individuals (50.2%). The 3-year cumulative psoriasis incidence was higher in the dupilumab cohort than the control cohort (2.86% vs 1.79%; P < .001). The number needed to harm for psoriasis was 94 for dupilumab vs the other systemic agents. The dupilumab cohort showed an increased risk for psoriasis (hazard ratio [HR], 1.58; 95% CI, 1.25-1.99), although the risk for psoriatic arthritis was not significant (HR, 1.97; 95% CI, 0.75-5.18). This increased risk was also observed in various AD subgroups, including those without atopic comorbidities (HR, 1.42; 95% CI, 1.06-1.89) or with pretreatment immunoglobulin E levels less than 0.048 mg/dL (to convert to mg/L, multiply by 10; HR, 1.59; 95% CI, 1.26-2.01). The association between dupilumab and psoriasis was further supported by validation in patients with asthma without AD (HR, 2.13; 95% CI, 1.38-3.31).39:T9f4,Patients with atopic dermatitis (AD) have been reported to develop psoriasis during dupilumab treatment. Whether this represents a true association or an incidental event remains unclear. To compare psoriasis risk in patients with AD who are prescribed dupilumab vs other systemic agents. This population-based retrospective cohort study with 3-year follow-up, with analyses completed on October 19, 2024, included 214 430 adult patients with AD from the TriNetX Global Collaborative Network. Individuals newly prescribed dupilumab (dupilumab cohort) and those newly prescribed the other systemic agents without dupilumab exposure (control cohort) were included. Propensity score matching at a 1:1 ratio based on age, sex, race, comorbidities, laboratory measurements, and prior medications was conducted. Dupilumab vs the other systemic agents (corticosteroids, methotrexate, cyclosporine, azathioprine, or mycophenolate mofetil). The primary outcome was incident psoriasis. Cumulative incidence was assessed using Kaplan-Meier plots and risks via Cox regression. After matching, each cohort comprised 9860 patients, with 10 891 female individuals (55.2%), a mean (SD) age of 44.8 (20.3) years, 3582 African American or Black individuals (18.2%), 2004 Asian individuals (10.2%), and 9901 White individuals (50.2%). The 3-year cumulative psoriasis incidence was higher in the dupilumab cohort than the control cohort (2.86% vs 1.79%; P < .001). The number needed to harm for psoriasis was 94 for dupilumab vs the other systemic agents. The dupilumab cohort showed an increased risk for psoriasis (hazard ratio [HR], 1.58; 95% CI, 1.25-1.99), although the risk for psoriatic arthritis was not significant (HR, 1.97; 95% CI, 0.75-5.18). This increased risk was also observed in various AD subgroups, including those without atopic comorbidities (HR, 1.42; 95% CI, 1.06-1.89) or with pretreatment immunoglobulin E levels less than 0.048 mg/dL (to convert to mg/L, multiply by 10; HR, 1.59; 95% CI, 1.26-2.01). The association between dupilumab and psoriasis was further supported by validation in patients with asthma without AD (HR, 2.13; 95% CI, 1.38-3.31). The results of this cohort study suggest that patients with AD who were prescribed dupilumab exhibited a higher relative risk of developing psoriasis compared with those receiving other systemic agents. Given an estimated number needed to harm of 94, the absolute risk may have limited clinical relevance and should be weighed against dupilumab's established efficacy in treating AD.3a:Tcd4,ImportancePatients with atopic dermatitis (AD) have been reported to develop psoriasis during dupilumab treatment. Whether this represents a true association or an incidental event remains unclear.ObjectiveTo compare psoriasis risk in patients with AD who are prescribed dupilumab vs other systemic agents.Design, Setting, and ParticipantsThis population-based retrospective cohort study with 3-year follow-up, with analyses completed on October 19, 2024, included 214 430 adult patients with AD from the TriNetX Global Collaborative Network. Individuals newly prescribed dupilumab (dupilumab cohort) and those newly prescribed the other systemic agents without dupilumab exposure (control cohort) were included. Propensity score matching at a 1:1 ratio based on age, sex, race, comorbidities, laboratory measurements, and prior medications was conducted.ExposuresDupilumab vs the other systemic agents (corticosteroids, methotrexate, cyclosporine, azathioprine, or mycophenolate mofetil).Main Outcomes and MeasuresThe primary outcome was incident psoriasis. Cumulative incidence was assessed using Kaplan-Meier plots and risks via Cox regression.ResultsAfter matching, each cohort comprised 9860 patients, with 10 891 female individuals (55.2%), a mean (SD) age of 44.8 (20.3) years, 3582 African American or Black individuals (18.2%), 2004 Asian individuals (10.2%), and 9901 White individuals (50.2%). The 3-year cumulative psoriasis incidence was higher in the dupilumab cohort than the control cohort (2.86% vs 1.79%; P &lt; .001). The number needed to harm for psoriasis was 94 for dupilumab vs the other systemic agents. The dupilumab cohort showed an increased risk for psoriasis (hazard ratio [HR], 1.58; 95% CI, 1.25-1.99), although the risk for psoriatic arthritis was not significant (HR, 1.97; 95% CI, 0.75-5.18). This increased risk was also observed in various AD subgroups, including those without atopic comorbidities (HR, 1.42; 95% CI, 1.06-1.89) or with pretreatment immunoglobulin E levels less than 0.048 mg/dL (to convert to mg/L, multiply by 10; HR, 1.59; 95% CI, 1.26-2.01). The association between dupilumab and psoriasis was further supported by validation in patients with asthma without AD (HR, 2.13; 95% CI, 1.38-3.31).Conclusions and RelevanceThe results of this cohort study suggest that patients with AD who were prescribed dupilumab exhibited a higher relative risk of developing psoriasis compared with those receiving other systemic agents. Given an estimated number needed to harm of 94, the absolute risk may have limited clinical relevance and should be weighed against dupilumab’s established efficacy in treating AD.3b:T64f,Since the increased use of dupilumab for atopic dermatitis (AD) in daily practice, several cases have been reported on the development of cutaneous T-cell lymphomas (CTCL) and lymphoid infiltrates. To provide insight in the clinical and histopathologic features of patients with AD clinically suspected for CTCL during dupilumab treatment. This retrospective observational case series included adult (≥18 years) patients with AD treated with dupilumab between October 2017 and July 2022 at the University Medical Center Utrecht in the Netherlands. Relevant patient, disease, and treatment characteristics were evaluated. Skin biopsies before, during, and after treatment were collected and reassessed. Fourteen patients (54.5% male) with a median (IQR) age of 56 (36-66) years suspected for CTCL with deterioration of symptoms during dupilumab treatment were included. Of 14 patients, 3 were retrospectively diagnosed with preexistent mycosis fungoides (MF). Eleven patients with AD were eventually diagnosed with a lymphoid reaction (LR). These patients showed MF-like symptoms; however, histopathologic findings were different, and included sprinkled distribution of small hyperchromatic lymphocytes in the upper epidermal section, a dysregulated CD4:CD8 ratio, and CD30 overexpression, without loss of CD2/CD3/CD5. The median time to clinical worsening was 4.0 months (IQR, 1.4-10.0). Posttreatment biopsies showed complete clearance of the LR in all patients. This study found that dupilumab treatment can cause a reversible and benign LR, which mimics a CTCL, though has distinctive histopathologic features.3c:T8aa,ImportanceSince the increased use of dupilumab for atopic dermatitis (AD) in daily practice, several cases have been reported on the development of cutaneous T-cell lymphomas (CTCL) and lymphoid infiltrates.ObjectiveTo provide insight in the clinical and histopathologic features of patients with AD clinically suspected for CTCL during dupilumab treatment.Design, Setting, and ParticipantsThis retrospective observational case series included adult (≥18 years) patients with AD treated with dupilumab between October 2017 and July 2022 at the University Medical Center Utrecht in the Netherlands.Main outcomes and measuresRelevant patient, disease, and treatment characteristics were evaluated. Skin biopsies before, during, and after treatment were collected and reassessed.ResultsFourteen patients (54.5% male) with a median (IQR) age of 56 (36-66) years suspected for CTCL with deterioration of symptoms during dupilumab treatment were included. Of 14 patients, 3 were retrospectively diagnosed with preexistent mycosis fungoides (MF). Eleven patients with AD were eventually diagnosed with a lymphoid reaction (LR). These patients showed MF-like symptoms; however, histopathologic findings were different, and included sprinkled distribution of small hyperchromatic lymphocytes in the upper epidermal section, a dysregulated CD4:CD8 ratio, and CD30 overexpression, without loss of CD2/CD3/CD5. The median time to clinical worsening was 4.0 months (IQR, 1.4-10.0). Posttreatment biopsies showed complete clearance of the LR in all patients.Conclusions and relevanceThis study found that dupilumab treatment can cause a reversible and benign LR, which mimics a CTCL, though has distinctive histopathologic features.25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"IL-4/IL-13 Inhibitor: modality Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on IL-4/IL-13 Inhibitor (modality). Clinician-written summaries and actionable practice insights. 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regulatory status may vary by region and specific drug combination.","value_numeric":null},{"paper_doi":"10.1111/all.70452","tag_type":"warning","value":"No control arm or comparator group was included; improvement from baseline on single therapy to dual therapy may reflect disease trajectory or regression to the mean rather than a true treatment effect.","value_numeric":null},{"paper_doi":"10.1111/all.70452","tag_type":"warning","value":"The five biologic combinations used were heterogeneous and sample sizes per combination were very small (as low as n=1), making combination-specific conclusions unreliable.","value_numeric":null},{"paper_doi":"10.1111/all.70452","tag_type":"warning","value":"The VAS overall disease severity improvement (−4.3) did not reach conventional statistical significance (p = 0.054), but is reported alongside significant outcomes — clinicians should interpret this measure cautiously.","value_numeric":null}],"summaries":{"what_studied":"This retrospective, multicentric study evaluated simultaneous dual type 2 biologic therapy in 34 adult patients with severe uncontrolled CRSwNP across six centers in Germany, the Netherlands, and Italy, comparing sinonasal outcomes at 6 months on dual therapy vs. baseline on single biologic therapy (median follow-up 25 months).","key_result":"Dual biologic therapy significantly improved all key sinonasal outcomes at 6 months: SNOT-22 improved by −32.8 (p < 0.0001), nasal polyp score by −3.2 (p < 0.0001), and smell by +3.4 (p = 0.003). Adverse reactions occurred in 4 of 34 patients (11.8%), including urticaria, erythema, GI symptoms, weight gain, and arthralgia (each n = 1).","limitations":"- Very small sample size (n = 34) limits generalizability.\n- Retrospective design with no control arm; no head-to-head comparison between dual-therapy combinations.\n- Long-term efficacy and safety remain unknown, with median follow-up only 25 months.","practice_takeaway":"For rare, complex CRSwNP cases with refractory type 2 comorbidities (e.g., EGPA, hypereosinophilic syndrome) that fail single biologic therapy, dual biologic therapy may offer meaningful symptom improvement — but it should only be considered after interdisciplinary consultation, given off-label status in some countries and high costs."}},{"doi":"10.1038/s41584-026-01406-1","pmid":"42552373","title":"Advances in the treatment of eosinophilic granulomatosis with polyangiitis","journal_title":"Nature Reviews Rheumatology","journal_issn":"1759-4790","published_at":"2026-08-04T00:00:00.000Z","url":"https://doi.org/10.1038/s41584-026-01406-1","source_score":20,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-11T13:26:18.599Z","updated_at":"2026-08-11T13:26:18.599Z","tags":[{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"brand","value":"Fasenra","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"brand","value":"Nucala","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"category","value":"Rheumatology","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"condition","value":"ANCA-Associated Vasculitis","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"condition","value":"Eosinophilic Granulomatosis With Polyangiitis","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"generic","value":"benralizumab","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"generic","value":"mepolizumab","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"level_of_evidence","value":"5","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"modality","value":"Glucocorticoid","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"modality","value":"IL-4/IL-13 Inhibitor","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"modality","value":"IL-5 Inhibitor","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"modality","value":"TSLP Inhibitor","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"study_design","value":"Narrative Review","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"warning","value":"Full page text was not available in the provided source — only the abstract was parseable. Summary and tags are based solely on abstract content.","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"warning","value":"No sample size tag was applied as this is a narrative review without a primary study population.","value_numeric":null},{"paper_doi":"10.1038/s41584-026-01406-1","tag_type":"warning","value":"Study design classified as 'Narrative Review'; the paper may include systematic elements not determinable from available text.","value_numeric":null}],"summaries":{"what_studied":"This review evaluates the evolving treatment landscape for eosinophilic granulomatosis with polyangiitis (EGPA), including historical glucocorticoid-based regimens and emerging targeted therapies — particularly IL-5 pathway inhibitors (mepolizumab, benralizumab) and agents targeting IL-4, IL-13, and thymic stromal lymphopoietin (TSLP) — for newly diagnosed and relapsing disease.","key_result":"Clinical trial data support that targeting the IL-5 pathway with mepolizumab or benralizumab effectively controls persistent respiratory symptoms and reduces glucocorticoid dependence in EGPA; however, their role at diagnosis and in long-term management remains undefined. Retrospective data on IL-4/IL-13/TSLP-targeting agents suggest benefit for relapsing respiratory symptoms, but prospective evidence is limited and safety is not yet established.","limitations":"- Full text content was not extractable beyond the abstract, limiting granular data retrieval.\n- Most evidence for novel biologics beyond IL-5 inhibitors comes from retrospective studies only.\n- No prospective safety data yet exist for IL-4, IL-13, or TSLP-targeting agents in EGPA.","practice_takeaway":"For EGPA patients with persistent or relapsing respiratory disease, IL-5 pathway inhibitors (mepolizumab or benralizumab) offer a glucocorticoid-sparing option supported by trial data. Agents targeting IL-4, IL-13, or TSLP are promising for refractory respiratory symptoms but should be used cautiously given the absence of prospective safety evidence."}},{"doi":"10.2340/actadv.v106.adv-2026-0669","pmid":"42516098","title":"Clinical Characterization and Outcomes of Dupilumab for Pemphigoid Gestationis: A Case Series of Five Patients and Literature Review","journal_title":"Acta Dermato-Venereologica","journal_issn":"1651-2057","published_at":"2026-07-28T00:00:00.000Z","url":"https://doi.org/10.2340/actadv.v106.adv-2026-0669","source_score":1,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-01T13:22:05.147Z","updated_at":"2026-08-01T13:22:05.147Z","tags":[{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"category","value":"Dermatology","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"condition","value":"Pemphigoid Gestationis","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"level_of_evidence","value":"4","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"modality","value":"IL-4/IL-13 Inhibitor","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"sample_size","value":"n=15","value_numeric":15},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"sex","value":"female","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"study_design","value":"Retrospective Case Series with Literature Review","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"warning","value":"Dupilumab is used off-label in pregnancy; the level of evidence tag reflects the aggregate case series, not a controlled trial.","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"warning","value":"One patient's placental histopathology showed chronic villitis and other inflammatory findings whose clinical significance is uncertain.","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"warning","value":"Sample size is very small (5 new cases; 15 cumulative across literature review), so all outcome estimates should be interpreted cautiously.","value_numeric":null},{"paper_doi":"10.2340/actadv.v106.adv-2026-0669","tag_type":"warning","value":"Study design is retrospective with no comparator group; causality between dupilumab and outcomes cannot be established.","value_numeric":null}],"summaries":{"what_studied":"Retrospective case series of 5 pregnant women with severe, refractory pemphigoid gestationis (PG) treated with dupilumab (600 mg loading dose, then 300 mg every 2 weeks, with interval adjustment), plus a literature review of 10 previously published dupilumab-treated PG cases.","key_result":"Blistering ceased within 1 week in 2 patients and within 4 weeks in a third; 2 patients needed weekly dosing for control. Systemic corticosteroids were discontinued in 3 patients and tapered to ≤10 mg/day in 2 before delivery. All 5 infants were born healthy. Across all 15 reported cases, rapid pruritus improvement and corticosteroid-sparing were consistent findings.","limitations":"- Very small sample (n=5 new cases; 15 total); no control group.\n- Off-label use in pregnancy with no randomized safety data; anti-BP180 IgG trends were variable and not clearly predictive of response.\n- Placental histopathology available for only 1 patient, limiting conclusions about placental safety.","practice_takeaway":"For pregnant patients with severe PG unresponsive to corticosteroids, dupilumab may offer rapid blister control and allow steroid tapering, with healthy infant outcomes across all 15 reported cases. Given off-label status and limited data, use should involve shared decision-making with close obstetric monitoring."}},{"doi":"10.1016/j.jaci.2026.07.006","pmid":"42498125","title":"Dupilumab for patients with allergic fungal rhinosinusitis","journal_title":"Journal of Allergy and Clinical Immunology","journal_issn":"0091-6749","published_at":"2026-07-24T00:00:00.000Z","url":"https://doi.org/10.1016/j.jaci.2026.07.006","source_score":7,"is_retracted":false,"is_open_access":null,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":false},"created_at":"2026-08-13T13:22:51.099Z","updated_at":"2026-08-13T13:22:51.099Z","tags":[{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"age_group","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"condition","value":"Allergic Fungal Rhinosinusitis","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"condition","value":"Asthma","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"condition","value":"Chronic Rhinosinusitis With Nasal Polyps","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"level_of_evidence","value":"1","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"modality","value":"IL-4/IL-13 Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"sample_size","value":"n=62","value_numeric":62},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"warning","value":"Funded by Sanofi and Regeneron Pharmaceuticals (dupilumab manufacturers); industry sponsorship is a potential source of bias.","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"warning","value":"The study included patients aged ≥6 years (pediatric and adult), but age-stratified results are not reported in the abstract; generalizability across age groups is uncertain.","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.07.006","tag_type":"warning","value":"Total sample size is very small (N=62), which may limit the robustness of subgroup findings, including the comorbid asthma analysis.","value_numeric":null}],"summaries":{"what_studied":"Phase 3 RCT (LIBERTY AFRS AIMS) evaluating dupilumab vs. matched placebo over 52 weeks in patients aged ≥6 years with allergic fungal rhinosinusitis (AFRS), a severe type 2 inflammatory subtype of chronic rhinosinusitis.","key_result":"Dupilumab (n=33) significantly reduced sinus opacification vs. placebo (n=29) at 52 weeks (LMK-CT LSMD −7.36; 95% CI −9.38 to −5.35; P<.001) and cut the risk of systemic corticosteroids and/or sinonasal surgery by 92% (risk difference −29.1%; P=.001). Nasal polyp scores, nasal congestion, and total symptom scores all improved significantly by week 24 and continued to improve at week 52. Adverse event rates were similar between groups (69.7% dupilumab vs. 78.6% placebo).","limitations":"Very small sample size (N=62 total) limits statistical power and generalizability. The trial duration of 52 weeks does not address long-term outcomes or recurrence after stopping treatment. Imbalance in group sizes (33 vs. 29) warrants attention in interpreting effect estimates.","practice_takeaway":"For patients with AFRS—especially those at high risk of repeat surgery or steroid exposure—dupilumab offers significant radiographic, symptomatic, and clinical benefit with a favorable safety profile. Consider dupilumab as a disease-modifying option, particularly in those with comorbid asthma."}},{"doi":"10.1016/j.jaci.2026.06.012","pmid":"42379525","title":"Dupilumab outcomes in pediatric asthma by early eosinophil status: Post hoc analysis of VOYAGE/EXCURSION","journal_title":"Journal of Allergy and Clinical Immunology","journal_issn":"0091-6749","published_at":"2026-06-30T00:00:00.000Z","url":"https://doi.org/10.1016/j.jaci.2026.06.012","source_score":8,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-09-07T06:30:44.195Z","updated_at":"2026-09-07T06:30:44.195Z","tags":[{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"age_group","value":"child","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"condition","value":"Eosinophilia","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"condition","value":"Pediatric Asthma","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"condition","value":"Type 2 Asthma","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"impact_flag","value":"safety_signal","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"modality","value":"Biologic","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"modality","value":"IL-4/IL-13 Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"sample_size","value":"n=156","value_numeric":156},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"study_design","value":"Post Hoc Analysis of Randomized Controlled Trial with Open-Label Extension","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"warning","value":"Level of evidence is rated 3 due to the post hoc and open-label extension design, despite originating from an RCT (VOYAGE).","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"warning","value":"The early eosinophil increase subgroup was small (n=35, 22.4% of 156), limiting statistical power for safety and efficacy comparisons.","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"warning","value":"The impact_flag 'safety_signal' is used here in a reassuring direction — the signal is the absence of harm from transient eosinophilia, not a new adverse finding.","value_numeric":null},{"paper_doi":"10.1016/j.jaci.2026.06.012","tag_type":"warning","value":"This is a post hoc subgroup analysis; results should be interpreted as hypothesis-generating rather than confirmatory.","value_numeric":null}],"summaries":{"what_studied":"This post hoc analysis of the VOYAGE RCT and EXCURSION open-label extension evaluated long-term dupilumab efficacy and safety in children aged 6–11 with type 2 asthma, specifically in subgroups with and without early blood eosinophil increases (baseline <500 cells/μL rising to ≥500 cells/μL by week 12), over up to 2 years.","key_result":"At VOYAGE week 12, 22.4% (35/156) of dupilumab-treated children had an early eosinophil increase (≥500 cells/μL). Dupilumab reduced severe exacerbation rates vs. placebo in both subgroups, with sustained improvements in FEV1, ACQ-5-IA score, FeNO, and total IgE — and no safety differences observed between subgroups.","limitations":"Post hoc subgroup analysis limits causal inference; sample sizes within subgroups (especially early eosinophil increase group, n=35) are small; open-label extension design introduces potential bias.","practice_takeaway":"Clinicians can reassure families that early transient eosinophil rises on dupilumab do not appear to affect efficacy or safety outcomes in children with type 2 asthma. Dupilumab benefits on exacerbations, lung function, and asthma control were consistent regardless of early eosinophil status."}},{"doi":"10.18176/jiaci.1160","pmid":"42370853","title":"Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Moderate-to-Severe Asthma, Type 2 Inflammation, and Nocturnal Awakenings: The MORPHEO Randomized Controlled Trial","journal_title":"Journal of Investigational Allergology and Clinical Immunology","journal_issn":"1018-9068","published_at":"2026-06-29T00:00:00.000Z","url":"https://doi.org/10.18176/jiaci.1160","source_score":1,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-08T13:26:39.542Z","updated_at":"2026-07-08T13:26:39.542Z","tags":[{"paper_doi":"10.18176/jiaci.1160","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"condition","value":"Moderate-to-Severe Asthma","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"condition","value":"Sleep Disturbance","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"condition","value":"Type 2 Airway Inflammation","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"modality","value":"IL-4/IL-13 Inhibitor","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"sample_size","value":"n=202","value_numeric":202},{"paper_doi":"10.18176/jiaci.1160","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"warning","value":"Exclusion criteria for comorbid primary sleep disorders are not specified in the abstract, which could confound sleep endpoint interpretation.","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"warning","value":"FEV1, ACQ-7, and FeNO improvements with dupilumab are described as 'nominally statistically significant,' suggesting these secondary results should be interpreted cautiously without full correction for multiple comparisons.","value_numeric":null},{"paper_doi":"10.18176/jiaci.1160","tag_type":"warning","value":"The study enrolled adults aged 18–65 only; findings may not generalize to older adults or pediatric patients with type 2 asthma and sleep disturbance.","value_numeric":null}],"summaries":{"what_studied":"The MORPHEO phase 4 RCT evaluated dupilumab 200 mg vs. placebo every 2 weeks for 12 weeks in 202 adults (18–65 years) with uncontrolled type 2 moderate-to-severe asthma (ACQ-5 ≥2.5, eosinophils ≥150/μL, FeNO ≥25 ppb) and frequent nocturnal awakenings (≥1/night). The primary endpoint was change in Asthma Sleep Disturbance Questionnaire (ASDQ) score at week 12.","key_result":"The primary endpoint was not met: dupilumab showed no significant improvement in ASDQ score vs. placebo (LS mean difference −0.07, SE 0.107; P=.512), and nocturnal awakenings did not differ between arms (difference 0.00, 95% CI −0.21 to 0.22). Sleep quality, restorative sleep, and WASO improved similarly in both groups. Dupilumab did nominally improve FEV1, ACQ-7, and FeNO vs. placebo.","limitations":"- Primary endpoint was not met, raising questions about whether sleep disturbance in this population is driven by factors beyond type 2 airway inflammation alone.\n- Short 12-week trial duration may not capture longer-term sleep benefits if lung function gains take more time to translate to sleep improvement.\n- High completion rate (91.6%) but no detail on comorbid sleep disorders (e.g., obstructive sleep apnea) that could confound sleep outcomes.","practice_takeaway":"Do not expect dupilumab to meaningfully improve sleep disturbance or nocturnal awakenings in type 2 moderate-to-severe asthma beyond what placebo achieves, even as it improves lung function and inflammation. Evaluate and treat comorbid sleep disorders separately in this population."}},{"doi":"10.1016/s2468-1253(26)00116-0","pmid":"42341804","title":"Dupilumab versus placebo in adults and adolescents with eosinophilic gastritis (DEGAS): a double-blind, placebo-controlled, phase 2, multicentre, randomised controlled trial","journal_title":"The Lancet Gastroenterology & Hepatology","journal_issn":"2468-1253","published_at":"2026-06-24T00:00:00.000Z","url":"https://doi.org/10.1016/s2468-1253(26)00116-0","source_score":10,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-26T13:25:23.840Z","updated_at":"2026-06-26T13:25:23.840Z","tags":[{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"age_group","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"category","value":"Gastroenterology & Hepatology","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"condition","value":"Eosinophilic Gastritis","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"modality","value":"IL-4/IL-13 Inhibitor","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"sample_size","value":"n=41","value_numeric":41},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"warning","value":"Baseline imbalances existed between groups (years since diagnosis, proportion with active eosinophilic esophagitis), which may have influenced results despite regression adjustment.","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"warning","value":"Open-label extension data lack a placebo comparator, limiting interpretability of longer-term findings.","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"warning","value":"The dupilumab dose used (300 mg every 2 weeks) is lower than the dose later shown to improve symptoms in eosinophilic esophagitis (300 mg weekly), potentially explaining the lack of symptomatic benefit.","value_numeric":null},{"paper_doi":"10.1016/s2468-1253(26)00116-0","tag_type":"warning","value":"The study was not powered to detect symptom differences; the EoG-SQ symptom tool used is not yet validated in a large cohort, making symptom results difficult to interpret.","value_numeric":null}],"summaries":{"what_studied":"This phase 2 RCT (DEGAS) evaluated subcutaneous dupilumab (600 mg once, then 300 mg every 2 weeks) versus placebo over 12 weeks in 41 adults and adolescents (ages 12–59) with histologically active eosinophilic gastritis and moderate-to-severe symptoms, followed by a 24-week open-label extension where all patients received dupilumab.","key_result":"At week 12, dupilumab reduced mean gastric eosinophil count by 50% vs. 4% with placebo (difference −47 percentage points, p<0.0001). Histologic (EoG-HSS, p=0.0055) and endoscopic (EoG-REFS, p=0.016) secondary endpoints also favored dupilumab. However, symptom scores (EoG-SQ) did not differ significantly (p=0.15). Adverse event rates were similar (81% dupilumab vs. 85% placebo); no serious adverse events or deaths occurred.","limitations":"- Very small sample (n=41), underpowered for symptom and subgroup endpoints.\n- Short 12-week double-blind period; symptom tools (EoG-SQ) remain unvalidated.\n- Sample was 90% White, limiting generalizability.","practice_takeaway":"Dupilumab meaningfully reduced gastric eosinophilia and improved histologic and endoscopic outcomes in eosinophilic gastritis—a disease with no approved therapy—though symptom improvement was not significant at this dose and duration. Clinicians should await phase 3 data (including weekly dosing, NCT05831176) before adopting dupilumab routinely for this indication."}},{"doi":"10.1016/j.jaip.2026.06.012","pmid":"42314928","title":"Dupilumab Efficacy in Children With Uncontrolled, Moderate-to-Severe, Type 2 Asthma by Allergen Sensitization Level","journal_title":"The Journal of Allergy and Clinical Immunology: In Practice","journal_issn":"2213-2198","published_at":"2026-06-19T00:00:00.000Z","url":"https://doi.org/10.1016/j.jaip.2026.06.012","source_score":7,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-01T13:27:13.717Z","updated_at":"2026-07-01T13:27:13.717Z","tags":[{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"age_group","value":"child","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"condition","value":"Asthma","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"condition","value":"Type 2 Asthma","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"modality","value":"IL-4/IL-13 Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"sample_size","value":"n=336","value_numeric":336},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"study_design","value":"Post Hoc Analysis of Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"warning","value":"Level of evidence assigned as 2 based on the RCT source data, but the post hoc nature downgrades interpretive strength.","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"warning","value":"The 'practice_changing' impact flag reflects the clinically significant finding that allergen sensitization status does not appear to moderate dupilumab benefit, but the non-sensitized result did not reach statistical significance.","value_numeric":null},{"paper_doi":"10.1016/j.jaip.2026.06.012","tag_type":"warning","value":"This is a post hoc subgroup analysis of the VOYAGE RCT; findings, especially for the non-sensitized subgroup (n=75), should be interpreted with caution due to limited statistical power.","value_numeric":null}],"summaries":{"what_studied":"Post hoc analysis of the VOYAGE RCT examining dupilumab (100/200 mg q2w by weight vs. placebo for 52 weeks) in 336 children aged 6–11 with uncontrolled moderate-to-severe type 2 asthma, stratified by baseline allergen sensitization status (non-sensitized, monoallergen, multiallergen).","key_result":"Dupilumab reduced annualized severe exacerbation rates vs. placebo by 45% (non-sensitized, P=.13), 75% (monoallergen, P=.04), and 60% (multiallergen, P=.0004) at 52 weeks; no significant interaction between treatment and sensitization subgroup (P=.48). Improvements in ppFEV1, ACQ-7-IA, and total IgE were consistent across all subgroups.","limitations":"Post hoc subgroup analysis limits causal inference. The non-sensitized subgroup was small (n=75, 22%), contributing to the non-significant exacerbation result in that group. Sensitization was defined using total and perennial allergen-specific IgE only, which may not capture all clinically relevant sensitization patterns.","practice_takeaway":"Dupilumab significantly cuts exacerbations in multiallergen- and monoallergen-sensitized children with type 2 asthma, and shows a directionally consistent but non-significant benefit even in non-sensitized children. Allergen sensitization status alone should not gate dupilumab use in children aged 6–11 with type 2 asthma."}},{"doi":"10.1111/all.70391","pmid":"42215290","title":"Effect of Dupilumab on Airway Inflammation in Patients With Persistent Asthma","journal_title":"Allergy","journal_issn":"0105-4538","published_at":"2026-05-29T00:00:00.000Z","url":"https://doi.org/10.1111/all.70391","source_score":1,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-09T13:50:27.511Z","updated_at":"2026-06-09T13:50:27.511Z","tags":[{"paper_doi":"10.1111/all.70391","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"category","value":"Allergy","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"condition","value":"Persistent Asthma","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"condition","value":"Type 2 Asthma","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"modality","value":"IL-4/IL-13 Inhibitor","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"sample_size","value":"n=42","value_numeric":42},{"paper_doi":"10.1111/all.70391","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"warning","value":"Goblet cell and mucus area reductions lost significance after multiple testing correction — unadjusted p-values should not be over-interpreted.","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"warning","value":"Small sample size (n=42) in a phase 2a trial; results, especially biopsy-level findings, may not be powered for definitive conclusions and should be interpreted cautiously.","value_numeric":null},{"paper_doi":"10.1111/all.70391","tag_type":"warning","value":"The study population is described as 'persistent asthma' but the mechanism focus is on type 2 endotype; generalizability to non-type 2 asthma is unclear.","value_numeric":null}],"summaries":{"what_studied":"Phase 2a RCT (EXPEDITION, NCT02573233) evaluating add-on dupilumab 300 mg Q2W vs. placebo over 12 weeks in 42 patients (aged 18–65) with persistent asthma, assessing airway mucosal and systemic inflammation via bronchial biopsies, BAL, brushings, and blood samples.","key_result":"Dupilumab improved lung function and asthma control vs. placebo, and significantly reduced circulating type 2 biomarkers (p_unadj < 0.001, p_adj < 0.01). However, no significant changes in eosinophil, mast cell, or type 2 helper cell counts were seen in bronchial biopsies. Goblet cell numbers and mucus area trended lower (p_unadj < 0.05) but did not survive adjustment. Downregulation of M2 macrophage- and eosinophil-associated gene sets was found in BAL and brushing samples.","limitations":"- Small sample size (n=42) limits statistical power for biopsy-level cell count changes.\n- Adjusted p-values for goblet cell and mucus area reductions were non-significant, suggesting possible false positives in unadjusted analyses.\n- Short 12-week treatment duration may be insufficient to capture full mucosal cellular remodeling.","practice_takeaway":"Dupilumab's benefits in asthma appear driven more by systemic type 2 biomarker suppression and gene expression changes than by direct reduction of inflammatory cell counts in the airway mucosa. Clinicians should not expect biopsy-proven mucosal eosinophil clearance to be the primary marker of dupilumab response."}},{"doi":"10.1080/09546634.2025.2605426","pmid":"41486954","title":"From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases","journal_title":"Journal of Dermatological Treatment","journal_issn":"0954-6634","published_at":"2026-01-05T00:00:00.000Z","url":"https://doi.org/10.1080/09546634.2025.2605426","source_score":4,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-01-08","doi":"10.1080/09546634.2025.2605426","days":"7","issn":"0954-6634","rank":"8","field":"Clinical Medicine","score":"4","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1080/09546634.2025.2605426","title":"From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases.","journal":"The Journal of dermatological treatment","methods":"","results":"A significant disproportionality signal was identified across all four methods (ROR 3.873; PRR 3.872; IC 1.865 with IC025 1.653; EBGM 3.642), with reports predominantly in adults and females. In the case review, a consistent phenotype emerged: papulopustules on persistent centrofacial erythema with frequent burning; facial predominance with occasional extension to neck, scalp, or upper trunk; frequent Demodex detection by scraping, KOH, or in vivo imaging; and occasional granulomatous histology. Onset ranged from approximately 2 weeks to 21 months, including one post-discontinuation case. Most patients improved with rosacea-directed therapy (topical ivermectin or metronidazole; anti-inflammatory-dose doxycycline). However, dechallenge or rechallenge patterns and the need for dose-interval extension, temporary interruption, or switching biologic (e.g., lebrikizumab, upadacitinib) in a subset support a drug-related pattern at the reporting level.","abstract":"$30","keywords":["Dupilumab","FAERS","Rosacea","atopic dermatitis","disproportionality analysis","pharmacovigilance"],"pubmed_id":"41486954","conclusions":"","publication_date":"2026-01-05T00:00:00"},"crossref":{"DOI":"10.1080/09546634.2025.2605426","URL":"https://doi.org/10.1080/09546634.2025.2605426","ISSN":["0954-6634","1471-1753"],"link":[{"URL":"https://www.tandfonline.com/doi/pdf/10.1080/09546634.2025.2605426","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":"1","score":1,"title":["From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases"],"author":[{"given":"Sitong","family":"Li","sequence":"first","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital"}]},{"given":"Jiacheng","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital"}]},{"given":"Xuefan","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital"}]},{"given":"Xinlan","family":"Qiu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital"}]},{"given":"Dandan","family":"Ruan","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital"}]},{"given":"Jiaqi","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital"}]},{"given":"Xiang","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital"}]},{"given":"Xiaohui","family":"Mo","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital"}]},{"given":"Qiang","family":"Ju","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Jiao Tong University School of Medicine Affiliated Renji 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The study sponsors participated in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication."},{"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"},"order":3,"value":"$37"},{"name":"Ethics","group":{"name":"EthicsHeading","label":"Data Availability"},"order":4,"value":"Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the product and indication have been approved by major health authorities (e.g., FDA, EMA, PMDA), if there is legal authority to share the data, and there is not a reasonable likelihood of participant re-identification. Submit requests to ."},{"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"},"order":5,"value":"This study was conducted in accordance with the ethical standards of the responsible committees and with the Declaration of Helsinki and the International Council for Harmonisation guidelines for Good Clinical Practice. The trial was overseen by an independent data and safety monitoring board. The protocol was reviewed and approved by institutional review boards/ethics committees at all centers."},{"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors’ Contributions"},"order":6,"value":"Amy S. Paller and Annie Zhang contributed to the study concept and design. Ledit R.F. Ardusso, Vania Oliveira Carvalho, Danielle Marcoux, Michelle Ramien, Mirna Toledo-Bahena, Suzanne Pasmans, Marlies de Graaf, Joel C. Joyce, Cory Rubin, and Lara Wine Lee contributed to data acquisition. Rajan Gupta and Bryan Adams conducted the statistical analyses of the data. All authors interpreted the data, provided critical feedback on the manuscript, approved the final manuscript for submission, and are accountable for the accuracy and integrity of the manuscript."},{"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed Consent"},"order":7,"value":"Written informed consent was obtained from all patients or their proxies."},{"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"},"order":8,"value":"Written informed consent was obtained from all patients or their proxies."},{"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"},"order":9,"value":"Not applicable."},{"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"},"order":10,"value":"Not applicable."}],"deposited":{"date-time":"2025-09-19T08:45:20Z","timestamp":1758271520000,"date-parts":[[2025,9,19]]},"issn-type":[{"type":"print","value":"1175-0561"},{"type":"electronic","value":"1179-1888"}],"published":{"date-parts":[[2025,9,19]]},"publisher":"Springer Science and Business Media LLC","reference":[{"DOI":"10.4081/dr.2012.e1","key":"962_CR1","year":"2011","issue":"1","author":"G Ricci","volume":"4","first-page":null,"unstructured":"Ricci G, Bellini F, Dondi A, Patrizi A, Pession A. 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Outcomes (EASI, %BSA, worst itch/scratch, CDLQI, DFI) were assessed as change from therapy start to last observation (data cutoff or discontinuation).","key_result":"At last observation, mean EASI indicated mild disease in the dupilumab cohort and moderate disease in the methotrexate and cyclosporine cohorts. Pruritus improved more with dupilumab; QoL gains were similar with dupilumab and methotrexate but showed no significant change with cyclosporine; AD exacerbations and discontinuation rates were lowest with dupilumab, intermediate with methotrexate, and highest with cyclosporine, with fewer reported side effects on dupilumab.","limitations":"Observational, non-randomized registry with a 3-year interim analysis. The abstract reports qualitative ('numerically greater') differences without sample size, absolute effects, or event counts.","practice_takeaway":"In routine care for children under 12 with moderate-to-severe atopic dermatitis, dupilumab was associated with greater improvements in signs and itch and lower exacerbation and discontinuation rates than methotrexate or cyclosporine, with QoL benefits similar to methotrexate. Cyclosporine showed no significant QoL improvement in this analysis."}},{"doi":"10.1001/jamadermatol.2025.2567","pmid":"40736743","title":"Use of Dupilumab to Manage Antibody-Drug Conjugate–Induced Cutaneous Toxicities","journal_title":"JAMA Dermatology","journal_issn":"2168-6068","published_at":"2025-07-30T00:00:00.000Z","url":"https://doi.org/10.1001/jamadermatol.2025.2567","source_score":40,"is_retracted":false,"is_open_access":false,"raw_metadata":{"ooir":{"day":"2025-09-21","doi":"10.1001/jamadermatol.2025.2567","days":"14","issn":"2168-6068","rank":"10","field":"Clinical Medicine","score":"40","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1001/jamadermatol.2025.2567","title":"Use of Dupilumab to Manage Antibody-Drug Conjugate-Induced Cutaneous Toxicities.","journal":"JAMA dermatology","methods":"","results":"","abstract":"This case series examines the effectiveness of dupilumab as a steroid-sparing therapy among patients with antibody-drug conjugate–related cutaneous toxicities.","keywords":[],"pubmed_id":"40736743","conclusions":"","publication_date":"2025-07-30T00:00:00"},"crossref":{"DOI":"10.1001/jamadermatol.2025.2567","URL":"https://doi.org/10.1001/jamadermatol.2025.2567","ISSN":["2168-6068"],"link":[{"URL":"https://jamanetwork.com/journals/jamadermatology/articlepdf/2837008/jamadermatology_nykaza_2025_ld_250016_1757438064.29344.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"980","type":"journal-article","issue":"9","score":1,"title":["Use of Dupilumab to Manage Antibody-Drug Conjugate–Induced Cutaneous Toxicities"],"author":[{"given":"Ian","family":"Nykaza","sequence":"first","affiliation":[{"name":"Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York"}]},{"given":"Stephen W.","family":"Dusza","sequence":"additional","affiliation":[{"name":"Dermatology Service, Department of 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matching (n=9860 per group).","key_result":"Three-year cumulative psoriasis incidence was 2.86% with dupilumab vs 1.79% with other systemic agents (P<.001), hazard ratio 1.58 (95% CI, 1.25-1.99); number needed to harm was 94. Psoriatic arthritis risk was not significant (HR 1.97; 95% CI, 0.75-5.18), the increased risk persisted in selected subgroups (e.g., no atopic comorbidities HR 1.42; 95% CI, 1.06-1.89; low pretreatment IgE HR 1.59; 95% CI, 1.26-2.01), and was supported by validation in asthma without AD (HR 2.13; 95% CI, 1.38-3.31).","practice_takeaway":"Dupilumab was associated with a higher relative risk of new-onset psoriasis vs other systemic agents in adults with AD, but the absolute excess risk over 3 years was small (NNH ~94). Counsel patients and monitor for psoriatic lesions during therapy, weighing this risk against dupilumab’s benefits."}},{"doi":"10.1001/jamadermatol.2023.3849","pmid":"37851456","title":"Dupilumab-Associated Lymphoid Reactions in Patients With Atopic Dermatitis","journal_title":"JAMA Dermatology","journal_issn":"2168-6068","published_at":"2023-10-18T00:00:00.000Z","url":"https://www.ncbi.nlm.nih.gov/pmc/articles/10585590","source_score":54,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2023-11-15","doi":"10.1001/jamadermatol.2023.3849","days":"30","issn":"2168-6068","rank":"5","field":"Clinical Medicine","score":"54","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1001/jamadermatol.2023.3849","title":"Dupilumab-Associated Lymphoid Reactions in Patients With Atopic Dermatitis.","journal":"JAMA dermatology","methods":"","results":"Fourteen patients (54.5% male) with a median (IQR) age of 56 (36-66) years suspected for CTCL with deterioration of symptoms during dupilumab treatment were included. Of 14 patients, 3 were retrospectively diagnosed with preexistent mycosis fungoides (MF). Eleven patients with AD were eventually diagnosed with a lymphoid reaction (LR). These patients showed MF-like symptoms; however, histopathologic findings were different, and included sprinkled distribution of small hyperchromatic lymphocytes in the upper epidermal section, a dysregulated CD4:CD8 ratio, and CD30 overexpression, without loss of CD2/CD3/CD5. The median time to clinical worsening was 4.0 months (IQR, 1.4-10.0). Posttreatment biopsies showed complete clearance of the LR in all patients.","abstract":"$3b","keywords":[],"pubmed_id":"37851456","conclusions":"","publication_date":"2023-10-18T00:00:00"},"crossref":{"DOI":"10.1001/jamadermatol.2023.3849","URL":"https://doi.org/10.1001/jamadermatol.2023.3849","ISSN":["2168-6068"],"link":[{"URL":"https://jamanetwork.com/journals/jamadermatology/articlepdf/2810836/jamadermatology_boesjes_2023_oi_230050_1699989182.38982.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"1240","type":"journal-article","issue":"11","score":1,"title":["Dupilumab-Associated Lymphoid Reactions in Patients With Atopic Dermatitis"],"author":[{"given":"Celeste M.","family":"Boesjes","sequence":"first","affiliation":[{"name":"Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, the Netherlands"}]},{"given":"Lian F.","family":"van der Gang","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, the Netherlands"}]},{"given":"Daphne S.","family":"Bakker","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, the Netherlands"}]},{"given":"Tess A.","family":"ten Cate","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, the Netherlands"}]},{"given":"Lotte S.","family":"Spekhorst","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, the Netherlands"}]},{"given":"Marlies","family":"de Graaf","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, the Netherlands"}]},{"given":"Marijke R.","family":"van Dijk","sequence":"additional","affiliation":[{"name":"Department of Pathology, University Medical Center Utrecht, Utrecht, the Netherlands"}]},{"given":"Marjolein S.","family":"de Bruin-Weller","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, the 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versus mycosis fungoides.","key_result":"Among 14 patients, 3 were retrospectively diagnosed with preexisting mycosis fungoides and 11 with a dupilumab‑associated lymphoid reaction that mimicked MF clinically but showed distinctive histology (sprinkled small hyperchromatic lymphocytes in upper epidermis, dysregulated CD4:CD8 ratio, CD30 overexpression without loss of CD2/CD3/CD5); median time to clinical worsening was 4.0 months (IQR 1.4–10.0), and posttreatment biopsies showed complete clearance of the lymphoid reaction in all patients.","limitations":"Single‑center retrospective case series with a small, selected cohort limited to patients who clinically deteriorated and were suspected of CTCL; posttreatment biopsies were not available for all patients; molecular (TCR clonality) data were frequently unavailable.","practice_takeaway":"Dupilumab can trigger a benign, reversible lymphoid reaction that mimics CTCL in adults with atopic dermatitis; recognizing its distinctive 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