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:T686,Prurigo nodularis (PN) is a chronic, intensely pruritic skin disorder characterized by hyperkeratotic nodules and a debilitating itch-scratch cycle. Conventional therapies have limited efficacy and safety issues, while biologics have recently emerged as a promising alternative. A systematic search of PubMed, Embase, and CENTRAL databases was conducted on November 20, 2023, to identify studies assessing treatments for PN. Primary outcomes were changes in pruritus and quality of life. Safety was evaluated by adverse event incidence. Random-effects meta-analyses were conducted when sufficient data were available. Of 4914 records screened, 128 studies met the inclusion criteria, of which 25 were included in the meta-analysis. In studies of dupilumab, treatment was associated with marked reductions in pruritus (mean difference [MD], -5.76; 95% confidence interval [CI], -6.86 to -4.67) and significant improvement in quality of life (MD, -11.84; 95% CI, -22.76 to -0.92), with adverse events reported in 13% of patients (95% CI, 0.02-0.52). Phototherapy achieved complete responses in 23% (95% CI, 9%-48%), partial responses in 60% (95% CI, 39%-78%), and no response in 7% (95% CI, 1%-40%). Thalidomide was associated with complete, partial, and no response rates of 15% (95% CI, 1%-71%), 49% (95% CI, 23%-75%), and 12% (95% CI, 6%-23%), respectively. Dupilumab offers consistent, clinically meaningful improvements in PN with a favorable safety profile, supporting its use as the preferred first-line treatment. Phototherapy and thalidomide remain alternatives for selected patients but achieve complete clearance in few cases and carry greater safety concerns.31:T6ef,ABSTRACT Prurigo nodularis (PN) is a chronic, intensely pruritic skin disorder characterized by hyperkeratotic nodules and a debilitating itch–scratch cycle. Conventional therapies have limited efficacy and safety issues, while biologics have recently emerged as a promising alternative. A systematic search of PubMed, Embase, and CENTRAL databases was conducted on November 20, 2023, to identify studies assessing treatments for PN. Primary outcomes were changes in pruritus and quality of life. Safety was evaluated by adverse event incidence. Random‐effects meta‐analyses were conducted when sufficient data were available. Of 4914 records screened, 128 studies met the inclusion criteria, of which 25 were included in the meta‐analysis. In studies of dupilumab, treatment was associated with marked reductions in pruritus (mean difference [MD], −5.76; 95% confidence interval [CI], −6.86 to −4.67) and significant improvement in quality of life (MD, −11.84; 95% CI, −22.76 to −0.92), with adverse events reported in 13% of patients (95% CI, 0.02–0.52). Phototherapy achieved complete responses in 23% (95% CI, 9%–48%), partial responses in 60% (95% CI, 39%–78%), and no response in 7% (95% CI, 1%–40%). Thalidomide was associated with complete, partial, and no response rates of 15% (95% CI, 1%–71%), 49% (95% CI, 23%–75%), and 12% (95% CI, 6%–23%), respectively. Dupilumab offers consistent, clinically meaningful improvements in PN with a favorable safety profile, supporting its use as the preferred first‐line treatment. Phototherapy and thalidomide remain alternatives for selected patients but achieve complete clearance in few cases and carry greater safety concerns.32:T4e5,Of 190 randomized participants, 189 received 1 or more doses of the study drug (141 vixarelimab, 48 placebo). A total of 114 (60.3%) were female, 75 (39.7%) were male, and the mean (SD) age was 55.4 (13.8) years. There were 47 participants in the high-dose vixarelimab group, 47 in the mid-dose group, 47 in the low-dose group, and 48 in the placebo group. Vixarelimab significantly reduced mean (SE) WI-NRS scores at week 16 compared with placebo across all doses (vixarelimab at high-dose, mid-dose, and low-dose levels: -56.2% [4.84], -51.0% [4.83], and -33.0% [4.86], respectively; placebo, -14.5% [4.76]). Clinically meaningful 4-point or greater reductions in WI-NRS were achieved by 31 (66.0%), 29 (61.7%), and 14 (29.8%) in the high-dose, mid-dose, and low-dose vixarelimab groups, respectively, compared with 8 (16.7%) in the placebo group. PN Investigator Global Assessment scores of 0 or 1 were also higher in vixarelimab groups (high-dose group, 18 [38.3%]; mid-dose group, 14 [29.8%]; low-dose group, 7 [14.9%]; placebo group, 5 [10.4%]). No fatal or serious drug-related treatment-emergent adverse events were reported during the study, and no serious treatment-related treatment-emergent adverse events were observed during the DB period.33:Tb8f,Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by severe pruritus and nodule formation, significantly affecting patients' quality of life. There is an unmet need for effective therapies to address both symptoms and disease progression. To evaluate the efficacy, safety, tolerability, and pharmacokinetics of monthly dosed vixarelimab in participants with moderate to severe PN. This double-blind (DB), placebo-controlled, phase 2b randomized clinical trial was conducted from December 1, 2020, to August 24, 2023, across 72 centers in the US, Canada, Europe, and Asia. The study included male and female participants aged 18 to 80 years with physician-diagnosed PN of at least 6 months' duration and moderate to severe pruritus. Data were analyzed from October 2023 to March 2024. Participants were randomized into 4 arms during the 16-week DB period: vixarelimab, 540 mg (high-dose group); vixarelimab, 360 mg (mid-dose group); vixarelimab, 120 mg (low-dose group); or placebo. Vixarelimab and placebo were administered subcutaneously every 4 weeks. During the 36-week open-label extension, all participants received vixarelimab, 360 mg, every 2 weeks. Key outcomes included percentage change from baseline in the Worst Itch Numeric Rating Scale (WI-NRS) at week 16, the proportion of participants achieving at least a 4-point reduction in WI-NRS at week 16, and the proportion achieving scores of 0 or 1 in the PN Investigator Global Assessment at week 16. Of 190 randomized participants, 189 received 1 or more doses of the study drug (141 vixarelimab, 48 placebo). A total of 114 (60.3%) were female, 75 (39.7%) were male, and the mean (SD) age was 55.4 (13.8) years. There were 47 participants in the high-dose vixarelimab group, 47 in the mid-dose group, 47 in the low-dose group, and 48 in the placebo group. Vixarelimab significantly reduced mean (SE) WI-NRS scores at week 16 compared with placebo across all doses (vixarelimab at high-dose, mid-dose, and low-dose levels: -56.2% [4.84], -51.0% [4.83], and -33.0% [4.86], respectively; placebo, -14.5% [4.76]). Clinically meaningful 4-point or greater reductions in WI-NRS were achieved by 31 (66.0%), 29 (61.7%), and 14 (29.8%) in the high-dose, mid-dose, and low-dose vixarelimab groups, respectively, compared with 8 (16.7%) in the placebo group. PN Investigator Global Assessment scores of 0 or 1 were also higher in vixarelimab groups (high-dose group, 18 [38.3%]; mid-dose group, 14 [29.8%]; low-dose group, 7 [14.9%]; placebo group, 5 [10.4%]). No fatal or serious drug-related treatment-emergent adverse events were reported during the study, and no serious treatment-related treatment-emergent adverse events were observed during the DB period. In this phase 2b randomized clinical trial, vixarelimab demonstrated rapid, sustained, dose-dependent clinical benefits in patients with PN, with a favorable safety profile. ClinicalTrials.gov Identifier: NCT03816891.34:T115f, Importance Prurigo nodularis (PN) is a chronic inflammatory skin disease characterized by severe pruritus and nodule formation, significantly affecting patients’ quality of life. There is an unmet need for effective therapies to address both symptoms and disease progression. Objective To evaluate the efficacy, safety, tolerability, and pharmacokinetics of monthly dosed vixarelimab in participants with moderate to severe PN. Design, Setting, and Participants This double-blind (DB), placebo-controlled, phase 2b randomized clinical trial was conducted from December 1, 2020, to August 24, 2023, across 72 centers in the US, Canada, Europe, and Asia. The study included male and female participants aged 18 to 80 years with physician-diagnosed PN of at least 6 months’ duration and moderate to severe pruritus. Data were analyzed from October 2023 to March 2024. Interventions Participants were randomized into 4 arms during the 16-week DB period: vixarelimab, 540 mg (high-dose group); vixarelimab, 360 mg (mid-dose group); vixarelimab, 120 mg (low-dose group); or placebo. Vixarelimab and placebo were administered subcutaneously every 4 weeks. During the 36-week open-label extension, all participants received vixarelimab, 360 mg, every 2 weeks. Main Outcomes and Measures Key outcomes included percentage change from baseline in the Worst Itch Numeric Rating Scale (WI-NRS) at week 16, the proportion of participants achieving at least a 4-point reduction in WI-NRS at week 16, and the proportion achieving scores of 0 or 1 in the PN Investigator Global Assessment at week 16. Results Of 190 randomized participants, 189 received 1 or more doses of the study drug (141 vixarelimab, 48 placebo). A total of 114 (60.3%) were female, 75 (39.7%) were male, and the mean (SD) age was 55.4 (13.8) years. There were 47 participants in the high-dose vixarelimab group, 47 in the mid-dose group, 47 in the low-dose group, and 48 in the placebo group. Vixarelimab significantly reduced mean (SE) WI-NRS scores at week 16 compared with placebo across all doses (vixarelimab at high-dose, mid-dose, and low-dose levels: −56.2% [4.84], −51.0% [4.83], and −33.0% [4.86], respectively; placebo, −14.5% [4.76]). Clinically meaningful 4-point or greater reductions in WI-NRS were achieved by 31 (66.0%), 29 (61.7%), and 14 (29.8%) in the high-dose, mid-dose, and low-dose vixarelimab groups, respectively, compared with 8 (16.7%) in the placebo group. PN Investigator Global Assessment scores of 0 or 1 were also higher in vixarelimab groups (high-dose group, 18 [38.3%]; mid-dose group, 14 [29.8%]; low-dose group, 7 [14.9%]; placebo group, 5 [10.4%]). No fatal or serious drug-related treatment-emergent adverse events were reported during the study, and no serious treatment-related treatment-emergent adverse events were observed during the DB period. Conclusions and Relevance In this phase 2b randomized clinical trial, vixarelimab demonstrated rapid, sustained, dose-dependent clinical benefits in patients with PN, with a favorable safety profile. Trial Registration ClinicalTrials.gov Identifier: NCT03816891 35:Tc53,Itch is the most burdensome symptom in atopic dermatitis (AD) and prurigo nodularis (PN) and is associated with significant psychological distress, sleep deprivation and impaired quality of life. Achieving rapid control of itch is expected to minimize symptomatology and disease burden. Nemolizumab, which targets the interleukin 31 (IL-31) pathway, rapidly relieved itch in Phase 2 trials; thus, a post hoc analysis of four pivotal randomized controlled clinical trials of nemolizumab in AD and PN was performed to further evaluate the improvement of itch over the first 14 days of therapy. Data from ARCADIA 1 and 2 in AD (N = 1728) and OLYMPIA 1 and 2 in PN (N = 560) were analysed. Patients reported itch intensity and sleep disturbance daily. Differences in the proportion of itch and sleep responders (patients with ≥4-point improvement from baseline in peak pruritus numerical rating scale [PP-NRS] or sleep disturbance [SD-NRS] score) between nemolizumab and placebo groups were calculated. Nemolizumab rapidly reduced itch in AD (ARCADIA 1 and 2), with a difference versus placebo in PP-NRS responders apparent by Day 2 (pooled data: 10.7% vs. 2.9%; 95% CI: 5.6-10.1; p < 0.0001) that steadily increased through Day 14. Nemolizumab also reduced itch rapidly in PN (OLYMPIA 1 and 2); a difference versus placebo occurred by Day 2 (pooled data: 17.2% vs. 3.7%; 95% CI: 6.8-16.7; p < 0.0001). Early improvement (Day 2) was also observed in sleep in nemolizumab-treated patients. In pooled analyses in AD, 9.9% (nemolizumab) versus 4.6% (placebo; 95% CI: 2.8-7.7; p = 0.0001) were SD-NRS responders and in PN, 13.4% versus 4.3% (95% CI: 4.0-13.0; p = 0.0013). Itch and sleep response data in individual studies were consistent with the pooled data. This analysis confirms previously reported data that nemolizumab relieves itch and sleep disturbance by Day 2 in patients with moderate-to-severe AD and PN, indicating that targeting the IL-31 pathway presents an important way to achieve rapid itch response. People with skin diseases such as atopic dermatitis and prurigo nodularis experience itch, which can be severe and can interfere with their daily lives with missed school or work days and psychological well‐being impairment, especially when the itching lasts for a long time as is often the case with these diseases. Itching can also make it hard to sleep. A medicine that quickly stops itching can help people with atopic dermatitis and prurigo nodularis to feel better. Nemolizumab is a medicine that is approved to treat atopic dermatitis and prurigo nodularis and it works fast to stop itching. This study looked at data from four clinical studies of nemolizumab, focusing on how itch changed during the first 14 days of treatment. Patients in the studies who had atopic dermatitis or prurigo nodularis recorded daily in diaries how much itch they felt and how they slept. The researchers found that nemolizumab started working to control itching in just 2 days and patients also slept better. Less itching and better sleep may improve well‐being in people with atopic dermatitis and prurigo nodularis.36:Tcac,Abstract Background/Objectives Itch is the most burdensome symptom in atopic dermatitis (AD) and prurigo nodularis (PN) and is associated with significant psychological distress, sleep deprivation and impaired quality of life. Achieving rapid control of itch is expected to minimize symptomatology and disease burden. Nemolizumab, which targets the interleukin 31 (IL‐31) pathway, rapidly relieved itch in Phase 2 trials; thus, a post hoc analysis of four pivotal randomized controlled clinical trials of nemolizumab in AD and PN was performed to further evaluate the improvement of itch over the first 14 days of therapy. Methods Data from ARCADIA 1 and 2 in AD ( N = 1728) and OLYMPIA 1 and 2 in PN ( N = 560) were analysed. Patients reported itch intensity and sleep disturbance daily. Differences in the proportion of itch and sleep responders (patients with ≥4‐point improvement from baseline in peak pruritus numerical rating scale [PP‐NRS] or sleep disturbance [SD‐NRS] score) between nemolizumab and placebo groups were calculated. Results Nemolizumab rapidly reduced itch in AD (ARCADIA 1 and 2), with a difference versus placebo in PP‐NRS responders apparent by Day 2 (pooled data: 10.7% vs. 2.9%; 95% CI: 5.6–10.1; p < 0.0001) that steadily increased through Day 14. Nemolizumab also reduced itch rapidly in PN (OLYMPIA 1 and 2); a difference versus placebo occurred by Day 2 (pooled data: 17.2% vs. 3.7%; 95% CI: 6.8–16.7; p < 0.0001). Early improvement (Day 2) was also observed in sleep in nemolizumab‐treated patients. In pooled analyses in AD, 9.9% (nemolizumab) versus 4.6% (placebo; 95% CI: 2.8–7.7; p = 0.0001) were SD‐NRS responders and in PN, 13.4% versus 4.3% (95% CI: 4.0–13.0; p = 0.0013). Itch and sleep response data in individual studies were consistent with the pooled data. Conclusions This analysis confirms previously reported data that nemolizumab relieves itch and sleep disturbance by Day 2 in patients with moderate‐to‐severe AD and PN, indicating that targeting the IL‐31 pathway presents an important way to achieve rapid itch response. 37:T9b7,Prurigo nodularis (PN) is a chronic and debilitating skin condition, characterized by intense itch with multiple nodular lesions. Nemolizumab demonstrated significant improvements in itch and skin nodules in adults with moderate to severe PN in a previous 16-week phase 3 study (OLYMPIA 2). To assess the efficacy and occurrence of adverse events in adults with moderate to severe PN treated with nemolizumab vs those receiving placebo. OLYMPIA 1 was a multicenter, placebo-controlled, phase 3 randomized clinical trial, conducted from August 2020 to March 2023 at 77 centers across 10 countries in adults with moderate to severe PN (at least 20 nodules and an Investigator's Global Assessment [IGA] score ≥3) and Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 7.0; consisted of screening (up to 4 weeks), 24-week treatment, and 8-week follow-up periods. Patients were randomized (2:1) to nemolizumab monotherapy, 30 mg or 60 mg (depending on baseline weight of less than 90 kg vs 90 kg or greater, respectively), or matching placebo administered every 4 weeks for 24 weeks. The primary end points were the proportion of patients with itch response (≥4-point improvement from baseline in weekly average PP-NRS) and IGA success (score of 0/1 [clear/almost clear] and 2-grade or more improvement from baseline) at week 16. Of 286 patients (mean [SD] age, 57.5 [13.0] years; mean [SD] body weight, 85.0 [20.7] kg; 166 [58.0%] female), 190 were randomized to receive nemolizumab, and 96 were randomized to placebo. A significantly greater proportion of patients assigned to nemolizumab vs placebo achieved itch response (111/190 [58.4%] vs 16/96 [16.7%]; Δ, 40.1% [95% CI, 29.4%-50.8%]; P < .001) and IGA success (50/190 [26.3%] vs 7/96 [7.3%]; Δ, 14.6% [95% CI, 6.7%-22.6%]; P = .003) at week 16. At week 24, the proportion of patients with itch response was 58.3% vs 20.4% (Δ, 38.7% [95% CI, 27.5%-49.9%]) in the ad hoc analysis, and IGA success was 58/190 (30.5%) vs 9/96 (9.4%) (Δ, 19.2% [95% CI, 10.3%-28.1%]) in the nemolizumab-treated vs placebo group. During the treatment period, 134 patients (71.7%) receiving nemolizumab vs 62 patients (65.3%) receiving placebo had at least 1 adverse event; most events were of mild to moderate severity. In this randomized clinical trial, nemolizumab monotherapy led to clinically meaningful and statistically significant improvements in core signs and symptoms of PN. ClinicalTrials.gov Identifier: NCT04501666.38:Td12,ImportancePrurigo nodularis (PN) is a chronic and debilitating skin condition, characterized by intense itch with multiple nodular lesions. Nemolizumab demonstrated significant improvements in itch and skin nodules in adults with moderate to severe PN in a previous 16-week phase 3 study (OLYMPIA 2).ObjectiveTo assess the efficacy and occurrence of adverse events in adults with moderate to severe PN treated with nemolizumab vs those receiving placebo.Design, Setting, and ParticipantsOLYMPIA 1 was a multicenter, placebo-controlled, phase 3 randomized clinical trial, conducted from August 2020 to March 2023 at 77 centers across 10 countries in adults with moderate to severe PN (at least 20 nodules and an Investigator’s Global Assessment [IGA] score ≥3) and Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 7.0; consisted of screening (up to 4 weeks), 24-week treatment, and 8-week follow-up periods.InterventionsPatients were randomized (2:1) to nemolizumab monotherapy, 30 mg or 60 mg (depending on baseline weight of less than 90 kg vs 90 kg or greater, respectively), or matching placebo administered every 4 weeks for 24 weeks.Main Outcomes and MeasuresThe primary end points were the proportion of patients with itch response (≥4-point improvement from baseline in weekly average PP-NRS) and IGA success (score of 0/1 [clear/almost clear] and 2-grade or more improvement from baseline) at week 16.ResultsOf 286 patients (mean [SD] age, 57.5 [13.0] years; mean [SD] body weight, 85.0 [20.7] kg; 166 [58.0%] female), 190 were randomized to receive nemolizumab, and 96 were randomized to placebo. A significantly greater proportion of patients assigned to nemolizumab vs placebo achieved itch response (111/190 [58.4%] vs 16/96 [16.7%]; Δ, 40.1% [95% CI, 29.4%-50.8%]; P &lt; .001) and IGA success (50/190 [26.3%] vs 7/96 [7.3%]; Δ, 14.6% [95% CI, 6.7%-22.6%]; P = .003) at week 16. At week 24, the proportion of patients with itch response was 58.3% vs 20.4% (Δ, 38.7% [95% CI, 27.5%-49.9%]) in the ad hoc analysis, and IGA success was 58/190 (30.5%) vs 9/96 (9.4%) (Δ, 19.2% [95% CI, 10.3%-28.1%]) in the nemolizumab-treated vs placebo group. During the treatment period, 134 patients (71.7%) receiving nemolizumab vs 62 patients (65.3%) receiving placebo had at least 1 adverse event; most events were of mild to moderate severity.Conclusions and RelevanceIn this randomized clinical trial, nemolizumab monotherapy led to clinically meaningful and statistically significant improvements in core signs and symptoms of PN.Trial RegistrationClinicalTrials.gov Identifier: NCT0450166639:T960,Prurigo nodularis (PN) and chronic pruritus of unknown origin (CPUO) are chronic pruritic diseases that dramatically impair quality of life, but therapeutic options are limited. Abrocitinib, a Janus kinase 1 inhibitor, represents a promising therapy for both conditions. To assess the efficacy and safety of 200-mg oral abrocitinib administered once daily in adults with moderate to severe PN or CPUO. This phase 2, open-label, nonrandomized controlled trial conducted between September 2021 and July 2022 took place at a single center in the US. A total of 25 adult patients with moderate to severe PN or CPUO were screened. Ten patients with PN and 10 patients with CPUO were enrolled. All 20 patients completed the 12-week treatment period, 18 of whom completed the 4-week follow-up period. Abrocitinib, 200 mg, by mouth once daily for 12 weeks. The primary efficacy end point was the percent change in weekly Peak Pruritus Numerical Rating Scale (PP-NRS) scores from baseline to week 12. Key secondary end points included the percentage of patients achieving at least a 4-point reduction in weekly PP-NRS score from baseline to week 12 and the percent change in Dermatology Life Quality Index (DLQI) scores. A total of 10 patients with PN (mean [SD] age, 58.6 [13.1] years; all were female) and 10 patients with CPUO (mean [SD] age, 70.7 [5.6] years; 2 were female) enrolled in the study. The mean (SD) baseline PP-NRS score was 9.2 (1.0) for PN and 8.2 (1.2) for CPUO. PP-NRS scores decreased by 78.3% in PN (95% CI, -118.5 to -38.1; P < .001) and 53.7% in CPUO (95% CI, -98.8 to -8.6; P = .01) by week 12. From baseline to week 12, 8 of 10 patients with PN and 6 of 10 patients with CPUO achieved at least a 4-point improvement on the PP-NRS. Both groups experienced significant improvement in quality of life as demonstrated by percent change in DLQI scores (PN: -53.2% [95% CI, -75.3% to -31.1%]; P = .002; CPUO: -49.0% [95% CI, -89.6% to -8.0%]; P = .02). The most common adverse event among patients was acneiform eruption in 2 of 20 patients (10%). No serious adverse events occurred. The results of this nonrandomized controlled trial suggest that abrocitinib monotherapy may be effective and tolerated well in adults with PN or CPUO. Randomized, double-blind, placebo-controlled trials are warranted to validate these findings. ClinicalTrials.gov Identifier: NCT05038982.3a:Td0a,ImportancePrurigo nodularis (PN) and chronic pruritus of unknown origin (CPUO) are chronic pruritic diseases that dramatically impair quality of life, but therapeutic options are limited. Abrocitinib, a Janus kinase 1 inhibitor, represents a promising therapy for both conditions.ObjectiveTo assess the efficacy and safety of 200-mg oral abrocitinib administered once daily in adults with moderate to severe PN or CPUO.Design, Setting, and ParticipantsThis phase 2, open-label, nonrandomized controlled trial conducted between September 2021 and July 2022 took place at a single center in the US. A total of 25 adult patients with moderate to severe PN or CPUO were screened. Ten patients with PN and 10 patients with CPUO were enrolled. All 20 patients completed the 12-week treatment period, 18 of whom completed the 4-week follow-up period.InterventionAbrocitinib, 200 mg, by mouth once daily for 12 weeks.Main Outcomes and MeasuresThe primary efficacy end point was the percent change in weekly Peak Pruritus Numerical Rating Scale (PP-NRS) scores from baseline to week 12. Key secondary end points included the percentage of patients achieving at least a 4-point reduction in weekly PP-NRS score from baseline to week 12 and the percent change in Dermatology Life Quality Index (DLQI) scores.ResultsA total of 10 patients with PN (mean [SD] age, 58.6 [13.1] years; all were female) and 10 patients with CPUO (mean [SD] age, 70.7 [5.6] years; 2 were female) enrolled in the study. The mean (SD) baseline PP-NRS score was 9.2 (1.0) for PN and 8.2 (1.2) for CPUO. PP-NRS scores decreased by 78.3% in PN (95% CI, −118.5 to −38.1; P &lt; .001) and 53.7% in CPUO (95% CI, −98.8 to −8.6; P = .01) by week 12. From baseline to week 12, 8 of 10 patients with PN and 6 of 10 patients with CPUO achieved at least a 4-point improvement on the PP-NRS. Both groups experienced significant improvement in quality of life as demonstrated by percent change in DLQI scores (PN: −53.2% [95% CI, −75.3% to −31.1%]; P = .002; CPUO: −49.0% [95% CI, −89.6% to −8.0%]; P = .02). The most common adverse event among patients was acneiform eruption in 2 of 20 patients (10%). No serious adverse events occurred.Conclusions and RelevanceThe results of this nonrandomized controlled trial suggest that abrocitinib monotherapy may be effective and tolerated well in adults with PN or CPUO. Randomized, double-blind, placebo-controlled trials are warranted to validate these findings.Trial RegistrationClinicalTrials.gov Identifier: NCT0503898225:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Prurigo Nodularis: condition Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Prurigo Nodularis (condition). Clinician-written summaries and actionable practice insights. 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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":"10.1007/s13555-026-01777-z","pmid":"42120670","title":"Dupilumab Treatment Provides Multidimensional Benefits in Patients with Prurigo Nodularis","journal_title":"Dermatology and Therapy","journal_issn":"2193-8210","published_at":"2026-05-13T00:00:00.000Z","url":"https://doi.org/10.1007/s13555-026-01777-z","source_score":7,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-18T13:25:29.328Z","updated_at":"2026-05-18T13:25:29.328Z","tags":[{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"brand","value":"Dupixent","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"category","value":"Dermatology","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"condition","value":"Prurigo Nodularis","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"generic","value":"dupilumab","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"modality","value":"Biologic - IL-4/IL-13 Receptor Antagonist","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"sample_size","value":"n=243","value_numeric":243},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"study_design","value":"Pooled Post-Hoc Analysis of Randomized Controlled Trials","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"warning","value":"Study design is labeled as a pooled post-hoc analysis rather than a prospectively planned secondary analysis; level of evidence may be closer to 3 depending on interpretation.","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"warning","value":"The sample size of 243 reflects only the non-optimal-response subgroup, not the full PRIME/PRIME2 ITT population.","value_numeric":null},{"paper_doi":"10.1007/s13555-026-01777-z","tag_type":"warning","value":"This is a post-hoc subgroup analysis — causal inference is limited and p-values are nominal without multiplicity correction.","value_numeric":null}],"summaries":{"what_studied":"This pooled post-hoc analysis of LIBERTY-PN PRIME and PRIME2 RCTs assessed multidimensional week-24 outcomes in the subset of PN patients who did **not** achieve the stringent composite endpoint (≥4-point WI-NRS reduction + IGA PN-S 0/1) — 99 dupilumab 300 mg q2w recipients and 144 placebo recipients.","key_result":"Among dupilumab-treated non-optimal responders at week 24: **61.1%** achieved ≥9-point DLQI reduction, **55.8%** reached PGIS 'none'/'mild,' **53.7%** achieved PAS-75 (≥75% healed lesions), and **45.7%** met the less-stringent itch+skin composite (≥3-point WI-NRS + ≥1-point IGA PN-S reduction) — all nominally significant vs. placebo.","limitations":"- Post-hoc, non-pre-specified subgroup analysis limits inferential strength.\n- Study duration was 24 weeks; longer-term trajectory of non-optimal responders is unknown.\n- No multiplicity correction was applied; all p-values are nominal.","practice_takeaway":"Patients with PN who don't hit the tightest response threshold at 24 weeks on dupilumab may still gain meaningful itch relief, skin clearance, and quality-of-life benefit — consider continuing treatment rather than stopping early. These findings support developing a formal treat-to-target strategy for long-term PN management."}},{"doi":"10.1111/ijd.70246","pmid":"41495913","title":"Efficacy and Safety of Conventional and Biologic Therapies in Prurigo Nodularis: A Systematic Review and Meta‐Analysis","journal_title":"International Journal of Dermatology","journal_issn":"0011-9059","published_at":"2026-01-07T00:00:00.000Z","url":"https://doi.org/10.1111/ijd.70246","source_score":15,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-01-11","doi":"10.1111/ijd.70246","days":"14","issn":"0011-9059","rank":"8","field":"Clinical Medicine","score":"15","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1111/ijd.70246","title":"Efficacy and Safety of Conventional and Biologic Therapies in Prurigo Nodularis: A Systematic Review and Meta-Analysis.","journal":"International journal of 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Detailed adverse event rates beyond the absence of serious treatment-related events are not provided here.","practice_takeaway":"In moderate to severe prurigo nodularis, monthly vixarelimab produced dose-dependent, clinically meaningful itch and lesion improvements by 16 weeks versus placebo, with no serious treatment-related adverse events reported short term. These results are promising but need confirmation in larger, longer phase 3 trials before altering routine care."}},{"doi":"10.1111/jdv.70250","pmid":"41401055","title":"Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis phase 3 studies","journal_title":"Journal of the European Academy of Dermatology and Venereology","journal_issn":"0926-9959","published_at":"2025-12-16T00:00:00.000Z","url":"https://doi.org/10.1111/jdv.70250","source_score":276,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2025-12-16","doi":"10.1111/jdv.70250","days":"30","issn":"0926-9959","rank":"2","field":"Clinical Medicine","score":"276","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1111/jdv.70250","title":"Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis phase 3 studies.","journal":"Journal of the European Academy of Dermatology and Venereology : JEADV","methods":"","results":"Nemolizumab rapidly reduced itch in AD (ARCADIA 1 and 2), with a difference versus placebo in PP-NRS responders apparent by Day 2 (pooled data: 10.7% vs. 2.9%; 95% CI: 5.6-10.1; p < 0.0001) that steadily increased through Day 14. Nemolizumab also reduced itch rapidly in PN (OLYMPIA 1 and 2); a difference versus placebo occurred by Day 2 (pooled data: 17.2% vs. 3.7%; 95% CI: 6.8-16.7; p < 0.0001). Early improvement (Day 2) was also observed in sleep in nemolizumab-treated patients. In pooled analyses in AD, 9.9% (nemolizumab) versus 4.6% (placebo; 95% CI: 2.8-7.7; p = 0.0001) were SD-NRS responders and in PN, 13.4% versus 4.3% (95% CI: 4.0-13.0; p = 0.0013). Itch and sleep response data in individual studies were consistent with the pooled data.","abstract":"$35","keywords":["atopic dermatitis","eczematous disease","interleukin 31","itch","nemolizumab","onset of action","prurigo nodularis","pruritus","sleep disturbance"],"pubmed_id":"41401055","conclusions":"","publication_date":"2025-12-16T00:00:00"},"crossref":{"DOI":"10.1111/jdv.70250","URL":"https://doi.org/10.1111/jdv.70250","ISSN":["0926-9959","1468-3083"],"link":[{"URL":"https://onlinelibrary.wiley.com/doi/pdf/10.1111/jdv.70250","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":null,"type":"journal-article","issue":null,"score":1,"title":["Rapid improvement of itch with nemolizumab in atopic dermatitis and prurigo nodularis phase 3 studies"],"author":[{"given":"Sonja","family":"Ständer","sequence":"first","affiliation":[{"name":"Section Pruritus Medicine, Department of Dermatology and Center for Chronic Pruritus University 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Dermatitis","value_numeric":null},{"paper_doi":"10.1111/jdv.70250","tag_type":"condition","value":"Prurigo Nodularis","value_numeric":null},{"paper_doi":"10.1111/jdv.70250","tag_type":"generic","value":"nemolizumab","value_numeric":null},{"paper_doi":"10.1111/jdv.70250","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1111/jdv.70250","tag_type":"modality","value":"IL-31 Pathway Inhibitor","value_numeric":null},{"paper_doi":"10.1111/jdv.70250","tag_type":"sample_size","value":"n=2288","value_numeric":2288},{"paper_doi":"10.1111/jdv.70250","tag_type":"study_design","value":"Post Hoc Analysis","value_numeric":null},{"paper_doi":"10.1111/jdv.70250","tag_type":"warning","value":"Age group and sex distribution are not specified in the abstract.","value_numeric":null},{"paper_doi":"10.1111/jdv.70250","tag_type":"warning","value":"Design classification is approximate: this is a post hoc pooled analysis of four randomized trials, not a standalone RCT.","value_numeric":null},{"paper_doi":"10.1111/jdv.70250","tag_type":"warning","value":"Responder outcomes are based on ≥4‑point improvements in PP‑NRS and SD‑NRS at early time points.","value_numeric":null}],"summaries":{"what_studied":"Post hoc pooled analysis of four phase 3 randomized trials (ARCADIA 1/2 in atopic dermatitis; OLYMPIA 1/2 in prurigo nodularis; N=1728 and N=560) evaluating nemolizumab versus placebo for early itch and sleep improvement over the first 14 days using daily PP-NRS and SD-NRS diaries.","key_result":"By Day 2, PP-NRS responder rates (≥4‑point improvement) were higher with nemolizumab vs placebo: 10.7% vs 2.9% in atopic dermatitis (95% CI 5.6–10.1; p<0.0001) and 17.2% vs 3.7% in prurigo nodularis (95% CI 6.8–16.7; p<0.0001); Day 2 SD-NRS responders were 9.9% vs 4.6% in atopic dermatitis (95% CI 2.8–7.7; p=0.0001) and 13.4% vs 4.3% in prurigo nodularis (95% CI 4.0–13.0; p=0.0013), with effects increasing through Day 14.","limitations":"Post hoc design pooling four trials; analyses focus on the first 14 days only and rely on patient-reported NRS outcomes.","practice_takeaway":"Nemolizumab produced clinically meaningful itch relief by 48 hours and improved sleep versus placebo in moderate-to-severe atopic dermatitis and prurigo nodularis, with benefits growing over two weeks."}},{"doi":"10.1001/jamadermatol.2024.4796","pmid":"39602139","title":"Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis","journal_title":"JAMA Dermatology","journal_issn":"2168-6068","published_at":"2024-11-27T00:00:00.000Z","url":"https://doi.org/10.1001/jamadermatol.2024.4796","source_score":80,"is_retracted":false,"is_open_access":false,"raw_metadata":{"ooir":{"day":"2024-12-09","doi":"10.1001/jamadermatol.2024.4796","days":"30","issn":"2168-6068","rank":"5","field":"Clinical Medicine","score":"80","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1001/jamadermatol.2024.4796","title":"Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis: The OLYMPIA 1 Randomized Clinical Phase 3 Trial.","journal":"JAMA dermatology","methods":"","results":"Of 286 patients (mean [SD] age, 57.5 [13.0] years; mean [SD] body weight, 85.0 [20.7] kg; 166 [58.0%] female), 190 were randomized to receive nemolizumab, and 96 were randomized to placebo. A significantly greater proportion of patients assigned to nemolizumab vs placebo achieved itch response (111/190 [58.4%] vs 16/96 [16.7%]; Δ, 40.1% [95% CI, 29.4%-50.8%]; P < .001) and IGA success (50/190 [26.3%] vs 7/96 [7.3%]; Δ, 14.6% [95% CI, 6.7%-22.6%]; P = .003) at week 16. At week 24, the proportion of patients with itch response was 58.3% vs 20.4% (Δ, 38.7% [95% CI, 27.5%-49.9%]) in the ad hoc analysis, and IGA success was 58/190 (30.5%) vs 9/96 (9.4%) (Δ, 19.2% [95% CI, 10.3%-28.1%]) in the nemolizumab-treated vs placebo group. During the treatment period, 134 patients (71.7%) receiving nemolizumab vs 62 patients (65.3%) receiving placebo had at least 1 adverse event; most events were of mild to moderate severity.","abstract":"$37","keywords":[],"pubmed_id":"39602139","conclusions":"","publication_date":"2024-11-27T00:00:00"},"crossref":{"DOI":"10.1001/jamadermatol.2024.4796","URL":"https://doi.org/10.1001/jamadermatol.2024.4796","ISSN":["2168-6068"],"link":[{"URL":"https://jamanetwork.com/journals/jamadermatology/articlepdf/2827129/jamadermatology_stnder_2024_oi_240054_1739305473.3964.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"147","type":"journal-article","issue":"2","score":1,"title":["Efficacy and Safety of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis"],"author":[{"given":"Sonja","family":"Ständer","sequence":"first","affiliation":[{"name":"Center for Chronic Pruritus and Department for Dermatology, University Hospital Münster, Münster, Germany"}]},{"given":"Gil","family":"Yosipovitch","sequence":"additional","affiliation":[{"name":"Miami Itch Center, Miller School of Medicine at the University of Miami, Miami, Florida"}]},{"given":"Franz J.","family":"Legat","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria"}]},{"given":"Adam","family":"Reich","sequence":"additional","affiliation":[{"name":"Department of Dermatology, University of Rzeszów, Rzeszów, Poland"}]},{"given":"Carle","family":"Paul","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Medical University of Toulouse, Toulouse, France"}]},{"given":"Dagmar","family":"Simon","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland"}]},{"given":"Luigi","family":"Naldi","sequence":"additional","affiliation":[{"name":"Academic Research Centre, Centro Studi GISED, Bergamo, Italy"}]},{"given":"Martin","family":"Metz","sequence":"additional","affiliation":[{"name":"Institute of Allergology, Charité-Universitätsmedizin, Berlin, Germany"}]},{"given":"Athanasios","family":"Tsianakas","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Fachklinik Bad Bentheim, Bad Bentheim, Germany"}]},{"given":"Andrew","family":"Pink","sequence":"additional","affiliation":[{"name":"St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom"}]},{"given":"Simon","family":"Fage","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark"}]},{"given":"Giuseppe","family":"Micali","sequence":"additional","affiliation":[{"name":"UOC Dermatology Clinic University of Catania, Catania, Italy"}]},{"given":"Elke","family":"Weisshaar","sequence":"additional","affiliation":[{"name":"Division of Occupational Dermatology, Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany"}]},{"given":"Hema","family":"Sundaram","sequence":"additional","affiliation":[{"name":"Dermatology, Cosmetic & Laser Surgery, Rockville, Maryland & Fairfax, Virginia"},{"name":"Division of Musculoskeletal and Dermatological Sciences, University of Manchester, Manchester, United Kingdom"}]},{"given":"Andrei","family":"Metelitsa","sequence":"additional","affiliation":[{"name":"Beacon Dermatology, Calgary, Alberta, Canada"}]},{"given":"Matthias","family":"Augustin","sequence":"additional","affiliation":[{"name":"University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}]},{"given":"Andreas","family":"Wollenberg","sequence":"additional","affiliation":[{"name":"Deptartment of Dermatology, Augsburg University Hospital, Augsburg, Germany"},{"name":"Department of Dermatology and Allergy, University Hospital, Ludwig-Maximilian University, Munich, Germany"},{"name":"Comprehensive Center for Inflammation 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The primary endpoints were itch response and IGA success at week 16.","key_result":"At week 16, itch response occurred in 111/190 (58.4%) on nemolizumab vs 16/96 (16.7%) on placebo (Δ 40.1%, 95% CI 29.4%-50.8%; P<.001), and IGA success in 50/190 (26.3%) vs 7/96 (7.3%) (Δ 14.6%, 95% CI 6.7%-22.6%; P=.003). Ad hoc week‑24 results were similar for itch (58.3% vs 20.4%; Δ 38.7%, 95% CI 27.5%-49.9%) and IGA success (58/190 [30.5%] vs 9/96 [9.4%]; Δ 19.2%, 95% CI 10.3%-28.1%); any adverse event occurred in 134 (71.7%) vs 62 (65.3%), mostly mild to moderate.","limitations":"Week‑24 efficacy analyses were ad hoc rather than prespecified. Safety was summarized at a high level in the abstract without detailing specific event types or severities.","practice_takeaway":"Nemolizumab every 4 weeks improved itch and skin clearance by week 16 vs placebo in adults with moderate to severe prurigo nodularis, with mostly mild to moderate adverse events. It provides a targeted option for patients meeting these trial criteria."}},{"doi":"10.1001/jamadermatol.2024.1464","pmid":"38837144","title":"Efficacy and Safety of Abrocitinib in Prurigo Nodularis and Chronic Pruritus of Unknown Origin","journal_title":"JAMA Dermatology","journal_issn":"2168-6068","published_at":"2024-06-05T00:00:00.000Z","url":"https://doi.org/10.1001/jamadermatol.2024.1464","source_score":129,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2024-07-23","doi":"10.1001/jamadermatol.2024.1464","days":"30","issn":"2168-6068","rank":"5","field":"Clinical Medicine","score":"129","category":"Dermatology","categories":["Dermatology"],"_categories":["Dermatology"]},"pubmed":{"doi":"10.1001/jamadermatol.2024.1464","title":"Efficacy and Safety of Abrocitinib in Prurigo Nodularis and Chronic Pruritus of Unknown Origin: A Nonrandomized Controlled Trial.","journal":"JAMA dermatology","methods":"","results":"A total of 10 patients with PN (mean [SD] age, 58.6 [13.1] years; all were female) and 10 patients with CPUO (mean [SD] age, 70.7 [5.6] years; 2 were female) enrolled in the study. The mean (SD) baseline PP-NRS score was 9.2 (1.0) for PN and 8.2 (1.2) for CPUO. PP-NRS scores decreased by 78.3% in PN (95% CI, -118.5 to -38.1; P < .001) and 53.7% in CPUO (95% CI, -98.8 to -8.6; P = .01) by week 12. From baseline to week 12, 8 of 10 patients with PN and 6 of 10 patients with CPUO achieved at least a 4-point improvement on the PP-NRS. Both groups experienced significant improvement in quality of life as demonstrated by percent change in DLQI scores (PN: -53.2% [95% CI, -75.3% to -31.1%]; P = .002; CPUO: -49.0% [95% CI, -89.6% to -8.0%]; P = .02). The most common adverse event among patients was acneiform eruption in 2 of 20 patients (10%). 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nonrandomized controlled, but appears to be a single-arm, open-label trial without an external control group.","value_numeric":null},{"paper_doi":"10.1001/jamadermatol.2024.1464","tag_type":"warning","value":"Two participants did not complete the 4-week follow-up.","value_numeric":null}],"summaries":{"what_studied":"A single-center, phase 2, open-label, nonrandomized trial evaluated abrocitinib 200 mg orally once daily for 12 weeks in adults with moderate to severe prurigo nodularis (n=10) or chronic pruritus of unknown origin (n=10), with 4-week follow-up.","key_result":"By week 12, weekly Peak Pruritus NRS decreased by 78.3% in PN (95% CI, -118.5 to -38.1; P<.001) and 53.7% in CPUO (95% CI, -98.8 to -8.6; P=.01); 8/10 PN and 6/10 CPUO achieved ≥4-point PP‑NRS reduction, and DLQI decreased by 53.2% and 49.0%, respectively. Acneiform eruption occurred in 2/20 (10%); no serious adverse events were reported.","limitations":"Small, single-center, open-label, nonrandomized design (n=20) limits internal validity and generalizability. Imbalanced sex distribution (PN all female; CPUO mostly male) and incomplete follow-up for 2 participants may bias results.","practice_takeaway":"Abrocitinib monotherapy produced large 12-week itch reductions and quality-of-life gains in PN and CPUO with few adverse events in this small study; confirmation in randomized, placebo-controlled trials is needed before changing practice."}}],"initialOffset":7,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"condition","value":"Prurigo Nodularis"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Conditions","href":"/hub/tag/condition"},{"name":"Prurigo Nodularis"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"condition","hub_tag_value":"Prurigo Nodularis"}}}]]

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