Trial reportAllergy2025
Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis.
Trial report in Allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 7 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 3 randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of pf-04965842 monotherapy in subjects aged 12 years and older, with moderate to severe atopic dermatitis
A phase 3 multi-center, long-term extension study investigating the efficacy and safety of abrocitinib, with or without topical medications, administered to subjects aged 12 years and older with moderate to severe atopic dermatitis
A phase 3 randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of pf-04965842 monotherapy in subjects aged 12 years and older, with moderate to severe atopic dermatitis
A phase 3 randomized withdrawal, double-blind, placebo-controlled, multi-center study investigating the efficacy and safety of pf-04965842 in subjects aged 12 years and over, with moderate to severe atopic dermatitis with the option of rescue treatment in flaring subjects
A phase 3, randomized, double-blind, placebo-controlled, multi-center study investigating the efficacy and safety of pf-04965842 co-administered with background medicated topical therapy in adolescent participants 12 to <18 years of age with moderate-to-severe atopic dermatitis
Who cites it
7 citing papers in PubMed.
- Long-term efficacy of abrocitinib in patients with moderate-to-severe atopic dermatitis to 2 years.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Trial
- Update on biologic and small molecules treatments in pediatric allergic diseases.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026Review
- From Barrier Disruption and Immune Dysregulation to Targeted Therapies in Atopic Dermatitis.Clinical reviews in allergy & immunology · 2026Review
- Tailoring Abrocitinib Treatment for Moderate-to-Severe Atopic Dermatitis to Patient Disease Course: A Narrative Review.Dermatology and therapy · 2026Review
- JAK-Inhibitors Beyond the Label: Emerging Applications in Dermatology.Medicina (Kaunas, Lithuania) · 2026Review
- Systemic Therapies for Moderate-to-Severe Atopic Dermatitis in Children and Adolescents: A Systematic Review.Cureus · 2025Review
- Healthcare Service Utilization and Medication Use in 128,239 Children with Atopic Dermatitis in Israel-A Cross-Sectional Case-Control Study.Journal of clinical medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
backgroundAbrocitinib has demonstrated long-term efficacy (48 weeks) and safety (~4 years) in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This analysis evaluated abrocitinib efficacy in adolescents through 112 weeks, and safety of up to 4.6 years of exposure.
methodsData were from adolescents in JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), TEEN (NCT03796676), REGIMEN (NCT03627767; safety analysis only), and the ongoing phase 3 extension trial, EXTEND (NCT03422822; data cutoff: September 5, 2022). Efficacy assessments included proportions of patients achieving an Investigator's Global Assessment score of 0 or 1 (IGA 0/1) and ≥ 75%/≥ 90% improvement in Eczema Area and Severity Index (EASI-75/-90). Treatment-emergent adverse events (TEAEs) and AEs of special interest were reported as incidence rate/100 patient-years. A substudy of JADE TEEN assessed immune response to vaccination.
resultsEfficacy was assessed in 170 and 187 patients in the abrocitinib 200-mg and 100-mg arms, respectively; median exposure was 971.0 and 899.0 days. At Week 112, comparable proportions of patients treated with abrocitinib (200, 100 mg) achieved EASI-75 (85%, 83%), EASI-90 (62%, 60%), and IGA 0/1 (57%, 57%). Safety was assessed in 289 and 201 patients in the abrocitinib 200- and 100-mg arms, respectively; median exposure was 882.0 and 863.0 days. Incidence rates were numerically higher with abrocitinib 200 mg versus 100 mg, with overlapping confidence intervals for serious TEAEs (IR [95% CI]; 5.47 [3.69-7.80] vs. 3.45 [1.89-5.80]) and TEAEs leading to discontinuation (6.78 [4.80-9.31] vs. 5.39 [3.38-8.16]).
conclusionsEfficacy and safety results support long-term abrocitinib use in adolescent patients. TRAIL REGISTRATION: ClinicalTrials.gov Identifiers NCT03349060, NCT03575871, NCT03796676, NCT03627767, NCT03422822.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.