Trial reportAmerican journal of clinical dermatology2021
Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program.
Trial report in American journal of clinical dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 6 registered trials, which are not on this map. Cited by 68 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 2b randomized, double-blind, placebo-controlled, parallel, multicenter, dose-ranging, study to evaluate the efficacy and safety profile of pf-04965842 in subjects 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 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, double-dummy, placebo-controlled, parallel group, multi-center study investigating the efficacy and safety of pf-04965842 and dupilumab in comparison with placebo in adult subjects on background topical therapy, with moderate to severe atopic dermatitis
Who cites it
68 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- JAK Inhibitor Safety in Atopic Dermatitis and Alopecia Areata: A 4.5-Year Real-World Retrospective Cohort Study.Dermatology and therapy · 2026Pooled it
- Review of Herpes Zoster Occurrence in Patients With Atopic Dermatitis Treated With JAK Inhibitors.Clinical and translational science · 2026Pooled it
- Real-World Evidence of Effectiveness and Safety of Abrocitinib, Baricitinib and Upadacitinib in Atopic Dermatitis: A Systematic Review and Meta-Analysis.American journal of clinical dermatology · 2026Pooled it
- Real-World Evidence of Effectiveness and Safety of Abrocitinib, Baricitinib and Upadacitinib in Atopic Dermatitis: A Systematic Review and Meta-Analysis.American journal of clinical dermatology · 2026Pooled it
- European Guideline (EuroGuiDerm) on atopic eczema: Living update.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025Guideline
- Real-World Effectiveness and Safety of JAK Inhibitors in Atopic Dermatitis: A Systematic Review and Meta-Analysis.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2025Pooled it
- The impact of abrocitinib treatment on lesion area and pruritus in patients with atopic dermatitis: a systematic review and meta-analysis.European journal of medical research · 2025Pooled it
- Safety, tolerability, pharmacokinetics, and pharmacodynamics of LW402, a preferential Janus kinase 1 inhibitor in healthy volunteers: a randomized, double-blinded, placebo-controlled phase 1 trial.Frontiers in pharmacology · 2026Trial
- Integrated Safety Update of Abrocitinib in 3802 Patients with Moderate-to-Severe Atopic Dermatitis: Data from More than 5200 Patient-Years with Up to 4 Years of Exposure.American journal of clinical dermatology · 2024Trial
- Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program.American journal of clinical dermatology · 2024Trial
- Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis.Dermatology and therapy · 2026Article
- The JAK-STAT pathway in allergic diseases: from pathogenesis to targeted therapy.Biomarker research · 2026Review
- Lebrikizumab ADvocate1 and 2 Monotherapy and ADjoin (Long-Term) Trials: Use of Topicals Therapies.Dermatology and therapy · 2026Review
- Long-Term Effectiveness and Safety of Abrocitinib in Patients with Atopic Dermatitis: A Real-World, Retrospective Study.Dermatology and therapy · 2026Article
- Real-World Effectiveness and Safety of Abrocitinib in Patients with Atopic Dermatitis: A 16-Week Single-Center Retrospective Cohort Study Compared with Upadacitinib and Baricitinib.Dermatology and therapy · 2026Article
- Systemic Corticosteroid Exposure in Patients with Atopic Dermatitis: A US Population-Based Study.Dermatology and therapy · 2026Article
- 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
- The role of JAK3 and TEC family kinases in vitiligo pathogenesis.Frontiers in immunology · 2026Review
- Update of the evidence- and consensus-based S3 guideline on atopic dermatitis: Systemic therapy with biologics or Janus kinase inhibitors and specific aspects of systemic therapy in pregnancy and lactation.Allergologie select · 2026Article
8 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
14 authors.
Funding
Abstract
backgroundPivotal phase III studies demonstrated that abrocitinib, an oral, once-daily, JAK1-selective inhibitor, is effective treatment for moderate-to-severe atopic dermatitis (AD) as monotherapy and in combination with topical therapy.
objectiveThe aim of this study was to evaluate the long-term safety of abrocitinib 200 mg and 100 mg in an integrated analysis of a phase IIb study, four phase III studies, and one long-term extension study.
methodsTwo cohorts were analyzed: a placebo-controlled cohort from 12- to 16-week studies and an all-abrocitinib cohort including patients who received one or more abrocitinib doses. Adverse events (AEs) of interest and laboratory data are reported.
resultsTotal exposure in the all-abrocitinib cohort (n = 2856) was 1614 patient-years (PY); exposure was ≥ 24 weeks in 1248 patients and ≥ 48 weeks in 606 (maximum 108 weeks). In the placebo-controlled cohort (n = 1540), dose-related AEs (200 mg, 100 mg, placebo) were nausea (14.6%, 6.1%, 2.0%), headache (7.8%, 5.9%, 3.5%), and acne (4.7%, 1.6%, 0%). Platelet count was reduced transiently in a dose-dependent manner; 2/2718 patients (200-mg group) had confirmed platelet counts of < 50 × 10
conclusionAbrocitinib, with proper patient and dose selection, has a manageable tolerability and longer-term safety profile appropriate for long-term use in patients with moderate-to-severe AD. TRIAL REGISTRIES: ClinicalTrials.gov: NCT02780167, NCT03349060, NCT03575871, NCT03720470, NCT03627767, NCT03422822.
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What OpenQuestion holds
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.