ArticleDermatology and therapy2024
Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis.
Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 2 papers.
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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 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis
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 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
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
2 citing papers in PubMed.
- Abrocitinib Achieves Early and Complete/Near-Complete Skin Clearance Plus Itch-Free State in Atopic Dermatitis: Phase 3 Pooled Post Hoc Analysis.Dermatology and therapy · 2026Article
- Tailoring Abrocitinib Treatment for Moderate-to-Severe Atopic Dermatitis to Patient Disease Course: A Narrative Review.Dermatology and therapy · 2026Review
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9 authors.
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No grant is acknowledged in the PubMed record.
Abstract
introductionEarly prediction of abrocitinib efficacy in atopic dermatitis (AD) could help identify candidates for an early dose increase. A predictive model determined week 12 efficacy based on week 4 responses in patients receiving abrocitinib 100 mg/day and assessed the effect of an abrocitinib dose increase on platelet counts.
methodsAnalysis included the phase 3 trials JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), COMPARE (NCT03720470), and TEEN (NCT03796676). For platelet counts and simulations, a phase 2 psoriasis trial (NCT02201524) and phase 2b (NCT02780167) and phase 3 (MONO-1, MONO-2, and REGIMEN (NCT03627767)) abrocitinib trials were pooled. A training-and-validation framework assessed potential predictors of response at week 4: score and score change from baseline in the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), and Peak Pruritus Numerical Rating Scale (PP-NRS), and percentage change from baseline in EASI. The dependent variables at week 12 were ≥ 75% improvement in EASI (EASI-75) and IGA score of 0 (clear) or 1 (almost clear) and ≥ 2-point improvement from baseline. The probability of each variable to predict week 12 EASI-75 and IGA responses was calculated.
resultsIn the training cohort (n = 453), 72% of the ≥ 50% improvement in EASI (EASI-50) at week 4 responders and 16% of the nonresponders with abrocitinib 100 mg achieved EASI-75 at week 12; 48% and 6% of the week 4 EASI-50 responders and nonresponders, respectively, achieved week 12 IGA response. Similar results occurred with week 4 IGA = 2, ≥ 4-point improvement from baseline in PP-NRS, or EASI = 8 responders/nonresponders. Platelet counts after an abrocitinib dose increase from 100 to 200 mg were similar to those seen with continuous dosing with abrocitinib 100 mg or 200 mg.
conclusionAchieving week 4 clinical responses with abrocitinib 100 mg may be useful in predicting week 12 responses. Week 4 nonresponders may benefit from a dose increase to abrocitinib 200 mg, and those that receive this dose increase are likely to achieve treatment success at week 12, with no significant impact on platelet count recovery. Video abstract available for this article. CLINICAL
trial registrationNCT03349060, NCT03575871, NCT03720470, NCT03796676, NCT02201524, NCT02780167 and NCT03627767.
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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.