ArticleDermatology and therapy2026
Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis.
Article in Dermatology and therapy, 2026. 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. Not yet cited in PubMed.
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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, 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
A phase 3b randomized, double-blind, double-dummy, active controlled multi-center study assessing the efficacy and safety of abrocitinib compared with dupilumab in adult participants on background topical therapy with moderate to severe atopic dermatitis
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Abstract
introductionSigns and symptoms of atopic dermatitis (AD) can fluctuate over time, necessitating a flexible dosing treatment approach for long-term management. This study evaluated the long-term efficacy and safety of variable-dose abrocitinib treatment in patients with moderate-to-severe AD compared with continuous abrocitinib 200-mg dosing.
methodsPatients from phase 3 trials in the JADE clinical program were divided into a continuous abrocitinib 200-mg dose cohort or a variable-dose cohort that received abrocitinib 100 mg and 200 mg at different phases of the trial(s).
resultsAt week 48 of abrocitinib treatment, 82% and 69% attained 75% improvement from baseline in the Eczema Area and Severity Index in the continuous abrocitinib 200 mg (n = 941) and variable-dose (n = 90) cohorts, respectively, while 67% and 44% achieved a ≥ 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (PP-NRS4) response. In the continuous abrocitinib 200 mg and variable-dose cohorts, respectively, 23% and 13% achieved complete skin clearance per the Investigator's Global Assessment score of 0, and 44% and 21% achieved a PP-NRS of 0/1 (profound itch control). Similar trends were observed for patient-reported outcomes. Incidence rates for serious adverse events-those leading to discontinuation, deaths, and serious infections-were numerically higher in the variable-dose cohort but numerically lower for malignancies (excluding nonmelanoma skin cancer, major adverse cardiovascular events, venous thromboembolism, thrombocytopenia, lymphopenia, and retinal detachment compared with the continuous abrocitinib 200 mg cohort.
conclusionThus, sustained long-term efficacy was observed with both continuous abrocitinib 200 mg and variable-dose abrocitinib, with no new safety signals. Treatment with continuous abrocitinib 200 mg was the more efficacious treatment regimen, but flexible dosing with abrocitinib may be a viable treatment approach depending on individual patient characteristics and needs. Video abstract available for this article.
trial registrationClinicalTrials.gov identifiers NCT03349060 (trial registration date: November 17, 2017); NCT03575871 (trial registration date: June 15, 2018); NCT03720470 (trial registration date: October 24, 2018); NCT03796676 (trial registration date: January 4, 2019); NCT03627767 (trial registration date: May 29, 2018); NCT04345367 (trial registration date: March 27, 2020); NCT03422822 (trial registration date: December 20, 2017). Video Abstract (mp4 2239 KB).
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