Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis

Abstract

an oral, once-daily Janus kinase 1 selective inhibitor, was effective and well tolerated in a phase 3 monotherapy trial of patients with moderate-to-severe atopic dermatitis (AD). OBJECTIVE To investigate the efficacy and safety of abrocitinib in adolescents and adults with moderate-to-severe AD in an identically designed trial. DESIGN, SETTING, AND PARTICIPANTS This phase 3, double-blinded, placebo-controlled, parallel-group randomized clinical trial included patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months. Patients were enrolled from 115 centers in Australia,

Quantifying patient preferences for systemic atopic dermatitis treatments using a discrete-choice experiment

“…abrocitinib, baricitinib, and upadacitinib) and injectable anti-IL-13 antibodies (i.e. tralokinumab and lebrikizumab) that have shown promise in early-phase clinical studies [17][18][19][20][21][22].…”

Emerging systemic JAK inhibitors in the treatment of atopic dermatitis: a review of abrocitinib, baricitinib, and upadacitinib

“…At week 12, 43.8%, 23.7%, and 7.9% of those participants receiving 200 mg abrocitinib, 100 mg abrocitinib, and placebo, respectively, achieved an IGA response in the JADE-MONO-1 study, 18 whereas the IGA response was 38.1%, 28.4%, and 9.1%, respectively, in the JADE MONO-2 trial. 19 According to the JADE MONO-1 study, an improvement of at least 75% in EASI score (EASI-75) was reached in 62.7%, 39.7%, and 11.8% of those treated with 200 mg, 100 mg, and placebo, respectively, whereas EASI-75 was achieved in 61.0%, 44.5%, and 10.4% of participants receiving 200 mg, 100 mg, and placebo, respectively, in the JADE MONO-2 study. At week 12, a Peak Pruritus Numerical Rating Scale score improvement of 4 or more was achieved in 57%, 38%, and 15% of those participants receiving 200 mg abrocitinib, 100 mg abrocitinib, and placebo, respectively, in the JADE MONO-1 study and in 55.3%, 45.2%, and 11.5% of participants in the JADE MONO-2 study.…”

“…TEAEs were reported in 77.9%, 69.2%, and 57.1% of the 200 mg abrocitinib, 100 mg abrocitinib, and placebo groups, respectively. According to the JADE MONO-2 study, 19 of 391 subjects, SAEs were reported in 1.3%, 3.2%, and 1.3% of patients in the 200 mg abrocitinib, 100 mg abrocitinib, and placebo groups, respectively, with one sudden cardiac death reported in the 100 mg abrocitinib group occurring during the follow-up period and was deemed not to be related to treatment. TEAEs were reported in 65.8%, 62.7%, and 53.8% of patients in the 200 mg abrocitinib, 100 mg abrocitinib, and placebo treatment arms, respectively.…”

“…TEAEs were reported in 65.8%, 62.7%, and 53.8% of patients in the 200 mg abrocitinib, 100 mg abrocitinib, and placebo treatment arms, respectively. 19 In both the JADE MONO-1 and JADE MONO-2 trials, the most common TEAEs were headache, nausea, nasopharyngitis, upper respiratory tract infection, and AD. Platelet count reductions as well as lipid level elevations were reported in both JADE MONO-1 and JADE MONO-2.…”

<p>Emerging Role of Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis</p>

“…42,43 A phase II randomized, double-blind, placebo-controlled trial assessed the safety and the efficacy of abrocitinib in AD patients via improvement in IGA scores, with a focus on the proportion of patients achieving IGA scores of 0 or 1 (clear or almost clear skin). 44 46 The results of these trials suggest the most efficacious dosing for abrocitinib is either 100 mg or 200 mg oral tablets once daily. 42,45,47…”