Abrocitinib improves atopic dermatitis signs, symptoms

Both 100 mg and 200 mg doses of once-daily abrocitinib improved signs and symptoms in patients with moderate to severe atopic dermatitis, according to a study.

“Abrocitinib, a small-molecule JAK1 inhibitor that is administered orally once daily, inhibits signaling of interleukin-4, interleukin-13 and other cytokines involved in the pathogenesis of atopic dermatitis,” Thomas Bieber, MD, PhD, professor of dermatology and allergy at University Hospital of Bonn, Germany, and colleagues wrote.

The multicenter, randomized, double-blind, placebo-controlled JADE COMPARE trial included 838 patients randomly assigned to receive once-daily abrocitinib 100 mg, abrocitinib 200 mg, dupilumab or placebo.

Primary endpoints were an Investigator’s Global Response score of 0 or 1 with an improvement of at least two points from baseline and an Eczema Area and Severity Index response of 75% improvement or more from baseline at week 12.

Of those in the 200 mg treatment group, 106 of 219 patients (48.4%) had an IGA response at week 12 compared with 86 of 235 (36.6%) in the 100 mg group, 88 of 241 (36.5%) in the dupilumab group and 18 of 129 (14%) in the placebo group.

An EASI-75 score was found in 154 of 219 patients (70.3%) in the 200 mg abrocitinib cohort, 138 of 235 (58.7%) in the 100 mg cohort, 140 of 241 (58.1%) in the dupilumab cohort and 35 of 129 (27.1%) in the placebo cohort.

The 200 mg abrocitinib group and the placebo group had a weighted difference of 34.8 percentage points (95% CI, 26.1-43.5; P < .001) regarding IGA response at week 12, with a difference of 23.1 percentage points (95% CI, 14.7-31.4; P < .001) between the 100 mg abrocitinib group and the placebo group. The 200 mg abrocitinib group and the placebo group had a weighted difference of 43.2 percentage points (95% CI, 33.7-52.7; P < .001) regarding EASI-75 response at week 12, with a difference of 31.9 percentage points (95% CI, 22.2-41.6; P < .001) between the 100 mg abrocitinib group and the placebo group.

Secondary endpoints of the trial included itch improvement and IGA and EASI-75 responses at week 16.

At week 2, 111 of 226 patients (49.1%) in the 200 mg treatment group had an itch response compared with 75 of 236 (31.8%) in the 100 mg group, 63 of 239 (26.4%) in the dupilumab group and 18 of 130 (13.8%) in the placebo group. The weighted difference was 34.9 percentage points between the 200 mg and placebo groups and 17.9 percentage point between the 100 mg and placebo groups (both P < .001).

At week 16, an IGA response was recorded in 105 of 221 patients (47.5%) in the 200 mg group, 80 of 230 (34.8%) in the 100 mg group, 90 of 232 (38.8%) in the dupilumab group and 16 of 124 (12.9%) in the placebo group.

At week 16, EASI-75 response was recorded in 157 of 221 patients (71%) in the 200 mg group, 138 of 229 (34.8%) in the 100 mg group, 152 of 232 (65.5%) in the dupilumab group and 38 of 124 (30.6%) in the placebo group.

“In the JADE COMPARE trial, abrocitinib at a dose of either 200 mg or 100 mg once daily resulted in significantly greater reductions in signs and symptoms of moderate to severe atopic dermatitis than placebo on the basis of IGA and EASI-75 responses at weeks 12 and 16,” the authors wrote. “The 200 mg dose, but not the 100 mg dose, of abrocitinib was superior to dupilumab with respect to itch response at week 2, but neither abrocitinib dose differed significantly from dupilumab with respect to most other key secondary endpoints at week 16.”