Abrocitinib, a once-daily oral Janus kinase (JAK) 1-selective inhibitor, is currently undergoing a number of phase 3 trials to test its efficacy and safety for the treatment of atopic dermatitis (AD). In particular, researchers sought to determine the effect of abrocitinib on Peak Pruritus Numerical Rating Scale (PP-NRS); the results of their study were reported in a poster abstract presented at the American Academy of Dermatology Virtual Meeting Experience 2020.
A previously completed phase 3 trial, JADE MONO-1, demonstrated that abrocitinib was a well-tolerated and effective treatment for adolescents and adults with moderate to severe AD. To build off of that available data, the present research group sought out to assess the PP-NRS2 and PP-NRS4 responder rates (≥2-point and ≥4-point improvement, respectively) and times to PP-NRS response, as well as the percentage change from baseline in PP-NRS overall and by baseline PP-NRS.
This randomized, double-blind, placebo-controlled study looked at the differences in atopic dermatitis presentation in 200-mg and 100-mg abrocitinib and compared it with placebo. Patients were aged greater than or equal to 12 years and had moderate to severe AD for greater than or equal to 1 year. PP-NRS was assessed at baseline, daily through day 15, and subsequently at weeks 4, 8, and 12.
Included in the study were 387 participants (placebo, n=77; 100-mg abrocitinib, n=156; 200-mg abrocitinib, n=154). At baseline, 229 and 158 patients reported Investigator’s Global Assessment scores of 3 and 4, respectively, along with a mean Eczema Area and Severity Index score of 30.5 (SD, 13.6). The mean PP-NRS score was 7.0 (SD, 1.9), with 139 reporting a score of 7 or less and 247 reporting a score of greater than or equal to 7.
At the trial conclusion, abrocitinib demonstrated impressive results. The median time to response in the 200-mg group was 4 (range, 3-5) days vs 7 (range, 6-9) for the 100-mg group and 19 (range, 8-57) in the placebo group. Notably, 68.1% of the 200-mg group and 57.4% of the 100-mg group saw greater than or equal to 2 points improvement in PP-NRS response by day 15, vs placebo, which saw only 30.2% achieving improvement. Further, 57.2% and 37.7% of patients in the 200-mg and 100-mg groups, respectively, saw greater than or equal to 4-point improvement in PP-NRS by week 12 of treatment.
Overall, 200-mg abrocitinib saw a -56.5% change in PP-NRS compared with -39.5% for the 100-mg dose and only -19.5% for placebo.
“Abrocitinib was well tolerated,” said the researchers, “and it rapidly (within 1 day) and significantly improved pruritus versus placebo, regardless of baseline PP-NRS.”
Simpson EL, Ständer S, Yosipovitch G, et al. Peak Pruritus Numeric Rating Scale (PP-NRS) response with abrocitinib in patients with moderate-to-severe atopic dermatitis (AD): results from a randomized, phase 3 clinical trial. Presented at: American Academy of Dermatology Virtual Meeting Experience 2020; June 12-14, 2020.