Abrocitinib was associated with greater improvement in itch-related symptoms compared with placebo in patients with moderate to severe atopic dermatitis (AD), according to a post hoc analysis of results from a randomized, double-blind, double-dummy, placebo-controlled trial published in the American Journal of Clinical Dermatology.
The JADE COMPARE trial randomly assigned patients (N=837) with moderate to severe AD in a 2:2:2:1 ratio to receive 100 mg daily oral abrocitinib (n=238), 200 mg daily oral abrocitinib (n=226), 300 mg subcutaneous dupilumab every 2 weeks after a 600-mg loading dose (n=242), or placebo (n=131) for 16 weeks. In this post hoc analysis, the relationship between itch-specific outcomes and quality of life outcomes were evaluated. Moderate Investigator’s Global Assessment (IGA) scores were defined as 3 points.
The study cohorts were well balanced at baseline and patients reported average Eczema Area and Severity Index (EASI) scores of 30.9 (standard deviation [SD], 12.8) points, Peak Pruritus (PP) numeric rating scale (NRS) scores of 7.3 (SD, 1.7), Dermatology Life Quality Index (DLQI) scores of 15.7 (SD, 6.6) points, and 64.6% had moderate IGA scores.
At day 4, more 200 mg abrocitinib recipients achieved a 4-point or greater improvement in PP-NRS score (18.6%) compared with either placebo (6.0%; P <.001) or dupilumab (5.6%; P <.001) recipients. This level of response was maintained by 49.0% of the 200 mg abrocitinib recipients compared with 11.1% of placebo recipients (P <.001) and 26.5% of dupilumab recipients (P <.001) at day 15.
Similarly, for the 100 mg abrocitinib treatment arm, more participants achieved a 4-point or greater improvement in PP-NRS score by day 4 and maintained that level of response through day 15 compared with both comparator treatment arms (all P ≤.03).
In general, PP-NRS responses were correlated with other endpoints among the abrocitinib and placebo recipients, in which more patients who achieved a 4-point or greater improvement in PP-NRS score achieved IGA 0/1, EASI-75, EASI-90, and DLQI 0/1 endpoints.
The change in PP-NRS scores were found to predict whether abrocitinib recipients achieved IGA 0/1, EASI-75, EASI-90, or DLQI 0/1 at week 12 (receiver operating characteristic [ROC] curve range, 0.602-0.694).
The optimal threshold for predicting IGA 0/1, EASI-75, EASI-90, or DLQI 0/1 achievement at week 12 among 200 mg abrocitinib recipients ranged between a decrease in 3 to 5 PP-NRS points (sensitivity range, 57.6%-72.3%; specificity range, 51.3%-72.9%) and for the 100 mg recipients, between -2 to -3 PP-NRS points (sensitivity range, 61.6%-69.6%; specificity range, 45.7%-66.4%).
This study was limited by its post hoc design and the small group samples.
Study authors concluded, “Abrocitinib provides rapid improvement in itch, with significant relief as early as day 4 after treatment, in patients with moderate to severe AD. Early itch relief was associated with additional treatment benefits of skin clearance and improvement in quality-of-life outcomes by week 12.”
Disclosure: Several authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Ständer S, Kwatra SG, Silverberg JI, et al. Early itch response with abrocitinib is associated with later efficacy outcomes in patients with moderate‑to‑severe atopic dermatitis: subgroup analysis of the randomized phase III JADE COMPARE Trial. Am J Clin Dermatol. Published online December 13, 2022. doi:10.1007/s40257-022-00738-4