High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents

Abstract

Background: Once-daily abrocitinib treatment provided meaningful improvements in signs and symptoms of moderate-to-severe atopic dermatitis (AD) in randomized controlled studies.

Objective: To evaluate proportions of patients with responses meeting higher threshold efficacy responses than commonly used efficacy end points and to determine if these responses were associated with quality-of-life (QoL) benefits.

Methods: Data from a phase 2b (NCT02780167) and two phase 3 studies (NCT03349060/JADE MONO-1; NCT03575871/JADE MONO-2) in adult and adolescent patients (N = 942) with moderate-to-severe AD receiving once-daily abrocitinib 200 mg, abrocitinib 100 mg or placebo were pooled. Commonly used (Eczema Area and Severity Index [EASI]-75 and ≥4-point improvement in Pruritus Numerical Rating Scale [PP-NRS4]) and higher threshold efficacy end points (EASI-90 to <EASI-100, EASI-100 or PP-NRS0/1 response) were evaluated. Proportions of patients across Children's Dermatology Life Quality Index/Dermatology Life Quality Index (CDLQI/DLQI) band descriptors who achieved various efficacy end points were analysed.

Results: More abrocitinib-treated patients achieved commonly used or higher threshold efficacy end points at week 12 vs. placebo. More abrocitinib-treated patients who achieved higher threshold efficacy end points reported 'no effect' of AD on QoL (by CDLQI/DLQI) at week 12 vs. those who achieved commonly used but not higher threshold efficacy end points (PP-NRS0/1 vs. PP-NRS4 but not PP-NRS0/1 responders [200 mg: 66.3% vs. 17.5%; 100 mg: 62.1% vs. 20.0%]; EASI-100, EASI-90 to <EASI-100 vs. EASI-75 to <EASI-90 responders [200 mg: 67.6%, 48.9% vs. 28.8%; 100 mg: 63.2%, 48.1% vs. 36.7%]).

Conclusions: Substantial proportions of patients with moderate-to-severe AD receiving abrocitinib met higher threshold efficacy end points, and this was associated with meaningful additional QoL benefits compared with those who did not meet these higher efficacy thresholds. Not only do a substantial proportion of abrocitinib-treated patients achieve higher threshold efficacy end points but they also do so in a similar timeframe as the more commonly used thresholds for efficacy end points.

Clinical trials: NCT02780167, NCT03349060 and NCT03575871.

© 2022 Pfizer Inc. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.

Figures

Figure 1

Proportion of patients with moderate‐to‐severe AD who achieved (a) EASI‐75 response, (b) EASI‐75 to

Figure 2

Proportion of patients with moderate‐to‐severe AD who achieved (a) PP‐NRS4 response (≥4‐point improvement from baseline), (b) PP‐NRS4 but not PP‐NRS0/1 response and (c) PP‐NRS0/1 response (baseline score ≥ 2; achieving score 

Figure 3

Distribution of CDLQI/DLQI severity bands at (a) baseline and (b) week 12 of patients with moderate‐to‐severe AD who achieved EASI‐75 to

Figure 4

Distribution of CDLQI/DLQI severity bands at (a) baseline and (b) week 12 of patients with moderate‐to‐severe AD who achieved PP‐NRS4 response but not PP‐NRS0/1 response and PP‐NRS0/1 response at week 12 in the placebo, abrocitinib 100 mg and abrocitinib 200 mg treatment groups. AD, atopic dermatitis; CDLQI, Children's Dermatology Life Quality Index; DLQI, Dermatology Life Quality Index; PP‐NRS, Peak Pruritus Numerical Scale.

Figure 5

Photographs of patients who received abrocitinib 100 mg at baseline, week 2 and week 12. EASI, Eczema Area and Severity Index.