Baricitinib Provides Significant Improvements in Quality of Life and Functioning in Adults with Moderate-to-Severe Atopic Dermatitis with Baseline Body Surface Area ≤ 40% and Severe Itch.

Abstract

Introduction: Patients with moderate-to-severe atopic dermatitis (AD), a body surface area (BSA) of ≤ 40%, and an itch numerical rating scale (NRS) score of ≥ 7 ("BARI itch dominant") have been characterized as an important group to consider for the oral janus kinase (JAK) 1/2 inhibitor baricitinib (BARI). Herein we aim to evaluate quality of life (QoL) and functioning outcomes in adult patients with BSA ≤ 40% and itch NRS ≥ 7 at baseline (BL) who received BARI 4 mg in the topical corticosteroid (TCS) combination trial BREEZE-AD7.

Materials: BREEZE-AD7 was a randomized, double-blind, placebo-controlled, parallel-group outpatient study involving adult patients with moderate-to-severe AD who received once-daily placebo or 2-mg or 4-mg BARI in combination with TCS for 16 weeks. Patients eligible for enrollment had to have BSA ≥ 10%. This post-hoc analysis focused on placebo and BARI 4 mg for patients with BSA ≤ 40% and itch NRS ≥ 7. QoL impairment was measured using a Dermatology Life Quality Index (DLQI) of ≤ 5, and functioning outcomes were assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported descriptively. Last observation carried forward (LOCF) data were reported, excluding data collected after the first rescue therapy date or permanent study drug discontinuation. Non-responder imputation was used to account for missing data.

Results: At BL, patients with BSA ≤ 40% and itch NRS ≥ 7 had high QoL impairment. The mean DLQI score at BL for patients who received BARI 4 mg and placebo indicates a very large effect of AD on patients' QoL. Patients who received BARI and placebo experienced a significant itch burden and reported a similar itch NRS. At week 16, 61.5% of patients treated with BARI 4 mg indicated that it had no to only a small effect on their QoL (DLQI ≤ 5), versus 24.1% for patients receiving placebo (p < 0.01). A decrease in WPAI work impairment score of - 41.6 for BARI patients and - 7.0 for placebo patients was observed at week 16 (p < 0.01). Patients receiving BARI also observed a noticeable improvement in WPAI daily activity impairment of - 30.4 from baseline at week 16 compared to patients on placebo, who achieved - 12.2 (p < 0.01).

Conclusion: Despite having high QoL impairment at baseline, patients with itch-dominant AD treated with BARI 4 mg showed marked benefits in QoL, daily life activity, and work function compared to placebo after 16 weeks of treatment. Limitations include the small sample size analyzed.