Patient-oriented measures for phase 3 studies of tralokinumab for the treatment of atopic dermatitis (ECZTRA 1, 2, and 3)

Background: Tralokinumab, as monotherapy or in combination with topical corticosteroids (TCS), has exhibited marked efficacy through 52 weeks in phase 3 trials of adults with moderate-to-severe atopic dermatitis and additional efficacy in a long-term extension trial. Early changes in patient-reported symptoms have not been communicated. Objective: To evaluate early changes in patient-reported outcomes (PROs) across the ECZTRA 1, 2, and 3 tralokinumab trials. Methods: Monotherapy data (ECZTRA 1 + 2) was pooled; ECZTRA 3 evaluated tralokinumab plus optional TCS. The PROs were assessed through the trials. Results: A total of 1596 and 380 patients were randomized in ECZTRA 1 and 2 and ECZTRA 3, respectively. Baseline demographics and clinical characteristics were similar between groups. Early separation from placebo was observed in percentage improvement in worst average daily pruritus numerical rating score (NRS) (week 1, ECZTRA 1 + 2; week 2, ECZTRA 3) and from day 2 in ECZTRA 1 and 2 daily data. More tralokinumab-treated patients achieved clinically meaningful improvements (≥ 4 points) in NRS by week 2 (ECZTRA 1 + 2) or week 3 (ECZTRA 3) vs placebo. Improvements in eczema-related sleep NRS were seen within 2 weeks (week 1, ECZTRA 1 + 2; week 2, ECZTRA 3), supported by similar improvements in other sleep measures. Meaningful changes in Dermatology Life Quality Index were observed from week 2 (ECZTRA 1 + 2). Results were supported by numerical differences from placebo in Patient-Oriented Eczema Measure total score (week 2, both data sets). Conclusion: Tralokinumab with or without TCS exhibited early and clinically meaningful improvements vs placebo in several PROs, which may be beneficial to patients because atopic dermatitis symptom relief is a key treatment concern for patients.