Patient-oriented measures for phase 3 studies of tralokinumab for treatment of atopic dermatitis (ECZTRA 1, 2 and 3)
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
atopic dermatitis; clinical trial; immunotherapy; patient-reported outcomes; pruritus; tralokinumab
BACKGROUND: Tralokinumab, as monotherapy or in combination with topical corticosteroids (TCS), has demonstrated significant efficacy through 52 weeks in phase 3 trials of adults with moderate-to-severe atopic dermatitis (AD) and additional efficacy in a long-term extension trial. Early changes in patient-reported symptoms have not been communicated. OBJECTIVE: To examine 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 examined tralokinumab + optional TCS. PROs were assessed through the trials. RESULTS: 1596 and 380 patients were randomized in ECZTRA 1+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+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) versus 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-Orientated Eczema Measure total score (week 2, both datasets). CONCLUSION: Tralokinumab +/- TCS demonstrated early and clinically meaningful improvements versus placebo in several PROs, which may be beneficial to patients because AD symptom relief is a key treatment concern for patients.
Simpson, Eric L.; Wollenberg, Andreas; Soong, Weily; Steffensen, Louise Abildgaard; Kurbasic, Azra; Schneider, Shannon; Zoidis, John; and Silverberg, Jonathan I., "Patient-oriented measures for phase 3 studies of tralokinumab for treatment of atopic dermatitis (ECZTRA 1, 2 and 3)" (2022). GW Authored Works. Paper 1304.