Continuous Tralokinumab Treatment over 4 Years in Adults with Moderate-to-Severe Atopic Dermatitis Provides Long-Term Disease Control

Introduction: Tralokinumab, a monoclonal antibody that specifically neutralizes interleukin-13, is approved for the treatment of moderate-to-severe AD in multiple countries. Clinical trials of up to 52-week duration showed tralokinumab was effective and well-tolerated as monotherapy and in combination with TCS. ECZTEND (NCT03587805) is an ongoing open-label, 5-yr extension trial investigating the long-term safety and efficacy of tralokinumab ± optional TCS. To assess the efficacy of long-term tralokinumab treatment, we conducted a post hoc interim subgroup analysis restricted to the largest, most homogenous patient population, with the longest treatment duration. Methods: Adult patients with moderate-to-severe AD who were continuously treated with tralokinumab ± optional TCS for 52 weeks in the phase 3 parents trials (PTs) ECZTRA 1 (NCT03131648) or ECZTRA 2 (NCT03160885) and for up to 152 weeks in ECZTEND as of data cutoff 04/30/2022 were included. Endpoints included proportion of patients achieving IGA 0/1, EASI-75 or EASI-90 relative to PT baseline, EASI ≤7, worst weekly pruritus (itch) NRS ≤4, and DLQI ≤5. Results are presented using observed data (AO). Sensitivity analyses on patients who completed Week152 in ECZTEND (or who withdrew, but were enrolled in the study ≥152 weeks prior to cutoff) were performed using mNRI with discontinuations due to AEs or lack of efficacy imputed as non-responders and a 2-step MI for other missing data. Results: 347 patients with mean age (SD) of 42. 2 (14. 5) years and mean EASI (SD) of 30. 8 (13. 7) at PT baseline were included. After 4 years of total tralokinumab treatment (at Week 152 in ECZTEND), IGA 0/1 % (n/N) was observed in 52. 6% (92/175) of patients. EASI-75 % (n/N) 95% CI was achieved in 84. 5% (147/174) 78. 4, 89. 1 of patients AO, and 73. 4% (254. 8/347) 68. 6, 78. 3 using mNRI. EASI-90 was achieved in 64. 4% (112/174) 57. 0, 71. 1 of patients AO, and 53. 4% (185. 2/347) 47. 8, 59. 0 using mNRI. EASI ≤7 was observed in 84. 5% (147/174), itch NRS ≤4 in 68. 0% (119/175), and DLQI ≤5 in 79. 0% (128/162) of patients. The safety profile was favorable and consistent with earlier analyses, with no new safety signals arising with continued tralokinumab use. Conclusions: Continuous use of tralokinumab ± optional TCS provided long-term disease control over 4 years in adult patients with moderate-to-severe AD.