Tralokinumab Does Not Impact Vaccine-induced Immune Responses: Results From a 30-week, Randomized, Placebo-controlled Trial in Adults With Moderate-to-severe Atopic Dermatitis.

Abstract Background Atopic dermatitis (AD) is a chronic inflammatory skin disease. Interleukin (IL)-13, a type 2 cytokine, is key in AD inflammation. Tralokinumab is a first-in-class, fully human, monoclonal antibody that specifically binds with high affinity and neutralizes IL-13 in AD. Immunomodulatory treatments may impair vaccine-induced immune responses. Objective Assess immune responses to standard vaccines in tralokinumab-treated adults with moderate-to-severe AD. Methods ECZTRA 5 (NCT03562377) was a phase 2, double-blind, randomized, placebo-controlled, 30-week trial. Eligible adults were randomized 1:1 (tralokinumab 300 mg or placebo, 107:108 every 2 weeks [q2w] for 16 weeks), receiving Tdap (tetanus/diphtheria/pertussis) and meningococcal vaccines at week 12. Primary endpoints were positive anti-tetanus and anti-meningococcal responses (week 12−week 16; noninferiority margin, –25%; responder, >3-fold immunoglobulin-G increase). Results At week 16, noninferiority of tralokinumab versus placebo for immune responses to Tdap (91.9% vs 96.1%) and meningococcal (86.0% vs 84.2%) vaccines was demonstrated. During treatment, adverse-event rates were lower for tralokinumab versus placebo; most events were mild or moderate. Limitations Responses to other vaccines (including influenza) not examined. Conclusion Tralokinumab 300 mg q2w treatment did not affect immune responses to Tdap and meningococcal vaccines, and was well tolerated when administered concomitantly, with safety profile comparable to phase 3 trials.