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

BackgroundAtopic dermatitis (AD) is a chronic inflammatory skin disease. Interleukin (IL) 13 type 2 cytokine that key to the inflammation underlying AD. Tralokinumab first-in-class, fully human, monoclonal antibody specifically binds with high affinity IL-13, neutralizing it in Immunomodulatory treatments may impair vaccine-induced immune responses.ObjectiveAssess responses standard vaccines adults moderate-to-severe AD who are undergoing treatment tralokinumab.MethodsECZema TRAlokinumab Trial No. 5 (ECZTRA 5; NCT03562377) was phase 2, double-blind, randomized, placebo-controlled trial taking place over 30 weeks. Eligible were randomized 1:1, 107 patients receiving tralokinumab 300 mg and 108 placebo every weeks for 16 All received Tdap (tetanus/diphtheria/pertussis) meningococcal at week 12. The primary end points positive antitetanus antimeningococcal between 12 (noninferiority margin, −25%; responder, >3-fold increase IgG).ResultsThe noninferiority of versus response (91.9% vs 96.1%) (86.0% 84.2%) demonstrated 16. During treatment, rates adverse events lower than placebo, most being mild or moderate.LimitationsResponses other (including influenza) not examined.ConclusionsTreatment did affect vaccines. Treatment well tolerated when administered concomitantly safety profile comparable 3 trials. Atopic responses. Assess tralokinumab. ECZema IgG). moderate. Responses examined.