Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Eczema Treatment Center of New Jersey, East Windsor, New Jersey.
J Am Acad Dermatol. 2021 Jul;85(1):71-78. doi: 10.1016/j.jaad.2021.03.032. Epub 2021 Mar 17.
Atopic dermatitis (AD) is a chronic inflammatory skin disease. Interleukin (IL) 13 is a type 2 cytokine that is key to the inflammation underlying AD. Tralokinumab is a first-in-class, fully human, monoclonal antibody that specifically binds with high affinity to IL-13, neutralizing it in AD. Immunomodulatory treatments may impair vaccine-induced immune responses.
Assess the immune responses to standard vaccines in adults with moderate-to-severe AD who are undergoing treatment with tralokinumab.
ECZema TRAlokinumab Trial No. 5 (ECZTRA 5; NCT03562377) was a phase 2, double-blind, randomized, placebo-controlled trial taking place over 30 weeks. Eligible adults were randomized 1:1, with 107 patients receiving tralokinumab 300 mg and 108 patients receiving a placebo every 2 weeks for 16 weeks. All patients received Tdap (tetanus/diphtheria/pertussis) and meningococcal vaccines at week 12. The primary end points were positive antitetanus and antimeningococcal responses between weeks 12 and 16 (noninferiority margin, -25%; responder, >3-fold increase in IgG).
The noninferiority of tralokinumab versus placebo for immune response to Tdap (91.9% vs 96.1%) and meningococcal (86.0% vs 84.2%) vaccines was demonstrated at week 16. During treatment, the rates of adverse events were lower for tralokinumab than for the placebo, with most events being mild or moderate.
Responses to other vaccines (including influenza) were not examined.
Treatment with tralokinumab 300 mg every 2 weeks did not affect immune responses to Tdap and meningococcal vaccines. Treatment was well tolerated when administered concomitantly with the vaccines and demonstrated a safety profile comparable to phase 3 trials.
特应性皮炎（AD）是一种慢性炎症性皮肤病。白细胞介素（IL）13 是一种 2 型细胞因子，是 AD 炎症的关键。特利鲁单抗是一种首创的、全人源、单克隆抗体，能够与 IL-13 特异性高亲和力结合，中和 AD 中的 IL-13。免疫调节治疗可能会损害疫苗诱导的免疫反应。
评估中重度 AD 成人在接受特利鲁单抗治疗时对标准疫苗的免疫反应。
ECZema TRAlokinumab 试验 5（ECZTRA 5；NCT03562377）是一项为期 30 周的 2 期、双盲、随机、安慰剂对照试验。符合条件的成年人按 1:1 随机分组，107 例患者接受特利鲁单抗 300mg 每 2 周 1 次，共 16 周，108 例患者接受安慰剂。所有患者在第 12 周时接种 Tdap（破伤风/白喉/百日咳）和脑膜炎球菌疫苗。主要终点是第 12 至 16 周时抗破伤风和抗脑膜炎球菌的阳性反应（非劣效性边界为-25%；应答者为 IgG 增加 3 倍以上）。
第 16 周时，特利鲁单抗与安慰剂相比，对 Tdap（91.9%对 96.1%）和脑膜炎球菌（86.0%对 84.2%）疫苗的免疫反应无差异。治疗期间，特利鲁单抗的不良事件发生率低于安慰剂，大多数事件为轻度或中度。
未检测其他疫苗（包括流感疫苗）的反应。
每 2 周接受特利鲁单抗 300mg 治疗不会影响 Tdap 和脑膜炎球菌疫苗的免疫反应。当与疫苗同时给药时，特利鲁单抗具有良好的耐受性，且安全性与 3 期试验相当。
