Soung Jennifer, Laquer Vivian, Merola Joseph F, Moore Angela, Elmaraghy Hany, Hu Chaoran, Piruzeli Maria Lucia Buziqui, Pierce Evangeline, Garcia Gil Esther, Jarell Abel D
Southern California Dermatology, 1125 E 17th St., Santa Ana, CA, 92701, USA.
Harbor University of California Los Angeles, Torrance, CA, USA.
Dermatol Ther (Heidelb). 2024 Aug;14(8):2181-2193. doi: 10.1007/s13555-024-01217-w. Epub 2024 Jul 15.
Lebrikizumab, a high-affinity IgG4 monoclonal antibody that selectively inhibits interleukin-13 with high binding affinity and slow dissociation rate, prevents the formation of the interleukin-4Rα/interleukin-13Rα1 heterodimer receptor signaling complex. Here we report the impact of lebrikizumab on responses to two non-live vaccines in adult patients with moderate-to-severe atopic dermatitis (AD).
ADopt-VA (NCT04626297) was a double-blind, placebo-controlled, parallel-group, 16-week, phase 3 randomized study to assess the impact of lebrikizumab treatment on non-live vaccine immune responses, and efficacy and safety of lebrikizumab compared with placebo. Eligible patients included adults from 18 to 55 years of age with moderate-to-severe chronic AD who were randomly assigned 1:1 to lebrikizumab 250 mg every 2 weeks or placebo and stratified according to disease severity. The primary endpoints were the development of a booster response to tetanus toxoid and a positive antibody response to meningococcal conjugate vaccine (MCV), 4 weeks after administration of the corresponding vaccine.
At week 16, 73.6% of patients in the lebrikizumab group (n = 78/106) achieved Tdap booster response compared with 73.4% of patients in the placebo group (n = 58/79). MCV vaccine response was observed in 86.9% of patients in the lebrikizumab group (n = 86/99) and 75.0% of patients in the placebo group (n = 60/80). At week 16, IGA 0,1 with ≥ 2-point improvement from baseline was achieved by 40.6% (n = 51/125) of patients treated with lebrikizumab and 18.9% (n = 23/122) of patients who received placebo (p < 0.001). There was a higher proportion of patients achieving EASI 75 at week 16 in the lebrikizumab-treated patients (58.0%, n = 72/125) compared with placebo (32.7%, n = 40/122, p < 0.001).
Treatment with lebrikizumab did not impact response to non-live vaccines Tdap and MCV in this study. Lebrikizumab treatment had a significant degree of efficacy compared to placebo across multiple endpoints.
ClinicalTrials.gov identifier NCT04626297.
瑞莎珠单抗是一种高亲和力IgG4单克隆抗体，以高结合亲和力和缓慢解离速率选择性抑制白细胞介素-13，可防止白细胞介素-4Rα/白细胞介素-13Rα1异二聚体受体信号复合物的形成。在此，我们报告了瑞莎珠单抗对中度至重度特应性皮炎（AD）成年患者两种非活疫苗反应的影响。
ADopt-VA（NCT04626297）是一项双盲、安慰剂对照、平行组、为期16周的3期随机研究，旨在评估瑞莎珠单抗治疗对非活疫苗免疫反应的影响，以及与安慰剂相比瑞莎珠单抗的疗效和安全性。符合条件的患者包括18至55岁患有中度至重度慢性AD的成年人，他们被随机1:1分配接受每2周一次250mg瑞莎珠单抗或安慰剂治疗，并根据疾病严重程度进行分层。主要终点是在接种相应疫苗4周后，对破伤风类毒素的加强反应以及对脑膜炎球菌结合疫苗（MCV）的阳性抗体反应。
在第16周时，瑞莎珠单抗组73.6%的患者（n = 78/106）实现了破伤风、白喉、无细胞百日咳（Tdap）加强反应，而安慰剂组为73.4%的患者（n = 58/79）。瑞莎珠单抗组86.9%的患者（n = 86/99）观察到MCV疫苗反应，安慰剂组为75.0%的患者（n = 60/80）。在第16周时，接受瑞莎珠单抗治疗的患者中有40.6%（n = 51/125）实现了从基线改善≥ 2分的IGA 0、1，接受安慰剂的患者中有18.9%（n = 23/122）实现了这一改善（p < 0.001）。与安慰剂组（32.7%，n = 40/122，p < 0.001）相比，瑞莎珠单抗治疗组在第16周时有更高比例的患者达到EASI 75（58.0%，n = 72/125）。
在本研究中，瑞莎珠单抗治疗对非活疫苗Tdap和MCV的反应没有影响。与安慰剂相比，瑞莎珠单抗治疗在多个终点上具有显著疗效。
ClinicalTrials.gov标识符NCT04626297。
