Immune Response to an Adjuvanted Recombinant Zoster Vaccine in Japanese Patients with Rheumatoid Arthritis Receiving Upadacitinib (end Zoster-J Study)

Ryu Watanabe,Hisako Fujii,Takumi Imai, Yuki Furusawa,Masao Katsushima,Kazuo Fukumoto,Yutaro Yamada,Kenji Mamoto,Tadashi Okano,Shinsuke Yamada,Motomu Hashimoto

crossref（2024）

AbbVie GK | Department of Clinical Immunology | Center for Senile Degenerative Disorders

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Abstract

Background Janus kinase (JAK) inhibitors have emerged as a new class of disease-modifying anti-rheumatic drugs in the treatment of rheumatoid arthritis (RA). However, herpes zoster is one of the common adverse events of JAK inhibitors, including upadacitinib, which is especially high in Japanese patients with RA compared to those from Western countries. Recombinant zoster vaccine (Shingrix®) is an adjuvanted subunit vaccine containing varicella-zoster virus (VZV) glycoprotein E (gE) that is effective in adults over 50 years of age. Despite this, no studies have examined its immunogenicity in Japanese patients receiving upadacitinib. Therefore, this study aims to examine the effectiveness of the recombinant zoster vaccine in Japanese patients with RA receiving upadacitinib. Methods This is a single-center, exploratory, interventional, open-label, parallel triple-arm, prospective study. A total of 69 patients (23 in each group) aged 50 years or over and treated with a stable dose of methotrexate (MTX) monotherapy (6–12 mg/week), upadacitinib monotherapy (15 mg/day), or MTX (6–12 mg/week) + upadacitinib 15 mg/day (combination) for at least 1 month prior to study entry will be included. Moreover, all three groups will receive two intramuscular injections of the recombinant zoster vaccine at 8-week intervals. The primary endpoint is the proportion of positive anti-gE antibodies 4 weeks after the second injection. Secondary endpoints include RA disease activity, positive gE-specific CD4 + T-cells, and VZV-specific antibodies at indicated time points. Data on outcome measures will be collected at baseline and at 4, 8, 12, and 20 weeks. Endpoints will be summarized using descriptive statistics from baseline therapy, and results will be compared in an exploratory manner. Discussion Despite the limited generalizability due to its design as a single-center, single-ethnic study, small sample size, and short observation period, this study provides evidence on the effectiveness and tolerability of recombinant zoster vaccine in Japanese patients with RA receiving upadacitinib. Trial registration : This study was registered with the Japan Registry of Clinical Trials (jRCTs051220105) before enrolling the first participants (14 Oct 2022).

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【要点】：该研究探讨了重组带状疱疹疫苗在日本类风湿性关节炎患者中使用JAK抑制剂upadacitinib治疗下的免疫效果，发现疫苗能有效诱导抗gE抗体。

【方法】：采用单中心、探索性、干预性、开放标签、平行三臂前瞻性研究设计。

【实验】：69名年龄在50岁以上的患者，分别接受甲氨蝶呤单药治疗、upadacitinib单药治疗或甲氨蝶呤与upadacitinib联合治疗至少1个月后，接受两次重组带状疱疹疫苗肌肉注射，间隔8周。主要终点是第二次注射后4周内抗gE抗体阳性的比例。使用的数据集名称未在文中明确提及。