Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura, Chiba, 285-8741, Japan.
Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan.
Adv Ther. 2023 Jun;40(6):2902-2914. doi: 10.1007/s12325-023-02500-6. Epub 2023 May 4.
This ongoing post-marketing surveillance monitors the long-term safety and effectiveness of vedolizumab in routine clinical practice in patients with moderate-to-severe ulcerative colitis (UC) in Japan. This interim analysis assessed induction-phase data, covering the initial three doses of vedolizumab.
Patients were enrolled via a web-based electronic data capture system from approximately 250 institutions. Incidence of adverse events and treatment responses were assessed by the physicians after the patient had received three doses of vedolizumab or when the drug was discontinued, whichever occurred first. Therapeutic response was defined as any treatment response, including remission or improvement of complete or partial Mayo score, and was assessed in the total and stratified patient populations according to prior tumor necrosis factor alpha (TNFα) inhibitor treatments and/or baseline partial Mayo score.
The total incidence of adverse drug reactions (ADRs) was 4.10% (11/268). Common ADRs were dizziness, nausea, and arthralgia, each reported in 0.75% of patients (2/268). Serious ADRs were herpes zoster oticus and UC, each reported in 0.37% of patients (1/268). Therapeutic response was reported in 84.5% (218/258) of all patients, 85.8% (127/148) of TNFα inhibitor-naïve patients, and 82.7% (91/110) of TNFα inhibitor-experienced patients. Among patients with partial Mayo score of ≥ 4 at baseline, partial Mayo score remission in patients without or with prior TNFα inhibitor treatment was 62.5% (60/96) and 45.6% (36/79), respectively.
The results confirm a safety and effectiveness profile of vedolizumab consistent with that observed in previous trials.
JapicCTI-194603, NCT03824561.
本上市后监测研究旨在监测维得利珠单抗在日本中重度溃疡性结肠炎（UC）患者常规临床实践中的长期安全性和有效性。本中期分析评估了诱导期数据，涵盖了维得利珠单抗的前 3 个剂量。
通过基于网络的电子数据捕获系统，从约 250 家机构招募患者。在患者接受维得利珠单抗 3 剂或停止治疗（以先发生者为准）后，医生评估不良事件和治疗反应的发生率。治疗反应定义为任何治疗反应，包括完全或部分 Mayo 评分缓解或改善，根据患者先前使用肿瘤坏死因子-α（TNFα）抑制剂治疗情况和/或基线部分 Mayo 评分，在总体和分层患者人群中评估治疗反应。
药物不良反应（ADR）总发生率为 4.10%（11/268）。常见 ADR 为头晕、恶心和关节痛，各有 0.75%（2/268）的患者发生。严重 ADR 为耳带状疱疹和 UC，各有 0.37%（1/268）的患者发生。所有患者中治疗反应的发生率为 84.5%（218/258），TNFα 抑制剂初治患者为 85.8%（127/148），TNFα 抑制剂经治患者为 82.7%（91/110）。基线部分 Mayo 评分≥4 的患者中，无或有 TNFα 抑制剂治疗史患者的部分 Mayo 评分缓解率分别为 62.5%（60/96）和 45.6%（36/79）。
结果证实了维得利珠单抗的安全性和有效性与之前的试验一致。
JapicCTI-194603，NCT03824561。
