Vedolizumab found safe, effective in post-marketing surveillance
An interim analysis of an ongoing post-marketing surveillance study in Japan has found that vedolizumab, a drug used to treat moderate-to-severe ulcerative colitis (UC), has a safety and effectiveness profile consistent with that observed in previous trials. The study assessed induction-phase data covering the initial three doses of the drug.
Patients were enrolled via a web-based electronic data capture system from approximately 250 institutions, and physicians assessed the incidence of adverse events and treatment responses after the patient had received 3 doses of vedolizumab or when the drug was discontinued, whichever occurred first. The therapeutic response was defined as any treatment response, including remission or improvement of complete or partial Mayo score.
Of the 268 patients enrolled in the study, the total incidence of adverse drug reactions (ADRs) was 4.10%, with common ADRs being dizziness, nausea, and arthralgia. Serious ADRs were herpes zoster oticus and UC, each reported in 0.37% of patients. However, therapeutic response was reported in 84.5% of all patients, with slightly higher rates observed in TNFα inhibitor-naïve patients (85.8%) than in TNFα inhibitor-experienced patients (82.7%).
Among patients with a partial Mayo score of ≥ 4 at baseline, partial Mayo score remission was achieved in 62.5% of patients without prior TNFα inhibitor treatment and 45.6% of patients with prior TNFα inhibitor treatment.
Matsuoka K, Hisamatsu T, Mikami Y, et al. Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study. Adv Ther. 2023;doi: 10.1007/s12325-023-02500-6. Epub ahead of print. PMID: 37140705.