1. Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study
- Author
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Yasuo Suzuki, Takashi Hagiwara, Mariko Kobayashi, Kazuo Morita, Tomoyo Shimamoto, and Toshifumi Hibi
- Subjects
adalimumab ,behçet syndrome ,tumor necrosis factor-alpha ,Medicine ,Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Background/Aims The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P
- Published
- 2021
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