Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study
| Autor: | Takashi Hagiwara, Kazuo Morita, Toshifumi Hibi, Mariko Kobayashi, Tomoyo Shimamoto, Yasuo Suzuki |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Disease Behcet's disease RC799-869 Behçet syndrome 03 medical and health sciences 0302 clinical medicine Internal medicine Clinical endpoint medicine Adalimumab Tumor necrosis factor-alpha 030203 arthritis & rheumatology business.industry Incidence (epidemiology) Gastroenterology Diseases of the digestive system. Gastroenterology medicine.disease Inflammatory Bowel Diseases Clinical trial Concomitant Medicine 030211 gastroenterology & hepatology Observational study Original Article business medicine.drug |
| Zdroj: | Intestinal Research Intestinal Research, Vol 19, Iss 3, Pp 301-312 (2021) |
| ISSN: | 2288-1956 1598-9100 |
| Popis: | Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behcet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japa nese patients with intestinal Behcet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behcet’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 recom mended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) pa tients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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