Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn's disease: 3-year results from a real-world study.
| Autor: | Hisamatsu T; Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan., Suzuki Y; Inflammatory Bowel Disease Center, Toho University, Sakura Medical Centre, Sakura, Japan., Kobayashi M; Medical, AbbVie GK, Tokyo, Japan., Hagiwara T; Medical, AbbVie GK, Tokyo, Japan., Kawaberi T; Medical, AbbVie GK, Tokyo, Japan., Ogata H; Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan., Matsui T; Department of Gastroenterology, Fukuoka University Chikushi Hospital, Chikushino, Japan., Watanabe M; Advanced Research Institute, Tokyo Medical and Dental University, Tokyo, Japan., Hibi T; Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan. |
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| Jazyk: | angličtina |
| Zdroj: | Intestinal research [Intest Res] 2021 Oct; Vol. 19 (4), pp. 408-418. Date of Electronic Publication: 2020 Nov 20. |
| DOI: | 10.5217/ir.2020.00025 |
| Abstrakt: | Background/aims: Crohn's disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn's disease in real-world settings. Methods: This was a multicenter, single-cohort, observational study of patients with Crohn's disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI). Results: The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks. Conclusions: Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn's disease in the real-world setting. |
| Databáze: | MEDLINE |
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