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논문 기본 정보

자료유형
학술저널
저자정보
Tadakazu Hisamatsu (Kyorin University School of Medicine) Yasuo Suzuki (Toho University Sakura Medical Center) Mariko Kobayashi (Medical AbbVie GK) Takashi Hagiwara (Medical AbbVie GK) Takeshi Kawaberi (Medical AbbVie GK) Haruhiko Ogata (Keio University School of Medicine) Toshiyuki Matsui (Fukuoka University Chikushi Hospital) Mamoru Watanabe (Tokyo Medical and Dental University) Toshifumi Hibi (Kitasato University Kitasato Institute Hospital)
저널정보
대한장연구학회 Intestinal research Intestinal research Vol.19 No.4
발행연도
2021.10
수록면
408 - 418 (11page)
DOI
10.5217/ir.2020.00025

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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.
#Adalimumab #Crohn disease #Inflammatory bowel diseases #Japanese #Postmarketing surveillance

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참고문헌 (31)

참고문헌 신청
Rutgeerts P / 2012 / Adalimumab induces and maintains mucosal healing in patients with Crohn’s disease : data from the EXTEND trial / Gastroenterology 142:1102~1111 google schola Lichtenstein GR / 2018 / ACG clinical guideline : management of Crohn’s disease in adults / Am J Gastroenterol 113:481~517 google schola Williams H / 2008 / Extraintestinal manifestations of inflammatory bowel disease / Curr Gastroenterol Rep 10:597~605 google schola Zippi M / 2014 / Extraintestinal manifestations in a large series of Italian inflammatory bowel disease patients / World J Gastroenterol 20:17463~17467 google schola Louis E / 2013 / Adalimumab improves patient-reported outcomes and reduces indirect costs in patients with moderate to severe Crohn’s disease : results from the CARE trial / J Crohns Colitis 7:34~43 google schola

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