{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:42:56Z","timestamp":1787031776747,"version":"build-2736575974"},"reference-count":31,"publisher":"Korean Association for the Study of Intestinal Diseases","issue":"4","license":[{"start":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T00:00:00Z","timestamp":1605830400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["irjournal.org"],"crossmark-restriction":true},"short-container-title":["Intest Res"],"published-print":{"date-parts":[[2021,10,31]]},"abstract":"<jats:p>Background\/Aims: Crohn\u2019s 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\u2019s disease in real-world settings.Methods: This was a multicenter, single-cohort, observational study of patients with Crohn\u2019s 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 &gt; 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 &gt; 2 to \u2264 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\u2019s disease in the real-world setting.<\/jats:p>","DOI":"10.5217\/ir.2020.00025","type":"journal-article","created":{"date-parts":[[2020,11,19]],"date-time":"2020-11-19T01:57:29Z","timestamp":1605751049000},"page":"408-418","update-policy":"https:\/\/doi.org\/10.5217\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn\u2019s disease: 3-year results from a real-world 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