ArticleIntestinal research2021
Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn's disease: 3-year results from a real-world study.
Article in Intestinal research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
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Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Adalimumab Therapy for Crohn's Disease and Axial Spondyloarthritis in Latent Tuberculosis:Sultan Qaboos University medical journal · 2026Pooled it
- Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis.European journal of medical research · 2022Pooled it
- Adalimumab Safety in Inflammatory Bowel Disease: A Clinical Cohort Study with Time-to-Event Analysis and FAERS Signal Assessment.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet's disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study.The Korean journal of internal medicine · 2023Article
- Clinical features of enteric and colo-duodenal fistula in patients with Crohn's disease.Intestinal research · 2023Article
- Natural history of inflammatory bowel disease: a comparison between the East and the West.Intestinal research · 2022Review
- Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α.The Korean journal of internal medicine · 2022Review
- [Viral Hepatitis in Patients with Inflammatory Bowel Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2022Review
- Prevention of postoperative recurrence in Crohn's disease: the never-ending story.Intestinal research · 2022Article
- TNF-alpha inhibitors and ustekinumab for the treatment of psoriasis: therapeutic utility in the era of IL-17 and IL-23 inhibitors.Journal of psoriasis and psoriatic arthritis · 2022Article
- Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?Gut and liver · 2022Article
- Biological Therapies for the Management of Enteric Disease: Considerations for the Clinician.Biologics : targets & therapy · 2022Review
- Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?Gut and liver · 2021Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
aimsCrohn'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.
methodsThis 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).
resultsThe 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.
conclusionsResults 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.
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