ArticleIntestinal research2021
Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational 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 15 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review.Journal of managed care & specialty pharmacy · 2024Pooled it
- Adalimumab Safety in Inflammatory Bowel Disease: A Clinical Cohort Study with Time-to-Event Analysis and FAERS Signal Assessment.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Safety and Effectiveness of Adalimumab for the Treatment of Pyoderma Gangrenosum: A 52-Week Real-World Prospective Observational Study.Dermatology and therapy · 2026Article
- Review
- A targeted review of clinical outcomes of advanced IBD therapies in Latin America.Therapeutic advances in gastroenterology · 2025Review
- Reviewing not Homer's Iliad, but "Kai Bao Ben Cao": indigo dye-the past, present, and future.Intestinal research · 2023Article
- Circulating Profile of ECM-Related Proteins as Diagnostic Markers in Inflammatory Bowel Diseases.Journal of clinical medicine · 2022Article
- Do We Have an Opportunity to Avoid Opportunistic Infections in Asian Patients with Inflammatory Bowel Disease?Gut and liver · 2022Article
- Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study.Gut and liver · 2022Observational
- Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α.The Korean journal of internal medicine · 2022Review
- [Latent and Active Tuberculosis Infection in Patients with Inflammatory Bowel Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2022Review
- [Viral Hepatitis in Patients with Inflammatory Bowel Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2022Review
- Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study.Intestinal research · 2022Article
- Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?Gut and liver · 2022Article
- 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
5 authors.
Funding
Abstract
BACKGROUND/
aimsAdalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC.
methodsIn this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline.
resultsOf 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52.
conclusionsThis large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.
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