ArticleAnnals of gastroenterology
Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers.
Article in Annals of gastroenterology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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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
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The efficacy of CT-P13, a biosimilar of infliximab, in inflammatory bowel diseases: a systematic review and meta-analysis.BMC gastroenterology · 2024Pooled it
- Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY).Journal of Crohn's & colitis · 2025Trial
- Review
- Accelerating Earlier Access to Anti-TNF-α Agents with Biosimilar Medicines in the Management of Inflammatory Bowel Disease.Journal of clinical medicine · 2025Review
- Adalimumab biosimilar ABP 501 is equally effective and safe in long-term management of inflammatory bowel diseases patients when used as first biologic treatment or as replace of the ADA originator for a non-medical reason.Frontiers in gastroenterology (Lausanne, Switzerland) · 2023Article
- Measuring Mood and Anxiety Disorders by Patient Reported Outcomes in Inflammatory Bowel Disease: A Literature Review Update.Reviews on recent clinical trials · 2022Review
- Real-world data on the infliximab biosimilar CT-P13 (RemsimaWorld journal of clinical cases · 2021Article
- Real-life burden of adverse reactions to biological therapy in inflammatory bowel disease: a single-centre prospective case series.Medicine and pharmacy reports · 2021Article
- Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Observational
- The Reality of Patient-Reported Outcomes of Health-Related Quality of Life in an Italian Cohort of Patients with Inflammatory Bowel Disease: Results from a Cross-Sectional Study.Journal of clinical medicine · 2020Article
- Process and Clinical Outcomes of a Biosimilar Adoption Program with Infliximab-Dyyb.Journal of managed care & specialty pharmacy · 2020Article
Corrections and comments
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Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers.
methodsConsecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety.
resultsOne hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission.
conclusionThis study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator.
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