Safety and efficacy of switching from infliximab biosimilar CT-P13 to infliximab biosimilar SB2 in patients with inflammatory bowel disease
| Autor: | Fabrizio Bossa, Giuseppe Biscaglia, R. Lovero, Mariabeatrice Principi, Rosa Federica La Fortezza, M. Nardella, Giuseppe Losurdo, Giuseppina Martino, Fulvia Terracciano, Alfredo Di Leo, Angelo Andriulli |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Inflammatory bowel disease Gastroenterology 03 medical and health sciences 0302 clinical medicine Gastrointestinal Agents Internal medicine medicine Humans Adverse effect Biosimilar Pharmaceuticals Retrospective Studies Univariate analysis Hepatology biology business.industry C-reactive protein Antibodies Monoclonal Odds ratio Inflammatory Bowel Diseases medicine.disease Ulcerative colitis Infliximab Confidence interval Treatment Outcome 030220 oncology & carcinogenesis biology.protein 030211 gastroenterology & hepatology business medicine.drug |
| Zdroj: | European Journal of Gastroenterology & Hepatology. 32:201-207 |
| ISSN: | 0954-691X |
| DOI: | 10.1097/meg.0000000000001988 |
| Popis: | Introduction For patients with inflammatory bowel diseases, switching from infliximab originator to biosimilars is effective and safe. Few data on single switch have been published, and data on multiple switches of different infliximab are unavailable. Methods A retrospective analysis of patients who switched from CT-P13 to SB2, and of those with multiple switches among different infliximab compounds was conducted. Clinical activity, C reactive protein (CRP), adverse events (AE) and loss of response (LOR) were recorded. Results Thirty-six patients (26 males, 14 Crohn's disease and 22 ulcerative colitis) were enrolled and followed up for >6 months. All patients switched from CT-P13 to SB2; 12 of them (33.3%) had already switched from reference Infliximab to CT-P13, and for the remaining patients CT-P13 was the first infliximab. The clinical remission rate six months before and three months after SB2-switch was the same (58.3%) and the rate of mild activity varied from 27.8 to 33.3% (P = 0.68); the percentage of patients with normal CRP values passed from 94.4 to 91.7% (P = 1). Two patients (5.5%) had AE and 11 (30.5%) a LOR. At univariate analysis, patients with a single switch had a non-significant risk of LOR during SB2 [odds ratio (OR) = 7.86; 95% confidence interval (CI) 0.87-71, P = 0.06]. SB2-LOR was associated with previous AE under CT-P13 (OR = 9.1, 95% CI 0.82-100, P = 0.07). None of such factors was significant at multivariate analysis. Conclusion Switching from CT-P13 to SB2 seems to be safe and effective either in patients with a single than in those with multiple switches. |
| Databáze: | OpenAIRE |
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