The SPOSIB SB2 Sicilian Cohort: Safety and Effectiveness of Infliximab Biosimilar SB2 in Inflammatory Bowel Diseases, Including Multiple Switches
| Autor: | A. Trovatello, Giulia Rizzuto, Marco Ventimiglia, E. Giangreco, Andrea Centritto, R. Orlando, Fabio Salvatore Macaluso, Giovita Piccillo, Maria Cappello, E. Giuffrida, C. Bertolami, Walter Fries, R. Vassallo, S. Camilleri, A. Magnano, Sara Renna, Ambrogio Orlando, Anna Viola, Antonino Carlo Privitera, N. Belluardo, Elisa Vinci, S. Garufi |
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| Rok vydání: | 2020 |
| Předmět: |
safety
medicine.medical_specialty SB2 biosimilar infliximab switch Inflammatory bowel disease 03 medical and health sciences 0302 clinical medicine Gastrointestinal Agents Internal medicine medicine Humans Immunology and Allergy Prospective Studies Adverse effect Prospective cohort study Biosimilar Pharmaceuticals business.industry Gastroenterology Biosimilar Inflammatory Bowel Diseases medicine.disease Ulcerative colitis Infliximab Treatment Outcome 030220 oncology & carcinogenesis Cohort 030211 gastroenterology & hepatology Observational study business medicine.drug |
| Zdroj: | Inflammatory Bowel Diseases. 27:182-189 |
| ISSN: | 1536-4844 1078-0998 |
| Popis: | Background No data on the recently introduced infliximab (IFX) biosimilar SB2 in inflammatory bowel disease (IBD) are available. Methods The Sicilian Prospective Observational Study of Patients With IBD Treated With Infliximab Biosimilar SB2 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease. All consecutive IBD patients starting the IFX biosimilar SB2 from its introduction in Sicily (March 2018) to September 2019 (18 months) were enrolled. Results Two hundred seventy-six patients (Crohn disease: 49.3%, ulcerative colitis: 50.7%) were included: 127 (46.0%) were naïve to IFX and naïve to anti-tumor necrosis factor medications (anti-TNFs), 65 (23.5%) were naïve to IFX and previously exposed to anti-TNFs, 17 (6.2%) were switched from an IFX originator to SB2, 43 (15.6%) were switched from the biosimilar CT-P13 to SB2, and 24 (8.7%) were multiply switched (from IFX originator to CT-P13 to SB2). The cumulative number of infusions of SB2 was 1798, and the total follow-up time was 182.7 patient-years. Sixty-seven serious adverse events occurred in 57 patients (20.7%; incidence rate: 36.7 per 100 patient-year), and 31 of these events caused the withdrawal of the drug. The effectiveness after 8 weeks of treatment was evaluated in patients naïve to IFX (n = 192): 110 patients (57.3%) had steroid-free remission, while 56 patients had no response (29.2%). At the end of follow-up, 72 patients (26.1%) interrupted the treatment, without significant differences in treatment persistency estimations between the five groups (log-rank P = 0.15). Conclusions The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13. |
| Databáze: | OpenAIRE |
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