Switching from infliximab innovator to biosimilar in patients with inflammatory bowel disease: a 12-month multicentre observational prospective cohort study
| Autor: | M. E. C. van de Poll, Luc Brunsveld, Luc J J Derijks, E. M. H. Schmitz, Maarten A. C. Broeren, Volkher Scharnhorst, P. J. Boekema, Jan Willem A Straathof, D. C. van Renswouw |
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| Přispěvatelé: | Chemical Biology |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Disease Inflammatory bowel disease Infliximab/immunology Cohort Studies 03 medical and health sciences 0302 clinical medicine Gastrointestinal Agents Inflammatory Bowel Diseases/drug therapy Internal medicine Humans Medicine Gastrointestinal Agents/immunology Pharmacology (medical) Prospective cohort study Adverse effect Biosimilar Pharmaceuticals Hepatology Drug Substitution business.industry Remission Induction Gastroenterology Biosimilar Middle Aged Inflammatory Bowel Diseases medicine.disease Infliximab Biosimilar Pharmaceuticals/therapeutic use Treatment Outcome 030220 oncology & carcinogenesis Cohort Female 030211 gastroenterology & hepatology Observational study business Follow-Up Studies medicine.drug |
| Zdroj: | Alimentary Pharmacology and Therapeutics, 47(3), 356-363. Wiley-Blackwell |
| ISSN: | 0269-2813 |
| DOI: | 10.1111/apt.14453 |
| Popis: | SummaryBackground Infliximab biosimilars have become available for treatment of inflammatory bowel disease (IBD). However, data showing long-term safety and effectiveness of biosimilars in IBD patients are limited. Aim To study prospectively the switch from infliximab innovator to biosimilar in an IBD cohort with 12 months follow-up to evaluate safety and effectiveness. Methods Adult IBD patients from two hospitals treated with infliximab innovator (Remicade; Janssen Biotech, Horsham , Pennsylvania, USA) were switched to infliximab biosimilar (Inflectra; Hospira, Lake Forest, Illinois, USA) as part of routine care, but in a controlled setting. Blood samples were taken just before the first, second, fourth and seventh infusion of biosimilar. Infliximab trough levels, antibodies-to-infliximab (ATI), CRP and ESR were measured and disease activity scores were calculated. Results Our cohort consisted of 133 IBD patients (64% CD, 36% UC). Before switching we found widely varying infliximab levels (median 3.5 μg/mL). ATI were detected in eight patients (6%). Most patients were in remission or had mild disease (CD: 82% UC: 90%). After switching to biosimilar, 35 patients (26%) discontinued therapy within 12 months, mostly due to subjective higher disease activity (9%) and adverse events (AE, 9.8%). AE included general malaise/fatigue (n = 7), arthralgia (n = 2), skin problems (n = 2) and infusion reactions (n = 2). No differences in IFX levels, CRP, and disease activity scores were found between the four time points (P ≥ .0917). Conclusions We found no differences in drug levels and disease activity between infliximab innovator and biosimilar in our IBD cohort, indicating that biosimilars are safe and effective. The high proportions of discontinuers were mostly due to elective withdrawal or subjective disease worsening. |
| Databáze: | OpenAIRE |
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