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Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France
- Source :
- Seminars in Arthritis and Rheumatism. 47:741-748
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
Abstract
- Objective To investigate effectiveness of systematic switching treatment from innovator infliximab to biosimilar infliximab, and its associated factors. Methods In this prospective observational study, all adult patients receiving maintenance therapy with innovator infliximab in Cochin University Hospital were systematically switched to biosimilar infliximab. Effectiveness was assessed by the retention rate of biosimilar infliximab at the time of the third infusion. Sensitivity analyses for effectiveness included changes of disease activity parameters and infliximab trough levels between baseline and the last visit as well as the occurrence of adverse events leading to drug discontinuation. Factors associated with biosimilar infliximab discontinuation at the last visit were explored. Results 260 patients fulfilled the inclusion criteria, including 31 rheumatoid arthritis (RA), 131 axial spondyloarthritis (axSpA) and 64 inflammatory bowel diseases. The retention rate was 85% (221/260 patients) at the time of the third biosimilar infusion. Between baseline and the last visit (mean follow-up of 34 weeks), 59 patients (23%) discontinued biosimilar infliximab, mainly due to experienced inefficacy (n=47, 80%). No clinical or biological factors were associated with biosimilar discontinuation. No serious adverse events occurred. No change in objective disease activity parameters or infliximab trough levels was detected. However, a significant increase of BASDAI (2.94±2.20 vs. 3.18±2.21, p=0.046, before vs. after switch, respectively) was observed in patients with axSpA. Innovator infliximab was re-established in 47/59 patients (80%). Conclusion No changes in drug trough levels or objective parameters were observed after the systematic switch to biosimilar infliximab in a real clinical practice setting. Only changes in patient-reported outcomes were observed, suggesting attribution effects rather than pharmacological differences.
- Subjects :
- Adult
Male
musculoskeletal diseases
medicine.medical_specialty
Anti-Inflammatory Agents
Arthritis, Rheumatoid
Hospitals, University
03 medical and health sciences
0302 clinical medicine
Rheumatology
Maintenance therapy
Internal medicine
Spondylarthritis
medicine
Humans
Prospective Studies
skin and connective tissue diseases
Adverse effect
Biosimilar Pharmaceuticals
BASDAI
030203 arthritis & rheumatology
Drug Substitution
business.industry
Remission Induction
Biosimilar
Middle Aged
Inflammatory Bowel Diseases
medicine.disease
Infliximab
Surgery
Discontinuation
stomatognathic diseases
Treatment Outcome
Anesthesiology and Pain Medicine
Rheumatoid arthritis
Female
030211 gastroenterology & hepatology
Observational study
France
business
medicine.drug
Subjects
Details
- ISSN :
- 00490172
- Volume :
- 47
- Database :
- OpenAIRE
- Journal :
- Seminars in Arthritis and Rheumatism
- Accession number :
- edsair.doi.dedup.....6c0cab1bf7d25cca2dd818560dbeb871