Abstract
| Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France Avouac J1, Moltó A2, Abitbol V3, Etcheto A2, Salcion A2, Gutermann L4, Klotz C3, Elhai M5, Cohen P6, Soret PA3, Morin F7, Conort O4, Chast F4, Goulvestre C7, Jeunne CL6, Chaussade S3, Kahan A5, Roux C8, Allanore Y5, Dougados M9. Semin Arthritis Rheum. 2017 Oct 5. pii: S0049-0172(17)30436-5. doi: 10.1016/j.semarthrit.2017.10.002. [Epub ahead of print] |
| Author information 1 Rheumatology A Department, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France; Paris Descartes University, Sorbonne Paris Cité, INSERM U1016, Cochin Institute, CNRS UMR8104, Paris, France. Electronic address: jerome.avouac@aphp.fr. 2 Rheumatology B Department, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 3 Gastroenterology Department, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 4 Department of Pharmacy, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 5 Rheumatology A Department, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France; Paris Descartes University, Sorbonne Paris Cité, INSERM U1016, Cochin Institute, CNRS UMR8104, Paris, France. 6 Internal Medicine Department, Paris Descartes University, Sorbonne Paris Cité, Cochin Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 7 Paris Descartes University, Sorbonne Paris Cité, Immunology Laboratory, Cochin Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France. 8 Paris Descartes University, Sorbonne Paris Cité, INSERM U1016, Cochin Institute, CNRS UMR8104, Paris, France. 9 Paris Descartes University, Sorbonne Paris Cité, INSERM U1016, Cochin Institute, CNRS UMR8104, Paris, France; INSERM U1153, Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France. 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: A total of 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. |
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