Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France

Jérôme Avouac; Anna Moltó; Vered Abitbol; Adrien Etcheto; Axelle Salcion; Loriane Gutermann; Caroline Klotz; Muriel Elhai; Pascal Cohen; Pierre Antoine Soret; Florence Morin; Ornella Conort; François Chast; Claire Goulvestre; Claire Le Jeunne; Stanislas Chaussade; André Kahan; Christian Roux; Yannick Allanore; Maxime Dougados

doi:10.1016/j.semarthrit.2017.10.002

Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris, France

Semin Arthritis Rheum. 2018 Apr;47(5):741-748. doi: 10.1016/j.semarthrit.2017.10.002. Epub 2017 Oct 5.

Authors

Jérôme Avouac¹, Anna Moltó², Vered Abitbol³, Adrien Etcheto², Axelle Salcion², Loriane Gutermann⁴, Caroline Klotz³, Muriel Elhai⁵, Pascal Cohen⁶, Pierre Antoine Soret³, Florence Morin⁷, Ornella Conort⁴, François Chast⁴, Claire Goulvestre⁷, Claire Le Jeunne⁶, Stanislas Chaussade³, André Kahan⁵, Christian Roux⁸, Yannick Allanore⁵, Maxime Dougados⁹

Affiliations

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.

PMID: 29102156
DOI: 10.1016/j.semarthrit.2017.10.002

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.

Keywords: Axial Spondyloarthritis; Biosimilar; CT-P13; Crohn’s disease; Infliximab; Rheumatoid Arthritis; Switch; Ulcerative Colitis; Uveitis.

Publication types

Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Anti-Inflammatory Agents / therapeutic use*
Arthritis, Rheumatoid / drug therapy*
Biosimilar Pharmaceuticals / therapeutic use*
Drug Substitution
Female
France
Hospitals, University
Humans
Inflammatory Bowel Diseases / drug therapy*
Infliximab / therapeutic use*
Male
Middle Aged
Prospective Studies
Remission Induction
Spondylarthritis / drug therapy*
Treatment Outcome

Substances

Anti-Inflammatory Agents
Biosimilar Pharmaceuticals
Infliximab