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. 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.
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.
Authors: Hillel P Cohen; Andrew Blauvelt; Robert M Rifkin; Silvio Danese; Sameer B Gokhale; Gillian Woollett Journal: Drugs Date: 2018-06 Impact factor: 9.546
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Authors: Claudia Fabiani; Antonio Vitale; Giacomo Emmi; Arianna Sgheri; Giuseppe Lopalco; Jurgen Sota; Silvana Guerriero; Florenzo Iannone; Bruno Frediani; Lorenzo Vannozzi; Maria Teresa Bianco; Valtere Giovannini; Gian Marco Tosi; Luca Cantarini Journal: Front Pharmacol Date: 2019-12-09 Impact factor: 5.810
Authors: Viktoria Bergqvist; Mohammad Kadivar; Daniel Molin; Leif Angelison; Per Hammarlund; Marie Olin; Jörgen Torp; Olof Grip; Stefan Nilson; Erik Hertervig; Jan Lillienau; Jan Marsal Journal: Therap Adv Gastroenterol Date: 2018-10-11 Impact factor: 4.409