Antoine Meyer, MD; Jérémie Rudant, MD, PhD; Jérôme Drouin; Alain Weill, MD; Franck Carbonnel, MD, PhD; Joël Coste, MD, PhD
Acknowledgment: The authors thank Anthony Saul, MD, for assistance with grammar and spell-checking in English.
Financial Support: Caisse Nationale de l'Assurance Maladie. All authors are employees of a public French organization.
Disclosures: Dr. Rudant reports personal fees from CNAM during the conduct of the study. Dr. Carbonnel reports personal fees from Abbvie, personal fees from BMS, personal fees from Medtronic, personal fees from Janssen, personal fees from Takeda, personal fees from Amgen, personal fees from Pfizer, personal fees from Pileje, personal fees from Enterome, personal fees from BMS, personal fees from Ferring, personal fees from Roche, outside the submitted work. Authors not named here have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-1512.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Proctor & Gamble, Pfizer, and Johnson & Johnson.
Reproducible Research Statement:Study protocol, statistical code, and data set: Not available, owing to SNDS regulations. Applications to access the French health insurance claims data must be submitted to the Institut National des données de santé (www.indsante.fr).
Corresponding Author: Antoine Meyer, MD, Caisse Nationale de l'Assurance Maladie, 50 Avenue du Professeur André Lemierre, 75020 Paris, France; email, firstname.lastname@example.org.
Current Author Addresses: Drs. Meyer and Carbonnel: Service d'hépato-gastro-entérologie adulte, Hôpital Bicêtre, 78 rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France.
Drs. Rudant and Weill and Mr. Drouin: Caisse Nationale de l'Assurance Maladie, 50 Avenue du Professeur André Lemierre, 75020 Paris, France.
Dr. Coste: Biostatistics and Epidemiology, Hôtel-Dieu de Paris, Hôpitaux Universitaire de Paris Centre, 27 Rue du Faubourg Saint-Jacques, 75014 Paris, France.
Author Contributions: Conception and design: A. Meyer, J. Rudant, A. Weill, F. Carbonnel, J. Coste.
Analysis and interpretation of the data: A. Meyer, J. Rudant, F. Carbonnel, J. Coste.
Drafting of the article: A. Meyer.
Critical revision for important intellectual content: A. Meyer, J. Rudant, A. Weill, F. Carbonnel, J. Coste.
Final approval of the article: A. Meyer, J. Rudant, J. Drouin, A. Weill, F. Carbonnel, J. Coste.
Provision of study materials or patients: A. Meyer.
Statistical expertise: A. Meyer, J. Rudant, J. Coste.
Administrative, technical, or logistic support: A. Meyer, J. Rudant, J. Coste.
Collection and assembly of data: A. Meyer, J. Drouin.
CT-P13 is a biosimilar of the reference product (RP) infliximab, with demonstrated efficacy and safety for some inflammatory arthritides. It was approved for the treatment of Crohn disease (CD) on that basis, without specific studies examining its effects in CD.
To compare the effectiveness and safety of CT-P13 and RP in infliximab-naive patients with CD.
Comparative equivalence cohort study.
Système National des Données de Santé (SNDS), a French nationwide health administrative database (1 March 2015 to 30 June 2017).
5050 infliximab-naive patients with CD who were older than 15 years, had started treatment with RP (n = 2551) or CT-P13 (n = 2499), and had no other indications for infliximab.
The primary outcome was a composite end point of death, CD-related surgery, all-cause hospitalization, and reimbursement of another biologic therapy. Equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus RP in a multivariable marginal Cox model situated within prespecified margins (0.80 to 1.25).
Overall, 1147 patients in the RP group and 952 patients in the CT-P13 group met the composite end point (including 838 and 719 hospitalizations, respectively). In multivariable analysis of the primary outcome, CT-P13 was equivalent to RP (HR, 0.92 [95% CI, 0.85 to 0.99]). No differences in safety outcomes were observed between the 2 groups: serious infections (HR, 0.82 [CI, 0.61 to 1.11]), tuberculosis (HR, 1.10 [CI, 0.36 to 3.34]), and solid or hematologic cancer (HR, 0.66 [CI, 0.33 to 1.32]).
The SNDS does not contain all relevant clinical data (for example, disease activity).
This analysis of real-world data indicates that the effectiveness of CT-P13 is equivalent to that of RP for infliximab-naive patients with CD. No difference was observed for safety outcomes.
Caisse Nationale de l'Assurance Maladie.
Meyer A, Rudant J, Drouin J, Weill A, Carbonnel F, Coste J. Effectiveness and Safety of Reference Infliximab and Biosimilar in Crohn Disease: A French Equivalence Study. Ann Intern Med. [Epub ahead of print 11 December 2018]170:99–107. doi: 10.7326/M18-1512
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Published: Ann Intern Med. 2019;170(2):99-107.
Published at www.annals.org on 11 December 2018
Gastroenterology/Hepatology, Hospital Medicine, Inflammatory Bowel Disease.
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