Real-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD)

ABSTRACT

Background

The objective of this non-interventional, observational prospective cohort study (CONNECT-IBD) was to assess the use of CT-P13 (Inflectra®) in the treatment of patients with Crohn’s disease (CD) and ulcerative colitis (UC) in the context of treatment with reference infliximab (IFX; Remicade®).

Methods

Patients (recruited April 2015 to October 2018) at 150 sites across 13 European countries were followed for up to 2 years. Primary outcomes were safety, population characteristics, and drug utilization patterns. Secondary outcomes included clinical assessment of disease activity. Data were analyzed descriptively.

Results

Overall, 2543 patients (CD, n = 1676; UC, n = 867) were included. In the CT-P13 cohort (n = 1522), median disease duration was 63 (0–579) months and 30% of patients were IFX naïve; median duration of prior IFX treatment was 5 months. During the observation period, median duration of drug exposure was 14 (0–28) months. 41% of patients reported 912 all-causality treatment-emergent adverse events (TEAEs); 24% experienced treatment-related TEAEs. Most TEAEs were of mild-to-moderate severity. Treatment-emergent serious adverse events were reported by 17% of patients.

Conclusion

Safety information for CT-P13 in this large study was consistent with the known safety profile for IFX and did not alter the established benefit-risk profile of CT-P13.

KEYWORDS:

• Biosimilar
• CT-P13
• Crohn’s disease
• infliximab
• observational
• ulcerative colitis

Acknowledgments

Medical writing support was provided by Sue Reinwald and Iain McDonald of Engage Scientific Solutions and was funded by Pfizer.

Declaration of interest

B Bokemeyer has received grants, research funding, consulting fees, or has served as a speaker for AbbVie, MSD, Shire, Ferring, UCB, Hospira, Takeda, Shield Therapeutics, Pfizer, Biogen, Janssen, Hexal, Celgene, Boehringer Ingelheim, Allergan, Celltrion, Merckle, Dr. Falk Pharma GmbH, HLR, Mundipharma, Given Imaging, and Galapagos. T Hlavaty has received research funding from Hospira Inc and has served as a speaker for AbbVie, Takeda Pharmaceuticals, Janssen Pharmaceuticals, Pfizer, Egis Pharmaceuticals PLC, and Amgen Inc. M Allez has served as a speaker, a consultant, and advisory member for, or has received research funding from Janssen, Roche/Genentech, Takeda, Pfizer, Celgene, Novartis, Amgen, Biogen, MSD, Ferring, and Tillotts. JP Gisbert has served as a speaker, a consultant, and advisory member for, or has received research funding from MSD, AbbVie, Hospira, Pfizer, Kern Pharma, Biogen, Takeda, Janssen, Roche, Sandoz, Celgene, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, and Vifor Pharma. M Mueller, S Moosavi, MJ Cadatal, and KF Liau are employees of and own stock or options in Pfizer. H Fowler has received consultancy fees from Pfizer. P Selema was an employee of Pfizer at the time the work was conducted and owns stock or options in Pfizer.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors made substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data. All authors contributed to the development of the first draft of the manuscript, revised it critically for important intellectual content, and read and approved the final version for publication.

Ethics statement

All protocol and informed consent documents were approved by the Institutional Review Boards and/or Independent Ethics Committees of each participating study site. Each patient completed a written informed consent form prior to enrollment.

Data sharing statement

Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.

Trial Registration

ClinicalTrials.gov. NCT02539368

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2023.2200883.

Additional information

Funding

This study was funded by Hospira, Inc., which was acquired by Pfizer, Inc., in September 2015.