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P590 An interim analysis of real-world safety data from an ongoing, non-interventional, observational study of patients with inflammatory bowel disease treated with CT-P13, an infliximab biosimilar, in the context of usual care with reference infliximab

B. Bokemeyer*1, T. Hlavaty2, M. Allez3, P. Selema4, S. Moosavi4, M. J. Cadatal5, H. Fowler6, R. Cheung4, M. Lukas7, J. P. Gisbert8

1Gastroenterology Practice Minden, Minden, Germany, 2University Hospital Bratislava and Comenius University, Bratislava, Slovakia, 3AP-HP - Hôpitaux Univ Saint-Louis-Lariboisière-Fernand-Widal, Paris, France, 4Pfizer Inc., New York City, USA, 5Pfizer Inc., Manila, Philippines, 6Pfizer Inc., Maidenhead, UK, 7IBD Clinical and Research Centre, ISCARE IVF and 1st Medical Faculty, Charles University, Prague, Czech Republic, 8Hospital Universitario de La Princesa, IIS-IP, CIBEREHD, Madrid, Spain

Background

CT-P13 (Inflectra®/Remsima®) is an infliximab biosimilar of the reference product Remicade® (IFX-RP). We report an interim analysis of preliminary safety data for CONNECT-IBD, an ongoing, non-interventional, observational cohort study evaluating CT-P13 in the context of usual care with IFX-RP in the treatment of patients with Crohn’s disease (CD) or ulcerative colitis (UC) in a real-world setting.

Methods

Patients were recruited during usual care at 150 academic and community sites in 13 European countries. Adult CD or UC patients prescribed CT-P13 or EU-sourced IFX-RP at the investigator’s discretion and according to the approved label were eligible. This interim analysis reports primary outcomes (drug utilisation patterns and long-term safety) for patients who received CT-P13 either as their first biologic or as continuing treatment (CT-P13) or who switched from IFX-RP to CT-P13 (Switched) based on data collection from April 2015 to December 2017. Data were analysed descriptively.

Results

This analysis included 1957 patients (CT-P13, n = 1825; Switched, n = 132; Table 1). Of these, 1264 had CD, 692 had UC and 1 had missing diagnosis. Demographics and baseline characteristics were similar between groups. In total, 626 treatment-emergent adverse events (TEAEs) were reported in 438 (22.4%) patients: CT-P13 (22.2%) and Switched (25.0%). Incidences of TEAEs, serious TEAEs (12.1% vs. 12.1%) and TEAEs leading to discontinuation of study drug (8.1% vs. 6.8%) were balanced between CT-P13 and Switched groups, respectively. A higher percentage of Switched (2.3%) vs. CT-P13 (0.9%) patients discontinued from study due to AEs; however, this was likely driven by the smaller number of patients in the Switched group. Majority of patients reported TEAEs of mild-to-moderate intensity (overall: mild, 7.3%; moderate, 9.2%; severe, 5.8%). TEAEs and TEAES of special interest are summarised (Table 2). Two deaths were reported, both unrelated to study drug. Among the limitations were the difference in CT-P13 (n = 1825) vs. Switched (n = 132) group size and AE reporting which, due to the observational study design, had limited clinical details.

Table 1. Disposition, population characteristics and drug utilisation patterns for patients receiving CT-P13.

Table 2. Most frequently (≥2.0%, all patients) reported all-causality TEAEs and TEAE S of special interest for patients receiving CT-1)13a.

Conclusion

Results from this interim analysis of CT-P13 in a real-world setting were consistent with the known safety profile of infliximab and did not identify new safety information to change the benefit–risk profile of CT-P13.