Switching from Reference Infliximab to Biosimilar CT-P13 did not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

Author:

Pierik Marieke J1,van der Meulen Andrea E2ORCID,Van der Linde Klaas3,Lutgens Maurice4,Kuijvenhoven Johan P5ORCID,Akol Halil6,Klompmaker Ids J7,Sikkens Michelle S G8,van Megen Yvonne J B9,Stoop Corinne M9,Bloemsaat-Minekus Joanne P J9ORCID,Dijkstra Gerard10

Affiliation:

1. Marieke J. Pierik, MD PhD, Division of Gastroenterology and Hepatology, MUMC Maastricht The Netherlands

2. Andrea E. van der Meulen MD, PhD Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands

3. Klaas Van der Linde MD PhD, Department of Gastroenterology and Hepatology, MCL Leeuwarden, The Netherlands

4. Maurice Lutgens MD PhD, Department of Gastroenterology and Hepatology, Elisabeth Tweesteden ziekenhuis, The Netherlands

5. Johan P. Kuijvenhoven MD PhD, Department of Gastroenterology and Hepatology, Spaarne Gasthuis Haarlem, The Netherlands

6. Halil Akol MD, Department of Gastroenterology and Hepatology, MC De Veluwe, Apeldoorn, The Netherlands

7. Ids J. Klompmaker MD PhD, Department of Gastroenterology and Hepatology, Wilhelmina Ziekenhuis Assen, The Netherlands

8. Michelle S.G. Sikkens Dijklander ziekenhuis, The Netherlands

9. Yvonne J.B. van Megen PhD, Medical department, Mundipharma Pharmaceuticals B.V. Leusden, The Netherlands

10. Gerard Dijkstra Prof, PhD, MD, Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, The Netherlands

Abstract

Abstract Background Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate non-inferiority for QoL and efficacy after switching. Methods OoL and clinical efficacy were measured prior to and after 2, 4 and 6 CT-P13 infusions. Results 178 patients were included. Non-inferiority was established for QoL (ratio 97.95% (95% CI 95.93-100.01) and efficacy (difference –0.02 (95% CI -0.68-0.64)). Five patients reported 6 non-related, serious adverse events. Conclusion Switching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated.

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology

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