Switching from originator to biosimilar infliximab – real world data of a prospective 18 months follow-up of a single-centre IBD population

Abstract

Background and aims: Long-term data regarding switching from originator infliximab to biosimilar CT-P13 are sparse. Concerns about increased immunogenicity after switching have been raised. We aimed to study the effectiveness, safety and immunogenicity after switching from originator infliximab to CT-P13 in a real-world IBD population with 18 months prospective follow-up.

Methods: All adult IBD patients treated with originator infliximab at the Department of Gastroenterology, Oslo University Hospital, were switched to CT-P13 and followed prospectively for 18 months.

The primary endpoints were (i) the proportion of patients remaining on CT-P13 18 months after switching and (ii) immunogenicity during 18 months after switching. The secondary endpoints included (i) adverse events, (ii) changes in disease activity, C-reactive protein, anaemia, faecal calprotectin, infliximab dose and interval and p-infliximab.

Results: In total, 143 IBD patients were switched, 99 with Crohn’s disease and 44 with ulcerative colitis. Altogether, 130 (91%) remained on CT-P13 throughout 18 months.

Two patients developed ADAs at moderate level and discontinued CT-P13. Another 10 patients discontinued CT-P13 (two due to loss of response without ADAs, four due to adverse events, and four in remission and a personal wish to stop).

There was no overall change in disease activity scores or in the other studied variables except for p-infliximab, which increased significantly.

Conclusions: The present study provides valuable evidence for the safety and effectiveness of switching from originator to biosimilar infliximab over a prolonged period of 18 months and demonstrates that switching was well tolerated and did not affect the long term clinical outcome.

Keywords:

• Inflammatory bowel disease
• Crohn’s disease
• ulcerative colitis
• biosimilar
• infliximab
• switching

Acknowledgements

The authors thank Elisabeth Finnes for administration of the study patients, Lars Aabakken for set-up and facilitation of the database and Kristin Kaasen Jørgensen for the preparation of the first CRF drafts.

No data, figures or tables has been published previously and the manuscript is not under consideration elsewhere.

Disclosure statement

Marte L. Høivik has received unrestricted research grants from Takeda, Ferring and Tilotts and she has received speaker honorarium from MSD, MEDA, AbbVie

Bjorn Moum has been a member of advisory boards for Orion Pharma and Hospira.

No potential conflict of interest was reported by the authors.