Format

Send to

Choose Destination
J Crohns Colitis. 2017 Jun 1;11(6):690-696. doi: 10.1093/ecco-jcc/jjw216.

Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme.

Author information

1
Department of Gastroenterology, Southampton General HospitalSouthampton, UK.
2
Pharmaceutical Commissioning, West Hampshire CCG, Eastleigh, UK.
3
University of Southampton, Southampton General Hospital, Southampton, UK.
4
Department of Finance, Southampton General Hospital, Southampton, UK.
5
Department of Pharmacy, Southampton General Hospital, Southampton, UK.
6
Department of Allergy and Immunology, Southampton General Hospital, Southampton, UK.

Abstract

Background and Aims:

Biosimilar infliximab CT-P13 offers the potential for large drug acquisition cost savings. However, there are limited published data regarding its efficacy, safety, and immunogenicity in inflammatory bowel disease [IBD], particularly in switching IBD patients from originator to biosimilar infliximab. We present the outcomes of a service evaluation of switching IBD patients established on originator infliximab to biosimilar, using a managed switching programme funded via a gain share agreement in a UK teaching hospital.

Methods:

Evaluation outcomes included drug persistence, changes in drug acquisition costs, patient-reported side effects, adverse events, patient outcomes assessed using the IBD-control Patient-Reported Outcome Measures [PROM] questionnaire, serum drug and antibody levels, and routinely collected biochemical markers.

Results:

A total of 143 patients with IBD [118 Crohn's disease, 23 ulcerative colitis, 2 IBD unclassified] were switched from originator infliximab to CT-P13. Patients reported a similar incidence of side effects before and after switch. No clinically significant differences were observed in mean C-reactive protein [CRP], albumin, haemoglobin levels, or platelet and white cell counts after the switch to CT-P13, whereas mean IBD-control-8 score improved from 10.4 to 11.2 [p = 0.041]. There was no significant difference in drug persistence between biosimilar and originator infliximab [p = 0.94] and no increase in immunogenicity was found. Drug acquisition costs decreased by £40,000-60,000 per month.

Conclusions:

A managed switching programme from originator infliximab to biosimilar CT-P13 in IBD, using a gain-share agreement, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes, biochemical response, drug persistence, and adverse event profile.

KEYWORDS:

Inflammatory bowel disease; Infliximab; biosimilar switching; biosimilars; gain share

PMID:
28130330
DOI:
10.1093/ecco-jcc/jjw216
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center