Clinical outcomes and patient experience of biosimilar to biosimilar infliximab switching in patients with inflammatory bowel disease

Abstract

Background & aims:
Regulatory pathways compare biosimilars with originator molecules only and not with other biosimilars. With the development of multiple infliximab biosimilars, patients may be asked to transition between them. Data is emerging but there is still a gap in the evidence on switching between infliximab biosimilars. Our aim was to conduct a full evaluation of switching a cohort of IBD patients from one biosimilar (CT-P13) to another (SB2) in a real-world setting including clinical, patient experience, molecular and drug immunogenicity aspects of the process. The study was sponsored by University Hospital Southampton NHS Foundation Trust and financially supported by Biogen Idec Limited.

Method:
Prospective, phase IV interventional study of patients on CT-P13 switched to SB2. Demographics, disease history, validated disease activity scores, patient reported outcome measures and laboratory measurements were collected. Semi-structured qualitative interviews were also conducted.

Results:
133 out of 158 patients agreed to participate. Thirty-five subjects discontinued. Mean disease duration was 9.2 years. There was no difference in mean haemoglobin, platelet count, albumin and C-reactive protein before and after switching. Mean faecal calprotectin at baseline and at week 30/32 was 306ug/g versus 210ug/g. Mean partial Mayo Clinic Score and modified Harvey Bradshaw Index at baseline were 1.54 and 3.14 versus 1.18 and 2.91 at week 30/32 respectively. There were 16 serious adverse events. Thematic analysis of interview transcripts from 26 participants identified six major themes that reflected the patient experience – trust, clinical status at the point of switching, past experience, general disposition, information provision and concerns/anxiety.

Conclusions:
Switching from CT-P13 to SB2 is safe and effective. Certain factors must be considered in supporting patient decision-making and enabling trust in the process. The results from this study support the development of a clear, stream-lined and well-monitored biosimilar switching programme.

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Identifiers

ORCID for Clare Mallika Harris: orcid.org/0000-0002-8233-7509

ORCID for Sue Latter: orcid.org/0000-0003-0973-0512

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