Abstract and Introduction
Background: There are few data regarding multiple switching from the originator Infliximab to its biosimilars.
Aim: To assess outcomes and patient perspectives in a prospective manner after double switching from Infliximab to the biosimilars CT-P13 and SB2.
Methods: A total of 158 consecutive patients with inflammatory bowel disease (IBD) receiving CT-P13 maintenance therapy were switched to SB2 and followed for 54 weeks. Patients were stratified according to previous switch from the originator Infliximab to CT-P13 (double switch group) or not (single switch group).
Results: The drug persistence was high (94.9%) after 54 weeks. In total, 17 (10.8%) patients experienced loss of response to SB2, including 10 patients who were managed through dose optimisation and continued treatment. No changes were observed in clinical activity scores, fatigue, biological activity and pharmacokinetical parameters after the switch. The safety profile was in line with the current knowledge of Infliximab. According to the Beliefs about Medicines Questionnaire, the patients' perspectives did not change after switching from CT-P13 to SB2. The primary patient concerns remained after the switch, which were focused on effectiveness and safety rather than on the molecular differences between originator and biosimilars or socioeconomic benefits. There were also no differences in the concerns and beliefs between the double and single switch groups.
Conclusion: Double switching from the originator Infliximab to CT-P13 and then to SB2 was not associated with an impairment in patient beliefs, while the effectiveness, immunogeniity and safety of anti-TNF therapy remained stable after 54 weeks of follow-up.
Crohn's disease and ulcerative colitis are chronic, relapsing and disabling diseases. The development of biological agents, such as anti-TNF, has substantially improved disease management and established more ambitious therapeutic goals.[2,3] From the French population perspective, the 5-year cumulative probabilities of anti-TNF monotherapy have dramatically increased up to 33.8% and 12.9% after obtaining a diagnosis of Crohn's disease and ulcerative colitis respectively. As a result, biological agents now account for the highest proportion of national healthcare expenditure among patients with inflammatory bowel disease (IBD).[5,6]
Infliximab is a chimeric IgG1 antibody that targets the pro-inflammatory cytokine tumour necrosis factor-alpha (TNF-α). Since the end of its patent in 2015, biosimilar products have emerged offering the same efficacy and safety profile as the originator antibody, with a massive reduction in treatment cost.[8,9] The first Infliximab biosimilar was CT-P13 (Remsima®, Inflectra®, Celltrion), which has demonstrated a similar efficacy and safety as the originator Infliximab in anti-TNF-naive patients and after switching from the originator Infliximab.[10–12] The Infliximab biosimilar SB2 (Flixabi®, Samsung Bioepis) was similarly approved based on phase 1 and phase 3 randomised controlled trials in anti-TNF-naive patients and after switching from originator Infliximab.[13,14] However, there is still concern about the effectiveness and safety in the setting of multiple switches. Furthermore, patient beliefs and concerns have been poorly investigated, and these issues can affect their adherence to treatment.
In this study, we assessed the effectiveness, safety, pharmacokinetics and patient perspectives after double switching from the originator Infliximab to CT-P13 and then SB2 compared with patients who underwent a simple switch from CT-P13 to SB2. The patients were prospectively assessed and retrospectively analysed in two French IBD centres.
Aliment Pharmacol Ther. 2021;53(8):887-899. © 2021 Blackwell Publishing