While providers are increasingly comfortable with switching patients with inflammatory bowel disease (IBD) from reference biologics to biosimilars on the basis of a wealth of reassuring data on the safety and efficacy of such transitions, there are fewer data available about switching among multiple biosimilars of the same reference.
While providers are increasingly comfortable with switching patients from reference biologics to biosimilars on the basis of a wealth of reassuring data on the safety and efficacy of such transitions, there are fewer data available about switching among multiple biosimilars of the same reference.
However, switching among multiple products is increasingly common in countries where tenders for medicines are undertaken regularly and in which patients may also be asked to transition among products regularly based on the outcomes of those tenders. Data arising from these biosimilar-to-biosimilar switches is beginning to emerge, however, and the results may help providers gain more comfort with switching patients among multiple biosimilars.
A study on one such switch was presented this week during the United European Gastroenterology Week 2019, being held in Barcelona, Spain.1 In the study, 133 patients with inflammatory bowel disease (IBD) who were being treated at the Southampton General Hospital in Southampton, United Kingdom, consented to be switched from one biosimilar, CT-P13 (Remsima, Inflectra), to another, SB2 (Flixabi, Renflexis).
The patients’ disease activity scores were collected at baseline and again at week 16 or week 18, depending on whether patients were receiving dosing every 6 or 8 weeks. A historical cohort of patients receiving CT-P13 was used to assess drug persistence.
The research team found that the mean modified Harvey Bradshaw Index scores and partial Mayo scores at week 0 versus week 16 or 18 were 3.13 (standard deviation [SD], 3.31) versus 3.15 (SD, 3.17) (P = .32) and 1.53 (SD, 1.75) versus 0.91 (SD, 1.64) (P = .15) respectively.
In total, 7 patients stopped treatment due to treatment failure, 6 due to AEs, and 2 due to withdrawn consent. Two patients were lost to follow-up, and 1 withdrew for other reasons. There was no significant difference in persistence, say the authors, between this cohort and the historical CT-P13 cohort.
The authors note that more long-term data are required to confirm the current findings. However, this study does add to a growing body of evidence that suggests the safety and efficacy of multiple biosimilar switching.
In fact, these results are consistent with findings concerning switching between the same 2 infliximab biosimilars in other disease states; earlier this year, during the 6th Congress of Skin Inflammation and Psoriasis International Network, researchers from Italy presented findings from a study of 24 patients with chronic plaque psoriasis who were switched from CT-P13 to SB2.2 In these patients, disease activity was substantially unchanged after the switch, and there was no statistically significant increase in AEs.
1. Harris C, Harris R, Young D, et al. IBD biosimilar to biosimilar infliximab switching study: preliminary results. Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.
2. Gisondi P, Virga C, Girolomoni G. Cross-switch from CT-P13 to sb2 infliximab biosimilars in patients with chronic plaque psoriasis. Presented at: 6th Congress of Skin Inflammation and Psoriasis International Network; April 25-27, 2019; Paris, France. Abstract P049.