Switching Back to Reference Infliximab From Biosimilar Appears Effective for Patients With IBD

Among the reasons documented for some patients discontinuing biosimilar infliximab after switching from the reference product are subjective loss of response and adverse events.

At the United European Gastroenterology Week 2019, held in Barcelona, Spain, earlier this year, a research team from the Netherlands reported on the prevalence of patients with inflammatory bowel disease (IBD) switching back to the reference infliximab after a previous switch to biosimilar CT-P13, and found that switching back appeared to be effective in patients with IBD.

In the retrospective, observation, multicenter cohort study, data from patients with IBD who had switched to CT-P13 and had at least 52 weeks of follow-up were eligible for inclusion. In total, 254 patients were switched, 165 of whom had Crohn disease (CD), 52 of whom had ulcerative colitis (UC), and 2 of whom had unclassified IBD.

In total, 35 patients switched back to the originator drug during the follow-up period. Those who made the switch back were more often female than those who remained on the biosimilar. In total, 91.4% of those who switched back did so because of newly reported side effects. Only 3 (8.6%) switched back due to loss of response.

The side effects most commonly reported were skin reactions (37.1%), increased IBD-related symptoms (37.1%), and fatigue (25.7%). Three patients had calprotectin-objectified loss of response.

In 75% of the patients who reported new side effects and in 100% of the patients with loss of response, switching back to the reference product had the desired effect of improving the side effects or regaining response.

The authors concluded that, for those who experience side effects or a loss of response after a switch to the biosimilar product, a switch back may be justified, and appears to have been effective in this group of patients with IBD.

Reference

Mahmmod S, Schultheiss JPD, Mahmmod N, Tan AC, Dijkstra G, Fidder HH. Reverse switching to originator infliximab may be considered in patients with inflammatory bowel diseases experiencing new side effects or loss of response after switching to a CT-P13 biosimilar. Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.