Spanish Study: Switching to Biosimilar Infliximab in IBD Is Safe, Effective at 12 Months

June 18, 2018
Kelly Davio

Researchers from Spain, where biosimilar use is encouraged as a way to save on costs and expand access to biologic therapies, recently reported on a multicenter prospective observational study in patients with inflammatory bowel disease (IBD) who switched from reference infliximab to a biosimilar, CT-P13 (Inflectra, Remsima).

Researchers from Spain, where biosimilar use is encouraged as a way to save on costs and expand access to biologic therapies, recently reported on a multicenter prospective observational study in patients with Crohn disease (CD) and ulcerative colitis (UC) who switched from reference infliximab to a biosimilar, CT-P13 (Inflectra, Remsima). The researchers, who published their findings in Revista Española de Enfermedades Digestivas, concluded that, at 12 months after switching, CT-P13 was safe and effective.

In total, 167 patients with inflammatory bowel disease (IBD), 116 of whom had CD and 51 of whom had UC, were included in the study. All of the patients switched from the reference infliximab to CT-P13.

The study’s efficacy endpoint was the change in clinical remission at 12 months in patients who switched from the reference to the biosimilar. Clinical remission was defined as Harvey-Bradshaw scores of 4 or lower in patients with CD, and Mayo scores of 2 or lower in patients with UC. Adverse events (AEs) were measured from the first infusion of the biosimilar to the end of the study.

Among all 167 patients, baseline remission was 87.4% (n = 146), and remission in the 152 patients who completed 12 months of follow-up was 71.7% (n = 109). Overall loss of efficacy at 12 months was 15.7%, which is similar to that reported for reference infliximab, write the authors.

In the CD group, 109 patients (94%) completed 12 months of follow-up. Four patients stopped treatment due to AEs, 2 stopped treatment due to maintained remission, and 1 patient did not attend follow-up visits. At the start of the study, 88.8% of patients in this group were in remission, and at 12 months post-switch, 69.7% were in remission. The authors note that the difference in remission from baseline was not statistically significant at 12 months (P> .05). Additionally, 68.9% of patients with CD who were in remission at baseline retained remission at 12 months.

In the UC group, 43 patients (84.3%) completed follow-up, with 8 patients halting treatment. Three patients stopped due to AEs, and 5 stopped due to maintained remission. At baseline, 84.3% of patients were in remission, and at 12 months after switching, 76.7% were in remission. In this case, too, the authors write that the difference in remission from baseline to 12 months was not statistically significant (P > .05). In total, 72.1% of patients with UC who were in remission at baseline were in remission at 12 months.

AEs occurred in 12 patients (7.2%), and 3 of these AEs (1 case of Sweet syndrome, 1 case of severe paresthesia during infusion, and 1 meningioma) were considered serious.

The authors conclude that, after 12 months of follow-up, a switch to biosimilar infliximab proved to be safe and effective. “These results are the first presented in Spain that prove the safety of CT- P13 for the treatment of patients with IBD,” write the authors, who add that studies with longer follow-up times will be useful for corroborating these data.

Reference

Guerra Veloz MF, Vázquez Morón JM, Belvis Jiménez M. Switching form reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months. [Published online June 12, 2018.] Rev Esp Enferm Dig. doi: 10.17235/reed.2018.5368/2017.