CT-P13 in IBD Is Safe and Effective in the Long Term, Research Shows

Evidence to support treating inflammatory bowel disease (IBD), a category that includes Crohn disease (CD) and ulcerative colitis (UC), with biosimilar infliximab continues to develop, and several new studies highlight the safety and efficacy of long-term treatment with CT-P13 (Inflectra, Remsima).

One recent study investigated the long-term drug survival and immunogenicity of CT-P13 in patients who switched to the drug from its reference 2 years prior.¹ The single-center prospective observational cohort study enrolled 83 patients, 57 of whom had CD, 24 of whom had UC, and 2 of whom had unclassified IBD.

At week 104 post-switch, 66% of patients remained on CT-P13. Reasons for discontinuation of CT-P13 included loss of response in 10 patients, adverse events (AEs) in 8 patients, and remission in 7 patients. Three patients were lost to followup.

Antidrug antibodies (ADAs) were detected in 5 patients pre-switch, and 2 patients had new ADAs prior to week 52, but no new ADAs were detected by week 104.

“These results are reassuring and suggest that switching to CT-P13 does not impact long-term clinical outcomes,” wrote the study’s authors.

Another recent study found that treatment with CT-P13 is effective in maintaining endoscopic remission in patients with UC.² While previous research has shown that CT-P13 can induce mucosal healing in patients with UC, this multicenter observational cohort study sought to evaluate the efficacy of the biosimilar in maintaining mucosal healing.

The study reported on 61 patients with UC who were treated with CT-P13 for 54 weeks, and found that at week 14, 65.5% of patients had mucosal healing, and 31% had complete mucosal healing. By week 54, mucosal healing was evident in 62.1% of patients, and complete mucosal healing was present in 38% of patients.

According to the authors, this study confirmed the long-term efficacy of therapy with the biosimilar.

Finally, a third study reported on 12-month real-world outcomes of a switch to CT-P13 from the reference infliximab.³

In the study of 110 patients with CD who switched to the biosimilar, at 6 months and 12 months post-switch, there was no significant difference observed in disease activity as measured by the Harvey-Bradshaw Index (P = .07), C-reactive protein (P = .13), fecal calprotectin (P = .25), or trough infliximab levels (P = .47) compared with baseline measurements.

In total, 7 patients developed new ADAs after the switch. At 12 months, 84.5% of patients remained on the biosimilar, and the rate of AEs and serious AEs was 53.8 and 13.5 per 100 patient-years, respectively.

Switching to the biosimilar in patients with CD had no negative effect on clinical outcomes at 12 months, wrote the authors, who added that the switch resulted in a cost savings for the healthcare system of approximately 46.4%.

References

1. Smits LJT, van Esch AAJ, Derikx LAAP, et al. Drug survival and immunogenicity after switching from Remicade to biosimilar CT-P13 in inflammatory bowel disease patients: two-year follow-up of a prospective observational cohort study. Inflamm Bowel Dis. 2019;25(1): 172-179. doi: 10.1093/ibd/izy227.

2. Bálint A, Rutka M, Kolar M, et al. Infliximab biosimilar CT-P13 therapy is effective in maintaining endoscopic remission in ulcerative colitis - results from multicenter observational cohort. Expert Opin Biol Ther. 2018;18(11): 1181-1187. doi: 10.1080/14712598.2018.1530758.

3. Plevris N, Jones GR, Jenkinson PW, et al. Implementation of CT-P13 via a managed switch programme in Crohn’s disease: 12-month real-world outcomes [published online December 7, 2018]. Dig Dis Sci. doi: 10.1007/s10620-018-5406-8.