New Data Show Safe Switching From Reference Infliximab to CT-P13 in IBD

To date, only limited data have been available concerning long-term clinical outcomes of switching patients with inflammatory bowel disease (IBD) from reference infliximab (Remicade) to a biosimilar treatment. A new, single-center, prospective, observational cohort study—following an elective switch from reference infliximab to a biosimilar, CT-P13, in patients with IBD—sought to investigate the long-term efficacy, safety, pharmacokinetic (PK) profile, and immunogenicity of the biosimilar treatment. The study’s authors concluded that a switch to CT-P13 from reference infliximab was both safe and feasible.

At a tertiary IBD referral center in the Netherlands, all 83 study participants, regardless of disease activity, were switched to CT-P13 between May and June of 2015. Participants included 57 patients with Crohn’s disease, 24 with ulcerative colitis (UC), and 2 with unclassified IBD. Of this group, 68 patients completed 1 year of follow-up. Patients continued to receive the same dose of the biosimilar as they had of the reference infliximab, and received infusions at the same intervals (though dose optimization and concomitant IBD therapies were allowed).

The researchers collected IBD characteristics as the baseline, and the primary endpoint of the study was change in disease activity scores at week 52 compared with week 0 as measured by:

• The Harvey—Bradshaw Index (HBI) for patients who had Crohn’s disease
• The Simple Clinical Colitis Activity Index for patients with UC
• IBD unclassified (IBD-U) for patients who had unclassified IBD

The researchers also assessed C-reactive protein, fecal calprotectin, infliximab trough levels, antidrug antibodies to infliximab (ADA), and drug survival. The researchers further defined subgroups of patients who were previously treated with infliximab (versus those who were naïve to infliximab treatment), patients with prior anti-tumor necrosis factor (anti-TNF) treatment (versus those naïve to anti-TNF agents), and patients with concomitant immunosuppressive therapy at baseline (versus those who had received infliximab as monotherapy).

The study’s results were as follows:

• Median change in disease activity was 0 points for both the CD group and the UC group (HBI range: —23 to +15, SCCAI range: –4 to +4)
• Clinical remission rates for all groups were 64% at baseline and 73% at week 52
• Inflammatory biomarkers did not change during the observational period
• FCP was 83 (range: 5 to 1404) at week 0 and 56 (range: 5 to 957) at week 52
• Change in disease activity outcomes during follow-up was not significantly different between subgroups of patients
• Infliximab trough levels remained unchanged within the 1-year study period
• Serious adverse events occurred in 4% of patients in the study

The authors conclude that their 1-year data on switching from reference infliximab to biosimilar CT-P13 demonstrate no significant impact on clinical outcomes including disease activity, safety, drug survival, and PK.

While the authors caution that this study is limited by the absence of a control group of patients receiving reference infliximab without switching to a biosimilar, they state that their 1-year data on relevant clinical outcomes should help clinicians in their decision-making regarding switching patients to CT-P13, and that a switch to the biosimilar could result in significant cost savings for the treatment of patients with IBD.