Multiple Infliximab Biosimilar Switches Were Safe, Effective

Numerous successive switches from infliximab originator (Remicade) to biosimilar infliximab (IFX) are safe and effective in patients with inflammatory bowel disease (IBD), regardless of the amount of infliximab switches, according to the United European Gastroenterology Journal.

This is a graphic of the stomach and intestines.

It is known that switching from Remicade to biosimilar IFX is safe and effective, but data on multiple switching is limited. The Edinburgh IBD unit had conducted 3 switch programs:

1. Remicade to CT-P13 (Remsima; in 2016)
2. CT-P13 to SB2 (Remsima to Flixabi; in 2020)
3. SB2 to CT-P13 (Flixabi to Remsima; 2021).

IBD is an umbrella term for ulcerative colitis (UC) and Crohn disease (CD).

First, the study authors stated that the primary endpoint of the study was to evaluate patient adherence to CT-P13 after switching from SB2. Secondary endpoints consisted of persistence stratified by the number of biosimilar switches (single, double, and triple), safety, and effectiveness.

“Single and double switch appeared to be effective and safe in some observational studies, but data regarding three or more switches are lacking. In the present economic climate with multiple biosimilars available at competitive prices, data about multiple biosimilar switches is of increasing importance,” they emphasized.

Then, the study authors conducted a prospective, observational cohort study. All adult patients with IBD on IFX biosimilar SB2 underwent a voluntary switch to CT-P13. Patients were evaluated in a virtual biologic clinic with protocol driven collection of clinical disease activity, C-reactive protein (CRP), fecal calprotectin (FC), IFX trough/antibody levels, and drug survival.

Next, a total of 297 patients with IBD (CD, n = 196, 66%; UC or unclassified, n = 101, 34%) were switched with a follow-up of 7.5 (range, 6.8-8.1) months . Overall, 22.5% (n = 67) of the cohort underwent 3 switches between IFX products, 46.5% (n = 138) underwent 2 switches, and 31% (n = 92) experienced 1 switch. A total of 90.6% of patients stayed on their most recent IFX product during follow-up.

Switch number was not independently associated with IFX persistence after cofounder adjustment. Clinical (P = .77), biochemical (CRP ≤ 5 mg/ml; P = .75) and fecal biomarker (FC < 250 μg/g; P = .63) remission were analogous at baseline, week 12, and week 24.

In a large real-world cohort, study authors displayed that this methodology is safe and effective with similar clinical and biochemical remission rates over time, regardless of the number of switches. This new cohort displayed effectiveness and safety data to back the multiple switch approach. Other studies have supported this finding, as well.

“Immunogenicity has been a major concern regarding multiple switches, although both our study and previous literature demonstrated that this seemed to be not happening more often to patients who had multiple switches compared to those who had less number of switches or none,” said the study authors.

In the present study, 14 (7.1%) patients who developed de novo antibodies did not undergo 3 switches, suggesting that the antibody maifestation was not impacted by the switch or the biosimilar. This group might symbolize a selected cohort of patients on somewhat long-term IFX with a low immunogenicity risk.

Additionally, the study authors discovered that IFX duration rather than the number of IFX biosimilar switches as an independent predictor for IFX persistence. IFX duration and number of switches were found to be correlated.

To the best of the study authors’ knowledge, this is the first study analyzing the efficacy and safety of 3 successive switches in patients with IBD treated with IFX.

One limitation of this study is that the study design did not include a control arm that continued SB2, which obstructed the effectiveness and safety comparison between groups. Also, there was some missing data even though data were prospectively collected, that might have resulted in a conservative estimate of effectiveness outcomes.

“Multiple successive switches from the IFX originator to biosimilars appear effective and safe, irrespective of the number of switches. These findings are of major socioeconomic importance, especially in low and middle‐income countries where the access to healthcare may be limited,” the study authors concluded.

Reference

Gros B, Plevris N, Constantine-Cooke N, et al. Multiple infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort. United European Gastroenterol J. 2023;11(2):179-188. doi:10.1002/ueg2.12357