A retrospective study in Scotland found that multiple successive changes from originator infliximab to biosimilars seem to be safe and effective in patients with inflammatory bowel disease (IBD), irrespective of the number of switches.
Multiple successive switches from originator infliximab (Remicade) to biosimilars were safe and effective in patients with inflammatory bowel disease (IBD), regardless of the number of infliximab switches (single, double, and triple), according to a study in the United European Gastroenterology Journal. IBD is an umbrella term for ulcerative colitis and Crohn disease.
This study was conducted because there is scarce data on multiple switching, though it is known that switching from originator infliximab to biosimilar infliximab is safe and effective. “In the present economic climate with multiple biosimilars available at competitive prices, data about multiple biosimilar switches is of increasing importance,” said the researchers.
An IBD unit in Edinburgh had previously undertaken 3 switch programs as biosimilar prices dropped: originator infliximab to CT-P13 (sold as Remsima in Europe) in 2016; CT-P13 to SB2 (sold as Flixabi in Europe) in 2020; and SB2 to CT-P13 in 2021. In ex-EU regions (such as the United States, Canada, and Australia), SB12 is marketed under the brand name Renflexis by Organon.
The primary endpoint of the current study was to assess CT-P13 persistence after an elective switch from SB2 in 297 patients. Secondary endpoints comprised persistence stratified by the number of biosimilar switches (single, double, and triple), safety, and effectiveness.
Patients were included in the study if they had 3 doses of SB2.
Of the total, 196 patients had Crohn disease (66%) and 101 had IBD (34%). They were followed for a median of 7.5 months (interquartile range, 6.8-8.1 months).
Patient demographics and IBD characteristics were obtained from electronic medical health records.
Data collection included clinical disease activity, C-reactive protein (CRP) levels, fecal calprotectin, infliximab trough/antibody levels, and drug survival.
The switch to CT-P13 from SB2 was the third, second, and first infliximab change for 67/297 (22.5%), 138/297 (46.5%), and 92/297 (31%) of the cohort, respectively.
Nearly 91% of patients stayed on infliximab during follow-up. Switch number was not independently associated with infliximab persistence after adjusting for cofounders.
Remission rates were comparable at baseline, week 12, and week 24 as measured by clinical disease activity, CRP level, and fecal biomarker level.
Researchers said that the duration of infliximab, rather than the number of biosimilar switches, are an independent predictor for infliximab persistence. They also added that duration and number of switches are correlated, saying that this might be explained by the known disconnect between symptoms and active inflammation in IBD and by collinearity in the multivariable model.
In 5 patients, 6 adverse events were reported, and included psoriatic reaction, squamous cell carcinoma of the tonsil, arthralgia, severe COVID-19 infection necessitating intensive care unit (ICU) hospitalization, heart failure necessitating ICU admission, and mild skin reaction. Three of the adverse events were defined as severe, leading to drug discontinuation.
While immunogenicity has been a concern in biosimilar switching, the researchers noted this study and past research has not found this to be the case when involving multiple switching.
This is the first study analyzing the efficacy and safety of 3 successive switches in patients with IBD receiving infliximab, the authors said. Some limitations of the study were that the study design did not include a control arm that continued SB2, hindering the comparison of effectiveness and safety between groups. Baseline characteristics were not comparable between subgroups (ie, different duration), and there was some missing data that may have resulted in a conservative estimate of effectiveness outcomes.
The researchers concluded that multiple successive switches from originator infliximab to biosimilars appear effective and safe, regardless of the number of switches. Importantly, these results can contribute to saving health care costs.
“These findings are of major socioeconomic importance, especially in low and middle‐income countries where the access to healthcare may be limited,” they said.
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