Data presented at Digestive Disease Week (DDW) 2023 show that switching to an infliximab biosimilar compared to continuing on infliximab innovator based on an actual national patient cohort in the United States (US) and were not associated with adverse events. .1 The researchers say these results provide further assurance that switching to biosimilars for Crohn’s disease (CD) and ulcerative colitis (UC) patients is safe.
Jason Ken Ho, MD, MS
Credit: Baylor College of Medicine
“Infliximab biosimilars are widely available in CD and UC,” said Jason Ken Ho, M.D., Ph.D., of Baylor College of Medicine in Houston, Texas, and colleagues. “However, biosimilar switching practices are highly variable in the United States. Barriers to switching include patient and provider concerns about poor efficacy, immunogenicity, and safety.”
Researchers evaluated the safety of biosimilar switching in a US cohort of CD and US veterans. This cohort was less prone to selection bias as it was based on local institutional policy rather than patient and provider selection.
A retrospective cohort study of this patient population who received maintenance therapy originator infliximab between 2017 and 2019 was included in the analysis. Patients were identified using a validated algorithm and further confirmed by chart review. Maintenance Infliximab originators were identified by drug dispensed from a corporate data warehouse (CDW). For those who switched to biosimilars after 2017, the drug dispensed classified him as CDW, confirmed by chart review.
Adverse outcomes were classified as serious infections, including intravenous antibiotics or delayed intravenous administration, infusion reactions, or immunogenicity such as anti-infliximab antibodies or infliximab escalation. These adverse reactions were also confirmed in chart reviews. Via univariate and multivariate logistic regression models adjusting for patient and non-patient factors, the incidence of adverse events at his 12 months in patients continuing on starting infliximab compared with those switching to biosimilars. compared.
In total, 790 patients who were founders of maintenance infliximab were included in the study, 488 patients were diagnosed with CD, 298 were diagnosed with UC, and 4 patients had undefined inflammatory bowel disease. (IBDU). Of these patients, 380 were switched to biosimilars and 410 continued on starting infliximab.
Overall, adverse outcomes occurred in 35.6% of patients at 12 months (35.6% in the switch cohort, 35.3% in the non-switch group, P. = .87). No statistically significant differences between the groups were observed in the incidence of infusion reactions, serious reactions, or immunogenicity.Multivariate logistic regression including age, gender, race, concomitant medications, and veterans
(VA) Priority status, no significant differences in adverse outcomes were observed at 12 months between groups (adjusted odds ratio [aOR] 1.09, 95% confidence interval [CI] .76-1.42).
References
- Hou JK, Pham C, Sansgiry S, Modi V, Switching other biosimilars to infliximab is not associated with adverse outcomes: A real-world efficacy analysis in a national cohort of US veterans with inflammatory bowel disease. Abstract presented at Digestive Disease Week (DDW) 2023 Annual Meeting. Chicago, Illinois. May 6-10, 2023.