Persistence of Infliximab Biosimilar versus Originator in Patients with Crohn's Disease: a Retrospective Cohort Study in China
Author(s)
Yue Gao, MSc1, Jianfang Jiang, MD2, Fan Lan, MD2, Yongjia Zhuo, MSc1, Kangchen Lv, MSc1, Jianwei Xuan, PhD1, Qian Cao, MD2.
1Health Economic Research Institute, School of Pharmacy, Sun yat-sen university, Guangzhou, Guangdong, China, 2Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China.
1Health Economic Research Institute, School of Pharmacy, Sun yat-sen university, Guangzhou, Guangdong, China, 2Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China.
Presentation Documents
OBJECTIVES: Infliximab (IFX) is widely used in the treatment of Crohn's disease (CD), but the persistence difference between the original and IFX biosimilar (IFX-BS) remains insufficiently studied. This study aimed to compare the persistence of original IFX and IFX-BS in Chinese CD patients.
METHODS: We conducted a retrospective, single-center cohort study involving CD patients treated with IFX or IFX-BS between October 2021 and February 2024. Demographic data, clinical information and medication information were collected. Kaplan‐Meier analysis with log‐rank test was used to describe treatment persistence, which was defined as the time interval between initiation and discontinuation of IFX during 1-year follow-up. The Cox proportional hazard model was used to estimate hazard ratios (HRs) of discontinuation risk rate of two treatments.
RESULTS: A total of 471 patients were included, with 344 in the original IFX group and 127 in the IFX-BS group. During 1-year follow-up, Kaplan-Meier survival analysis showed no significant difference in the time to discontinuation between the two groups (P = 0.452). The Cox proportional hazard model found that after adjusting for baseline Crohn’s disease activity index (CDAI), disease localization (assessed by Montreal classification), and previous treatment with biological and immunosuppressive agents, there was no statistically significant difference in the discontinuation risk rate between the two groups of patients (HR = 1.15, 95%CI: 0.49-2.72, P = 0.741). In bio-naïve subgroup, which included patients who never received biologics, there was also no difference in time to discontinuation (P = 0.267) and discontinuation risk rate (HR = 0.84, 95%CI: 0.31-2.25, P = 0.730) between two groups.
CONCLUSIONS: In Chinese CD patients, original and biosimilar IFX had comparable persistence in 1-year follow-up. This provides valuable information for clinical decisions, yet further research on long-term persistence and other factors is warranted.
METHODS: We conducted a retrospective, single-center cohort study involving CD patients treated with IFX or IFX-BS between October 2021 and February 2024. Demographic data, clinical information and medication information were collected. Kaplan‐Meier analysis with log‐rank test was used to describe treatment persistence, which was defined as the time interval between initiation and discontinuation of IFX during 1-year follow-up. The Cox proportional hazard model was used to estimate hazard ratios (HRs) of discontinuation risk rate of two treatments.
RESULTS: A total of 471 patients were included, with 344 in the original IFX group and 127 in the IFX-BS group. During 1-year follow-up, Kaplan-Meier survival analysis showed no significant difference in the time to discontinuation between the two groups (P = 0.452). The Cox proportional hazard model found that after adjusting for baseline Crohn’s disease activity index (CDAI), disease localization (assessed by Montreal classification), and previous treatment with biological and immunosuppressive agents, there was no statistically significant difference in the discontinuation risk rate between the two groups of patients (HR = 1.15, 95%CI: 0.49-2.72, P = 0.741). In bio-naïve subgroup, which included patients who never received biologics, there was also no difference in time to discontinuation (P = 0.267) and discontinuation risk rate (HR = 0.84, 95%CI: 0.31-2.25, P = 0.730) between two groups.
CONCLUSIONS: In Chinese CD patients, original and biosimilar IFX had comparable persistence in 1-year follow-up. This provides valuable information for clinical decisions, yet further research on long-term persistence and other factors is warranted.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO89
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy, Relating Intermediate to Long-term Outcomes
Disease
SDC: Gastrointestinal Disorders, STA: Biologics & Biosimilars