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Comparable remission and health care use in real-world inflammatory bowel disease patients initiating originator biologics vs biosimilars
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DOI：10.3748/wjg.v32.i9.114580.png)
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Abstract
En 中文
BACKGROUND Biologic therapies, including anti-tumor necrosis factor agents, have significantly improved the management of inflammatory bowel disease (IBD). However, their high cost can limit patient access. Biosimilars are a more affordable option than originator biologics and offer potential for improved accessibility, though real-world evidence comparing their effectiveness remains limited. AIM To describe real-world, comparative outcomes of IBD patients taking biologics and biosimilars, focusing on remission and healthcare use. METHODS We used data from a multicenter registry-based cohort, which includes participants from six Canadian IBD clinical centers. Adults with ulcerative colitis or Crohn's disease who initiated biosimilar, or originator formulations of infliximab or adalimumab were included. The primary outcome was clinical remission; secondary outcomes included hospitalizations and emergency department (ED) visits. Kaplan-Meier survival analyses and multivariable Cox regression models were used to assess time to these outcomes, adjusting for disease activity, treatment history, and demographic characteristics. RESULTS A total of 258 individuals were analyzed (192 biosimilar initiators and 66 originator users). The median time to remission was similar between biosimilars (12.2 months) and originators (12.8 months). We did not detect difference in the likelihood of achieving remission when comparing biosimilar and originator treatments (adjusted hazard ratio: 1.49; 95% confidence interval: 0.96-2.32). Hospitalization and ED visit rates were also comparable. Corticosteroid use and prior hospitalizations were associated with increased hospitalization risk. CONCLUSION This study suggests biosimilars and originators have similar remission, ED visits, and hospitalization in IBD. This reinforces confidence in their equivalence, improving access while supporting healthcare system sustainability.
Keywords:
Inflammatory bowel disease
Adalimumab
Infliximab
Biosimilars
Emergency department visits
Hospitalization
Clinical remission
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