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Biologic Switch Timing and Risk of Infection in Patients With Ulcerative Colitis/Crohn's Disease: A Retrospective
Annie J Kruger1, Flavio Dormont2, Nicolas Capit3
1Immunology and Inflammation, Sanofi, Cambridge, Massachusetts.
Overlapping biologic switches in ulcerative colitis and Crohn's disease are common. These switches do not increase the risk of serious infections compared to non-overlapping switches, suggesting potential for improved therapy management.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Limited real-world data exists on biologic therapy switch timing in ulcerative colitis (UC) and Crohn's disease (CD).
- Understanding infection risk associated with different biologic switching strategies is crucial for patient safety and effective disease management.
Purpose of the Study:
- To investigate real-world patterns of biologic therapy switches in UC/CD patients.
- To compare the risk of any infection and serious infection between overlapping (OS) and non-overlapping switches (NOS).
Main Methods:
- Retrospective observational study using de-identified claims data (2017-2022).
- Identified UC/CD patients initiating biologic therapy and categorized switch timing (OS: ≤5 half-lives, NOS: >5 half-lives).
- Used weighted Cox proportional hazards models to estimate adjusted hazard ratios (aHRs) for infection risks.
Main Results:
- 1293 of 11,992 patients (10.8%) switched biologics; 64.2% were OS.
- Incidence rates of any infection were comparable between OS and NOS groups.
- No significant difference in adjusted hazard ratios for any infection (aHR=1.40, P=.17) or serious infection (aHR=0.95, P=.93) between OS and NOS.
Conclusions:
- Overlapping biologic switches are frequent in UC/CD clinical practice.
- Overlapping switches were not associated with an increased risk of serious infection compared to non-overlapping switches.
- Shortened washout periods may offer benefits for therapy management and clinical trial recruitment with minimal safety risks.
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