COVID-19 State of Emergency and Biological Therapy Persistence for Ulcerative Colitis: An Interrupted Time Series Study Using a Nationwide Claims Database

Pharmacoepidemiol Drug Saf. 2026 Apr;35(4):e70377. doi: 10.1002/pds.70377.

ABSTRACT

PURPOSE: To evaluate changes in biological therapy persistence for ulcerative colitis during Japan's first COVID-19 state of emergency.

METHODS: Using a nationwide health insurance claims database, we identified patients with ulcerative colitis who received biological maintenance therapy between January 2014 and December 2022. Interrupted time series analysis was used to evaluate immediate level changes and post-intervention changes in trends in treatment non-persistence after the state of emergency. Kaplan-Meier analysis compared time to non-persistence between patients initiating biological therapy in the pre- and post-intervention periods using log-rank tests.

RESULTS: Among 1197 eligible patients (67.1% male; median age, 40.0 years [interquartile range, 29.0-50.0 years]), 384 received infliximab; 375, adalimumab; 286, vedolizumab; and 152, golimumab. Interrupted time series analysis showed no clear evidence of an immediate level change in treatment non-persistence after intervention (level change, 0.38; p = 0.822) or a post-intervention change in trend (change in trend, -0.33; p = 0.167). Kaplan-Meier analysis showed no significant difference in time to non-persistence between pre- and post-intervention initiators.

CONCLUSIONS: Biological therapy persistence for ulcerative colitis was largely maintained during the COVID-19 pandemic in Japan. These findings suggest that the pandemic was not associated with a marked change in treatment persistence in this setting.

PMID:41990848 | DOI:10.1002/pds.70377