1. Overall, the use of 5-aminosalicylic acid (5-ASA) in combination with ustekinumab (UST) did not provide a significant benefit in patients with inflammatory bowel disease (IBD).
Evidence Rating Level: 2 (Good)
UST, a monoclonal antibody targeting interleukin-12/23, is a newer therapeutic option available to individuals living with Crohn’s disease (CD) or ulcerative colitis (UC). However, the efficacy of UST in combination with 5-ASAs for patients living with IBD has not been well characterized. This retrospective cohort study therefore sought to investigate the impact of concomitant UST and 5-ASA for the management of patients with CD or UC. 1971 patients (median age [IQR], 40.0 [29.0-50.0]; 65.5% female) rom the Medical Data Vision database of healthcare claims in Japan were included in the study. The primary outcome of the study was UST failure. Within the median follow-up period of 322 days, 726 patients (36.8%) experienced treatment failure. UST failure occurred in 36.2% of patients not receiving concomitant 5-ASA and 37.0% of patients who received concomitant 5-ASA therapy (P = 0.359). Based on post-hoc subgroup analysis, the cumulative rate of UST continuity was significantly higher in patients who received concomitant 5-ASA therapy in patients who were naïve to advanced drug therapies (ADT) like UST (P = 0.0121). Overall, this study found that the concomitant use of 5-ASA therapy together with UST does not provide a significant benefit for patients living with CD or UC, but may have a protective effect in patients who are ADT naïve.
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