Effectiveness and safety of dual advanced therapy in inflammatory bowel disease ‒ A multicenter series from Galicia, Spain.

Abstract

Background: Approximately one-third of patients with inflammatory bowel disease (IBD) do not achieve disease control despite the incorporation of new advanced therapies in recent years. The combination of two advanced therapies (AT) can overcome this therapeutic ceiling; therefore, these therapies have been empirically tested in real-life clinical practice, but evidence is lacking on how and when to combine them.

Methods: A multicenter retrospective study was designed, reviewing cases treated with dual advanced therapy (DAT). We describe its characteristics, effectiveness, adverse effects, and examine whether any variables are associated with effectiveness.

Results: We described 29 DAT regimens in 24 patients, with a median duration of 7 months (IQR 0.5-43 months). Overall clinical remission was 41.1% (36% when DAT was indicated for refractory IBD, and 60% when it was indicated for an immune-mediated inflammatory diseases (IMID) and IBD). Endoscopic/radiological response was 31.6% of the evaluated patients (n = 19). In 17 cases (58.6%), DAT was discontinued, although in 3 of these due to deep remission. The median survival without discontinuation due to inefficacy or adverse events was 20 months. No differences in effectiveness were detected based on the combined mechanisms of action, or on the strategy of adding new versus recycled AT.

Conclusions: Empirical use of DAT in refractory IBD may lead to clinical remission in approximately one-third of patients. Remission rates appeared more effective when DAT is used to simultaneously treat IBD and an IMID. However, further data are needed before specific recommendations can be made regarding type or timing strategy for DAT.