PGI35 - Systematic Literature Review of Real-World Evidence on Persistence, Switching, and Dose Escalation with Biologics in Inflammatory Bowel Disease in the United States

Abstract

Biologic therapies have become mainstays of treatment for inflammatory bowel disease (IBD), with numerous treatment options now approved in the United States (US). However, evidence of real-world benefits with biologic therapies in IBD is limited. Medication persistence, switching, and dose escalation have been suggested as proxies for real-world safety and effectiveness. This study sought to review evidence on real-world patterns of persistence, discontinuation, switching, and dose escalation with biologics for treatment of IBD (Crohn’s disease [CD] and ulcerative colitis [UC]) among adults in the US. A systematic search and review of electronic medical databases (PubMed, Embase, and Cochrane; 2012 forward), conference abstracts (2016-2017), and bibliographies. Thirty-two studies, mostly retrospective, reported outcomes related to persistence (lack of discontinuations), switching, and/or dose escalations in IBD (20 in CD, 9 in UC, and 11 in IBD). Most studies examined biologics or anti–tumor necrosis factor (TNF) as a category, infliximab, adalimumab, or vedolizumab. Patient populations differed in terms of prior exposure to biologics and prior/concurrent nonbiologic treatments. Study design, follow-up times, and endpoint definitions also varied between studies. The results of all identified studies revealed that a high proportion of patients with IBD, CD, and UC discontinued biologic therapy. In most studies, 10%-37.5% of patients who discontinued index biologic switched to another biologic (range, 0%-100%). Additionally, 8%-44% of patients experienced dose escalations. The main reasons for treatment discontinuation were lack or loss of response and adverse events. Discontinuation rates increased by line of therapy and were higher with step-up therapy versus early initiation of anti-TNF (top-down approach). This review highlights high rates of discontinuations, nonpersistence, switching, and dose escalations with biologics in IBD in the US.