P087 REAL-WORLD EFFECTIVENESS OF USTEKINUMAB IN ULCERATIVE COLITIS

Abstract

Abstract Introduction Ulcerative colitis (UC) is a chronic inflammatory condition of the colon. Ustekinumab is a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23 FDA approved for use in Crohn’s disease. A recent randomized control trial UNIFI [Sands et al, NEJM 2019] demonstrated the efficacy of ustekinumab in patients with moderate-to-severe UC. The goal of this study was to describe the real-world effectiveness of ustekinumab in patients with UC. Methods A retrospective, single-center, chart review was performed of all patients with UC who received ustekinumab between January 2017 and October 2019. As ustekinumab is not yet FDA approved for UC, for patients who have exhausted other treatment options its use is considered “off-label”. Patient demographics, disease characteristics and prior treatment history were recorded. The primary outcome was clinical remission at 12 months after initiation of ustekinumab. Secondary outcomes were clinical response and remission at 3 months, and endoscopic response, corticosteroid-free remission, and deep remission (combined clinical and endoscopic remission) at 12 months (all outcomes defined in Figure 1). Results 19 pts received ustekinumab for moderate-to-severe UC. They were 47.4% male with a mean age of 42.7 ±17.0 years. Mean total Mayo score was 7.6 ± 1.5 and 47.4% of pts had disease limited to the left colon. 18/19 pts received a weight-based IV induction dose (520 mg, 390 mg or 260 mg for > 85 kg, >55 to 85 kg or ≤55 kg respectively) and 1/19 received 90mg subcutaneous injection as induction. All pts received 90mg subcutaneous injections every 8 weeks initially for maintenance, and 9/19 eventually needed dose escalation to every 4 weeks. All pts had prior exposure to a TNF antagonist, 26.3% had exposure to two or more TNF antagonists, 89.5% had prior failure of vedolizumab and 10.5% had prior failure of tofacitinib (Table 1). At 12 months, 38.5% had a clinical response, 30.8% were in clinical remission, 38.5% had an endoscopic response, and 30.8% were in deep remission (Figure 1). Two infectious adverse events (shigellosis, Escherichia coli enterocolitis) were reported in follow-up. Conclusions Ustekinumab is effective in patients with UC. The efficacy of ustekinumab in the UNIFI trial translated to our real-world population, despite higher rates of prior biologic failure with TNF antagonists and vedolizumab in our cohort. Further studies of large, real-world cohorts are needed to assess the long-term effectiveness and safety of ustekinumab in UC.