EFFICACY AND SAFETY OF USTEKINUMAB AS MAINTENANCE THERAPY IN ULCERATIVE COLITIS: WEEK 44 RESULTS FROM UNIFI

Background: The study objective was to evaluate the safety and efficacy of SC ustekinumab (UST) as maintenance therapy in UC patients (pts) who were in clinical response to a single IV induction dose of UST. Methods: This was a Phase 3, double-blind, randomized withdrawal study in pts with moderate-severe active UC who failed conventional or biologic therapy (including anti-TNF and/or vedolizumab) and were in clinical response 8 wks after receiving a single UST IV induction dose. The primary study population included 523 pts randomized 1:1:1 to placebo (PBO) SC, UST 90 mg SC q8w or q12w at Wk 0. The primary endpoint was clinical remission at Wk 44 (52 wks after IV induction); key secondary endpoints were maintenance of clinical response, endoscopic healing, corticosteroid-free clinical remission, and maintenance of clinical remission among pts who achieved clinical remission at baseline. Results: Baseline (induction Wk 0) demographics, UC disease characteristics, concomitant UC medications and medication history were generally similar among treatment groups. Significantly greater proportions of UST q8w and q12w pts were in clinical remission at Wk 44 (43.8% and 38.4%, respectively) vs PBO pts (24.0%; p<0.001 and p=0.002, respectively). Significantly greater proportions of UST q8w and q12w pts maintained clinical response through Wk 44 and achieved endoscopic healing and corticosteroid-free clinical remission vs PBO pts. Clinical remission through Wk 44 was maintained for a significantly greater proportion of q12w pts and a numerically greater proportion of q8w vs PBO pts (Table 1). The proportions of pts with AEs, serious AEs, infections, and serious infections in the UST groups were generally comparable to PBO group. The proportions of pts who discontinued study agent were lower with UST q8w and q12w vs PBO. Among the primary population in the maintenance study: no deaths, 2 malignancies other than NMSC (1 colon cancer, q8w; 1 papillary renal cell carcinoma, q12w) were reported (Table 2). One pt reported NMSC (2 SCC events, q12w). Conclusion: Both UST 90 mg q8w and q12w SC achieved clinical remission and maintained clinical response and were effective in achieving endoscopic healing and corticosteroid-free remission among pts with moderate to severe UC induced into clinical response with single IV dose of UST. The safety for UST in UC pts was consistent with the known safety profile of UST in Crohn's Disease. [Table presented] [Table presented]