P565 Efficacy and safety of long-term treatment with ustekinumab in moderate–severe ulcerative colitis patients with delayed response to ustekinumab induction: Results from UNIFI 2-year long-term extension

Abstract

Background: Ustekinumab (UST) has been shown to induce and maintain clinical response and remission in moderate-severe ulcerative colitis (UC) patients in the UNIFI study. 1 In the UNIFI maintenance study, the primary randomized population consisted of patients who were in clinical response 8 weeks after UST induction treatment. Patients who had a delayed response to induction were also eligible for the maintenance study but were not included in the randomized analysis set. Here, we present the efficacy and safety of UST maintenance among delayed responders who were treated in the UNIFI long-term extension (LTE). Method(s): UNIFI was a single protocol of induction and randomized withdrawal maintenance studies in patients with moderate-severe UC who failed conventional or biologic therapy (including TNF antagonists and/or vedolizumab). Delayed responders were patients who were not in clinical response to UST intravenous (IV) induction at Week 8 but achieved response at Week 16 following a single UST 90 mg subcutaneous (SC) dose at Week 8. These patients entered the maintenance study and continued to receive UST 90 mg SC q8w. Patients who completed Week 44 evaluations were eligible to enter the long-term extension (LTE) continuing to receive UST 90 mg SC q8w. Efficacy in delayed responders to UST (who were treated in the LTE) was evaluated over time through Week 92 and safety through Week 96. Result(s): 116 delayed responders to UST induction were treated in the LTE, including 58 who had previously failed biologic therapy and 58 who had not failed biologic therapy, 54 of whom were biologic naive. Symptomatic remission (defined as stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0) rates in delayed responders to UST induction increased from maintenance baseline to Weeks 44 and 92 (Table 1). Similar trends were seen within the biologic failure subgroups; although, the rates among patients who had not failed biologics (primarily biologic naive) were greater than those of patients who had failed biologics. Among the 79.3% (n=92/116) of delayed responders to UST in symptomatic remission at Week 92, 94.6% (n=87/92) were corticosteroid free. Safety data for the randomized and non-randomized patients treated in the UNIFI LTE is presented in Table 2. The safety profile for UST in the delayed responders was generally similar to that observed among patients randomized to UST; no new safety signals were observed. Conclusion(s): Delayed responders to UST treatment maintained symptomatic remission through Week 92 with UST 90 mg SC q8w and the majority did so in the absence of corticosteroids. Reference: 1. Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019; 381(13):1201-1214. Copyright © 2020