S1402 Corticosteroid Sparing Effects of Treatment With Guselkumab in Patients With Moderate to Severely Active Ulcerative Colitis: Phase 3 QUASAR Maintenance Study Results Through Week 44

Introduction: The Phase 3 QUASAR Maintenance Study (NCT04033445) evaluated the efficacy of maintenance treatment with SC guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor that binds to CD64, in patients (pts) with ulcerative colitis (UC). Here we report the corticosteroid sparing effects of maintenance treatment with GUS compared with GUS withdrawal (placebo [PBO]) through Week (Wk) 44. Methods: At maintenance baseline, clinical responders to 12 wks of GUS intravenous induction were randomized 1:1:1 to GUS 200 mg SC every 4 weeks, GUS 100 mg SC every 8 weeks, or GUS withdrawal (PBO). Pts who were receiving oral corticosteroids upon entry into the maintenance study were required to begin tapering their daily corticosteroid dose at Wk0, unless medically not feasible. Corticosteroid use and corticosteroid-free clinical remission at Wk44 were assessed. Results: The primary analysis population included 568 pts (induction baseline: mean age, 40.7yr; mean UC duration, 7.8yr; mean modified Mayo score, 6.9 [63.9% with severe disease]; Mayo endoscopy subscore of 3, 66.4%). At maintenance baseline, 38.9% (221/568) of pts were receiving oral corticosteroids. Among pts who were receiving oral corticosteroids (excluding budesonide and beclomethasone dipropionate) at maintenance baseline, the mean decreases from baseline in the average daily prednisone-equivalent corticosteroid dose at Wk44 were greater in the GUS 100mg and 200mg groups compared with the withdrawal group (-10.22 and -10.25 vs -7.35mg/day, respectively, both nominal P < 0.001). As early as Wk8, higher proportions of pts in both GUS treatment groups had eliminated oral corticosteroids compared with the withdrawal group (65.8% [48/73] and 64.4% [47/73] for GUS 100mg and GUS 200mg groups, respectively, vs 32.0% [24/75] for withdrawal group, both nominal P < 0.001). At Wk44, higher proportions of pts in the GUS treatment groups vs withdrawal group had eliminated oral corticosteroids (Table 1). Higher proportions of pts in the GUS treatment groups were in clinical remission at Wk44 and had eliminated oral corticosteroids for at least 8 wks prior to Wk44, compared with the withdrawal group (Table 1). Among GUS-treated pts, 180 achieved clinical remission at Wk44 and 178 (98.9%) of them had eliminated oral corticosteroids at least 8 wks prior to Wk44. Conclusion: In patients with UC, maintenance treatment with GUS 100mg SC every 8 weeks and GUS 200mg SC every 4 weeks sustained clinically meaningful efficacy through Wk44 and allowed successful elimination of concomitant corticosteroids. Table 1. - Corticosteroid Use and Corticosteroid-free Clinical Remission at Week 44: Primary Analysis Population GUS Withdrawal (Placebo) GUS 100mg SC every 8 weeks GUS 200mg SC every 4 weeks Primary analysis population, N 190 188 190 Clinical remission at Wk44 (multiplicity-controlled),a1b n (%)Adjusted treatment difference (95% CI)c P-value d 36 (18.9%) 85 (45.2%)25.2 (16.4,33.9) P < 0.001 95 (50.0%)29.5 (20.9, 38.1) P < 0.001 Clinical remission at Wk44 and not receiving corticosteroids for ≥8 wks prior to Wk44 (multiplicity-controlled), a1b n (%)Adjusted treatment difference (95% CI)c P-value d 35 (18.4%) 85 (45.2%)25.7% (17.0%, 34.5%)< 0.001 93 (48.9%)29.0% (20.5%, 37.6%)< 0.001 Clinical remission at Wk44 and not receiving corticosteroids for ≥12 wks prior to Wk44 a1b n (%)Adjusted treatment difference (95% CI)c Nominal P-value d 35 (18.4%) 85 (45.2%)25.7% (17.0%, 34.5%)< 0.001 93 (48.9%)29.0% (20.5%, 37.6%)< 0.001 Patients receiving oral corticosteroids at maintenance baseline, n (%) 75 (39.5%) 73 (38.8%) 73 (38.4%) Eliminating oral corticosteroids ≥12 wks prior to Wk44,a2b n (%)Adjusted treatment difference (95% CI)cNominal P-value d 27 (36.0%) 51 (69.9%)33.5% (19.0%, 48.0%)< 0.001 48 (65.8%)29.2% (14.4%, 44.0%)< 0.001 Eliminating oral corticosteroids ≥8 wks prior to Wk44 and in clinical remission at Wk44,a2b n (%)Adjusted treatment difference (95% CI)c Nominal P-valued 10 (13.3%) 35 (47.9%)34.2% (21.4%, 47.1%)< 0.001 29 (39.7%)25.8% (13.1%, 38.6%)< 0.001 Primary analysis population: Randomized and treated patients with a modified Mayo score 5-9 at induction baseline.a1Clinical remission is defined as a stool frequency subscore of 0 or 1 that has not increased from induction baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present. a2 Eliminating oral corticosteroids by a designated time point is defined as not requiring any oral corticosteroid treatment from that time point until maintenance Wk44. b Patients who had an ostomy or colectomy, a dose adjustment, a prohibited change in UC medications, or discontinued study agent due to lack of efficacy or an AE of worsening of UC or other reasons except for COVID-19 related reasons (excluding COVID-19 infection) or regional crisis in Russia and Ukraine prior to Wk44 were considered not to have achieved the endpoint. c The adjusted treatment difference and confidence intervals were based on the Wald statistic with Cochran-Mantel-Haenszel (CMH) weight. d The P-values were based on the CMH test, stratified by clinical remission status at maintenance baseline (Yes/No), and induction treatment (guselkumab 400 mg IV, guselkumab 200 mg IV, placebo IV crossover to guselkumab 200 mg IV).

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