P0872 Corticosteroid sparing effects of treatment with guselkumab in patients with moderately to severely active Crohn’s disease: Phase 3 GRAVITI study results through week 48

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Abstract Background The Phase 3 double-blind, placebo-controlled, treat-through GRAVITI study evaluated the efficacy and safety of subcutaneous (SC) induction and maintenance treatment with guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor that binds to IL-23 and CD64 (a receptor on cells that produce IL-23), in participants (pts) with Crohn’s disease (CD). Here we report the corticosteroid (CS)-sparing effects of treatment with GUS vs placebo (PBO) through Week (Wk) 48. Methods This study randomized pts 1:1:1 to GUS 400mg SC every 4 wks (q4w)→200mg SC q4w, GUS 400mg SC q4w→100mg SC q8w, or PBO. PBO pts who met rescue criteria were eligible for rescue treatment with GUS at Wk16. For pts receiving oral CS at baseline, doses were maintained through Wk12. Mandatory oral CS tapering began at Wk12 unless medically not feasible. CS use, CS-free clinical remission, and 90-day CS-free clinical remission at Wk48 were assessed. Results The full analysis set included 347 pts, mean (SD) age, 37.5 (12.89) yrs; mean CD duration, 8.0 (8.05) yrs; mean (SD) CDAI score, 296.9 (52.68); and mean (SD) SES-CD score, 12.0 (6.94). No pts were receiving beclomethasone at baseline. Among all pts receiving oral CS (prednisone or budesonide) at baseline (103/347; 29.7%), greater proportions of GUS-treated pts (100mg SC q8w: 62.5%, adjusted treatment difference ∆41.7%; 200mg SC q4w: 81.6%, ∆62.9%) were not receiving CS at Wk48 vs PBO (18.2%). Also, among pts receiving oral CS at baseline, greater proportions of GUS-treated pts (100mg SC q8w: 59.4%, ∆38.8%; 200mg SC q4w: 81.6%, ∆62.9%) were not receiving CS for at least 90 days prior to Wk48 vs PBO (18.2%) (Table 1). Significantly greater proportions of GUS-treated pts (100mg SC q8w: 60.0%, ∆42.8%; 200mg SC q4w: 66.1%, ∆48.9%) achieved clinical remission at Wk48 vs PBO (17.1%) (Figure 1). Likewise, greater proportions of GUS-treated pts (100mg SC q8w: 59.1%, ∆42.8%; 200mg SC q4w: 66.1%, ∆49.8%) achieved CS-free clinical remission at Wk48 vs PBO (16.2%). Similarly, greater proportions of GUS-treated pts (100mg SC q8w: 58.3%, ∆41.9%; 200mg SC q4w: 65.2%, ∆49.0%) achieved 90-day CS-free clinical remission at Wk48 vs PBO (16.2%). Conclusion In pts with moderately to severely active CD, greater proportions of GUS-treated pts achieved CS-free efficacy outcomes through Wk48 vs PBO.