Corticosteroid dose reduction in ulcerative colitis patients treated with vedolizumab during the GEMINI 1 trial

Introduction: Corticosteroids (CS) are effective for the short‐term treatment of patients with ulcerative colitis (UC), but serious side effects prohibit long‐term use. In the GEMINI 1 study, a significantly higher percentage of patients with moderately to severely active UC were in CS‐free remission at week 52 with vedolizumab (VDZ) treatment than with placebo (PBO).1 Methods: In GEMINI 1, patients who responded to VDZ induction therapy at week 6 were re‐randomized to PBO or VDZ for 46 weeks. From week 6 onward, patients with clinical response to VDZ began a CS tapering regimen. We characterized CS dose reductions achieved with VDZ therapy in exploratory and post hoc analyses of patients with baseline (week 0) CS use (<30 mg/day prednisone or equivalent). Median CS dose over time, change from baseline CS dose, and CS‐free status at week 52 were summarized overall and by tumor necrosis factor antagonist (anti‐TNF) treatment (naive or failure) history. Results: Among patients with baseline CS use, 74% decreased their CS dose with VDZ treatment compared with 57% with PBO (Table). At week 52, 56% of VDZ‐treated patients compared with 32% of PBO‐treated patients were on <7.5 mg/day of CS (Table); the median CS dose was 2.5 mg/day for VDZ‐treated patients and 10.0 mg/day for PBO‐treated patients. Numerically higher percentages of VDZ‐treated patients were CS‐free for 90 or 180 consecutive days at week 52 than PBO‐treated patients (Table). Similar trends were observed in the anti‐TNF‐naive and anti‐TNF‐failure populations (Table). Conclusion: Numerically greater reductions in CS use were achieved with VDZ maintenance therapy compared with PBO. At week 52, VDZ therapy was associated with numerically higher percentages of CS‐free patients and patients who were CS‐free for 90 or 180 consecutive days than PBO. Interpretation of these post hoc analyses, including the degree of dose reduction, is limited by differing initiation weeks for CS tapering per patient and small sample sizes.. (Table Presented).