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P366 Vedolizumab maintenance therapy reduced use of corticosteroids in patients with Crohn’s disease in the GEMINI 2 trial

D'Haens, G.(1);Candela, N.(2);Uddin, S.(3);Peterson, T.(2);Dubinsky, M.(4);Colombel, J.F.(5);

(1)Academic Medical Center, Department of Gastroenterology and Hepatology, Amsterdam, The Netherlands;(2)Takeda Pharmaceuticals USA Inc., US Medical, Lexington, United States;(3)Takeda Pharmaceuticals USA Inc., Biostatistics, Lexington, United States;(4)Icahn School of Medicine at Mount Sinai Hospital, Pediatric Gastroenterology and Hepatology, New York, United States;(5)Icahn School of Medicine at Mount Sinai Hospital, Gastroenterology, New York, United States

Background

Corticosteroids (CSs) can induce clinical remission of Crohn’s disease (CD), but long-term use is associated with serious side effects. In the GEMINI 2 trial, a greater proportion of patients with moderately to severely active CD treated with vedolizumab (VDZ) maintenance therapy achieved CS-free remission at week 52 compared with placebo (PBO).1 Response to VDZ is influenced by prior exposure to anti-TNF therapy. In this post hoc exploratory analysis of GEMINI 2, we investigated the impact of VDZ maintenance therapy on use of CSs stratified by prior anti-TNF therapy failure status and baseline disease activity (moderate or severe).

Methods

In GEMINI 2, patients who responded to VDZ induction therapy at week 6 were re-randomized to receive VDZ or PBO every 4 or 8 weeks and began a prespecified CS tapering regimen (Figure 1).1 In patients receiving CSs at baseline, we measured change in CS dose from baseline to week 52 , proportion of patients with CS dose ≤ 7.5 mg/day, and proportion of patients with ≥ 90 or ≥ 180 consecutive CS-free days at week 52. Analyses were conducted overall and stratified by prior anti-TNF therapy failure status, baseline Crohn's Disease Activity Index (CDAI) score (moderate: ≤ 330, severe: > 330), and the composite of both measures.

Results

In the overall population, a greater proportion of patients treated with VDZ (67.7%) vs PBO (61.5%) had their CS dose reduced from baseline. This trend was also observed among patients with no prior anti-TNF therapy failure, with a baseline CDAI score ≤ 330, and with no prior anti-TNF therapy failure and a baseline CDAI score ≤ 330 (Figure 2). Similarly, numerically higher proportions of patients treated with VDZ vs PBO received a CS dose of ≤ 7.5 mg/day in the overall population and in subgroups with no prior anti-TNF therapy failure, with baseline CDAI score ≤ 330, and with no prior anti-TNF therapy failure and a baseline CDAI score ≤ 330 (Figure 3). Overall, 35.2% and 32.7% of patients receiving VDZ had ≥ 90 and ≥ 180 consecutive CS-free days, respectively, compared with 28.0% and 22.0% of those receiving PBO. The proportion of patients with ≥ 180 consecutive CS-free days was numerically higher for the VDZ group vs the PBO group, regardless of prior anti-TNF therapy failure status or baseline CDAI score.

Conclusion

VDZ maintenance therapy was associated with more successful CS withdrawal than PBO, particularly in patients with no prior anti-TNF therapy failure and moderate disease activity. Interpretation of these results is limited by the exploratory nature of the analyses, small sample sizes and different initiation weeks for CS tapering per patient.

Reference
1. Sandborn WJ et al. N Engl J Med 2013;369:711–21.





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