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COMPLETE MUCOSAL HEALING AND STEROID-FREE MUCOSAL HEALING WITH INFLIXIMAB, AZATHIOPRINE, OR INFLIXIMAB+AZATHIOPRINE: UC SUCCESS SUBANALYSIS
R Panaccione1, S Ghosh1, S Middleton2, J Márquez3, I Khalif4, L Flint5, H van Hoogstraten5, H Zheng5, S Danese6, P Rutgeerts71University of Calgary, Alberta, AB; 2U Cambridge, Cambridge, United Kingdom; 3Clínica Las Américas, Medellín, Colombia; 4State Scientific Centre of Coloproctology, Moscow, Russian Federation; 5Merck Research Laboratories, Kenilworth, New Jersey, USA; 6Istituto Clinico Humanitas, Milan, Italy; 7Universiteit Leuven, Leuven, Belgium
Aims: To assess the best treatment strategy in patients with moderate to severe ulcerative colitis (UC) failing steroids.
Methods: This 16-week, double-blind, controlled trial included 239 patients with moderate to severe UC (baseline total Mayo score 6-12). All had failed corticosteroids and were biologic and azathioprine (AZA)/6-MP naïve or had stopped AZA >=3 months prior. Patients were randomized to: AZA 2.5 mg/kg+placebo; infliximab (IFX) 5 mg/kg+placebo; or IFX 5 mg/kg+AZA 2.5 mg/kg. Nonresponders at week 8 (partial Mayo score reduction <1) in AZA group were eligible for IFX 5 mg/kg at weeks 8, 10 and 14. Primary endpoint was steroid-free remission at week 16 (total Mayo score =<2 without steroids and no individual subscore >1). Major secondary endpoints were response at week 8 (decrease in partial Mayo score >=1) and response at week 16 (decrease in total Mayo score >=3 and >=30% reduction from baseline total Mayo score). Primary comparison was IFX+AZA vs AZA. To control for multiplicity, secondary comparisons of IFX vs AZA and IFX+AZA vs IFX were conducted in sequence if prior test achieved statistical significance at 0.05 level. Other secondary endpoints included mucosal healing (MH; Mayo endoscopy subscore 0 or 1) at week 16. Subanalyses included impact of treatment on complete (Mayo endoscopy subscore 0) and steroid-free MH (Mayo endoscopy subscore 0 or 1) at week 16.
Results: Data from 231 patients were analyzed. Primary endpoint was achieved, with a significantly greater percentage of patients in steroid-free remission at week 16 in IFX+AZA arm vs AZA arm (percentages were similar in IFX and AZA arms, and differences were not statistically significant) (Table). Greater percentages of patients receiving IFX-based strategies achieved MH and steroid-free MH. Safety was similar across all arms.
Conclusions: IFX+AZA was superior to AZA monotherapy for achieving steroid-free remission and response at week 16.