Clinical Outcomes in Continuous Clinical Responders with Moderately to Severely Active Ulcerative Colitis: Subanalyses from the PURSUIT-SC Maintenance Study

Abstract

Introduction: To evaluate long-term clinical outcomes in patients with moderately to severely active UC who achieved complete continuous response (CCR) compared with patients who did not achieve CCR (non-CCR) through week 54 of SC golimumab (GLM) maintenance therapy. Methods: During PURSUIT-Maintenance, GLM induction responders (464 patients) were randomized to receive PBO, SC GLM 50 mg, or SC GLM 100 mg at baseline (week 0) and every 4 weeks through week 52. The primary endpoint was clinical response through week 54 (CCR). Clinical remission, mucosal healing, corticosteroid use, and IBDQ outcomes and fecal markers at week 54 among CCR versus non-CCR were assessed. All sub-analyses are based on patients randomized at week 0 of maintenance (n=456). Results: On all of the selected endpoints evaluated, CCR patients had better results when compared with non-CCR patients (Table 1). Among patients receiving corticosteroids at baseline, a greater proportion of CCR patients were not receiving corticosteroids at week 54 versus non-CCR patients. Greater proportions of CCR patients were also in clinical remission versus non-CCR patients. Additionally, mean decreases in fecal lactoferrin and fecal calprotectin at week 54 from week 0 of maintenance were greater for CCR patients compared with non-CCR patients. Data between the GLM groups were similar and thus were pooled in the table.Table 1: Clinical Outcomes Based on Continuous Clinical Response at Week 54 in the PURSUIT-SC Maintenance Study*Conclusion: These data continue to support that patients induced into clinical response who maintain a clinical response through week 54 are more likely to have better clinical outcomes. Disclosure - William J Sandborn, Jean-Frederic Colombel, Walter Reinisch, Peter Gibson, Brian G. Feagan, Haoling Weng, Ruji Yao, Dino Tarabar, Zbigniew Hebzda, Paul Rutgeerts-Janssen R&D, LLC-all Grant/Research Support. Colleen Marano, Richard Strauss, Jewel Johanns, and Hongyan Zhang-Janssen R&D, LLC-all employees of Janssen R&D, LLC. This research was supported by an industry grant from Janssen R&D, LLC.