Early and Sustained Remission after Treatment with Subcutaneously Administered Golimumab Is Associated with Normalized Health-Related Quality of Life in Patients with Moderate to Severe Ulcerative Colitis: Post-hoc Analysis from PURSUIT Induction and Maintenance Trials

Purpose: The PURSUIT studies were randomized, double-blind, placebo-controlled studies to evaluate the safety and efficacy of subcutaneous (SC) golimumab (GLM) in adults with moderate to severe ulcerative colitis (UC). Our purpose is to assess the impact of early and sustained clinical remission on heath-related quality of life (HRQOL) of patients with active UC after SC administered GLM therapy. Methods: Patients with moderate to severe UC, defined by a Mayo score of 6-12, including an endoscopy subscore of ≥2, with inadequate response or intolerance to conventional UC therapies but naïve to treatment with TNF inhibitors, were randomized in the Phase 3 portion of PURSUIT induction to receive PBO or golimumab (GLM) 200 mg, 100 mg, or 400 mg, 200 mg at weeks 0 and 2. At week 6, GLM-treated patients who achieved clinical response were randomized to PBO, or 50, or 100 mg GLM q4wk in PURSUIT maintenance. Disease-specific HRQOL was measured using the IBDQ, and generic HRQOL was measured using SF-36 and EQ-5D. SF-36 was summarized by physical and mental component summary scores (PCS and MCS). Normalized quality of life was defined as SF-36 PCS or MCS ≥50, and IBDQ remission with total score ≥170. Clinical remission was defined as a Mayo score ≤ two points, with no individual subscore > 1. Results: Compared to PBO, a significantly greater proportion of GLM-treated patients achieved remission at week 6. GLM-treated patients who achieved clinical remission at week 6 had greater mean improvement in PCS, MCS, EQ-5D, and IBDQ than those who did not achieve remission (PCS: 8.0 vs. 2.9, p<0.001; MCS: 10.7 vs. 2.6, p<0.001; EQ-5D: 21.4 vs. 7.2, p<0.001; and IBDQ: 54.7 vs. 17.7, p<0.001). Patients in clinical remission were more likely to achieve normalized PCS, normalized MCS, and IBDQ remission than those who did not achieve clinical remission (PCS: 53.6% vs. 25.3%, p<0.001; MCS: 63.6% vs. 31.6%, p<0.001; IBDQ: 85.5% vs. 32.2%, p<0.001). Additionally, GLM-treated patients who achieved clinical remission during induction AND maintained clinical remission at week 54 in maintenance were more likely to achieve normalized PCS, MCS, and IBDQ remission than those who did not (PCS: 73.5% vs. 22.7%, p<0.001; MCS: 63.3% vs. 28.4%, p<0.001; IBDQ remission: 89.8% vs. 22.7%, p<0.001). Similarly, those who achieved clinical response or mucosal healing also demonstrated better improvement in HRQOL than those who did not achieved these outcomes, but improvements in HRQOL were numerically lower than in patients in clinical remission. Conclusion: Early and sustained clinical remission was associated with normalized HRQOL outcomes, and should be considered as a treatment goal for patients with moderate to severe UC. Disclosure - William J Sandborn, Jean-Frederic Colombel, Brian G. Feagan, Peter Gibson, Judith Collins, Gunnar Jarnerot, Paul Rutgeerts, Walter Reinisch-All Grant/Reearch Support:Janssen Research and Development, LLC; Colleen Marano, Richard Strauss, Jewel Johanns, and Hongyan Zhang-All employees: Janssen Research and Development, LLC; Chenglong Han and Timothy Gathany-All employees: Janssen Global Services, LLC. This research was supported by an industry grant from Janssen Research and Development, LLC.

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