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• W2912287344 abstract "Introduction: Ozanimod, an oral, once-daily immunomodulator that selectively targets S1P1R and S1P5R, has demonstrated clinical efficacy in ulcerative colitis (UC) for induction and maintenance therapy in the TOUCHSTONE trial [1]. The objective of the open-label extension (OLE) of the TOUCH-STONE trial is to evaluate the long-term efficacy and safety of daily 1 mg ozanimod in patients with moderate to severe UC who had initially participated in the TOUCHSTONE trial for up to 32 weeks. Methods: A total of 197 patients were randomized (1:1:1) and treated with daily ozanimod 0.5 mg (n=65), 1 mg (n=67), or placebo (n=65) in the TOUCHSTONE trial. Of the initial 197, 170 (86%) entered the OLE and received daily ozanimod 1 mg. As of the data cut-off in March 2017, 100 (58.8%) had efficacy evaluations reported through Week 92; of these 100 patients, 94 (55.3%) had received ozanimod 1 mg/day in the OLE for ≥2 years. Efficacy data are reported as observed through Week 92 and safety includes all events through the data cut-off of March 2017. Results: At OLE entry, the partial Mayo Score (pMS) for patients on placebo, ozanimod 0.5 mg, and 1.0 mg was 4.6, 4.5, and 3.3 respectively, which improved significantly by OLE Week 8 (-2.3, -1.9 and -1.1), with the greatest improvement reported in patients who had received placebo or ozanimod 0.5 mg in the TOUCHSTONE trial. At the OLE Week 92 visit, 91/100 (91.0%) had little or no active disease based on the physician global assessment (PGA 0 or 1), 97/100 (97.0%) had little or no blood in their stools (rectal bleeding subscore [RBS] 0 or 1), 86/100 (86.0%) had no blood in the stools (RBS 0). Adverse events (AEs) and serious AEs were reported in 85 (50.0%) and 20 (11.1%) of patients respectively. The most common AEs (>2.0%) during OLE were UC flare, anaemia, nausea, upper respiratory tract infection, nasopharyngitis, back pain, arthralgia, headache, transaminase elevation, and hypertension. The only serious AEs in ≥2 patients were anaemia and UC flare. Transaminase level >3x upper limit of normal (ULN) occurred in 5 (2.9%) patients in the OLE. All elevations were asymptomatic,<5xULN, transient, and resolving while receiving continued treatment. Conclusion: Long-term treatment with ozanimod continues to be safe and well tolerated with good compliance and evidence of durable efficacy." @default.
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• W2912287344 date "2017-10-01" @default.
• W2912287344 modified "2023-10-18" @default.
• W2912287344 title "Safety and Efficacy of Long-term Treatment With Ozanimod: An Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative Colitis - TOUCHSTONE Extension 2-Year Follow-up" @default.
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• W2912287344 doi "https://doi.org/10.14309/00000434-201710001-00595" @default.
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