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Longitudinal clinical and MRI-outcomes in relapsing multiple sclerosis patients after short-term ponesimod treatment-interruption and re-initiation
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Longitudinal clinical and MRI-outcomes in relapsing multiple sclerosis patients after short-term ponesimod treatment-interruption and re-initiation
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Longitudinal clinical and MRI-outcomes in relapsing multiple sclerosis patients after short-term ponesimod treatment-interruption and re-initiation
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Journal Article
Longitudinal clinical and MRI-outcomes in relapsing multiple sclerosis patients after short-term ponesimod treatment-interruption and re-initiation
2023
Overview
IntroductionCurrent multiple-sclerosis(MS) disease-modifying treatments(DMTs) alter patients’ immune-sys- tem with varying degrees and speed of reversibility. Certain clinical situations require fast drug-elimination and a fully-functioning immune-system. For ponesimod, lymphocyte-counts return to normal-range in>90% of patients-within 1week of stopping.ObjectivesTo assess clinical and MRI-outcomes in RMS patients at 48weeks of follow-up after short-term interruption and re-initiation of ponesimod.MethodsPatients who completed 108weeks of ponesimod or teriflunomide in Phase3 OPTIMUM study and underwent an accelerated-elimination procedure were eligible to enrol in OLE(open-label exten- sion)-where they received ponesimod20 mg. Of the 567ponesimod-patients, 439(77.4%) entered OLE and 239(42.2%) had at least 48 weeks follow-up in OLE. Annualized-relapse-rate (ARR) and cumulative number ofcombined-unique-active-lesions (CUALs) followingshort-termtreatment-interruption (betweencore-study and OLE) and re-initiation (at start of OLE) were examined in the239 ponesimod-patients.ResultsThe mean duration of ponesimod treatment-interruption was 17.6 days (range 13–45days). The ARR at OLE-week48, and considering treatment-interruption and re-initiation, was 0.191 (95% CI: 0.140, 0.261). This was numerically lower than the 2-year ARR of 0.234 (95% CI: 0.186, 0.296) with a relative rate-reduction (RRR) of 18.4% (RRR: 0.816, 95% CI: 0.595, 1.120). At OLE-week 48, patients had 1.73CUALs/year (95% CI: 1.30, 2.31) which was not statistically significantly different from 1.48CUALs/year (95% CI: 1.19, 1.82) in OPTIMUM.ConclusionsIn this study, based on clinical and imaging outcomes, disease-activity at OLE-48weeks following short-term interruption and re-initiation of ponesimod treatment remained consistent with dis- ease-activity prior to interruption.
Publisher
BMJ Publishing Group Ltd,BMJ Publishing Group LTD
