While researchers are looking at the potential of stem cells in the treatment of multiple sclerosis (MS), novel, promising immune-modulating therapies are being developed. At this year’s virtual EAN Congress, Ludwig Kappos (Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Switzerland) presented the long-term follow-up data of the Phase 3 EXPAND study in the form of a virtual presentation.
In the study, Prof. Kappos and his colleagues examined the long-term efficacy of siponimod – a sphingosine-1-phosphate (S1P) receptor modulator that sequesters lymphocytes in secondary lymphoid organs – in patients with secondary progressive multiple sclerosis (SPMS).1,2 Patients underwent double-blind 2:1 randomisation to receive either siponimod 2 mg/day (n=1105) or placebo (n=546). Following the core part of the study, 74.1% of patients entered an open-label extension study in which all patients received siponimod.
Benefit of siponimod sustained in extension period
In his presentation, Prof. Kappos focused on the effect of siponimod in the extension period at a data cut-off of 5 years. As expected, the investigators observed a continuous benefit for patients who received only siponimod compared with those who were initially in the placebo group and switched only for the extension period. The time to ‘6-month confirmed disability progression’ (6mCDP) was significantly reduced in the siponimod-only group (P=0.0026) and the time to 6mCDP was prolonged by 40.3% on average. Similar results were seen when looking at the ‘6-month confirmed worsening’ (6 mCW), for which the risk was reduced by 23% for patients on continuous siponimod treatment (P=0.0047).
Switch to siponimod significantly reduced relapse rate in placebo group
The overall annualised relapse rate (ARR) was significantly reduced in the continuous siponimod group versus the switch group, with the risk of relapse being reduced by 52% (P<0.0001). Notably, the risk of relapse was also reduced by 62.7% within the placebo group once patients entered the extension phase with siponimod. A reduction was also seen in the siponimod-only group once entering the extension phase, highlighting the importance of continuous and prolonged siponimod treatment.
Data support the value of siponimod for patients with SPMS
This long-term analysis showed the benefits of early and continuous siponimod treatment in patients with SPMS. Prof. Kappos closed his presentation saying that “these sustained effects, together with the long-term safety profile of siponimod which was consistent with the core study, support the value of this compound for the treatment of active SPMS”.
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