Multiple sclerosis, new data on long-term efficacy for S1P modulator

In patients treated with ozanimodoral sphingosine 1-phosphate (S1P) receptor modulator, for relapsing forms of multiple sclerosisnew data from the Phase 3 Daybreak trial demonstrate that decreased rates of brain volume loss were maintained in the open-label extension (Ole). Patients who continuously received ozanimod treatment for up to 5 years reported low and stable rates of total brain volume (WBV) loss over 60 months (least squares mean annualized % change [LSM] compared to main study baseline: Radiace, −0.27; Sunbeam, −0.35).

Furthermore – we read from a note released by Bristol Myers Squibb (Bms) – the results of a separate safety analysis of Daybreak Ole demonstrate the decrease or stability of the incidence rates of adverse events deriving from the treatment (Teaes), with rates relatively low rates of infections, serious and opportunistic infections in more than eight years of treatment with ozanimod. These data and 12 other abstracts were presented at the 40th congress of the European Committee for Treatment and Research in Multiple Sclerosis (Ectrims) which was held in recent weeks in Copenhagen, Denmark. “If not treated early at diagnosis, multiple sclerosis can cause significant and irreversible loss of brain volume and cognitive decline,” he says. Jeffrey CohenMD, Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, Ohio and consultant to BMS – This new analysis reinforces the well-established safety and efficacy profile of ozanimod as an effective oral therapy, especially in patients recently diagnosed with relapsing forms of sclerosis multiple”.

In detail, the Daybreak Ole study included 2,257 patients from the Phase 3 Sunbeam and Radiace studies and evaluated rates of brain volume loss. Switching from interferon beta-1a (Ifn-β) to ozanimod treatment consistently reduced rates of Wbv loss (annualized % change in Lsm from baseline to month 24 of Radiace and Daybreak equal to −0, 48 and −0.19, respectively, with a similar pattern observed in Sunbeam). Furthermore, similar reductions were observed in thalamic volume change. High annualized %Lsm reductions in cortical gray matter volume (Cgmv) were observed with Ifn-β (annualized change at Month 12 from Sunbeam baseline, −1.02; Radiance, −0.59), but the trend changed 12 months after switching to ozanimod in Daybreak (annualized % increase in Lsm from baseline in Daybreak: Sunbeam patients, 0.10; in Radiance, 0.20), with a low annualized % Lsm loss of Cgmv observed in later times.

The final safety analysis of Daybreak Ole included 762 patients treated continuously with ozanimod with an average exposure of 83.9 months. Incidence rates per 1,000 person-years decreased over time from Phase 3 studies to Month 60 or even more in the Daybreak Ole study. Reductions were observed in global Teaes (896.1 versus 101.7), infections (300.5 versus 142.6), opportunistic infections (12.0 versus 4.9), cardiac disorders (22.8 versus 9.5), hepatic (77.0 versus 15.7) and pulmonary (11.3 versus 4.7), respectively.

“The data presented at Ectrims – he comments Alyssa JohnsenMD, PhD, Senior Vice President and Director Clinical Development, Immunology, Cardiovascular and Neuroscience, BMS – further confirm the long-term safety and efficacy of ozanimod and add to the robust body of evidence demonstrating its potential impact on decreasing progression of the disease over time. Based on our experience with ozanimod, we are expanding our pipeline as we continue to research new ways to advance the field of neuroscience. New modalities and disease targets fuel our goal of providing medicines that raise the standard of care for neurological diseases, including multiple sclerosis.”