Five years of data from long term DAYBREAK study reinforcing efficacy and safety profile of Zeposia in patients with relapsing forms of multiple sclerosis.

These data (Presentation #P737) and five additional abstracts from company-sponsored studies will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place virtually October 13-15, 2021.

“Early and effective intervention can significantly impact physical and cognitive results over time, with low relapse rates an important indicator of patient outcomes,” said Bruce Cree, M.D., Ph.D., M.A.S., study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. “These data from the DAYBREAK trial provide a clear picture of the long-term safety and efficacy profile of Zeposia, and reinforce its potential when used early in the treatment process for people living with relapsing forms of MS.”

In the DAYBREAK extension study, safety was consistent with prior findings and no new safety signals emerged during the reporting period with long-term use of Zeposia. Treatment with Zeposia demonstrated a low annualized relapse rate (ARR) of 0.103. At months 36 and 48, 75% and 71% of participants were relapse-free and 3- and 6-month confirmed disability progression was observed in 13.9% and 11.4% of participants in the trial, respectively.

In the DAYBREAK trial, of 2,494 participants exposed to Zeposia for an average of 46.8 months, 2,143 participants (85.9%) had any treatment-emergent adverse event (TEAE), 298 (11.9%) had a serious TEAE and 75 (3.0%) discontinued the study due to a TEAE. The most common TEAEs were nasopharyngitis (19.6%), headache (15.8%), upper respiratory tract infection (11.1%) and lymphopenia (10.3%). Data from this long-term observational study of patients treated for up to 62.7 months are consistent with the established safety profile of Zeposia and with sustained control of disease activity and disability progression.