Ozanimod Yields Positive Cognitive Results in SUNBEAM and DAYBREAK Studies Advances

Ozanimod, a sphingosine 1-phosphate receptor modulator, appears to have a positive impact on information processing speed compared with intramuscular interferon (IFN) among patients with relapsing multiple sclerosis (MS), according to findings presented at the American Academy of Neurology Virtual Annual Meeting.

John DeLuca, PhD, and colleagues arrived at this conclusion after evaluating adults aged 18 to 55 years with relapsing MS. In the SUNBEAM study, a double-blind, double-dummy study, participants were randomly assigned to oral ozanimod hydrochloride (HCI) 1 mg (n = 447) or 0.5 mg once per day, or intramuscular IFN 30μg (n = 448) once per week. SUNBEAM was conducted until the final participant was treated at month 12.

SUNBEAM participants who completed the study were eligible to enroll in DAYBREAK, an open-label extension study of ozanimod HCI 1 mg. Participants who had been treated with IFN during the SUNBEAM study were transitioned to ozanimod HCI between 12 and 24 months after baseline of SUNBEAM.

The researchers measured clinically meaningful (≥4 point or ≥10%) improvement or worsening of Symbol Digit Modalities Test (SDMT)—a screening instrument that measures neurological dysfunction—among participants who were originally randomly assigned to ozanimod HCI 1 mg or IFN at months 12 and 24 after baseline of SUNBEAM.

At baseline, mean SDMT scores were 47.7 among participants randomly assigned to ozanimod HCI 1 mg and 47.1 among participants randomly assigned to IFN. The results indicated that 158 (37.0%) of 427 ozanimod-treated participants experienced improvement in SDMT compared with 119 (27.9%) of IFN-treated participants. Meanwhile, 97 (22.7%) of 427 ozanimod-treated participants experienced worsening of SDMT compared with 127 (29.8%) of 426 IFN-treated participants.

In addition, 116 (42.3%) of 274 participants treated with continuous ozanimod experienced improvement in SDMT compared with 94 (35.6%) of 264 participants originally treated with IFN and subsequently transitioned to ozanimod. A total of 61 (22.3%) of 274 participants treated with continuous ozanimod had worsening of SDMT relative to the baseline of SUNBEAM compared with 67 (25.4%) of 264.

“In this exploratory analysis, the percentage of participants with SDMT improvement increased over 24 months of continuous ozanimod treatment,” the authors of the study concluded. “The percentage of participants with SDMT improvement was higher at month 24 than month 12 among those who transitioned from IFN to ozanimod during the latter 12 months.”

—Christina Vogt

Reference:
DeLuca J, Cohen JA, Cree BAC, et al. Effects of Ozanimod on information processing speed: findings from the phase 3 SUNBEAM and DAYBREAK Extension Trials (1670). Neurology. 2020;94(15 suppl.). doi:https://n.neurology.org/content/94/15_Supplement/1670