Ozanimod treatment linked to functional, cognitive improvements, reduced lesions in MS

Key takeaways:

• The ENLIGHTEN study included 185 people with MS given ozanimod for 1 year.
• Interim data showed that nearly half of the study population had improved cognitive scores.

Following 1 year of treatment with ozanimod, individuals with relapsing forms of multiple sclerosis saw functional and cognitive improvements as well as a reduction in MRI lesions, according to interim data presented at ECTRIMS 2023.

“It is important to understand the ability to improve outcomes and modify the disease progression for patients with [multiple sclerosis] given its progressive, irreversible nature,” Roland Chen, MD, senior vice president and head of Immunology and Cardiovascular Development at Bristol Myers Squibb, told Healio in an email. “In addition, there is a need to identify approaches that might protect cognitive function in patients with MS.”

Robert T. Naismith, MD, professor of neurology at Washington University School of Medicine and lead author for the ENLIGHTEN clinical trial, and colleagues provided an interim analysis to describe the safety and efficacy of ozanimod (Zeposia, Celgene) treatment in those with relapsing forms of MS for 1 year.

Their phase 3, multicenter, single-arm, open-label study included 185 individuals with early relapsing MS (mean aged 39.5 years; 78.4% female; 85.9% white), an Expanded Disability Status Scale [EDSS] score of 3.5 or higher, at least 5 years from initial diagnosis and with at least 10 gadolinium-enhancing [GdE] lesions, treated with 0.92 mg ozanimod. The primary endpoint was an increase of at least four points in Symbol Digit Modalities Test (SDMT), or 10% from baseline along with secondary endpoints of new/enlarging T2 lesion count on MRI and proportion of patients GdE lesion-free assessed at 1 year. Treatment-emergent adverse events were assessed from the study start of Jan. 16, 2020, until data cutoff of Feb. 14, 2023.

At time of analysis, one patient completed treatment, and 155 maintained treatments at cutoff date, with mean ozanimod exposure being 13.7 months and median EDSS score 2.

According to interim results, at baseline, mean SDMT score was 53.9, and after 1 year of ozanimod treatment, 47.4% of participants registered an improvement of greater than or equal to 10% or either four points or more; 25.9% of participants remained stable; and 26.7% registered a worsening of greater than or equal to 10% or four points or more.

The researchers also found mean T2 lesion count at baseline was 22.4, and mean new/enlarging T2 lesion count at 1 year was 0.4; further, 91 of 100 enrollees with MRI data were GdE lesion-free at 1 year compared with 123 of 185 at baseline.

Treatment-emergent adverse events occurred in 65.9% of participants, including COVID-19, headache, fatigue, urinary tract infection and sinusitis.

“These interim data demonstrated that almost half of the early MS patients actually experienced improved cognitive processing after a year of treatment, which is very encouraging for this patient population and highlights the potential for early intervention in this disease,” Chen told Healio.