DAYBREAK is an open-label extension (OLE) study of relapsing MS patients who participated and completed an ozanimod phase 1, 2, or 3 trial. In the OLE, patients received ozanimod 0.92 mg/day, equivalent to ozanimod HCl 1 mg. The analysis included 2,494 participants with a mean ozanimod exposure of 35.4 (range 0.03–50.2) months in the OLE.
Ozanimod was associated with a low (adjusted) ARR in the OLE of 0.112 (95% CI 0.093–0.135). After 24 months, 79% of participants were relapse-free; after 36 months this was 75%. Six-month confirmed disability progression was observed in 8.6%. Mean number of new/enlarging T2 lesions per scan was low and remained similar throughout (range 1.57–1.90 at month 36), as was mean number of gadolinium-enhancing lesions (range 0.2 ‒0.4).
No new safety concerns emerged. In the OLE, 2,039 participants (81.8%) had any treatment-emergent adverse event (AE), 236 (9.5%) had a serious treatment-emergent AE, and 56 (2.2%) discontinued treatment due to a treatment-emergent AE. The most common treatment-emergent AEs were nasopharyngitis (17.9%), headache (14%), upper respiratory tract infection (9.9%), and lymphopenia (9.6%). There were no serious opportunistic infections. During the parent trials and DAYBREAK combined, 1.2% of participants exposed to either dose of ozanimod developed malignancies, which is consistent with malignancy rates among patients treated with other disease-modifying treatments.
- Selmaj K, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis in DAYBREAK: an open-label extension study of ozanimod phase 1−3 trials. MSVirtual 2020, Abstract P0217.
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Table of Contents: MS Virtual 2020
Featured articles
Registry participation can enhance quality of rheumatology care
COVID-19 and MS
Biomarkers
Treatment Strategies and Results
Management of progressive MS with approved DMT
Novel Treatment Directions
T2T approach in women with RA associated with increased fertility
Positive results for vagus nerve stimulation in RA
Machine learning to aid evaluation of ANA pattern and titer
ICI therapy does not increase mortality risk in patients with pre-existing autoimmune disease
Registry participation can enhance quality of rheumatology care
Neuromyelitis Optica Spectrum Disorders
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