Laura is the editorial director of The American Journal of Managed Care® (AJMC®) and all its brands, including The American Journal of Accountable Care®, Evidence-Based Oncology™, and The Center for Biosimilars®. She has been working on AJMC® since 2014 and has been with AJMC®'s parent company, MJH Life Sciences, since 2011. She has an MA in business and economic reporting from New York University.
Long-term use of ozanimod may be associated with improved cognitive speed and higher rates of no evidence of disease activity among patients with relapsing multiple sclerosis (MS), according to 2 new abstracts presented at the 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers.
Long-term use of ozanimod may be associated with improved cognitive speed and higher rates of no evidence of disease activity (NEDA) among patients with relapsing multiple sclerosis (MS), according to 2 new abstracts presented at the 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers.
In the first study,1 a post hoc analysis of the phase 3 SUNBEAM trial was used to compare the effect of ozanimod with interferon β-1a (INF) in patients who completed 18 months of treatment. These patients had Symbol Digit Modalities Test (SDMT) assessments at months 6 and 18 during the trial, which primarily had assessed clinical and radiologic disease activity between ozanimod and INF. SDMT is used to assess processing speed and is the most sensitive cognitive measure used in MS.
A total of 400 patients completed 18 months of treatment and had SDMT data (ozanimod 0.5 mg, n = 136; ozanimod 1 mg, n = 132; INF, n = 132). The researchers determined the number of patients who had clinically meaningful improvement (≥4-point increase), worsened (≥4-point decrease), or were stable (<4-point ± change) compared with baseline at months 6 and 18.
The rate ratios for SDMT improvement were 1.6 for both ozanimod 0.5 mg and 1 mg at months 6 and 18 compared with INF. Among patients who had improvement at month 6, greater proportions of patients being treated with ozanimod had sustained improvement at month 12 compared with the INF group. Across treatment groups, approximately 41% to 50% of patients who worsened at month 6 also worsened at month 18, while 21% improved.
“Further studies designed to assess cognitive outcomes, with longer observation periods, are needed to confirm the potential long-term effects of ozanimod on cognitive processing speed,” the researchers concluded.
In the second abstract,2 the researchers analyzed 1313 patients treated with ozanimod HCI 1 mg (n = 433), ozanimod HCI 0.5 mg (n = 439), or INF (n = 441). They compared the proportion of patients with NEDA, defined using clinical and magnetic resonance imaging (MRI), through month 24 of the phase 3 RADIANCE trial. NEDA is a goal for treating patients with relapsing MS and was defined as no clinical relapses, no confirmed Expanded Disability Status Scale progression, and no new or enlarging T2 lesions or new gadolinium-enhancing lesions.
MRI was performed at screening and months 12 and 24 of the trial. Both groups of patients on ozanimod had higher proportions of patients with no relapses (1 mg, 76.4%; 0.5 mg, 72.4%) versus INF (66.2%). The proportion of patients who reported no progression of disability was similar across the groups (ozanimod 1 mg, 87.5%; ozanimod 0.5 mg, 90.7%; INF, 88.7%).
In both ozanimod groups, the proportion of patients with NEDA was higher than INF (ozanimod 1 mg, 24.2%; ozanimod 0.5 mg, 23.1%; INF, 17.0%).
1. DeLuca J, Cohen JA, Cree BAC, et al. Sustained improvement in cognitive processing speed in multiple sclerosis patients completing 18 months of ozanimod treatment: results from the phase 3 SUNBEAM trial. Presented at: 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers; May 28-June 1, 2019; Seattle, Washington. Abstract DXT21.
2. Steinman L, Comi G, Cree BAC, et al. Higher rates of no evidence of disease activity (NEDA) in relapsing multiple sclerosis patients treated with ozanimod versus interferon beta-1a in the phase 3 RADIANCE trial. Presented at: 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers; May 28-June 1, 2019; Seattle, Washington. Abstract DXT26.