In those with MS treated with subcutaneous interferon beta-1a, Magnetic Resonance Imaging in multiple sclerosis scores may be predictive of the time to new clinical disease activity and disease progression.
Maria Pia Sormani, PhD, MS, professor of Biostatistics, University of Genoa
Maria Pia Sormani, PhD, MS
Findings from a post-hoc analysis of PRISMS study data has revealed that Magnetic Resonance Imaging in multiple sclerosis (MAGNIMS) score may be able to predict clinical disease activity events or disability progression in patients with MS treated with subcutaneous interferon beta-1a (IFNβ-1a).1
Ultimately, the data revealed that when using a MAGNIMS score of 0 as a reference, hazard ratios (HRs) for having a clinical disease activity event and Expanded Disability Status Scale (EDSS) score progression were 1.8 (95% CI, 1.4 to 2.4) and 1.6 (95% CI, 1.1 to 2.2), respectively, in patients with MAGNIMS score of 1, and 1.5 (95% CI, 1.3 to 1.8) and 1.5 (95% CI, 1.3 to 1.7), respectively, in patients with MAGNIMS score of 2.
The authors, led by Maria Pia Sormani, PhD, MS, professor of Biostatistics, University of Genoa, and colleagues noted that “subcutaneous IFNβ-1a has been commercially available since 1998, with approximately 1.44 million patient-years of exposure; it reduces relapse rates and delays disability progression in patients with MS.”
The data were presented by Sormani et al. at the 2019 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), May 28-June 1, in Seattle, Washington. They detailed that they sought to determine if there was any association between MAGNIMS score at 1 year and the long-term disease activity status and EDSS score.
In 2016, new guidelines for MAGNIMS score—developed from the European collaborative research network— were released to help build upon the 2010 McDonald criteria updates.2
Those updates to MAGNIMS included a focus on dissemination in space and time on MRI. In space, this is done by detecting the participation of at least 2 of 5 areas of the central nervous system: periventricular: ≥3 lesions; cortical-juxtacortical: ≥1 lesion; infratentorial: ≥1 lesion; spinal cord: ≥1 lesion; and optic nerve: ≥1 lesion. As for dissemination in time, the new guidelines declared it can be established in 1 of 2 ways: A new lesion (T2 bright lesion and/or gadolinium-enhancing) when compared to a previous scan; and the presence of enhancing lesion and a non-enhancing T2 bright lesion on any 1 scan.3
The data included patients with relapsing-remitting MS who were included in the PRISMS-2 study, which randomized patients to either IFNβ-1a 22 μg (n = 189) or 44 μg (n = 184), or placebo (n = 187), to be administered 3 times weekly for 2 years. At the beginning of the third year, those randomized to placebo were then re-randomized to IFNß-1a 22 or 44 µg, while those treated with the study drug remained as such.
Altogether, patients were followed up to 15 years after randomization, with 95 patients in both treatment arms and 100 patients randomized to placebo followed for that length of time.
Pia Sormani and colleagues classified patients by MAGNIMS scores at year 1, defining a score of 0 as those with ≤2 new T2 lesions and no new relapses. Patients with ≤2 new T2 lesions and 1 relapse or >3 new T2 lesions and no new relapses got a score of 1. Patients with ≤2 new T2 lesions and ≥2 relapses or ≥3 new T2 lesions and ≥1 relapse were given a MAGNIMS score of 2. Patients were defined as free from clinical disease activity as long as they had no relapse or disability progression, defined as a 1-point increase in EDSS score from baseline, or a 1.5-point increase for patients with an EDSS score of 0.
At the 1-year mark, a total of 129 patients treated with subcutaneous IFNβ-1a had a MAGNIMS score of 0, while 108 and 130 patients had a score of 1 and 2, respectively. The median time to a clinical disease activity event was longer in patients with a score of 0 (2.6 years; 95% CI, 2.1 to 3.5) than those with a score of 1 (1.7 years; 95% CI, 1.5 to 2.0) or 2 (1.3 years; 95% CI, 1.2 to 1.4).
Likewise, the median time to EDSS progression was longer in patients with a year 1 MAGNIMS score of 0 (7.5 years; 95% CI, 6.9 to 13.5). In comparison, those with a score of 1 and 2 had respective median times to EDSS progression of 4.0 years (95% CI, 3.5 to 7.5) and 2.5 years (95% CI, 1.9 to 3.5).
1. Pia Sormani M, Freedman MS, Aldridge J, Marhadt K, de Stefano N. MAGNIMS Score-Assessed Disease Activity Predicts Long-Term Activity-Free Status and Disability Progression. Presented at: 2019 CMSC Annual Meeting. May 28-June 1, 2019; Seattle, WA. Abstract DXT02.
2. Filippi , Rocca MA, Ciccarelli O. MRI criteria for the diagnosis of multiple sclerosis: MAGNIMS consensus guidelines. Lancet Neurol. 2016;15:292—303. doi: 10.1016/S1474-4422(15)00393-2.
3. Bell DJ, Alberto da Veiga MG, et al. MAGNIMS consensus on MRI diagnosis of multiple sclerosis. Radiopaedia. Published 2016. radiopaedia.org/articles/magnims-consensus-on-mri-diagnosis-of-multiple-sclerosis?lang=us. Accessed May 28, 2019.