|The following article is part of conference coverage from the 2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers in Nashville, Tennesssee. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from CMSC 2018.|
Relapses in the first year of treatment and scores on the Kurtzke Expanded Disability Status Scale (EDSS) at baseline and in the first year of treatment were consistently reliable long-term predictors of the clinical outcomes of individuals with multiple sclerosis, according to research presented at the 32nd Annual Meeting of the Consortium of Multiple Sclerosis Centers, held May 30-June 2, 2018, in Nashville, Tennessee.
Using the variables found at baseline and in the first year of the TRANSFORMS, FREEDOMS, and FREEDOMS II trials for subjects in the 0.5 mg fingolimod subgroups, unadjusted logistic regression was used to assess which disease or subject characteristics could be used to predict 6 clinical outcomes of multiple sclerosis during months 12 to 48: EDSS scores, relapses, 3 month-confirmed disability progression, relapses and 3 month-confirmed disability progression, 6 month-confirmed disability progression, and relapses and 6 month-confirmed disability progression. Multiple-logistic regression analyses were conducted for all significant predictors found through the univariate analyses.
The multiple-logistic regression analyses determined that the most consistent predictors for negative clinical outcomes in months 12 to 48 were relapses during months 0 to 12 and EDSS scores at baseline and months 0 to 12. The TRANSFORMS study showed that relapses during months 0 to 12 only predicted relapses (odds ratio [OR] 1.745; 95% CI, 1.054-2.889, P =.0306), and EDSS changes from months 0 to 12 predicted EDSS ≥6 (OR 3.217; 95% CI, 1.77-5.837, P =.0001). In the 2 FREEDOMS studies, relapses during months 0 to 12 predicted relapses (OR 3.227; 95% CI, 1.756-5.931, P =.0002), relapses and 6 month-confirmed disability progression (OR 2.350; 95% CI, 1.287-1.291, P =.0054), and relapses and 3 month-confirmed disability progression (OR 2.606; 95% CI, 1.418-4.791, P =.0020).
The study investigators concluded, “In the FREEDOMS and TRANSFORMS trials, relapses [during months 0 to 12] and EDSS score (baseline and months 0 to 12) were consistently predictive of long term clinical outcomes, including relapses, [3 month-confirmed disability progression], and [6 month-confirmed disability progression], in patients receiving fingolimod 0.5 mg.”
Disclosures: See the abstract for a full list of disclosures.
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Sprenger T, Boster A, Meng X, et al. Long-term predictors of clinical outcomes in patients with multiple sclerosis in the phase 3 FREEDOMS, FREEDOMS II, and TRANSFORMS studies. Presented at: 2018 CMSC Annual Meeting. May 30-June 2, 2018; Nashville, Tennessee. Abstract DX20.