Clinical Trial Results and Other Research News From ECTRIMS/ACTRIMS

Both the extension of the phase 2 trial and an extension of the TEMSO trial reported minimal clinical and MRI activity. A trend toward greater benefit on both clinical and MRI parameters was seen in patients who were continually treated with teriflunomide compared with placebo-treated patients who were switched to active treatment.

Natalizumab-Associated PML Survival Rates Exceed 80%
Early diagnosis through the enhanced clinical vigilance and optimal management of progressive multifocal leukoencephalopathy (PML) may improve outcomes, according to researchers.

Survival rates in excess of 80% were seen in the first 133 postmarketing natalizumab-associated PML cases, reported Ludwig Kappos, MD, from the Departments of Neurology and Biomedicine, University Hospital, Basel, Switzerland, and colleagues. Improved survival was associated with younger age (median, 43 vs 51.5) and less disability (median EDSS, 4.0 vs 5.5) at diagnosis, shorter time from symptom onset to diagnosis (mean, 40 vs 53 days), and more localized disease on brain MRI, as compared with fatal cases.

Of 159 PML cases identified in the postmarketing setting, 130 patients were still alive as of September 1, 2011 (82% survival rate). In survivors with more than six months of follow-up, 13% had mild disability, 47% had moderate disability, and 40% had severe disability.

Higher Vitamin D Levels Are Associated With Fewer Brain Lesions
Vitamin D levels are inversely associated with the risk of MS activity on brain MRI, according to researchers.

Begun in 2004, EPIC is a five-year longitudinal MS cohort study that sought to determine if vitamin D status is associated with the development of new T2 lesions or contrast-enhancing lesions on brain MRI in a cohort of patients with clinically isolated syndrome (CIS) or relapsing-remitting MS. Participants had clinical evaluations, brain MRI, and blood draws annually.

From the overall cohort, researchers evaluated patients who had a diagnosis of CIS or relapsing-remitting MS at baseline visit. In univariate and multivariate (adjusted for age, sex, ethnicity, smoking status, and the use of MS treatments) models, annual 25-hydroxyvitamin D3 levels were evaluated for their association with the development of new T2-weighted lesions and gadolinium-enhancing T1-weighted lesions on brain MRI as well as with the occurrence of clinical relapses of MS.

A total of 469 subjects were studied and 2,362 3T brain MRI scans were acquired and analyzed. In multivariate analyses, each 10-ng/mL higher 25-hydroxyvitamin D3 level was associated with a 15% lower risk of developing a new T2 lesion and a 32% lower risk of a gadolinium-enhancing lesion. Higher vitamin D levels were associated with a lower relapse risk, although the association did not reach statistical significance.