Patients Using Gilenya Have Higher Probability of Achieving No Evidence of Disease Compared with Other MS Oral Drugs, According to New Study
To date there have been no head-to-head trials comparing the efficacy of approved oral therapies for multiple sclerosis including Gilenya (fingolimod), Tecfidera (dimethyl fumarate), and Aubagio (teriflunomide). Indirect comparisons of trial results can be troublesome. In a study funded by Novartis, the manufacturer of Gilenya, researchers used a statistical modeling approach to compare the efficacy of these medications, controlling for known or suspected treatment modifiers and differences in patient characteristics between trials, to predict that patients treated with Gilenya, in some comparisons, have a significantly higher probability of achieving NEDA (no evidence of disease activity) status compared with those treated with Tecfidera and Aubagio in both unadjusted and adjusted indirect comparisons.
The clinical composite of NEDA measured freedom from relapses and 3-month confirmed disability progression. The MRI composite of NEDA measured freedom from Gd-enhancing T1 lesions and new or newly enlarged T2 lesions. The overall composite or overall NEDA measured freedom from all of these disease outcomes.
The statistical modeling used suggests that differences in patient characteristics between the trials have a marginal impact on indirect comparisons of these treatments. In the absence of direct, head-to-head comparisons, authors suggest that this modeling approach may be used to make informed conclusions about the comparative efficacy of oral disease modifying therapies in patients with MS. These findings should, however, be interpreted with caution, owing to the assumptions inherent in any modeling approach.
Nixon R, Bergvall N, Tomic D, et al. No evidence of disease activity: indirect comparisons of oral therapies for the treatment of relapsing-remitting multiple sclerosis. Adv Ther. 2014 Nov;31(11):1134-54. doi: 10.1007/s12325-014-0167-z. Epub 2014 Nov 21.
Higher Survival Rates Seen for Asymptomatic MS Patients Diagnosed With Tysabri-Related PML.
As of September 3, 2013, there have been 399 confirmed cases of progressive multifocal leukoencephalopathy (PML) in MS patients taking Tysabri (natalizumab). In a recent study, researchers evaluated the outcomes of natalizumab-treated MS patients who were asymptomatic at PML diagnosis (determined by MRI findings and JC virus DNA detection) compared with patients who presented with symptoms at diagnosis. It was found that PML patients who were asymptomatic at diagnosis had better survival and less functional disability than those who were symptomatic at diagnosis.
Of the 372 PML cases which were analyzed, 30 patients were asymptomatic and 342 were symptomatic at PML diagnosis. MRI lesions in asymptomatic versus symptomatic patients were unilobar in 68% vs 37%, multilobar in 21% vs 24%, and widespread in 11% vs 40%. In both groups with unilobar lesions, frontal lobe lesions predominated.
While EDSS scores were similar prior to PML for both groups of patients, mean EDSS score at PML diagnosis was significantly lower for asymptomatic patients (4.1; n = 11) than for symptomatic patients (5.4; n = 193; P = 0.038). Six months after PML diagnosis, asymptomatic patients had less functional disability than symptomatic patients.
As of June 5, 2013, 96.7% (29 of 30) of asymptomatic patients and 75.4% (258 of 342) of symptomatic patients were alive. In the non-surviving asymptomatic PML case, the time to death from diagnosis was 13.2 months; cause of death was suicide likely due to the patient’s preexisting depression. The mean time from PML diagnosis to death in symptomatic PML patients (n = 78) was 4.2 months; data were not available for 6 patients.
Dong-Si T, Richman S, Wattjes MP, et al. Outcome and survival of asymptomatic PML in natalizumab-treated MS patients. Ann Clin Transl Neurol. 2014 Oct;1(10):755-64. doi: 10.1002/acn3.114. Epub 2014 Oct 9.
Other Studies of Interest:
Finsterer J, Leutmezer F. Celiac disease with cerebral and peripheral nerve involvement mimicking multiple sclerosis. J Med Life. 2014 Sep 15;7(3):440-4. Epub 2014 Sep 25.
Gottberg K, Chruzander C, Einarsson U, et al. Health-related quality of life in partners of persons with MS: a longitudinal 10-year perspective. BMJ Open. 2014 Dec 16;4(12):e006097. doi: 10.1136/bmjopen-2014-006097.
Killestein J, Vennegoor A, van Golde AE, et al. PML-IRIS during Fingolimod Diagnosed after Natalizumab Discontinuation. Case Rep Neurol Med. 2014;2014:307872. doi: 10.1155/2014/307872. Epub 2014 Nov 23.
Ramagopalan S, Wasiak R, Cox AP. Using Twitter to investigate opinions about multiple sclerosis treatments: a descriptive, exploratory study. F1000Res. 2014 Sep 10;3:216. doi: 10.12688/f1000research.5263.1. eCollection 2014.
Sedighi B, Pardakhty A, Kamali H, et al. Effect of Boswellia papyrifera on cognitive impairment in multiple sclerosis. Iran J Neurol. 2014 Jul 4;13(3):149-53.
Published On: December 29, 2014