Data analysis of two previous trials has shown that a higher number of patients with relapsing remitting multiple sclerosis (RRMS) achieved no evidence of disease activity (NEDA), over a two year period, with delayed-release dimethyl fumarate (DMF) compared to a placebo.
NEDA means the patient has not experienced any clinical relapse, no disability progression (measured by the Expanded Disability Status Scale (EDSS) for 12 weeks and no evidence of disease activity on MRI.
It was in phase III of the DEFINE and CONFIRM studies that scientists discovered that the treatment with delayed-release DMF demonstrated significant reductions in clinical neuroradiologic measures compared with a placebo they gave to RRMS patients.
Eva Havrdová, MD, PhD, of First Faculty of Medicine of Charles University in Prague, Czech Republic, and her colleagues conducted a post hoc analysis of integrated data from the two studies to assess the ability of DMF to achieve NEDA in patients with RRMS.
These integrated analyses enabled a more precise estimation of a treatment's effect than can be obtained from individual studies. They allow for investigation of the consistency of a treatment's effect in subgroups of patients, and enable the evaluation of clinical and neuroradiological outcomes with reduced variability due to the greater number of patients analysed.
Both of the studies were parallel multicenter, randomised, double-blind, placebo-controlled trials of DMF for RRMS. Patients enrolled in the trials received DMF 240mg two or three times daily, a placebo, or glatiramer acetate 20mg daily in the CONFIRM trial for two years.
Investigators concluded, “The analysis of NEDA provides further information on the clinical benefits achievable with DMF treatment in patients with RRMS. Analysis of data from the extension study may facilitate better understanding of the prognostic importance of NEDA and its components.”
Source: MS-UK (21/04/17)