Effect of delayed-release dimethyl fumarate on no evidence of disease activity in relapsing-remitting multiple sclerosis: integrated analysis of the phase III DEFINE and CONFIRM studies

What Was Tested

This randomized controlled trial paper looks at Glatiramer Acetate in the context of multiple sclerosis.

The researchers conducted a post hoc analysis of integrated data from DEFINE/CONFIRM to evaluate the effect of DMF on achieving no evidence of disease activity (NEDA) in patients with relapsing-remitting multiple sclerosis.

Who Took Part

By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.

A time-to-event method was used to estimate the percentage of patients achieving NEDA.

How the Study Was Run

In design terms this was a randomized and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Glatiramer Acetate and who got the comparison, which limits bias.

A placebo (an inactive look-alike) gave the Glatiramer Acetate group a baseline to be compared against.

Clinical NEDA (no relapses/no 12-week confirmed disability progression) was analysed in the intention-to-treat (ITT) population.

Neuroradiological (no new/newly enlarging T2 hyperintense lesions/no gadolinium-enhancing lesions) and overall NEDA (clinical and neuroradiological NEDA) were analysed in the magnetic resonance imaging (MRI) cohort.

What Was Measured

The subject headings attached to it are Dimethyl Fumarate, Disease Progression, Glatiramer Acetate, Immunosuppressive Agents, Magnetic Resonance Imaging, Multiple Sclerosis, Relapsing-Remitting and Recurrence.

The authors tagged it with the keywords clinical relapse, disability progression, disease monitoring, no evidence of disease activity and relapsing-remitting multiple sclerosis.

What This Means in Plain Language

The paper is a randomized and placebo-controlled study of Glatiramer Acetate in people with multiple sclerosis.

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2017 (European journal of neurology), a journal based in England.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.