Effectiveness of Delayed-release Dimethyl Fumarate on Clinical and Patient-reported Outcomes in Patients With Relapsing Multiple Sclerosis Switching From Glatiramer Acetate: RESPOND, a Prospective Observational Study

What Was Tested

This observational study looks at Glatiramer Acetate in the context of multiple sclerosis.

The primary objective was to estimate the annualized relapse rate (ARR) at 12 months based on data collected from medical records and compare it with the 12 months before DMF initiation.

Who Took Part

The abstract describes 12 patients taking part.

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

How the Study Was Run

The researchers set it up as an open-label and multicenter study.

Everyone knew when Glatiramer Acetate was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

More than one site took part, so the patients came from several places.

The study was conducted in the United States at 63 sites between August 2013 and February 2016.

Secondary objectives of the study included assessing the change in PRO scores from baseline to 12 months; PROs were recorded before and at 6 and 12 months after DMF initiation.

What Was Measured

The subject headings attached to it are Dimethyl Fumarate, Drug Substitution, Glatiramer Acetate, Immunosuppressive Agents, Multiple Sclerosis, Relapsing-Remitting and Patient Reported Outcome Measures.

The authors tagged it with the keywords annualized relapse rate, delayed-release dimethyl fumarate, patient-reported outcomes and relapsing multiple sclerosis.

What This Means in Plain Language

The paper is an open-label and multicenter study of Glatiramer Acetate in 12 patients in people with multiple sclerosis.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2018 (Clinical therapeutics), a journal based in United States.

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