Treatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A subgroup analysis of a randomized phase 4 study

What Was Tested

The paper reports a study of Glatiramer Acetate in the context of multiple sclerosis, published as a randomized controlled trial.

Retention on oral fingolimod and on iDMTs was evaluated in a post hoc analysis of data from African-American patients in the parallel-group, 48-week 'Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention on Fingolimod versus approved first-line disease modifying thErapies in adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS).

Why It Was Studied

African-American individuals with multiple sclerosis may experience a more aggressive disease course than Caucasian patients, with a greater risk of developing ambulatory difficulties and other disabilities, and may also have a diminished response to some disease-modifying therapies compared with patients of other ethnicities.

Who Took Part

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

In PREFERMS, patients with relapsing-remitting MS aged 18-65 years with an Expanded Disability Status Scale score ≤6 enrolled at 117 US study sites were treatment-naïve or had received only one iDMT class.

The primary outcome was patient retention on randomized treatment over 48 weeks.

How the Study Was Run

In design terms this was a randomized, open-label and parallel-group study.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Being open-label, the Glatiramer Acetate study did not mask who received what.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

The timeline in the abstract includes 48 weeks.

In this post hoc analysis of African-American patients in PREFERMS, outcome variables included rate of patient retention on randomized treatment, reasons for discontinuing randomized treatment, patient-reported treatment satisfaction, and safety.

Clinical and radiographic outcomes such as annualized relapse rate, brain volume loss, and lesion count changes were also investigated.

What Was Measured

The subject headings attached to it are Black or African American, Aggression, Disability Evaluation, Disease Progression, Fingolimod Hydrochloride, Glatiramer Acetate and Immunosuppressive Agents.

The authors tagged it with the keywords African-American patient, Injectable disease-modifying therapy, Multiple sclerosis and Treatment retention.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Glatiramer Acetate in people with multiple sclerosis over 48 weeks.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2018 (Multiple sclerosis and related disorders), a journal based in Netherlands.

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