Pregnancy and fetal outcomes after Glatiramer Acetate exposure in patients with multiple sclerosis: a prospective observational multicentric study

What Was Tested

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

Following a previous study assessing the safety of interferon beta (IFNB) pregnancy exposure in multiple sclerosis (MS), the researchers aimed to assess pregnancy and fetal outcomes after in utero exposure to GA, using the same dataset, with a specific focus on the risk of spontaneous abortion.

Why It Was Studied

Only few studies have assessed safety of in utero exposure to glatiramer acetate (GA).

Who Took Part

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

The researchers recruited MS patients, prospectively followed-up in 21 Italian MS Centres, for whom a pregnancy was recorded in the period 2002-2008.

Patients were divided into 2 groups: drug-exposed pregnancies (EP: suspension of the drug less than 4 weeks from conception); non-exposed pregnancies (NEP: suspension of the drug at least 4 weeks from conception or never treated pregnancies).

How the Study Was Run

All the patients were administered a structured interview which gathered detailed information on pregnancy course and outcomes, as well as on possible confounders.

Multivariate logistic and linear models were used for treatment comparisons.

What Was Measured

Only few studies have assessed safety of in utero exposure to glatiramer acetate (GA).

Topics PubMed links to this paper include Comorbidity, Drug-Related Side Effects and Adverse Reactions, Glatiramer Acetate, Incidence, Italy, Multiple Sclerosis and Peptides.

What This Means in Plain Language

This is a controlled clinical trial of Glatiramer Acetate in people with multiple sclerosis.

Its findings take up roughly 9 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2012 (BMC neurology), a journal based in England.

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