Antibodies to glatiramer acetate do not interfere with its biological functions and therapeutic efficacy

What Was Tested

The paper reports a study of Glatiramer Acetate, published as a phase 3 clinical trial.

GA acts as a specific immunomodulator by binding to MHC Class II molecules, inducing specific T suppressor (Ts) cells and interfering with T cell responses to myelin antigens.

In order to find out whether anti-GA antibodies may neutralize the therapeutic effect of GA, the researchers tested both polyclonal (mouse and human) and monoclonal GA specific antibodies for their ability to interfere with the biological activity of GA in several assay systems.

Who Took Part

The study group was 34 patients.

PubMed tags the participants as women only.

How the Study Was Run

In design terms this was an open-label study.

Nothing was hidden in this open-label Glatiramer Acetate study: the patients and staff both knew the treatment.

What Was Measured

In order to find out whether anti-GA antibodies may neutralize the therapeutic effect of GA, the researchers tested both polyclonal (mouse and human) and monoclonal GA specific antibodies for their ability to interfere with the biological activity of GA in several assay systems.

Topics PubMed links to this paper include Antibodies, Monoclonal, Encephalomyelitis, Autoimmune, Experimental, Glatiramer Acetate, Immunoglobulin G, Immunosuppressive Agents, Mice and Mice, Inbred BALB C.

What This Means in Plain Language

The paper is an open-label study of Glatiramer Acetate in 34 patients.

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.

The publication is from 2003 (Multiple sclerosis (Houndmills, Basingstoke, England)), a journal based in England.

More context: the Glatiramer Acetate compound page, all human trials.