MADRID — Glatiramer acetate significantly reduced relapse and disease progression in patients with multiple sclerosis who received the drug after a course of methotrexate, according to the results of a small Italian study.
“In our experience, six multiple sclerosis patients treated with methotrexate followed by glatiramer acetate showed a significant reduction of inflammatory activity parameters during the follow-up,” Dr. Yasmin Handouk wrote in a poster that was presented at the annual congress of the European Federation of Neurological Societies.
“This was associated with a lack of disease progression,” Dr. Handouk added.
Glatiramer acetate received Food and Drug Administration approval in 2001 for use in reduction of the frequency of relapses in relapsing-remitting multiple sclerosis.
The randomized trial included 12 patients with refractory MS (6 with relapsing-remitting disease and 6 with progressive-relapsing disease).
All of the patients had undergone a course of methotrexate after failing to respond to interferon therapy, wrote Dr. Handouk of the Università Politecnica delle Marche, Ancona, Italy.
After methotrexate, patients had magnetic resonance imaging of the brain. Within 3 months of ending methotrexate, six started maintenance therapy with glatiramer acetate 20 mg/day for a mean of 8 months; the rest received no further treatment.
Follow-up assessments were done at 6-month intervals for 2 years.
At the 2-year follow-up, only one patient in the active group had relapsed. Disability, as measured by the Expanded Disability Status Scale, had significantly improved, with patients dropping an average of 1 point on the scale.
There were no new or enhanced lesions.
In the nontreated group, two patients had relapsed. The disability score was not improved from baseline. Two patients showed new gadolinium-enhancing lesions.
“[Dr. Jason Ramtahal] previously proved the usefulness of 6-month glatiramer acetate beginning 2 months before ending methotrexate, although a case of acute promyelocytic leukemia was registered [J. Neuro. 2006;253:1160–4],” Dr. Handouk noted.
“Our patients started glatiramer acetate therapy at least 3 months after methotrexate without serious adverse event.”
Dr. Handouk made no financial declarations with regard to the study.