Glatiramer Acetate and IFN Beta Both Improve Cognitive Function and Depression in Patients With Relapsing-Remitting MS: Presented at ECTRIMS
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Glatiramer Acetate and IFN Beta Both Improve Cognitive Function and Depression in Patients With Relapsing-Remitting MS: Presented at ECTRIMS

By Chris Berrie

DÜSSELDORF, Germany -- September 14, 2009 -- Treatment with either glatiramer acetate (GA) or interferon (IFN) beta provides significant improvement in both cognitive function and depression in patients with relapsing-remitting multiple sclerosis (RRMS) who have maintained treatment for 2 years, researchers stated here at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Cognitive dysfunction is a common and disabling symptom of patients with MS, and contributes to the poor quality of life in affected patients, explained coinvestigator Sabrina Canale, PhD, Functional Unit of Psychology, Neurological Department, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) [Scientific Institute for Research, Hospitalisation and Health Care], San Raffaele Hospital, Milan, Italy, presenting results of this observational, longitudinal study here on September 11.

"The aim of the study was to determine if there are any differences in various cognitive, affective, and clinical aspects in patients treated with immunomodulating agents -- and with glatiramer acetate and interferon in particular," stated Dr. Canale.

In all, 752 patients with RRMS were enrolled and randomised to 24 months of active treatment with either GA (n = 397) or IFN beta (n = 354). Baseline characteristics were essentially the same for both groups: age (36 years for both); gender (female, 73% vs 72%, respectively); disease duration (6.9 vs 6.7 years, respectively); and baseline Expanded Disability Status Scale (EDSS) scores (2.2 vs 1.8, respectively). The majority of these patients were treatment naïve (72% vs 91%, respectively).

All patients underwent comprehensive neuropsychological evaluation, with a range of tests used to determine cognitive function, executive function, and memory function. The impairment of cognitive functionality was classified as severe (failure in 3 or more tests), mild (failure in 1 or 2 tests), or normal (no failure on any of the tests).

At baseline, the GA-treated patients showed significantly worse cognitive performance compared with those treated with IFN beta (P = .01). After 24 months of treatment, however, there was a significant improvement in the distribution of patients across these 3 levels of cognitive impairment (P < .0001), although this improvement was considered independent of treatment.

There were no significant changes in executive and memory functions, with respect to patient distributions across each class and over the duration of the study.

The GA-treated patients had significantly higher Fatigue Severity Scales at both baseline and 24 months (3.3 and 3.2, respectively) than the IFN-beta-treated patients (2.8 and 2.8; P <= .01 for both).

Similarly, the GA-treated patients had significantly higher EDSS scores than did the IFN-beta-treated patients from baseline (2.1 vs 1.8, respectively) through 12 months (2.2 vs 1.7) to 24 months (2.2 vs 1.7) (P < .001 for all).

"Patients treated with glatiramer acetate showed higher levels of fatigue and were more disabled," explained Dr. Canale, "which would also match with their worse cognitive impairment."

For the affective data, both at baseline and at 24 months, the GA-treated patients showed significantly higher Montgomery-Asberg Depression Rating scale (MADRS) scores than did the IFN-beta-treated patients (P < .01). Here again, improvements were seen for the MADRS score throughout the study, and were independent of treatment.

"These are only some of the results" explained Dr. Canale, "because the analyses are still being completed." She stressed, however, the need to focus in future on the possible influence of depressive symptoms, fatigue and quality of life on the cognitive performance of patients with RRMS.

Funding for this study was provided by sanofi-aventis.

[Presentation title: Cognitive and Affective 24-Month Follow-Up of Multiple Sclerosis Patients Treated With Glatiramer Acetate or Interferon Beta: "The Immunomodulating Treatments Affective and Cognitive Aspects" (ITACA) Study. Abstract P756]

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