“Interferon beta (IFNb) is a first-line treatment for people with MS. However, increasing evidence suggests that the presence of neutralising antibodies during treatment is associated with a reduction in treatment efficacy. The authors of this study found that anti-IFNb neutralising antibodies could persist after treatment cessation and were associated with higher disease activity and poorer clinical outcome.”

The antibodies are associated with overt clinical disease activity. This is made apparent by an increase in relapse rate and faster disability progression and is supported by the observed need for more aggressive therapy after interferon beta treatment cessation. Prospective studies are warranted to confirm these results.

authors: van der Voort LF, Gilli F, Bertolotto A, Knol DL, Uitdehaag BM, Polman CH, Killestein J

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Immunomodulatory Treatment Improves Cognitive Function in MS Patients

Patients with relapsing-remitting multiple sclerosis (RRMS) who receive glatiramer acetate (GA) or interferon (IFN) beta show a reduction in cognitive impairment and relative stability of cognitive and affective variables at 2 years, according to the results of an observational study presented here at the 19th Meeting of the European Neurological Society (ENS).

The aim of the observational study was to evaluate the long-term effects of first-line disease-modifying therapies with GA or IFN beta on cognitive functions, affective status, fatigue and quality of life in patients with RRMS (ITACA study).

“A total of 752 patients with RRMS and a

mean age of 36 years were enrolled in

79 Italian centres,” explained principal investigator Monica Falautano, PhD, Functional Unit of Psychology, IRCCS H. San Raffaele Milano, Milan, Italy, on June 24.

Study patients were treated with either GA or IFN beta.

At baseline and 6, 12, 18, and 24 months, a fatigue and physical disability evaluation was performed.

Cognitive and affective assessments were performed at baseline and 12 and 24 months.

A significant reduction [P < .0001] in cognitive impairment was observed at the 24-month follow-up, Dr. Falautano noted. At baseline, 40% of all patients showed mild cognitive impairment, and 16% showed severe cognitive impairment, which the researchers said was reduced to 30% and 11%, respectively, at 2 years.

A higher proportion of GA than IFN patients had been affected by severe cognitive impairment (20% vs 12%). At the 24-month follow-up, the percentage of severe impairment was reduced to similar amounts in both treatment groups (12% and 10%, respectively).

According to the mean Montgomery-Asberg Depression Rating Scale score, significant depressive symptoms were missing both at baseline and at the 24-month follow-up.

Physical and mental health assessed with the Multiple Sclerosis Quality of Life 54 questionnaire correlated highly significantly at baseline and at the 24-month follow-up (P < .001).

Patients did not report any changes in perception of their quality of life after 2 years of treatment. No changes were observed in Kurtzke’s Functional Systems Scores.

“The immunomodulatory treatment may have an impact on cognitive function,” Dr. Falautano summarised the primary result of the study. “Nevertheless, a longer follow-up is advisable to confirm our results.”

Funding for this study was provided by Sanofi-Aventis.

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By Judith Moser, MD

MILAN, Italy — June 23, 2009 — Patients with relapsing-remitting multiple sclerosis (RRMS) show early benefit from a new formulation of subcutaneous interferon (IFN) beta-1a as measured by magnetic resonance imaging (MRI), according to a study presented here at the 19th Meeting of the European Neurological Society (ENS).

Nicola De Stefano, MD, Department of Neurological and Behavioural Sciences, University of Siena, Siena, Italy, spoke on behalf of the researchers from the Study to Evaluate Rebif New Formulation (IFN-Beta-1a) in Relapsing Remitting Multiple Sclerosis (IMPROVE) here on June 22.

The phase 3b double-blind, placebo-controlled, multicentre study evaluated the efficacy, safety, and tolerability of a new formulation of IFN beta-1a compared with placebo in patients with active RRMS. This new formulation is free from serum-derived products and has been developed with the aim of improving injection tolerability and reducing immunogenicity.

In the double-blind phase, 180 patients were randomised to receive either the new formulation of IFN beta-1a 44 mcg 3 times weekly or placebo for 16 weeks.

The primary endpoint was the number of combined unique active (CUA) brain lesions at week 16. Secondary endpoints included changes in T2 load and cumulative number of new gadolinium-enhancing and T2 lesions.

“Every single MRI endpoint was significantly in favour of the active treatment,” Dr. De Stefano summarised.

At week 16, the number of CUA lesions was significantly lower with IFN beta-1a (0.9 vs 3.0 in the placebo group, P < .001).

More than half of the patients (53.3 %) in the active-treatment group had no CUA lesions at week 16, compared with 16.7% in the placebo group.

“A beneficial effect of the treatment can be seen even in a short period,” Dr. De Stefano noted. “Post hoc analyses showed a significant effect already at 4 weeks.”

From week 4 on, the mean cumulative number of CUA lesions was significantly lower in the IFN beta-1a group, with a 41% reduction compared with the placebo group.

The cumulative number of new gadolinium-enhancing and new T2 lesions was significantly reduced at 16 weeks (P <.001).

At week 16, the change in T2 burden of disease was significantly lower with IFN beta-1a than placebo (P < .001).

The most commonly reported adverse event was flulike illness (50% and 17% in the IFN and placebo groups, respectively).

As Dr. De Stefano mentioned, a 24-week, single-arm, rater-blind treatment phase was initiated after the double-blind phase and has been completed recently, and the results will be presented soon.

Funding for this study was provided by Merck Serono S.A.

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