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Initial Disability Scores and Progression Rather Than Relapses Affect Duration of Interferon Beta-1a (Avonex) Treatment: Presented at ECTRIMS

By Bruce Sylvester

THESSALONIKI, GREECE -- October 3, 2005 -- Low scores on the Expanded Disability Status Scale (EDSS) at the beginning of treatment with interferon beta-1a (Avonex) in multiple sclerosis patients is associated with a longer duration of treatment, according to research presented here on September 29^th at the 21^st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

In addition, said the investigators, treatment failure is mostly due to progression of disability rather than persistence of a high relapse rate.

"We have very few long-term follow-up studies of treatment of patients in a real-world setting," said investigator and presenter Patrick Vermersch, MD, professor of neurology and chief, department of neuro-inflammatory disorders, University of Lille, Lille, France.

"Here we had follow-up with the same neurologist for each subject," he explained. "We found that the discontinuation of treatment is more frequent in patients with baseline higher EDSS scores but there is no significant difference in terms of disability progression with subjects with low baseline EDSS and subjects with high EDSS."

"The reason for the discontinuation discrepancy in patients with higher baseline EDSS is the fact that the neurologist stopped the treatment earlier in patients with higher EDSS," he added.

The study included patients followed for at least 5 years who had started interferon beta-1a before April 1999. The researchers stratified subjects into 2 groups according to baseline EDSS (less than or equal to 3.0 vs. EDSS > 3.0).

Endpoints included number and reasons for dropout from treatment, relapse rate and number of confirmed disability progression.

The investigators analysed data on 400 patients taken from an initial cohort of 404.

Baseline mean EDSS was 2.95 (1.4 standard deviation [SD]) and the relapse rate was 1.5 (1.2 SD). Mean follow-up was 5.05 years.

Two hundred one of the subjects (50.4%) received interferon beta-1a treatment for at least 4 years, more in the group EDSS less than or equal to 3.0 than in the group EDSS > 3.0 (59.6% and 36.9, respectively, P < .0001).

The researchers found that the main reasons for dropouts were switch to secondary progressive form and disability progression. "Dropouts for persistence of relapses and for side-effects were rare," they noted.

Baseline EDSS scores greater than 3.0 were associated with a higher risk of dropout.

Relapse rate was 0.84. Mean increase of the EDSS score was 0.48 compared with baseline. The researchers reported disability progression in 126 patients (32%), but found no significant difference between the 2 stratified groups.

They found that disability progression in patients treated at least 4 years was rare, and that prior treatment with immunosuppressive or immunomodulating drugs showed no association with an increased risk of dropout (P = .01).

"After 5 years we observed that a little less than 50% are always treated by Avonex," Dr Vermersch said. "Discontinuations for side effects were rare, and most were due to a switch for secondary progressive disease and not for relapses. We saw a low percentage of disability progression for the whole group, with no significant differences between the high and low baseline EDSS groups. The disability progression was 31%, slightly lower than the rate seen in other studies with interferon beta."


[Presentation title: Long-Term Follow-Up of Multiple Sclerosis Patients Treated With Interferon Beta-1a (Avonex(R)). Poster 298]

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