By Jill Stein
BOSTON, MA -- May 2, 2007 -- Prompt initiation of interferon beta-1b (Betaseron) at the onset of a first event that is suggestive of multiple sclerosis (MS) cuts the risk of progression to long-term neurologic disability, researchers reported here at the American Academy of Neurology (AAN) 59th Annual Meeting.
"A lot of people, myself included, have endorsed a policy of watchful waiting in patients who start out with a mild clinical attack suggestive of MS," said Mark Freedman, MD, professor, neurology division¸ University of Ottawa, Ottawa, Ontario, Canada.
"We all agree that there is a small [patient] subgroup with a bad initial attack in whom you do not want to postpone treatment," Dr. Freedman noted. "But for the majority of patients, a lot of doctors are willing to wait for conversion to clinically definite or McDonald-positive MS with the rationale that the patient only then has met the criteria for MS and therefore you're assured of a clear diagnosis along with evidence for an active disease."
The new data, based on a follow-up of patients enrolled in the Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) trial, strongly argue against such a policy, he said in his presentation on May 2nd.
"To quote the stroke people, 'time is brain'," he said. "In our study, the group who got the head start is doing substantially better than the group in whom treatment was delayed."
In their study, Dr. Freedman and colleagues evaluated 468 patients with a first clinically demyelinating event suggestive of MS and typical magnetic resonance imaging findings. These patients were treated with subcutaneous interferon beta-1b 250 mcg or placebo every other day until either a diagnosis of clinically definite MS was established or they reached 2 years of evaluation. At this timepoint, they were eligible to enter an open-label, follow-up study and were offered interferon beta-1b for up to 5 years after the start of double-blind treatment.
Results showed that prompt initiation of interferon beta-1b treatment in patients with a first clinically demyelinating event was associated with a significant 40% reduced risk of confirmed progression over 3 years as determined using the Expanded Disability Status Scale (EDSS) compared with delayed treatment. Thus, 16% of the interferon beta-1b group had EDSS progression versus 24% of the placebo group (P =.0218).
At 3-year follow-up, the early-treatment group was 41% less likely to progress to clinically definite MS than patients who delayed the start of treatment (P =.0011). Thus, 37% of patients initially assigned to interferon beta-1b had a second attack within 3 years compared with 51% assigned to placebo.
"Importantly, the study is the first to demonstrate that early treatment delays EDSS progression," Dr. Freedman observed. "This finding has not been shown for any immunomodulatory treatment other than interferon beta-1b," he said.
The study was sponsored by Bayer HealthCare, which manufactures interferon beta-1b as Betaseron.
[Presentation title: Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT): Effects of Immediate Vs. Early Onset of Interferon Beta-1b Treatment. Abstract S02.004]
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