In: Main3 Apr 2010
Interferon Beta-1b for Multiple Sclerosis
Speaker: Ludwig Kappos, MD, Professor of Neurology and Clinical Neuroimmunology, Department of Neurology and Research, University of Basel and University Hospital Basel, Basel, Switzerland
In a large-scale European clinical trial, interferon beta-1b (IFN (5-1b) (Betaseron, Schering AG, Germany) was effective, safe, well tolerated, and well accepted for patients with a first clinical event suggestive of multiple sclerosis (MS).
The Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) trial enrolled 468 patients with a first clinical demyelinating event and at least two clinically silent brain lesions, as shown by magnetic resonance imaging (MRI). The patients were randomly selected to receive, in a 5:3 ratio, 250 mcg of IFN |3-1b subcutaneously (n = 292) or placebo (n = 176) every other day until a diagnosis of clinically definite MS (cd MS) was confirmed or until they had been observed for 24 months.
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To achieve maximum tolerability, the researchers escalated the dose during the first three weeks and encouraged administration with an auto-injector. Concomitant ibuprofen or acetaminophen was also used to reduce flu-like symptoms. Patients who completed the study could participate in a follow-up study with open-label IFN |3-1b for up to five years.
Primary efficacy endpoints were the time to cd MS and the time to diagnosis of MS, according to the McDonald criteria. Other endpoints included safety and tolerability.
IFN |3-1b significantly delayed the risk of progression from the first clinical event to cd MS by 50% (P < .0001) and for “McDonald criteria” MS by 46°% (P < .0000l). In terms of safety and tolerability, only 7.2% of patients receiving IFN | -1b discontinued the study prematurely, compared with 5.7% of the placebo group. Regarding adherence to therapy, only 15.1% of the IFN |3-1b patients and 10.2% of the placebo group discontinued therapy. Nearly all patients received at least 80% of the scheduled treatment until the end of the study (97.6% who took the study drug and 97.2% who took placebo).
Of all patients who reached the end of the study as scheduled, 418 (96%) entered the follow-up study. Of these, 261 patients (96%) had received IFN |3-1b in the double-blind phase of the BENEFIT study and 157 (95%) had received placebo. Of these, 96% of the two groups (combined) chose to receive IFN |3-1b 250 mcg every other day.
Patient-reported outcomes, including quality-of-life measures, did not indicate a negative impact of typical adverse effects from IFN | -1b.
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