SAN DIEGO—Early treatment with interferon beta-1b (Betaseron) in patients who have experienced a single clinical episode suggestive of multiple sclerosis (MS) significantly delays the onset of clinically definite MS, according to phase 3 results released at the annual meeting of the American Academy of Neurology.
The data are from the Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) trial, in which 487 patients with early disease were randomized in a 5:3 ratio to treatment with either 250 µg interferon beta-1b given every other day, as a subcutaneous injection, or placebo.
“There has been a controversy as to whether this particular patient population should be treated, and we now know that early treatment can make a difference,” said Mark S. Freedman, MD, professor of neurology, University of Ottawa, Ottawa, Canada.
All participants had a first clinically demyelinating event suggestive of MS within the last 60 days and had at least 2 clinically silent lesions that were documented by magnetic resonance imaging.
Patients were treated until clinically definite MS was diagnosed or they had been followed for 24 months; 28% of patients assigned to drug treatment were diagnosed with MS after 2 years compared with 45% of placebo patients (P <.001). “This amounts to a relative risk reduction of 50% in patients treated with interferon beta-1b,” Dr Freedman reported.
The drug prolonged the time to clinically definite MS by 363 days and was well tolerated.
Dr Freedman said that the study results support the use of interferon beta-1b for initial treatment of newly developing MS.