By John Gever, Senior Editor, MedPage Today
Published: June 05, 2011
Reviewed by Michael J. Olek, DO; Director, Newport Doctors Multiple Sclerosis Clinic and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
MONTREAL — Starting interferon-beta-1a (Rebif New Formulation) immediately upon an episode of a clinically isolated syndrome delayed progression to full-blown multiple sclerosis, but once-weekly treatment was less effective than the standard dosing interval, a researcher said here.
Published: June 05, 2011
Reviewed by Michael J. Olek, DO; Director, Newport Doctors Multiple Sclerosis Clinic and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
MONTREAL — Starting interferon-beta-1a (Rebif New Formulation) immediately upon an episode of a clinically isolated syndrome delayed progression to full-blown multiple sclerosis, but once-weekly treatment was less effective than the standard dosing interval, a researcher said here.
A randomized, placebo-controlled trial called REFLEX showed that 62% and 76% of patients assigned to 44 mcg of interferon subcutaneously three times or once weekly, respectively, met 2005 McDonald criteria for MS after two years — the study’s primary endpoint — compared with 86% of patients treated with placebo, said Mark Freedman, MD, of the University of Ottawa.
The differences between the two interferon dosing schedules, and between the interferon schedules and placebo, were all statistically significant (P<0.01), he told attendees at the annual meeting of the Consortium of Multiple Sclerosis Centers.
On the other hand, there was no difference between interferon regimens in the percentage of patients diagnosed with “clinically definite multiple sclerosis,” standards for which were set in 1983 with endpoints somewhat different from the 2005 McDonald criteria.
This “main secondary endpoint” was met by 21% and 22% of the three times and once weekly groups, respectively, versus 38% of the placebo group, Freedman reported.
Also similar between the two interferon regimens was the annualized relapse rate: 0.118 and 0.115, respectively, compared with 0.22 with placebo.
Overall, the REFLEX results were similar to those seen in an earlier study called BENEFIT, reported in 2006, which tested the three times weekly dosage — then as now the standard of care for MS treatment — against placebo in patients diagnosed with clinically isolated syndrome.
This condition is essentially the first definite disease event in MS, but under the current diagnostic framework, it is not sufficient for a diagnosis of MS until either symptoms worsen, or MRI scans confirm lesions characteristic of MS
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