AAN PRESENTATIONS ON CLINICAL TRIALS IN MS
At the recent American Academy of Neurology 64th annual meeting, held April 21–28,
clinicians presented several reports on clinical trials of drugs to treat multiple sclerosis.
Here are some results:
The CombiRx clinical trial tested acombination of Avonex (interferon beta-1a) and Copaxone (glatiramer acetate). The drug combination—when compared to the use of the individual drugs—showed some evidence from MRI that it was superior to taking either drug alone, according to Jerry Wolinsky, MD, of the University of Texas Health Science Center in Houston.
However, the combination showed little benefit in terms of reducing clinical relapses when compared to the better of the two single agents, Copaxone. There was no benefit in reducing progression, as reported by Fred Lublin of Mount Sinai School of Medicine. Avonex and Copaxone have been considered the mainstays of MS treatment for several years.
The National Institutes of Health funded the CombiRx trial. Started in 2005, it enrolled a total of 1,008 patients through April 2009. Gary Cutter, MD, and Stacey Cofield, MD, both NARCOMS staff, coordinated statistical and data management for the study
SECOND POSITIVE TRIAL FOR BG-12 IN MS
Full results of a second trial of the oral BG-12 (dimethyl fumarate) in relapsingremitting MS show that the drug significantly reduced relapse rates when compared to a placebo, and compared well with glatiramer acetate (Copaxone).
Dr. Robert Fox, medical director of the Mellen Center for MS at the Cleveland Clinic and Executive Director of NARCOMS, presented results of the Comparator and an Oral Fumarate in RRMS (CONFIRM) trial. The results are “quite consistent” with the previous phase 3 trial, Fox concluded, suggesting that, “this drug has quite robust efficacy and an acceptable safety and tolerability profile.”
Results of the Comparator and an Oral Fumarate in RRMS (CONFIRM) trial showed that the BG-12 significantly reduced the relapse rate by 44% for the twice-daily dose, and by 51% when taken 3 times a day when compared with placebo at 2 years.