(RxWiki News) In most patients, multiple sclerosis (MS) attacks in spurts. That is, periods of debilitating symptoms are followed by periods with few or no symptoms. Researchers are currently testing a new medication to reduce these attacks.
Results from a recent trial showed that patients with relapsing-remitting MS who took a medication called daclizumab had lower rates of relapse (periods of active symptoms) than patients who did not take the medication.
Relapse rates were reduced regardless of the daclizumab dosage. If approved, daclizumab will be marketed as Zenepax.
"Seek treatment for MS symptoms."
Relapsing-remitting MS is the most common type of MS. It is characterized by periods of symptom flare-up (relapse) and periods of stability between relapses (remission). During relapse, patients may experience new or worsening symptoms that, over time, can lead to permanent nerve damage and disability.
From this trial, Professor Ralf Gold, MD, of Ruhr University Bochum in Germany, and colleagues wanted to see if daclizumab alone would be an effective treatment to reduce relapse rates in patients with relapsing-remitting MS.
Daclizumab is given as an injection under the skin once a month.
The randomized, double-blind, placebo-controlled trial included patients from 76 centers in several European countries, India, Turkey and Russia. All the patients had relapsing-remitting MS and were between the ages of 18 and 55.
Patients were assigned to take daclizumab or placebo (fake medication) every four weeks for 52 weeks. A total of 208 patients were assigned to 150 mg doses of daclizumab, 209 were assigned to 300 mg doses of daclizumab and 204 were assigned to placebo.
The researchers found that annualized relapse rates were lower for patients given either dosage of daclizumab than for those given placebo.
Results showed that annualized relapse rates were reduced by 54 percent among patients who took 150 mg doses of daclizumab and by 50 percent among those who took 300 mg doses, compared to those who took placebo.
Annualized relapse rates were 21 percent among patients given 150 mg doses, 23 percent among patients given 300 mg doses and 46 percent among those given placebo.
Results also showed that more patients were relapse-free in the daclizumab groups than in the placebo group. A total of 81 percent of the 150 mg group and 80 percent of the 300 mg group went without relapse over the course of the study, while 64 percent of the placebo group remained relapse-free.
Serious side effects other than MS relapse were experienced by 15 patients (7 percent) in the 150 mg group, 19 patients (9 percent) in the 300 mg group and 12 patients (6 percent) in the placebo group.
While recovering from a serious rash, one of the patients taking 150 mg doses of daclizumab died from a local complication of psoas abscess (a collection of pus in the inner hip muscles).
According to the researchers, daclizumab given every four weeks "...led to clinically important effects on multiple sclerosis disease activity during one year of treatment."
They concluded, "Our findings support the potential for daclizumab to offer an additional treatment option for relapsing-remitting disease."
The trial results were published online April 4 in The Lancet.
The research was funded by Biogen Idec, manufacturer of Zenepax, and AbbVie Biotherapeutics Inc. Several of the co-authors are employees of Biogen Idec and AbbVie Biotherapeutics.