a first episode of MS-like symptoms), than among controls without MS. The risk of bone loss had been known for people with MS, but this study showed that it can occur very early, even before MS has been diagnosed. Stine Marit Moen, M.D., and colleagues at Oslo University Hospital reported their findings in July. The team measured bone density in several areas and the total body in 99 people newly diagnosed with MS, or those with CIS, compared to 159 controls without MS. They also administered a questionnaire concerning risk factors for osteoporosis, a disease that causes bones to thin. More than half of the people with MS or CIS had low bone mass, compared with 37.1 percent of controls, and low bone mass remained significantly lower in the spine and hip even after adjusting for other possible risk factors. The authors concluded that this study “calls for an active approach to optimize bone health in early stages of MS.” Positive Results Announced from First Phase III Study of Alemtuzumab in MS Sanofi and its subsidiary Genzyme announced that the experimental intravenous therapy alemtuzumab (with a proposed brand name Lemtrada) met one of two primary endpoints by significantly reducing relapse rates in a two-year study comparing two annual cycles of alemtuzumab against standard subcutaneous dosing of Rebif. The study, called CARE-MS I, involved 581 people with early relapsingremitting MS. The study did not meet its second primary endpoint of slowing disease progression compared to Rebif. Data analysis is ongoing and the company expects to provide a full report at an upcoming medical meeting. Another trial of alemtuzumab, called CARE-MS-II, is currently underway. Study Investigates Cost Effectiveness of Therapies to Treat MS A study co-funded by the National MS Society, the National Institutes of Health and the University of Rochester examined the cost-effectiveness of therapies to treat MS. Results were released in July 2011, finding that the cost for improving the quality of life for people
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MSConnection • FALL 2011
with MS in the United States is high. The study in no way suggested that anyone appropriate for these treatments should not be on them; in fact, it found that the earlier disease-modifying therapies were used, the more cost-effective they were. This adds to growing evidence suggesting that treating MS early and consistently is the best way to ward off future disease activity. Initial Results Released from Phase III Study of Laquinimod Teva Pharmaceutical Industries Ltd. and Active Biotech announced in August that the phase III BRAVO study – in which the experimental oral drug laquinimod was tested against inactive placebo in a study involving more than 1,300 people with relapsing-remitting MS – did not reach its primary goal of reducing the average number of relapses in a year. However, when the investigators adjusted the data to correct for differences in magnetic resonance imaging characteristics at the start of the study, a significant reduction in average annual relapse rate was observed in the group receiving laquinimod. Further analysis is ongoing. The companies plan to submit applications to regulatory authorities for the treatment of MS in the United States and European Union. Phase II Trial of Daclizumab Reduces Average Annual Relapse Rate Biogen Idec and Abbott Pharmaceuticals announced in an Aug. 10, 2011 press release that DAC HYP – a liquid formulation of the monoclonal antibody daclizumab delivered via monthly injection under the skin – reduced the average annual relapse rate significantly in a study of 600 people with relapsing-remitting MS over a one-year trial. Full data from the “SELECT Study” are to be presented at an upcoming medical meeting.