Pair of Multiple Sclerosis Drugs Produces Positive Long-Term Results

At the Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS) in Boston, Genzyme and Biogen Idec presented positive results from pivotal Phase 3 extension studies of their multiple sclerosis (MS) treatments.

According to the 2 companies, Genzyme’s alemtuzumab (Lemtrada) and Biogen’s dimethyl fumarate (Tecfidera) showed sustained efficacy in a broad range of patients with MS throughout the extension trials. For instance, results from Biogen’s ENDORSE study, which included patients treated up to 7.5 years, demonstrated that Tecfidera positively impacted MS relapse rates and disease-related disability progression over 5 years.

“Tecfidera continues to provide patients with effective oral treatment for MS that is supported by a growing body of data reinforcing its benefits and favorable safety profile,” said Alfred Sandrock, MD, PhD, group senior vice president and chief medical officer of Biogen, in a press release. “These new ENDORSE results provide further insight into the positive impact of using Tecfidera early in the course of MS and for long-term treatment of this chronic disease.”

Similarly, Genzyme’s extension study, which analyzed 4 years’ worth of data on patients with MS, found that, among those who had previously received Lemtrada, disability scores and relapse rates improved or remained stable for an additional 2 years beyond the conclusion of the Phase 3 CARE-MS I and CARE-MS II studies.

Of note, approximately 70% of those treated with 2 annual courses of Lemtrada did not receive a third course of treatment.

“These extension study results provide further evidence of the prolonged efficacy of Lemtrada on both relapses and disability,” said Alasdair Coles, PhD, senior lecturer in the Department of Clinical Neurosciences at the University of Cambridge, in a press release. “The majority of patients continued to experience reduced disease activity, even though their last Lemtrada treatment was 3 years earlier.”

The most common side effects associated with the long-term use of Lemtrada were headache, rash, and nausea, while flushing and gastrointestinal events were most frequently cited among those treated with Tecfidera.