LYON, FRANCE—The following news stories were originally written on site at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and posted on the Neurology Reviews website www.neurologyreviews.com. We have reproduced them here for readers who did not see our online conference reporting. More news from the ECTRIMS Congress can be found online and in upcoming issues of Neurology Reviews.
Postmarketing Safety Data Released for Ampyra (Dalfampridine)
Michele Jara, DSc, Director of Epidemiology at Accorda Therapeutics in Hawthorne, New Jersey, and colleagues presented the findings from a two-year safety study of Ampyra (dalfampridine) extended-release tablets (10 mg) indicated for the treatment of walking impairment in patients with multiple sclerosis (MS). Among the major findings, Dr. Jara reported that:
• The safety profile for Ampyra two years after FDA approval is similar to that observed in clinical trials.
• The most frequent associated adverse events were dizziness, insomnia, balance disorder, headache, nausea, urinary tract infection, back pain, and asthenia.
• Among the 62,400 patients prescribed Ampyra, the rate of seizure (4.6 per 1,000 patient-years of use) was comparable to that seen in the MS population overall. Length of treatment prior to seizure ranged from first dose to two years, with 20% of the seizures occurring within a week of starting treatment.
The analysis examined all postmarketing data that were reported to the drug maker (Acorda) and the FDA from March 2010 through March 2012.
Teva Announces Top-Line Data From the GALA Study—New Dosing Regimen for Glatiramer Acetate
Data from a phase III trial support the efficacy of a new dosing regimen for Copaxone (glatiramer acetate) for patients with relapsing-remitting multiple sclerosis (MS).
Teva Pharmaceutical Industries released data from the Glatiramer Acetate Low-Frequency Administration (GALA) study, which was designed to evaluate the efficacy, safety, and tolerability of 40 mg/mL of glatiramer acetate three times weekly instead of the 20-mg/mL daily subcutaneous injection that has been the recommended dose for almost two decades.
In the GALA study, a one-year, randomized, double-blind, placebo-controlled trial, glatiramer acetate 40 mg/mL injected three times weekly significantly reduced annualized relapse rates by 34.4% versus placebo. The cumulative number of new and enlarging T2 lesions was significantly reduced by the same percentage. In addition, a significant 44.8% reduction in the cumulative number of gadolinium-enhancing lesions was observed in patients treated with the investigational dosing regimen. At 12 months, there was no significant difference in percentage change of brain volume between the glatiramer acetate-treated patients and those receiving placebo. Discontinuation rates among the two cohorts were comparable.
Glatiramer acetate in a dose of 40 mg/mL also showed a favorable safety and tolerability profile. The overall frequency of adverse events in the GALA study was comparable to that of the placebo group. The most common reported adverse events were injection-site reactions, headaches, and nasopharyngitis.
The drug maker released only top-line data at a press conference. Lead study author Omar A. Khan, MD, Professor and Interim Chair of the Department of Neurology and Director of the Multiple Sclerosis Clinical Research Center and Image Analysis Laboratory at Wayne State University School of Medicine in Detroit, reported more detailed study results two days later on October 13 in a late-breaking news session of the 28th Congress of the ECTRIMS.
Second Phase III Study of Teriflunomide Confirms Significant Impact on Disability
Once-daily oral teriflunomide 14 mg significantly reduced the annualized relapse rate and slowed progression of disability in patients with relapsing forms of multiple sclerosis (MS) compared with placebo, according to data presented at the 28th Congress of ECTRIMS. In addition, the proportion of patients treated with teriflunomide who were relapse-free was significantly higher compared with placebo.
Ludwig Kappos, MD, Chair of Neurology, University Hospital Basel, Switzerland, and colleagues presented the results of TOWER (Teriflunomide Oral in people With relapsing multiplE scleRosis), the second phase III randomized, double-blind trial of teriflunomide. “The TOWER study results are consistent with the phase III TEMSO data, both in terms of the effect on progression of disability and the manageable safety profile of teriflunomide,”
said Dr. Kappos.
TOWER enrolled 1,169 patients with relapsing-remitting MS across 26 countries and compared 7 mg or 14 mg once-daily oral teriflunomide with placebo.
Dr. Kappos reported that patients treated with 14 mg had a 36.3% reduction in annualized relapse rate (ARR) compared with placebo and 31.5% reduced risk of 12-week sustained disability progression, as measured by the Expanded Disability Status Scale, compared with placebo. Patients treated with 7 mg had a 22.3% reduction in ARR; there was no significant effect of 7 mg on disability progression.