MS Exacerbations Continue to Decrease Among Patients in Extended Trial of Oral Fingolimod

The number of multiple sclerosis (MS) exacerbations continued to decline in patients who continued on the experimental drug fingolimod and among those placebo patients switched to the drug after conclusion of the original phase 2 trial, researchers reported here at the 131st Annual Meeting of the American Neurological Association (ANA). 

 "No unexpected adverse events emerged in patients treated up to 24 months compared with the 6-month placebo-controlled phase," said Ludwig Kappos, MD, head, outpatient clinic for neurology/neurosurgery and MS-Research Group, University Hospital, Basel, Switzerland. 

 In the original 6-month, placebo-controlled study of 281 patients with relapsing MS, fingolimod, an oral sphingosine-1-phosphate receptor modulator, showed clinical and radiological efficacy.  The clinical relapse rate was.36% per year with fingolimod compared with 0.77% per year with placebo, a difference that was statistically significant at the P < .01 level for both doses of fingolimod tested -- 1.25 mg or 5 mg a day. 

 Patients in the placebo arm were invited to remain in study and switch to the active treatment.  "Due to the observation that the 1.25 mg dose was as effective as the 5 mg dose -- and the higher incidence of adverse events observed in the 5 mg group, all patients receiving 5 mg were switched to 1.25 mg between the month 15 and month 24 visit," Dr.  Kappos said. 

 After 24 months, the annualized relapse rate in the 40 former placebo patients switched to 1.25 mg decreased from 0.70 to 0.38 attacks per year, and in the 43 former placebo patients switched to 5 mg, the rate decreased from 0.69 to 0.28 attacks per year. 

 In the 94 fingolimod patients on 1.25 mg the annualized relapse rate decreased from 0.36 to 0.20 attacks per year in the extended program, while in the 94 patients on 5 mg dose, the rate decreased from 0.32 to 0.22 attacks per year in the extended study. 

 Fingolimod, a sphingosine-1-phosphate receptor modulator disease- modifying treatment, is being studied in a phase 3 trial that is being funded by Novartis Pharma AG, Basel. 

 "These positive results support further evaluation of fingolimod as an oral treatment option for patients with relapsing multiple sclerosis," he said in his poster presentation on October 9th. 

[Presentation title: Oral FTY720 (Fingolimod) in Relapsing MS: Results of the Dose-Blinded Extension of a Placebo-Controlled Phase II Study.  Abstract M-4]