Wednesday, June 24, 2009

Oral Fingolimod Lowers Disease Activity in Patients With MS for Up to 4 Years

Just got this in my alert email today and wanted to share. My favorite part is in green.

Oral Fingolimod Lowers Disease Activity in Patients With MS for Up to 4 Years: Presented at ENS

By Judith Moser, MD

MILAN, Italy -- June 23, 2009 -- Patients with multiple sclerosis (MS) show sustained clinical benefit when treated with the novel sphingosine-1-phosphatase receptor modulator fingolimod (FTY720), according to the extension phase of a multicentre study presented here at the 19th Meeting of the European Neurological Society (ENS).

Ludwig Kappos, MD, Clinic of Neurology, University Hospital Basel, Basel, Switzerland, presented the 4-year follow-up findings of a phase 2 proof-of-concept study investigating oral fingolimod in the treatment of MS here on June 22.

Fingolimod targets MS via the immune system and probably via the central nervous system as well. "The main mode of action pertains to a redistribution of lymphocytes, which normally stay protected in lymph nodes," Dr. Kappos explained.

The core study, which covered the time between baseline and 6 months, compared once-daily fingolimod 1.25 and 5.00 mg with placebo. In the randomised, dose-blind extension study (months 7-48), patients formerly on placebo were rerandomised to once-daily oral fingolimod 1.25 or 5.00 mg so that all patients were on active treatment.

As Dr. Kappos noted, the number of circulating lymphocytes was permanently reduced in all dose groups by approximately 70% throughout the extension period.

Similarly, the number of gadolinium-enhancing lesions remained low in all arms over 48 months. More than 95% of the study population were free of gadolinium-enhancing lesions at the end of the 4-year extension period.

These findings translated into a low annualised relapse rate. Most patients (51%-70%) remained relapse-free for up to 48 months. Furthermore, most patients were free from disability progression at the end of the study.

"Fingolimod was well tolerated," Dr. Kappos reported. "The long-term safety profile was in line with previous findings."

In the group with the highest cumulative dose, a tendency toward higher infection and nasopharyngitis rates was seen. However, serious adverse events were equally distributed between the dose groups.

Blood pressure and pulmonary function measurements remained stable during the extension study. Asymptomatic elevations of liver enzymes were observed in 16% of patients without any evidence of serious drug-induced liver injury.

Seven cases of localised skin cancers, which were detected by regular examination, occurred within the first 36 months. Between months 37 and 48, no new cases were seen. "This indicates a lack of cumulative risk with increasing drug exposure," Dr. Kappos said.

A phase 3 study program is further characterising the efficacy, safety, and tolerability of oral fingolimod in patients with MS.

Funding for this study was provided by Novartis Pharma.

[Presentation title: Majority of Patients With Relapsing Multiple Sclerosis Receiving Oral Fingolimod (FTY720, a Sphingosine-1-Phosphatase Receptor Modulator) Remain Free From Any Inflammatory Activity: Results of a 4-Yr, Phase II Extension. Abstract O21]


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