Fingolimod (Gilenya) Found to Be an Effective Multiple Sclerosis Therapy for Up to Three Years of Treatment

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by Patricia Silva, PhD |

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An encouraging new analysis reveals that fingolimod is an effective multiple sclerosis (MS) therapy for a treatment period of up to three years. The results were presented at the Annual Meeting of the Consortium of MS Centers.

MS is a chronic, progressive neurodegenerative disorder that is the result of an attack on the central nervous system (brain, spinal cord and optical nerves) by the body’s own immune system, resulting in motor function impairment (coordination, balance, speech and vision), irreversible neurological disability and paralysis. The most frequent form of the disease is relapsing-remitting MS (RRMS), which is clinically characterized by recurring episodes of neurological symptoms. It is estimated that more than 2.3 million people in the world suffer from MS and there is currently no cure.

Fingolimod, marketed as Gilenya by Novartis, is an immunomodulatory drug able to reduce the rate of relapse in RRMS patients. The drug modulates the sphingosine-1-phosphate receptor, sequestering lymphocytes (important white blood cells) in the lymph nodes, preventing them from participating and contributing to autoimmune reactions.

A recent, large meta-analysis focused on patients who are non-responsive to fingolimod therapy showed that only a small subgroup of patients failed to obtain substantial clinical benefit from the drug.

In the study, the team analyzed data from three previously published phase 3 clinical trials (FREEDOMS, FREEDOMS II and TRANSFORMS) that assessed the use of fingolimod therapy in RRMS patients compared to interferon beta-1a (IFN beta-1a) or a placebo. The team found that fingolimod 0.5 mg offered consistent clinical benefits to RRMS patients in comparison to placebo or IFN beta-1a, irrespective of when the patient had the first symptom of the disease or the number of years of previous treatment.

The team reported that overall, fingolimod was able to significantly reduce the annualized relapse rate in patients with zero, less than three, and more than three years of therapy in comparison to placebo and IFN beta-1a. The only exception found was in a small subgroup of patients given IFN beta-1a treatment who had been previously treated for one year or less.

“We weren’t able to find any larger subgroup of patients who didn’t respond well,” said in a news release Dr. Daniel Ontaneda, assistant professor of medicine and neurology at the Cleveland Clinic, who presented the data. “One might have had an intuition that patients over age 40, say, weren’t going to respond. But the clinical take-away is that the medication works equally well for almost everyone.”

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The efficacy of fingolimod represents good news for the MS patient population; however, neurologists still have the difficult task of determining which of the currently available MS medications should be prescribed to a particular patient.

“We now have 12 available medications for MS,” noted Dr. Ontaneda. “For clinicians, the decision on which medication to prescribe is becoming ever more complex. We need to figure out if there are advantages for one type of patient versus another. Trying to identify responders and non-responders is something we need to continue to pursue.”

According to Dr. Timothy L. Vollmer from the University of Colorado School of Medicine, who was not involved in the study, the finding that fingolimod is effective up to three years after the initiation of the treatment goes against the position taken by a report from the Agency for Health Care Research and Quality (AHRQ). “The AHRQ consensus document said there is no evidence of drug benefit beyond two years,” said Dr. Vollmer. “This study will push back against some of those insurer groups and the AHRQ. It’s consistent with what we’ve all been saying, that we don’t see any loss of efficacy in patients kept on fingolimod for a long time.”

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