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PubMed Clinical Q&A [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2008-2013.

PubMed Clinical Q&A [Internet].

Comparing Fingolimod with other MS Drugs

Laura Dean, MD.

Created: November 30, 2011.

Multiple sclerosis (MS) is an autoimmune disease of the central nervous system. MS affects the myelin coating of nerves, interrupting nerve conduction and leaving lesions that can be seen on brain scans.

Symptoms of MS can be unpredictable, and include changes in sensation, muscle weakness, and problems with balance and coordination. Symptoms may gradually develop and worsen over time, or more commonly, occur in acute attacks (relapses) followed by symptom-free periods (remissions). About 85% of patients have the relapsing-remitting form of MS (RRMS), and most cases eventually develop into a secondary progressive form (SPMS).

The management of MS includes treating symptoms (e.g., muscle relaxants for muscle spasms) and acute flare-ups (e.g., high dose steroids for sudden loss of vision). Disease-modifying drugs are used to slow the progression of MS by modifying the immune response and include the β interferons, glatiramer acetate, mitoxantrone and natalizumab. These drugs are injected or given intravenously.

A new oral drug, fingolimod, was recently approved for patients with relapsing forms of MS. It is thought to reduce lymphocyte migration into the central nervous system by redistributing them to lymph nodes.

The "Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Single Drug Addendum: Fingolimod" compares the safety and effectiveness of fingolimod with other disease-modifying drugs used in the treatment of MS. A summary of the findings is below.

How does fingolimod compare in multiple sclerosis?

In patients with relapsing-remitting multiple sclerosis, fingolimod 0.5 mg and 1.25 mg once daily is superior to interferon beta-1a in improving relapse-related outcomes, including annualized relapse rates and proportion without relapse, over a 1 year period. The progression of disability was not different between the treatments at 12 months but longer-term trials are needed. [full review]

How does fingolimod compare in safety?

The typical symptoms from taking interferons such as fever, myalgia, and flu-like illnesses are more common in patients taking interferon beta-1a compared to 0.5 mg fingolimod. However, elevated liver enzymes are more common with fingolimod.

The FDA recommended dose for fingolimod is 0.5 mg orally, once daily. The higher dose of 1.25mg results in higher numbers and more severe adverse events, including herpes zoster infections and symptomatic bradycardia after the first dose, as well as more patients discontinuing treatment. Patients taking their first dose of fingolimod (at either dose) should do so in clinic with monitoring because of the risk of bradycardia and atrioventricular blockade.

While the absolute rate of adverse events for fingolimod is low, there are ongoing concerns with safety, including the risk of macular edema, the effect of lung function, cancers, and serious viral infections. Further studies are underway to better determine the risks. [full review]

How do patient factors affect the safety and effectiveness of fingolimod?

Limited evidence suggests that there is no difference in the efficacy of fingolimod based on age, gender, or baseline disability score when compared to either placebo or interferon beta-1a. [full review]

Drugs included in this review

Generic NameTrade Names
FingolimodGilenya
Glatiramer AcetateCopaxone
Interferon beta-1aAvonex
Avonex PS
Interferon beta-1aRebif
Interferon beta-1bBetaseron
Interferon beta-1bExtavia
MitoxantroneNovantrone
NatalizumabTysabri

Further Information

Image th-derp.jpgThis PubMed Clinical Q&A was reviewed by Marian McDonagh, PharmD.

For the full report and evidence tables, please see:
McDonagh MS. Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Single Drug Addendum: Fingolimod [Internet]. Portland (OR): Oregon Health & Science University; 2011 Feb. Available at http://www.ncbi.nlm.nih.gov/books/n/ms11/.

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