Seeing the Potential in Oral Fingolimod

Dr. Kantor Health Guide
  • As most of you know (since MS patients are the most educated in the world), there are a few big MS research meetings throughout the year (e.g. ECTRIMS, AAN and ENS).

    There has, however, been some recent data which has been released and which is very exciting to the MS community.

    The results of the international Phase III study of oral Fingolimod (FTY720) vs. intramuscular Avonex (interferon beta-1a) demonstrated a 52% reduction in annualized relapse rate in the Fingolimod arm vs. the Avonex arm.

    The annualized relapse rate (ARR) in the Fingolimod arm was 0.16 vs. the Avonex arm, which was 0.33. Although we are all cautioned against comparing among studies, the Avonex results make sense given recent trials, such as BEYOND and REGARD. This also suggests that we can trust the Fingolimod data and this is exciting since this was a study which was not placebo-controlled but instead compared an oral medication to a standard established injectable medication.

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    Of course, we are still waiting for the results of the international and the Maerican 2 year placebo-controlled Phase III trials, but if they show similar results in that Fingolimod is effective in the treatment of RRMS then we will probably see Fingolimod as the second oral disease modifying drug (DMD) for the treatment of RRMS in a few years.

    It is possible and likely, however, that Fingolimod will demonstrate superiority over placebo, but that the placebo arm of the study will do better than expected. This will be concerning because we won’t know what that means for most RRMS patients. The reason that this is possible is because, at least in America, neurologists and patients would be less likely to enroll in a placebo-controlled study if their MS is worse. This means that the study probably enrolled milder patients and that the placebo arm will do better than expected.

    As an aside, RRMS with milder or earlier MS should be encouraged, perhaps even more than advanced MS patients to start aggressive MS treatment based on the results of the clinically isolated (CIS) trials CHAMPS, ETOMS, BENEFIT and PreCISe. This is true because, unfortunately, we have less reason to think that potent anti-inflammatory disease modifying drugs work well in the treatment of advanced MS.

    This is, however, another exciting aspect of Fingolimod -- that it may potentially work in the treatment of PPMS (and by extension, SPMS as well). There is animal data to suggest that Fingolimod doesn't only keep whole blood cells trapped in the lymph nodes, but that it actually enters and has an effect within the Central Nervous System (CNS) itself. Because of this there will be a clinical trial of patients with PPMS. We all hope that finally there will be some hope.

    We should be careful, however, not to think that all RRMS patients will be switched to Fingolimod (or other oral medicines) since there is and will be serious safety concerns with these newer medicines. The older injectable medicines may be annoying, but no one has ever gotten cancer or died from them.

  • We may all be hopeful and optimistic, but we should also be realistic and patient.

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Published On: March 05, 2009