The New England Journal of Medicine (NEJM) recently published 2 studies on some promising new treatment for relapsing/remitting multiple sclerosis (R/R MS). Both medications reduce the number of lymphocytes which play a role in the immune-mediated disease.

The first study, dubbed Clarity, involved 1326 patients and took place over 96 weeks. Cladribine tablets were administered for 8 to 20 days per year, given in 2 or 4 short courses during the first 48 wks, then in 2 short courses starting at week 48 and week 52. The drug was administered in short courses with long gaps between to allow blood cells to recover.  

The study results showed significant benefit for patients with R/R MS using 3 measurements of disease progression:

1. rate of relapse
2. disability progresssion
3. MRI measure of disease activity (reduction in brain lesion counts)

The number of patients who remained free of relapse was  79.7% and 78.9% in both doses of cladribine administered compared to placebo (60.9%).

Adverse side effects  included lymphocytopenia (decreased lymphocyte counts) and herpes zoster.

The second study (called Freedoms) involved 1272 patients using fingolimod, an oral medication given daily. Fingolimod acts by prohibiting the exit of lymphocytes from the lymph nodes which reduces the chances of aggressive lymphocytes from entering the central nervous system where their inflammatory response is thought to play a role in causing MS. In addition, fingolimod is thought to provide protective and possibly reparative benefits to neurons in the brain.

The study’s success was measured using the same 3 critera used in the Clarity trials: relapse rates, MRI measurements of disease activity and disability progression.

Reductions in relapse rates were 54% and 60% in the respective 0.5 mg and 1.25 mg fingolimod dose. Similar positive results were seen in the time to disability progression and in the MRI results.

Adverse side effects included infections, cardiac related events (bradycardia – heart rate lower than 60 beats/minute, as well as electrical conduction blocks),  macular degeneration, abnormal liver function tests, which resolved once the drug was discontinued.

For more information about MS follow this link to the National Institute of Neurological Disorders.

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