Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
John Cavenagh, PhD, PA-C
OBJECTIVE: The objective of this systematic review is to determine whether or not is 1.25 mg oral fingolimod effective in reducing relapses in adults with relapsing multiple sclerosis.
STUDY DESIGN: Review of three English language primary studies published between 2006 and 2010.
DATA SOURCES: Randomized, double-blind, controlled clinical trials comparing daily 1.25 mg oral fingolimod to either identical placebo capsules or weekly intramuscular interferon beta-1a therapy were found using Pubmed and Cochrane Databases.
OUTCOMES MEASURED: Annualized relapse rate was assessed in all studies. Relapses were confirmed by neurologists and assessed using the Expanded Disability Status Scale (EDSS) to evaluate worsening symptoms. EDSS ranges from 0 (no disability) to 10 (death from multiple sclerosis). Adverse events were reported at every encounter between patients and treating physicians in Kappos et al. 2006. Independent data and safety monitoring boards were used to evaluate safety in Cohen et al. and Kappos et al. 2010, in these studies safety assessments were performed at set intervals throughout the studies.
RESULTS: Both Kappos et al. studies showed that 1.25 mg oral fingolimod was effective in reducing relapses in patients with relapsing multiple sclerosis compared to placebo. Cohen et al. demonstrated that 1.25 mg fingolimod was more effective in reducing relapses than the accepted therapy of interferon beta-1a injections. Adverse events were noted across all three studies. Patients in the 1.25 mg fingolimod groups were more likely to discontinue study due to serious adverse events compared to control groups. The most common serious adverse effects were bradycardia and atrioventricular block.
CONCLUSIONS: All studies showed that 1.25 mg oral fingolimod daily was effective in reducing relapses in patients with relapsing multiple sclerosis. Further studies are needed to assess the efficacy of fingolimod for other types of multiple sclerosis and to evaluate its effectiveness at various stages of disease progression. Adverse events have been associated with the use of fingolimod. Some of the noted effects are believed to be dose dependent.
Cook, Caitlin M., "Is 1.25 mg Oral Fingolimod Effective in Reducing Relapses in Adults with Relapsing Multiple Sclerosis?" (2012). PCOM Physician Assistant Studies Student Scholarship. 75.