Fingolimod Beats Avonex in Relapsing-Remitting MS

Fingolimod, a novel oral agent from Novartis, outperformed the standard treatment of IM interferon beta-1a (Avonex; Biogen Idec) in patients with moderately severe, but stable, relapsing-remitting multiple sclerosis (RRMS), according to phase 3 data (N = 1292) presented last week at the annual meeting of the American Academy of Neurology in Seattle. Specifically the annualized relapse rate (the primary endpoint) and the percentage of relapse-free patients at 1 year were significantly better with fingolimod at a dosage of 0.5 mg per day.

The mean number of new, gadolinium-enhancing lesions on T1-weighted MR images was also significantly lower with fingolimod. A higher dosage of the novel agent was no more efficacious than the lower dosage and was associated with an increased frequency of adverse effects.

Adverse events seen more frequently with fingolimod at either dosage included malignancies (12 vs 2 with interferon), fatal herpes infections (2 vs none with interferon), and bradycardia or AV block (20 vs none with interferon). Nevertheless, fingolimod was reported to be well tolerated; 87% of fingolimod-treated patients completed the study.

Fingolimod, a sphingosine-1-phospate receptor modulator, reduces circulating lymphocyte counts by trapping them within lymph nodes. The agent may also have direct deactivating effects on CNS cells.

Other novel, oral agents in development for MS include fumerate (Fumaderm or BG-12; Biogen Idec), laquinimod (Teva), and teriflunomide (sanofi-aventis). Merck KGaA and its Merck Serono division plan to submit phase 3 data to the FDA sometime this year for the fast-track approval of oral cladribine in patients with RRMS. Favorable, 2-year, placebo-controlled, phase 3 data for oral cladribine in RRMS were also presented last week at the AAN annual meeting.

AV = atrioventricular; EDSS = Extended Disability Status Scale; NS = not significant.

Primary sources: AAN, MedNewsToday.