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Evidence summaries

Fingolimod for Relapsing-Remitting Multiple Sclerosis

Fingolimod reduces inflammatory activity in relapsing multiple sclerosis over 2 years vs. placebo, but it may lead to little difference in preventing disability worsening. The risk of adverse events requires careful monitoring over time. The evidence on the risk/benefit profile of fingolimod vs. i.m. interferon beta-1a is uncertain. Level of evidence: "A"

Summary

A Cochrane review [Abstract] 1 included 6 studies with a total of 5152 participants with multiple sclerosis. The controls were treated either with placebo (n=923) or with other DMDs (n=698). The treatment duration was 6 months in 3, 12 months in one, and 24 months in 2 trials.

  • Fingolimod 0.5 mg vs. placebo:At 24 months fingolimod increased the probability of being relapse-free (RR 1.44, 95% CI 1.28 to 1.63; 2 studies, n= 1556), but it might lead to little or no difference in preventing disability progression (RR 1.07, 95% CI 1.02 to 1.11; 2 studies, n= 1556). Benefit was observed for other measures of inflammatory disease activity including clinical (annualised relapse rate: RR 0.50, 95% CI 0.40 to 0.62) and MRI activity (Gd-enhancing lesions: RR of being free from Gd-enhancing lesions: 1.36, 95% CI 1.27 to 1.45).The mean change of MRI T2-weighted lesion load favoured fingolimod at 12 and 24 months.No significant increased risk of discontinuation due to adverse events or serious adverse events was observed for fingolimod compared to placebo at 6 and 24 months.
  • Fingolimod 0.5 mg vs. i.m. interferon beta-1a: At one year fingolimod slightly increased the number of participants free from relapse (RR 1.18, 95% CI 1.09 to 1.27; one study, n=860) or from Gd-enhancing lesions (RR 1.12, 95% CI 1.05 to 1.19; one study, n=728), and decreased the relapse rate (rate ratio 0.48, 95% CI 0.34 to 0.70; one study, n=860). There was no advantage for preventing disability progression (RR 1.02, 95% CI 0.99 to 1.06) or significant difference for MRI T2-weighted lesion load change.There was a greater likelihood of participants discontinuing fingolimod, as compared to other DMDs, due to adverse events in the short-term (6 months) (RR 3.21, 95% CI 1.16 to 8.86), but there was no significant difference vs. interferon beta-1a at 12 months (RR 1.51, 95% CI 0.81 to 2.80). A higher incidence of adverse events was suggestive of the lower tolerability rate of fingolimod compared to interferon-beta 1a.

Clinical comments

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    References

    • La Mantia L, Tramacere I, Firwana B et al. Fingolimod for relapsing-remitting multiple sclerosis. Cochrane Database Syst Rev 2016;4():CD009371. [PubMed]

Primary/Secondary Keywords