RRMS: Long-term fingolimod shows positive benefit-risk profile in real-life settings

Key clinical point: This real-world analysis of patients with relapsing-remitting multiple sclerosis (RRMS) showed a favorable benefit-risk profile for up to 5 years of fingolimod treatment, with a sustained efficacy and manageable safety profile.

Major finding:  Overall, 69.6% of the patients remained relapse free after 5 years of treatment with fingolimod, with the annualized relapse rate reducing significantly from 0.804 at baseline to 0.185, 0.149, 0.122, 0.091, and 0.097 (P < .001) after 1, 2, 3, 4, and 5 years of fingolimod treatment, respectively. Overall, 65.5% and 12.5% of the patients reported any adverse and serious adverse events, respectively.

Study details: This was a 5-year prospective, cross-sectional, observational study including 570 patients with RRMS who were on fingolimod treatment for at least 1 year.

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Disclosures: This study was supported by Novartis Pharma AG, Basel, Switzerland. The authors declared no conflicts of interests.

Source: Biernacki T et al. The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary. PLoS One. 2022;17(4): e0267346 (Apr 22). Doi: 10.1371/journal.pone.0267346