Approval of fingolimod in 2011 heralded the era of oral therapies for multiple sclerosis (MS) in the European Union. Uptake of fingolimod across Europe was widespread, even though its indication was predominantly second-line; that is, for patients with a lack of response to interferon beta or those with highly active relapsing-remitting MS (RRMS). Safety concerns raised with the European Medicines Agency culminated in the revision of the European Union labeling for first-dose management in 2012. However, in addition to evidence from the pivotal clinical trials, cumulating real-world fingolimod experience in Europe provides reassurance on its safety and efficacy. Studies show that switching to fingolimod from approved first-line injectable therapies is beneficial for patients who might otherwise switch to another interferon beta or glatiramer acetate. Furthermore, in several recent European studies of patients who switched to fingolimod from natalizumab, disease control was improved compared with drug withdrawal and no immunomodulatory treatment, or withdrawal and first-line treatment, including the Disease Control and Safety in Patients with RRMS Switching from Natalizumab TO FINGOlimod (TOFINGO) study, which supported a shorter washout period before switching. The safety profile shown in clinical trials is supported by post-marketing observations; any first-dose effects on heart rate are managed easily, and severe complications as a result of herpes viral infections are rare. The use of newer oral drugs remains a key topic of discussion, in light of the recognized importance of an early shift of suboptimal responders to another therapy. The information on fingolimod summarized in the present review may contribute to define its role further in RRMS treatment in Europe.
- multiple sclerosis
ASJC Scopus subject areas
- Clinical Neurology
- Immunology and Microbiology (miscellaneous)
- Neuroscience (miscellaneous)