Ludwig Kappos1, Jeffrey Cohen2, William Collins3, Ana de Vera3, Lixin Zhang-Auberson3, Shannon Ritter4, Philipp von Rosenstiel3, Gordon Francis4. 1. Neurology, Department of Medicine, Clinical Research and Biomedicine, University Hospital, Petersgraben 4, CH-4031 Basel, Switzerland. Electronic address: ludwig.kappos@usb.ch. 2. Neurological Institute, The Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. 3. Novartis Pharma AG, CH-4056 Basel, Switzerland. 4. Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07849-1080, USA.
Abstract
BACKGROUND:Fingolimod 0.5mg once daily is the first approved oral therapy for relapsing multiple sclerosis (MS). OBJECTIVE: To report integrated long-term safety data from phase 2/3 fingolimod studies. METHODS: Descriptive safety data are reported from the FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) study, a 24-month, randomized, double-blind study comparing fingolimod 0.5mg and 1.25mg with placebo, and an All Studies group (patients who received fingolimod 0.5mg (n=1640) or 1.25-0.5mg (n=1776) in phase 2/3 studies and associated extensions). Relevant post-marketing experience, up to December 2011, is included. RESULTS: The incidence of adverse events (AEs) and serious AEs (SAEs) was similar with fingolimod and placebo in FREEDOMS. In the All Studies group, fingolimod 0.5mg was associated with transient, rarely symptomatic (0.5%), bradycardia and second-degree atrioventricular block on treatment initiation, minor blood pressure increases, frequent (9%) but generally asymptomatic liver enzyme elevations, and macular oedema (0.4%). The incidences of infections (including serious and herpes infections), malignancies, SAEs and treatment discontinuations due to AEs were similar with fingolimod 0.5mg and placebo. CONCLUSION: The safety profile of fingolimod has been well characterized in this large combined trial population. Although infrequent SAEs can occur, there is no increased risk of infections, malignancies or serious cardiovascular events versus placebo.
RCT Entities:
BACKGROUND:Fingolimod 0.5mg once daily is the first approved oral therapy for relapsing multiple sclerosis (MS). OBJECTIVE: To report integrated long-term safety data from phase 2/3 fingolimod studies. METHODS: Descriptive safety data are reported from the FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) study, a 24-month, randomized, double-blind study comparing fingolimod 0.5mg and 1.25mg with placebo, and an All Studies group (patients who received fingolimod 0.5mg (n=1640) or 1.25-0.5mg (n=1776) in phase 2/3 studies and associated extensions). Relevant post-marketing experience, up to December 2011, is included. RESULTS: The incidence of adverse events (AEs) and serious AEs (SAEs) was similar with fingolimod and placebo in FREEDOMS. In the All Studies group, fingolimod 0.5mg was associated with transient, rarely symptomatic (0.5%), bradycardia and second-degree atrioventricular block on treatment initiation, minor blood pressure increases, frequent (9%) but generally asymptomatic liver enzyme elevations, and macular oedema (0.4%). The incidences of infections (including serious and herpes infections), malignancies, SAEs and treatment discontinuations due to AEs were similar with fingolimod 0.5mg and placebo. CONCLUSION: The safety profile of fingolimod has been well characterized in this large combined trial population. Although infrequent SAEs can occur, there is no increased risk of infections, malignancies or serious cardiovascular events versus placebo.
Authors: L Klotz; A Berthele; W Brück; A Chan; P Flachenecker; R Gold; A Haghikia; K Hellwig; B Hemmer; R Hohlfeld; T Korn; T Kümpfel; M Lang; V Limmroth; R A Linker; U Meier; S G Meuth; F Paul; A Salmen; M Stangel; B Tackenberg; H Tumani; C Warnke; M S Weber; T Ziemssen; F Zipp; H Wiendl Journal: Nervenarzt Date: 2016-06 Impact factor: 1.214
Authors: Moritz Förster; Patrick Küry; Orhan Aktas; Clemens Warnke; Joachim Havla; Reinhard Hohlfeld; Jan Mares; Hans-Peter Hartung; David Kremer Journal: Drug Saf Date: 2019-05 Impact factor: 5.606
Authors: Xavier Montalban; Giancarlo Comi; Jack Antel; Paul O'Connor; Ana de Vera; Malika Cremer; Nikolaos Sfikas; Philipp von Rosenstiel; Ludwig Kappos Journal: J Neurol Date: 2015-09-04 Impact factor: 4.849