Abstract Details

Title Radiological Evidence for the Long-Term Effect of Fingolimod Treatment in Patients with Relapsing-Remitting Multiple Sclerosis

Topic

Presentation(s) P4 - (-)

Poster/Presentation
Number 409

Background Efficacy of fingolimod as assessed by clinical and radiological disease activity measures has been well-established in Phase 2 and 3 trials as well as its generally good tolerability in patients with RRMS. Over 180,000 patients have been treated with Gilenya^® (fingolimod), with more than 395,000 patient-years of total exposure in clinical trials and post-marketing setting worldwide. Assessment of the long-term effect of disease modifying therapies is important for managing MS in clinical practice.

Objective

Design/Methods LONGTERMS is an open-label, single-arm, extension study evaluating the long-term efficacy, safety, and tolerability of fingolimod in patients who previously participated in phase 2/3/3b fingolimod trials. The fingolimod full analysis set included all patients randomized to the approved dose of fingolimod 0.5 mg. The selected MRI endpoints were annualized rate of new or newly enlarging T2 lesions (ARneT2) and the proportion of patients free from gadolinium-enhancing (Gd+) T1 lesions until the end of the study as evaluated by Kaplan-Meier analysis. ARneT2 was evaluated through Month 96.

Results Overall, 3167 patients were included (women, 71.2%; age [mean±SD], 38.0±9.1 years). Median exposure to fingolimod was 526 days (range, 75-3619). At baseline, mean (±SD) duration of MS since diagnosis was 6.2±5.6 years and mean (±SD) Expanded Disability Status Scale was 2.4±1.5. In the full analysis set (N=3127), ARneT2 gradually decreased from 1.362 at Month 12 to 1.011 at Year 3, 0.915 at Year 5, and 0.801 at Year 8, suggesting continued radiological stability. Of the 924 evaluable patients, 48.3% (SE: 14.2) remained free from Gd+ T1 lesions throughout the study.

Conclusions Radiological evidence suggests a continuous long-term effect of fingolimod on disease activity in patients with RRMS.

Authors/Disclosures
Jeffrey A. Cohen, MD (Cleveland Clinic)	Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FiND. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for INMune. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sage.
Nadia Tenenbaum, MD (EMD Serono Research & Development Institute)	Dr. Tenenbaum has received personal compensation for serving as an employee of EMS Serono. Dr. Tenenbaum has stock in EMS Serono.
	No disclosure on file
	No disclosure on file
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	The institution of Dr. Kappos has received research support from Bayer. The institution of Dr. Kappos has received research support from Biogen. The institution of Dr. Kappos has received research support from Genentech. The institution of Dr. Kappos has received research support from Genzyme. The institution of Dr. Kappos has received research support from Janssen. The institution of Dr. Kappos has received research support from Merck Serono. The institution of Dr. Kappos has received research support from Minoryx. The institution of Dr. Kappos has received research support from Novartis. The institution of Dr. Kappos has received research support from Roche. The institution of Dr. Kappos has received research support from Sanofi. The institution of Dr. Kappos has received research support from Santhera. The institution of Dr. Kappos has received research support from Swiss MS Society, Swiss National Research Foundation, European Union, Roche Research Foundation, Innosuisse. The institution of Dr. Kappos has received research support from Shionogi. The institution of Dr. Kappos has received research support from Japan Tobacco. The institution of Dr. Kappos has received research support from Auriga Vision AG. The institution of Dr. Kappos has received research support from EMD Serono. The institution of Dr. Kappos has received research support from Glaxo Smith Kline. The institution of Dr. Kappos has received research support from Wellmera AG. The institution of Dr. Kappos has received research support from Eli Lilly (Suisse) SA. The institution of Dr. Kappos has received research support from Bristol Myers Squibb. The institution of Dr. Kappos has received research support from Celltrion Inc. Dr. Kappos has received intellectual property interests from a discovery or technology relating to health care.