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Abstract Details

Effectiveness and Safety of Fingolimod in Patients Switching from Dimethy Fumarate, Teriflunomide, and Daclizumab in Daily Clinical Routine: Interim Results from PANGAEA 2.0
Multiple Sclerosis
P3 - Poster Session 3 (5:30 PM-6:30 PM)
15-075

To assess the effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) switching from other oral disease-modifying treatments (oDMTs: dimethyl fumarate [DMF], teriflunomid [TEF]) and daclizumab (DAC).

Fingolimod, a first oral DMT for the treatment of relapsing forms of MS was approved in 2011. Since then, treatment options in MS have changed due to approval of other oDMTs or safety concerns of recently approved drugs.

PANGAEA 2.0 is an ongoing real-world study conducted in Germany assessing the effectiveness, safety, and patient-reported outcomes (PROs) data in RRMS patients switching from other DMTs to fingolimod due to clinical or subclinical disease activity. As of August 2018, PANGAEA 2.0 included approximately 2100 patients, of whom 24.9% of patients switched from oDMTs (n=316 DMF; n=180 TEF) and 2.9% from DAC (n=46) to fingolimod.

Baseline characteristics of all patients were comparable between oDMTs and DAC groups including the mean (±standard deviation [SD]) number of relapses 12 months before baseline (oDMTs: 1.3±0.9 vs DAC: 1.29±1.47; total: 1.25±0.94) and EDSS scores (oDMT: 2.3±1.7 vs DAC: 2.2±1.4; total: 2.1±1.6).

The mean treatment period with oDMTs before switch was 1.5 years (1.47 for DMF; 1.58 for TEF) and approximately 9 months for DAC. After 24 months, the mean annualized relapse rate (ARR±95%CI) reduction from baseline was 73.5% (1.31±0.10 to 0.35±0.05) in oDMT group; 72.5% reduction (1.31±0.12 to 0.36±0.06) in patients previously treated with DMF. An updated analysis will be presented focusing on effectiveness, PROs and safety of fingolimod in these subgroups including stratification according to the number and frequency of pretreatments.

Fingolimod showed benefit within 12 months of treatment and sustained effectiveness over 24 months in patients who switched from dimethyl fumarate, teriflunomid an daclizumab. Fingolimod is a safe and effective DMT for patients switching from other therapies.

Authors/Disclosures
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden) Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS . Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Dresden Internation University. The institution of Dr. Ziemssen has received research support from Novartis. The institution of Dr. Ziemssen has received research support from Merck. The institution of Dr. Ziemssen has received research support from Sanofi. The institution of Dr. Ziemssen has received research support from BMS. The institution of Dr. Ziemssen has received research support from Roche.
Ulf Schulze Topphoff (Novartis Pharma) Ulf Schulze Topphoff has received personal compensation for serving as an employee of Novartis Pharma GmbH.