Abstract

<h3>Objective:</h3> The aim of the PANGAEA 2.0 study was to investigate the efficacy and long-term benefits (3 years) of fingolimod in relapsing-remitting multiple sclerosis (RRMS) patients with disease activity switching from other disease-modifying therapies (DMTs). <h3>Background:</h3> In the treatment of RRMS, individualized sequential therapies can be used to optimize the outcome. It is, however, necessary to understand the efficacy and overall impact of sequential switching. <h3>Design/Methods:</h3> The non-interventional, real-world evidence study included 2,579 disease-active RRMS-patients treated with fingolimod at 240 neurological practices and clinics in Germany out of which 966 completed the study. The patients, who were either untreated or treated with an approved DMT other than fingolimod before study start, were observed for 3 years. To obtain insight into the effectiveness of changing to fingolimod, subgroup analyses were based on the patients’ last therapy before switching: oral DMT (oDMT; dimethyl fumarate, teriflunomide), injectable DMT (iDMT; interferons, glatiramer acetate), natalizumab, other DMTs and treatment-naive. <h3>Results:</h3> At baseline, the patient population was mostly female (71.1%) and patients were on average 39.2 (±10.8) years old. The majority of patients had received only 1 treatment prior to study start. In total, 1,138 patients had received an iDMT as last therapy before receiving fingolimod. On average, patients presented with an EDSS of 2.4±1.5 at study start. Over 3 years, the mean EDSS total score remained on a relatively stable level in the subgroups iDMT (EDSS: 2.4±1.6) and oDMT (EDSS: 2.6±1.5). The EDSS increased slightly in the group who was previously on natalizumab treatment (EDSS: 3.3±1.6) along with a slight increase in FSMC. The mean SDMT remained on a stable level in all subgroups. <h3>Conclusions:</h3> PANGAEA 2.0 brings us real-world insights into the effectiveness of fingolimod in disease-active RRMS-patients. The results show that the disease burden remained relatively stable during 3 years on fingolimod, regardless of the previous therapy. <b>Disclosure:</b> Dr. Weiss has received personal compensation for serving as an employee of Novartis Pharma GmbH. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. 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 $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS Celgene. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 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 $5,000-$9,999 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 $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for BMS Celgene. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. The institution of Dr. Ziemssen has received research support from Biogen. 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 Celgene.

Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call