PANGAEA is a non-interventional study, conducted in Germany, to investigate long-term safety, effectiveness and patient reported outcomes in daily clinical practice.

Once-daily fingolimod (Gilenya®) is a sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing MS. As of July 2018, more than 255,000 patients have been treated with fingolimod; total patient exposure exceeds 566,000 patient-years.

The proportion of female patients was 71.9 % and the mean age was 39.1 (±10.0 SD) years. The mean annual relapse rate of PANGAEA patients improved from 1.5 ± 0.04 (95%CI; baseline) to 0.26 ± 0.02 in the third year of treatment and remained stable over the following two years. The mean baseline EDSS in PANGAEA was 3.0 (±1.7 SD)) and remained stable over 5 years. In each year of treatment, approx. 90% of tpatients had a stable EDSS or experienced a 6 months confirmed improvement. In each year of treatment between 68.6% (year 1) and 81.0% (year 4) of patients were free of relapses and 6 months confirmed disability progression. 43.6% of patients neither had a relapse nor a 6 months confirmed disability progression over 4 years of treatment. The safety profile of fingolimod in real life is comparable to that observed in phase III clinical trials. An updated analysis will be presented focusing on effectiveness and safety over 5 years of treatment with fingolimod. 

The results of the 5 year analysis of PANGAEA support the positive effectiveness and benefit-risk profile of fingolimod demonstrated in phase III clinical trials with real world evidence data.