Long-term real-world effectiveness and safety of fingolimod over 5 years in Germany.

ABSTRACT:

Objective

To evaluate the 5-year real-world benefit-risk profile of fingolimod in patients with relapsing-remitting MS (RRMS) in Germany.

Methods

Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) is a non-interventional real-world study to prospectively assess the effectiveness and safety of fingolimod in routine clinical practice in Germany. The follow-up period comprised 5 years. Patients were included if they had been diagnosed with RRMS and had been prescribed fingolimod as part of clinical routine. There were no exclusion criteria except the contraindications for fingolimod as defined in the European label. The effectiveness and safety analysis set comprised 4032 and 4067 RRMS patients, respectively.

Results

At the time of the 5-year

SUBMITTER: Ziemssen T 

PROVIDER: S-EPMC9120082 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature