The population with
multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of
therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfety study of
GilEnyA (PANGAEA) to assess prospectively baseline characteristics and outcomes after 12 months (± 90 days) of
fingolimod treatment. Patients were divided into 2 cohorts:
fingolimod starter [first received
fingolimod in PANGAEA (n = 3315)] and previous study [received
fingolimod before enrollment in PANGAEA in RCTs (n = 875), some of whom also had baseline data at entry into RCTs (n = 505)]. At PANGAEA baseline, patients in the
fingolimod starter versus the previous study cohort had a higher annualized relapse rate [ARR (95% confidence interval): 1.79 (1.75-1.83) vs 1.32 (1.25-1.40)] and Expanded Disability Status Scale score [3.11 (3.04-3.17) vs 2.55 (2.44-2.66)]. A greater proportion in the
fingolimod starter versus previous study cohort had diabetes (2.0% vs 0.7%). After 12 months of
fingolimod, ARRs were lower than in the 12 months before PANGAEA enrollment in the
fingolimod starter [0.386 (0.360-0.414)] and previous study [0.276 (0.238-0.320)] cohorts. Expanded Disability Status Scale scores were stable versus baseline. Adverse events were experienced by similar proportions in both cohorts during
fingolimod treatment. Relevant differences exist in disease activity and comorbidities between patients receiving
fingolimod in clinical practice versus RCTs. Irrespective of baseline differences indicating a higher proportion at an advanced stage of
multiple sclerosis in the real world versus RCTs,
fingolimod remains effective, with a manageable safety profile.