Two studies in one: A propensity-score-matched comparison of fingolimod versus interferons and glatiramer acetate using real-world data from the independent German studies, PANGAEA and PEARL

• Published in: PloS one Vol. 12; no. 5; p. e0173353
• Main Authors: Alsop, Jonathan, Medin, Jennie, Cornelissen, Christian, Vormfelde, Stefan Viktor, Ziemssen, Tjalf
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 05.05.2017; Public Library of Science (PLoS)
• Subjects: Accessories; Adolescent; Adult; Aged; Aged, 80 and over; Analysis; Atrophy; Barometers; Biology and Life Sciences; Brain; Brain research; Central nervous system; Chin; Clinical trials; Cognitive ability; Cohort Studies; Comparative analysis; Confidence intervals; Copolymer 1; Disease Progression; Documentation; Dosage and administration; Drug therapy; Economics; Effectiveness; Epidemiology; Female; Fingolimod; Fingolimod Hydrochloride - therapeutic use; FTY720; Germany; Glatiramer acetate; Glatiramer Acetate - therapeutic use; Health; Health care; Humans; Interferon; Interferons - therapeutic use; Jaw; Lesions; Leukoencephalopathy; Magnetic resonance imaging; Male; Marketing; Medicine and Health Sciences; Middle Aged; Multiple sclerosis; Multiple Sclerosis - drug therapy; Multiple Sclerosis - pathology; Nervous system; Neuroimaging; Neurology; NMR; Nuclear magnetic resonance; Observational studies; Older people; People and Places; Pharmaceutical industry; Pharmacoeconomics; Pharmacology; Physical training; Progressive multifocal leukoencephalopathy; Quality of life; Receiving; Recovery; Remission; Research and Analysis Methods; Resonance; Risk assessment; Safety; Social Sciences; Studies; Switching; Therapy; Treatment outcome; Young Adult; β-Interferon
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0173353

This study compared outcomes following fingolimod or BRACE treatments (beta-interferons/glatiramer acetate) in patients with active MS (≥ 1 relapse in the previous year) following previous BRACE treatment. Patients with active MS who previously received BRACE were identified from German prospective, observational studies, PANGAEA and PEARL. A novel methodology was developed to compare outcomes between propensity-score-matched cohorts (3:1 ratio) from the independent single-arm studies. Patients in PANGAEA (n = 1287) experienced 48% fewer relapses per year than those in PEARL (n = 429; annualized relapse rate ratio: 0.52; p < 0.001). The risk of 3-month or 6-month confirmed disability progression (CDP) was reduced in PANGAEA versus PEARL (3-month: 37% reduction; hazard ratio [HR], 0.63; p < 0.001; 6-month: 47% reduction; HR, 0.53; p < 0.001). A higher proportion of patients in PANGAEA (n = 1234) than PEARL (n = 401) were free from relapses and 3-month (65.7% vs 38.7%; p < 0.001) or 6-month (68.2% vs 39.2%; p < 0.001) CDP. The probability of confirmed disability improvement was higher in PANGAEA (n = 1163) than PEARL (n = 372; 3-month: 175% increase; HR, 2.75; p < 0.001; 6-month: 126% increase; HR, 2.26; p < 0.001). Patients in PANGAEA (n = 149) were less likely than those in PEARL (n = 307) to have taken sick leave (proportion with 0 days off work: 62.4% vs 44.6%; p = 0.0005). For change in disease severity from baseline (assessed by clinicians using the Clinical Global Impressions scale; PANGAEA, n = 1207; PEARL, n = 427), a larger proportion of patients had subjective improvement and a smaller proportion had worsening status in PANGAEA than PEARL (improvement: 28.2% vs 15.2%; worsening: 16.4% vs 30.4%; p < 0.0001). Fingolimod appears to be more effective than BRACE in improving clinical and physician-/patient-reported outcomes in individuals with active MS.