Table 5.
Comparison of the labeling for new generation multiple sclerosis treatments (as of September 29, 2013)
| Natalizumab | Fingolimod | Alemtuzumab | Teriflunomide | |
|---|---|---|---|---|
| Indication | High disease activity despite treatment with a beta interferon or glatiramer acetatea Adult patients aged ≥18 years with rapidly evolving severe relapsing-remitting multiple sclerosisb |
High disease activity despite treatment with a beta interferona Patients with rapidly evolving severe relapsing-remitting multiple sclerosisb |
Relapsing-remitting multiple sclerosis with active disease defined by clinical or imaging features (ie, not recommended for patients with inactive disease or those stable on current therapy) | Relapsing-remitting multiple sclerosis |
| Posology | 300 mg is administered by intravenous infusion once every 4 weeks. Careful reassessment daily of risk of PML required after 24 months of treatment | One 0.5 mg capsule taken orally once daily | 12 mg/day administered by intravenous infusion for two treatment courses • Initial treatment course: 12 mg/day for 5 consecutive days (60 mg total dose) • Second treatment course: 12 mg/day for 3 consecutive days (36 mg total dose) administered 12 months after the initial treatment course |
One 14 mg tablet taken orally once |
| Main special warnings and precautions for use | PML | Bradyarrhythmia, QT interval, infections | Autoimmunity (immune thrombocytopenic purpura, nephropathies, thyroid disorders, cytopenias) | Hepatic effects (monitoring of alanine aminotransferase recommended) |
| Date of approval by the European Medicines Agency | June 2006 | March 2011 | September 2013 | August 2013 |
Notes:
Defined as patients who have failed to respond to a full and adequate course (normally at least 12 months of treatment) of beta interferon or glatiramer acetate. Patients should have had at least one relapse in the previous year while on therapy and have at least nine T2-hyperintense lesions in cranial magnetic resonance imaging (MRI) or at least one gadolinium-enhancing lesion. A “nonresponder” could also be defined as a patient with an unchanged or increased relapse rate or on-going severe relapses as compared to the previous year
two or more disabling relapses in 12 months, and with one or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a recent MRI.
Abbreviation: PML, progressive multifocal leukoencephalopathy.