The 12-month, double-blind TRANSFORMS study compared two dose regimens of oral fingolimod (0.5 and 1.25 mg/day) with intramuscular (i.m.) interferon beta-1a (IFN-beta-1a) administered once weekly at dosage of 30 mu g in a study population of 1292 patients with relapsing remitting multiple sclerosis. Both doses of fingolimod were shown to be superior to i.m. IFN-beta-1a in reducing relapse rate and disease activity as detected by magnetic resonance imaging, while no significant effect on disability progression was observed. Although about 90% of patients completed the study, a greater proportion receiving a higher dose of fingolimod discontinued treatment because of adverse events, such as herpes virus infections (fatal in two patients assigned to higher dose), dose-dependent bradyarrhytmias and lymphopenia, transient macular edema, skin cancer and liver enzyme increase. Because of these safety concerns, a long-term evaluation is required to define the risk-benefit ratio. The TRANSFORMS study clearly showed a superior efficacy of oral fingolimod over i.m. IFN-beta-1a, but it is still uncertain whether oral fingolimod could be used as first-line treatment, or as an alternative treatment for patients who have failed immunomodulating therapy.
Treating multiple sclerosis with fingolimod or intramuscular interferon / Pozzilli, Carlo; Prosperini, Luca; Borriello, Giovanna. - In: EXPERT OPINION ON PHARMACOTHERAPY. - ISSN 1465-6566. - 11:11(2010), pp. 1957-1960. [10.1517/14656566.2010.484422]
Treating multiple sclerosis with fingolimod or intramuscular interferon
POZZILLI, Carlo;PROSPERINI, luca;BORRIELLO, GIOVANNA
2010
Abstract
The 12-month, double-blind TRANSFORMS study compared two dose regimens of oral fingolimod (0.5 and 1.25 mg/day) with intramuscular (i.m.) interferon beta-1a (IFN-beta-1a) administered once weekly at dosage of 30 mu g in a study population of 1292 patients with relapsing remitting multiple sclerosis. Both doses of fingolimod were shown to be superior to i.m. IFN-beta-1a in reducing relapse rate and disease activity as detected by magnetic resonance imaging, while no significant effect on disability progression was observed. Although about 90% of patients completed the study, a greater proportion receiving a higher dose of fingolimod discontinued treatment because of adverse events, such as herpes virus infections (fatal in two patients assigned to higher dose), dose-dependent bradyarrhytmias and lymphopenia, transient macular edema, skin cancer and liver enzyme increase. Because of these safety concerns, a long-term evaluation is required to define the risk-benefit ratio. The TRANSFORMS study clearly showed a superior efficacy of oral fingolimod over i.m. IFN-beta-1a, but it is still uncertain whether oral fingolimod could be used as first-line treatment, or as an alternative treatment for patients who have failed immunomodulating therapy.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.