TRANSFORMS study of Gilenya (Novartis) shows sustained improvements in patients with Multiple Sclerosis

Two new analyses from the pivotal Phase III TRANSFORMS study of Gilenya (fingolimod), from Novartis, show early and sustained improvements in disease activity in patients with relapsing remitting Multiple Sclerosis. After switching from interferon to fingolimod, the proportion of patients who were disease activity free increased by almost 50% (from 44.3% to 66.0%) between the end of years one and two respectively. Patients who were disease activity free in year one were most likely to remain clinically disease activity-free till the end of the extension study (up to 4.5 years).

A separate post-hoc analysis showed that treatment with fingolimod resulted in an annualised relapse rate (ARR) reduction in patients who had prior disease activity despite treatment with an interferon treatment. n patients who were switched from interferon to fingolimod after one year, the ARR was reduced by more than 50% (from between 0.33-0.37 ARR on interferon to 0.14-0.16 ARR on fingolimod treatment) and remained low to the end of the study (up to 4.5 years). Results were presented at the European Neurological Society meeting.