Published: 13-Apr-2010
* Data of Novartis Pharma Freedoms study presented at the American Academy of Neurology (AAN) annual meeting showed that Gilenia 0.5mg, once-daily oral therapy for relapsing forms of multiple sclerosis (MS), reduced annual relapse rates (ARR) by 62% for treatment naive patients compared to placebo.
For patients previously receiving other treatments, the annual relapse rates were reduced by 44%. In addition, at two years Gilenia delayed the progression of disability by 30% for patients on 0.5 mg compared to placebo.
In the trial, of the 1153 patients who participated in the one-year Transforms study, 1027 (89%) elected to enter the one-year extension study. Patients in the extension study who also received Gilenia in the core study remained on their original dose (0.5mg or 1.25mg), while patients who had received intramuscular interferon beta-1a (Avonex) were randomised to receive Gilenia 0.5mg or 1.25mg.
Patients who received Gilenia 0.5mg for two years experienced a consistently low ARR at year one (0.16) and at year two (0.18). These patients also retained a reduction in relapses and MRI brain lesions over two years compared to the group originally randomized to intramuscular interferon beta-1a and later switched to Gilenia.
In the subset of patients who received intramuscular interferon beta-1a during year one and Gilenia 0.5mg during year two, the annual relapse rate in year two was reduced by 31% and the number of new or newly enlarged T2 lesions in the brain, a marker of disease activity, was reduced by 67% in the second year.
Novartis Pharma said that these findings on efficacy are consistent with those of the one-year core Transforms study demonstrating Gilenia reduced annualised relapse rates by 52% (0.5 mg dose) vs. intramuscular interferon beta-1a.
Additional data presented at AAN showed that patients in the core Transforms study taking Gilenia 0.5mg had a 71% reduction in relapses resulting in hospitalization, and a 52% reduction in relapses requiring steroid treatment compared with patients taking intramuscular interferon beta-1a[4].
Trevor Mundel, global head of development at Novartis Pharma, said: "These findings reinforce the potential for Gilenia to be a breakthrough therapy option for physicians and people with relapsing forms of MS. The data demonstrate the effectiveness of Gilenia irrespective of treatment history, and further support both the sustained efficacy of Gilenia over two years and the potential benefits of switching from interferon beta-1a, a currently approved MS therapy, to Gilenia."
0 comments:
Post a Comment