Novartis’ Gilenya earns positive results in extended phase III head-to-head study

Monday, June 11, 2012 02:52 PM

New long-term data for Gilenya (fingolimod), the only oral therapy approved to treat people with relapsing forms of multiple sclerosis (MS), show a sustained efficacy benefit and a consistent safety profile with up to 4.5 years of continuous treatment, according to Switzerland-based Novartis Pharma.

These results, from an extension of the phase III head-to-head TRANSFORMS study, also showed improved efficacy for patients who switched to Gilenya from Avonex (interferon-beta-1a IM), a commonly prescribed MS treatment.

"Patients who switched to Gilenya from interferon beta-1a IM showed a reduction in relapses and improvements in MRI measures,” said Tim Wright, global head of development, Novartis.

In the core TRANSFORMS study, Gilenya demonstrated superior efficacy to interferon-beta- 1a IM, reducing the annualized relapse rate (ARR) by 52% at one year (Gilenya 0.5mg, ARR = 0.16; interferon-beta- 1a IM, ARR = 0.33; p

For patients who switched to Gilenya for the open-label extension study (n=167), their ARR was 0.33 in the core study when treated with interferon-beta-1a IM and 0.20 in the extension phase when treated with Gilenya (n.s.). Patients in the switch group also displayed a slowing of brain atrophy following the switch to Gilenya.

These extension data from up to 4.5 years also showed long-term treatment with Gilenya was generally well tolerated with a safety profile consistent with pivotal trials. In line with previous studies, including the core TRANSFORMS study, the most common adverse events were nasopharyngitis, headache, and upper respiratory tract infections. Switching therapy from IFN beta-1a to Gilenya did not reveal any new or unexpected safety concerns. On treatment initiation, a low incidence of asymptomatic transient bradycardia was observed in patients who switched from interferon-beta-1a IM to Gilenya (IFN-0.5mg [0.6%]), which resolved without treatment. Overall cardiac events were similar across all patient groups.

In addition, all patients treated with Gilenya in the extension phase, regardless of original treatment in the core study, showed comparable percentage of patients free from MRI disease activity by the end of the study—free from Gd enhanced T1 lesions: 77.4% in switch group vs. 74.7% Gilenya 0.5mg; free from new/newly enlarged T2 lesions: 45.0% in switch group vs. 42.0% Gilenya 0.5mg. The continuous and switch groups did not significantly differ with respect to disability progression at the end of the study.

TRANSFORMS was a large phase III double-blind, double-dummy, head-to-head study that involved 1,292 patientswith relapsing-remitting MS that was conducted over one year, comparing the efficacy and safety of Gilenya to interferon-beta-1a IM. At the end of the 12-month core study, eligible patients could enroll in the extension study, which ran for an additional 3.5 years. Patients on once-daily oral Gilenya remained on drug and those who had been treated with interferon-beta-1a (IM) switched to Gilenya for the duration of the extension study.

As of February 2012, approximately 36,000 patients have been treated with fingolimod in clinical trials and in the post-marketing setting, some up to seven years, and currently there is approximately 34,000 patient years of exposure.

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