Novartis data show Gilenya® had significantly greater patient retention

                                                                  

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SOURCE Novartis Pharmaceuticals Corporation

– Data demonstrate at 12 months, 81% of patients started on fingolimod stay on therapy vs. 29% started on injectable disease-modifying therapies (iDMTs)(1)

– Injectable disease-modifying therapies are frequently used first-line for MS despite evidence of sub-optimal patient adherence(2),(3)

EAST HANOVER, N.J., June 3, 2016 /PRNewswire/ — Novartis today announced data from a randomized, prospective, Phase IV, open-label study that demonstrated patient retention rate with Gilenya^® (fingolimod) was significantly higher at 12 months than with injectable disease-modifying therapies in patients with early relapsing-remitting multiple sclerosis (RRMS), 81% vs. 29% respectively¹. Compared to injectable disease-modifying therapies, Gilenya also improved clinical and MRI outcomes and was associated with greater patient satisfaction¹. The findings were presented for the first time in the US at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in National Harbor, MD, June 1-4, 2016.

While injectable disease-modifying therapies typically are used as first-line therapies for RRMS, research suggests the requirement for injections may reduce patient adherence^2,3. The Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention of Fingolimod versus approved first-line disease-modifying therapies in adults with Relapsing-remitting Multiple Sclerosis (PREFERMS) was the first large randomized study of treatment retention comparing fingolimod 0.5 mg with injectable disease-modifying therapies (interferon ß or glatiramer acetate) over a period of 12-months¹. Safety outcomes for all treatments were consistent with the respective US Prescribing Information.

“Encouraging patients to stay on treatment is particularly important in relapsing MS, given lack of active management can lead to disability progression,” said PREFERMS lead investigator Bruce Cree, MD, Associate Professor, University of California San Francisco School of Medicine. “Our findings suggest that use of fingolimod may improve therapeutic retention compared to injectable disease-modifying treatments that are often times used as first-line therapies.”

Study Design¹PREFERMS was a 12-month, Phase IV, open-label, active-controlled, randomized, multicenter study conducted at 117 sites in the US. At enrollment, patients with RRMS were treatment-naïve or had received only one injectable disease-modifying therapy class (IFNß-1a, IFNß-1b or glatiramer acetate). A total of 875 patients were randomized (1:1) to Gilenya 0.5 mg or to a pre-selected injectable disease-modifying therapy, and followed up quarterly for 12 months. After a minimum of 3 months of treatment, a single on-study treatment switch was allowed, however, switches due to efficacy or safety were allowed at any month following randomization. The primary endpoint was to compare the patient retention on randomized treatment over 12 months.

Efficacy FindingsOf the 861 patients (98.4%) who completed the study (full analysis set), 477 (55.4%) completed the study while still receiving the randomized treatment¹. At the primary endpoint, patient retention with Gilenya was 81.3% (352 of 433 Gilenya patients) versus 29.2% (125 of 428 injectable disease-modifying therapy patients) with injectable disease-modifying therapy (p<0.0001) at 12 months¹.

Safety FindingsDuring the randomized open-label treatment phase, the overall rate of adverse events (AEs) per patient-year were higher with injectable disease-modifying therapies (7.001) versus Gilenya (4.008) and the rate of AEs per patient-year leading to treatment discontinuation were 0.540 with injectable disease-modifying therapies versus 0.112 with Gilenya¹. Most adverse events were mild or moderate in severity¹.

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