Relapsing MS patients more satisfied with Novartis oral drug Gilenya® than standard injectable therapies, according to …

EAST HANOVER, N.J., May 30, 2013 /PRNewswire/ --People with relapsing multiple sclerosis (MS) reported greater treatment satisfaction after starting the oral treatment Gilenya (fingolimod) vs. switching to, or staying on, injectable interferon beta or glatiramer acetate, according to new study data presented at the 2013 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in Orlando, Fla.1

The US phase IV randomized, multi-center, open-label study, called EPOC (Evaluate Patient OutComes), evaluated treatment satisfaction among more than 1,000 patients.1,2 The study compared Gilenya to interferon beta or glatiramer acetate using a 100-point scale based on the Treatment Satisfaction Questionnaire for Medication (TSQM),1 a validated tool that measures patient satisfaction with medical treatments.3 A higher TSQM score indicates higher satisfaction.

At six months, adjusted mean treatment global satisfaction subscale scores (a measure of the overall level of satisfaction with a medication that patients are taking) were 80.4 for Gilenya vs. 61.1 for the injectable disease modifying therapies (DMTs), an increase from baseline by 20.4 vs. 2.9, respectively.1 The mean difference between the two scores was a statistically significant 17.5 (p1

"Patient satisfaction is critical for the management of chronic conditions like MS," said Christopher LaGanke, MD, of North Central Neurology Associates in Cullman, Ala., and a study investigator. "These treatment satisfaction results are meaningful to clinicians and add important real-world insight to the established clinical trial evidence we already have for fingolimod."

A separate analysis of EPOC indicated that the overall incidence of infection was similar among patients taking Gilenya and patients taking standard injectable DMTs consistent with results from previous studies.4 The analysis also found no observed relationship between lymphocyte counts and infection rates.4

"We led a revolution in MS treatment two years ago with the introduction of the first oral disease modifying therapy," said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals AG. "We are committed to continuing to provide critical insights to help physicians understand the role of Gilenya."

With more than two years on the market, Gilenya is approved in 72 countries and more than 63,000 patients worldwide have been treated with Gilenya.5 This includes both clinical trials and patients prescribed Gilenya.5

About Gilenya

Gilenya is the first oral disease modifying therapy (DMT) approved to treat relapsing forms of MS6 and the first in a class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators.6,7 The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.6,7 In targeting the S1P receptor, initiation of treatment with Gilenya is known to be associated with bradycardia (slowing of the heart rate) and atrioventricular (AV) block (a problem with electrical impulse conduction in the heart).7,8

Gilenya is the only oral DMT for relapsing forms of MS with proven and consistent efficacy across two pivotal trials, including a head-to-head study (interferon beta-1a IM).9,10 In a two-year study, Gilenya reduced annualized relapse rate by 54 percent (p10 In addition, Gilenya showed a 30 percent reduction in the risk of three-month confirmed disability progression (p=0.02, key secondary endpoint) compared to placebo.10 However, in a separate one-year study, there was no significant risk reduction of disability progression between Gilenya and interferon beta-1a IM. Gilenya reduced annualized relapse rate by 52 percent (p9 A two-year pivotal clinical trial has shown that the majority of patients who started on Gilenya stayed on therapy compared to placebo (81.2 percent vs. 72.5 percent).10 Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.

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Relapsing MS patients more satisfied with Novartis oral drug Gilenya® than standard injectable therapies, according to ...