Fingolimod

Gilenya Tied to Treatment Satisfaction, Quality of Life in MS Patients

Treatment with Gilenya (fingolimod) is associated with treatment satisfaction, which, in turn, is linked to a better quality-of-life in patients withĀ relapsing-remitting multiple sclerosis (RRMS), a study has found. Gilenya, an oral disease-modifying treatment (DMT) for RRMS developed by Novartis, has been available in France since 2011. Studies have…

Study Identifies MS Patients at Risk of Severe Disease Reactivation After Gilenya Is Discontinued

Multiple sclerosis patients with high relapse rates but less physical impairment before starting on Ā Novartisā€™ Gilenya (fingolimod) are likely to experience a surge in disease activity if they stop the treatment, researchers in Turkey report. The study, which dealt with patients with relapsing forms of MS, referred to the surge as "severe disease reactivation," or SDR. Researchers published their article, ā€œFactors Predictive of Severe Multiple Sclerosis Disease Reactivation After Fingolimod Cessation,ā€ in the journal The Neurologist. Studies have shown that Gilenya, whichĀ the U.S. Food and Drug Administration approved in 2010, can benefit adults with relapsing MS. It reduces annualized relapse rates and prevents more brain lesions from forming, compared with standard interferon treatments. Lesions are damaged nerve cell areas. Despite its benefits, Gilenya is not recommended for patients with heart or liver problems, low levels of white blood cells, severe herpes virus infections or other infections. Also, patients who do not respond to Gilenya and women who are planning to become pregnant are advised to stop the treatment. Discontinuing Gilenya can lead to a return to pretreatment disease activity, or severe disease reactivation, in some patients. It is unclear why this happens and why it affects only some patients. To better understand what risk factors could be associated with reactivation, a team at Istanbul UniversityĀ compared the demographic and disease features of patients who developed SDR after stopping treatment with Gilenya. SDR was defined as including these elements within 6 months of Gilenya discontinuation: more than 5 gadolinium-enhanced lesions or a tumefactive demyelinating lesion detectable by magnetic resonance imaging, the disease progressing to the point that additional treatment with methylprednisolone or plasma exchange was required, and progressive physical disability reflected by a 1-point or more increase in patients' scores on the Expanded Disability Status Scale, or EDSS, Thirty-one patients at the universityā€™s MS clinic who had discontinued Gilenya were included in the study. Eight experienced SDR and 11 relapses. The mean time for SDR patients' reactivation to occur was 2.6 months, researchers said. Patients had significantly higher levels of lymphocytes ā€” white blood cells involved in autoimmunity ā€” than during Gilenya treatment. When the team compared the disease features of SDR and non-SDR patients, they found that SDR patients had significantly higher annualized relapse rates before starting Gilenya and lower EDSS scores. ā€œA higher ARR [annualized relapse rate] is the major contributory factor toward development of SDR,ā€ the researchers wrote. ā€œPatients who had higher ARRs before fingolimod [Gilenya] treatment must be closely followed up both clinically and radiologically in terms of the early signs of severe reactivation,ā€ they wrote. About 38 percent of the SDR patients failed to respond to steroid treatment. They received a plasma exchange, which led to moderate improvement in their condition. Based on this finding, the researchers suggested that ā€œplasmapheresis [plasma exchange] must be considered in patients exhibiting steroid-refractory SDR.ā€ "In conclusion, SDR may be observed within the first 3 months after cessation of fingolimod," the team wrote. "This may be explained by the rapid influx of lymphocytes into the CNS [central nervous system]. Patients with higher annualized relapse rates and lower Expanded Disability Status Scale scores before commencing fingolimod treatment were more likely to exhibit SDR." Ā 

#MSParis2017 ā€“ Promising Work in Pediatric and Secondary Progressive Patients Is Focus, Novartis Says in Interview

Gilenya (fingolimod) lowered relapse rates in children and adolescents with relapsing multiple sclerosis at a “magnitude” ā€” almost 82 percent ā€” never before seen in a scientific study and could be “life changing” for these hard-to-treat patients, a top researcher withĀ Novartis, the treatment’s developer, said in an…

#MSParis2017 – Lemtrada and Tysabri More Efficient Than Older Injectables in Preventing SPMS Onset, Study Finds

Sanofi Genzyme‘s Lemtrada (alemtuzumab) and Biogen’s Tysabri (natalizumab) are more effective in preventing conversion to secondary progressive multiple sclerosis (SPMS) compared to older injectable drugs, researchers from the University of Cambridge in the U.K. reported at the 7th Joint ECTRIMS-ACTRIMS MeetingĀ Oct. 25-28 in Paris. The…

#MSParis2017 – Gilenya Reduces Relapses in Children and Adolescents with MS, Novartis Trial Shows

Gilenya decreased relapses in children and adolescents with multiple sclerosis in the phase 3 PARADIGMS trial, according to the therapy's developer, Novartis. The Swiss company will present the trial's results at the 7th Joint ECTRIMS-ACTRIMS meeting, set for Oct. 25-28 in Paris. The study addressed the safety and efficacy of an oral, once-daily dose of Gilenya in 215 MS patients aged 10 to 17. Participants received 0.5 mg or 0.25 mg of Gilenya, according to their body weight, and results were compared with those of intramuscular Avonex (interferon beta-1a given once weekly). The trial ā€” conducted at 87 sites in 25 countries ā€” was designed in partnership with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Pediatric Multiple Sclerosis Study Group. Gilenya led to a "clinically meaningful decrease in the number of relapses" over a period of up to two years, compared to Avonex, according to the trial. The safety results of Gilenya matched those observed in previous trials, with adverse events more likely among the Avonex group. Importantly, the PARADIGMS trial is the first-ever randomized, controlled Phase 3 study of a disease-modifying therapy in pediatric MS. No treatment is currently available for children and adolescents with MS. Novartis will now complete a thorough evaluation of the results and later submit Gilenya for approval by regulatory agencies. It will also extend the study to a five-year period.

Real-world Spanish Study Confirms Gilenya’s Ability to Reduce Multiple Sclerosis Relapses

A real-world medical-facilities setting has confirmed clinical trial findings thatĀ GilenyaĀ (fingolimod) can reduce multiple sclerosis relapses, according to a Spanish study published inĀ Plos One. Gilenya, developed byĀ Novartis Pharmaceuticals,Ā was the first oral disease-modifying therapy to obtain U.S. and European approval. TheĀ Food and Drug Administration and European Medicines Agency authorized…

Gilenya Could Help Treat SPMS by Countering Astrocytes, Study Says

Gilenya (fingolimod)Ā a multiple sclerosis (MS) drug developed to target the immune system and control inflammation, can also reduce the negative action of astrocytes, further controlling inflammation, says a new study. The article, ā€œSphingosine 1-Phosphate Receptor Modulation Suppresses Pathogenic Astrocyte Activation and Chronic Progressive CNS Inflammation,ā€ appeared in the…

Long-term Treatment with Gilenya Found to Limit Lesions, Relapses in Japanese MS Patients

Continuous treatment with Gilenya (fingolimod)Ā helps limit relapses and detectable lesions in multiple sclerosis (MS) patients, according to a three-year, follow-upĀ studyĀ in Japan. The results confirmĀ the findings of trials conducted in predominantly Caucasian populations. The findings were reported in the study, ā€œLong-term efficacy and safety of fingolimod in…

GNS Unveils Platform to Predict New Therapy’s Likely Success in Real World at ISPOR

GNS HealthcareĀ isĀ presenting a data-driven causal machine learning solution, called Efficacy to Effectiveness,Ā designed toĀ predict how potential therapies will actually perform in distinct populations. The data, being releasedĀ today at ISPOR 2016, used pre-launch data from a study comparingĀ Gilenya (fingolimod)Ā and other multiple sclerosis (MS) therapies to build and validate causal models…

Tysabri May Be More Effective Than Gilenya at Reducing Disease Activity in MS Patients, Study Says

An indirect comparison of results from randomized clinical trials in relapsing-remitting multiple sclerosis (RRMS) patients suggests that Tysabri (natalizumab) is more effective than Gilenya (fingolimod) at reducing disease activity. The study, ā€œThe Efficacy of Natalizumab versus Fingolimod for Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review, Indirect…

#ECTRIMS2016 – MS Patients on Oral Gilenya Stick Longer with Treatment in Phase 4 Study

A recent study showed that after one year, the majority of multiple sclerosis (MS) patients taking oral Gilenya (fingolimod) therapy stuck with their treatment, while a large proportion of thoseĀ usingĀ injectable disease-modifying drugs did not. The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016…