Gilenya

Gilenya (fingolimod) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS) in everyday clinical practice, a new study shows. The therapy was shown to be effective even in patients switching from Tysabri (natalizumab) treatment. The study, “Effectiveness and baseline factors associated to fingolimod response in a…

Editor’s note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letter “P.” This post comes sixth in a series of seven. Symptoms of MS Progressive multifocal leukoencephalopathy (PML) Though progressive multifocal leukoencephalopathy (PML) isn’t an actual symptom of MS,…

Changing from injectable disease-modifying therapies (DMTs) to Gilenya (fingolimod) can benefit people with relapsing multiple sclerosis (MS), regardless of prior therapy regimens. The PREFERMS Phase 4 trial (NCT01623596) concluded that Gilenya, marketed by Novartis, reduces annualized relapse rates (ARR) and brain volume loss (BVL) in both…

Multiple sclerosis patients with high relapse rates but less physical impairment before starting on  Novartis’ 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, “Factors Predictive of Severe Multiple Sclerosis Disease Reactivation After Fingolimod Cessation,” in the journal The Neurologist. Studies have shown that Gilenya, which 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 University 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 university’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 — white blood cells involved in autoimmunity — 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. “A higher ARR [annualized relapse rate] is the major contributory factor toward development of SDR,” the researchers wrote. “Patients 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,” 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 “plasmapheresis [plasma exchange] must be considered in patients exhibiting steroid-refractory SDR.” "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."  

Multiple sclerosis patients whose first treatment is Genentech's Rituxan (rituximab) stay on it longer than other disease-modifying drugs that patients start with, a Swedish study reports. When they stop taking Rituxan,  it usually isn't for lack of effectiveness or side effects...

Treatment with Gilenya (fingolimod) may limit cerebral gray matter atrophy in relapsing-remitting multiple sclerosis (RRMS) patients, researchers at Boston’s Brigham and Women’s Hospital have found. Their report, “A two-year study using cerebral gray matter volume to assess the response to fingolimod therapy in multiple sclerosis,” appeared in the…

The U.S. Food and Drug Administration has given fingolimod a Breakthrough Therapy designation as a treatment for children 10 years and older and adolescents with relapsing multiple sclerosis. Novartis is marketing it in the United States under the brand name Gilenya for adults with relapsing MS. It has yet to approved…

U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global Insights reports. Another good sign for Genentech is that, in just three months, neurologists have increased by 50 percent their estimate of the numbers of relapsing-remitting MS patients who could benefit from Ocrevus.

 Novartis' Gilenya and interferon beta-1b-based therapies stop multiple sclerosis patients' cognitive decline, a Phase 4 clinical trial shows. Gilenya (fingolimod) also reduces patients' relapses and the number of their brain lesions — areas where a protein coating that protects nerve cells has deteriorated, researchers found.

Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate) in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartis’ Gilenya (fingolimod) — making immune…

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

Gilenya (fingolimod) was seen to significantly reduce relapses in children and teenagers with multiple sclerosis (MS), according to data from a Phase 3 study — the first successfully conducted in pediatric patients. Novartis, the therapy’s developer, is preparing to file requests for Gilenya to be approved to…

While early use of high-efficacy treatments lowers relapse rates among patients with relapsing-remitting multiple sclerosis (MS) compared to lower-efficacy ones, starting these therapies earlier may only impact the accumulation of disability among young patients, according to data presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France. Earlier treatment…

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 — conducted at 87 sites in 25 countries — 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.

(Editor’s note: Tamara Sellman continues her occasional series on the MS alphabet with the second of two columns about terms starting with the letter “G.” Read more “G” terms here.) Mastering an understanding of multiple sclerosis means you need to mind your Ps…

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

A real-world study of Gilenya (fingolimod) in relapsing multiple sclerosis (MS) confirms benefits of the treatment seen in clinical trials. The Novartis-sponsored study also demonstrated that measures of brain shrinkage can be used in a clinical setting to evaluate disease progression. The data, presented at the American Academy of…

Gilenya (fingolimod) 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, “Sphingosine 1-Phosphate Receptor Modulation Suppresses Pathogenic Astrocyte Activation and Chronic Progressive CNS Inflammation,” appeared in the…

Switching from Gilenya (fingolimod) to Lemtrada (alemtuzumab) triggers significant and unexpected disease activity in some patients with multiple sclerosis (MS), according to a study published in the scientific journal Neurology Neuroimmunology and Neuroinflammation.

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

A number of important discoveries, therapeutic developments, and events related to multiple sclerosis (MS) were reported daily by Multiple Sclerosis News Today throughout 2016. Now that the year is over, it is time to briefly review the articles that appealed most to our readers. Here are the top 10 most-read articles of 2016, with…

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

Changes in the composition of certain immune system cells may be associated with relapses in multiple sclerosis (MS) patients being treated with Gilenya (fingolimod), according to a study published in the journal Scientific Reports. The study, “Altered T Cell Phenotypes Associated With Clinical Relapse Of Multiple Sclerosis Patients Receiving…

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, “The Efficacy of Natalizumab versus Fingolimod for Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review, Indirect…

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 those using injectable disease-modifying drugs did not. The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016…

Novartis recently announced positive results from the ACROSS study, which is assessing the clinical effect of Gilenya (fingolimod) in 10-year disability outcomes in people with relapsing-remitting multiple sclerosis (RRMS). The results were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Sept. 14-17 in London. The ACROSS study…

A five-year study comparing the efficacy of different treatments for relapsing-remitting multiple sclerosis (RRMS) found that, in general, Lemtrada (alemtuzumab) and Tysabri (natalizumab) are more effective as therapies than Gilenya (fingolimod) and interferon β. Study results were presented in an oral presentation, “Comparison of 5-year treatment outcomes between alemtuzumab versus natalizumab, fingolimod and interferon β-1a,”…

Scientists recently reported additional mechanisms of action that may underlie Gilenya (fingolimod) beneficial effects in relapsing-remitting multiple sclerosis (RRMS). The results were in an oral presentation, “Fingolimod therapy modulates B cell functions: reduces CXCR4-mediated migration and increases B cell -mediated anti-inflammatory cytokine profile,” given at the 32nd Congress of the European Committee for Treatment…

Low-quality unauthorized generic versions of approved multiple sclerosis (MS) drugs can expose patients to danger, both through their toxic properties and a lack of efficacy that allows the disease to progress, researchers reported in the study, “Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod,” published…

Disease-modifying therapies, a group of treatments for people with relapsing-remitting multiple sclerosis (RRMS), work to stabilize patients’ cognitive functions just as they do their physical symptoms. Research, conducted over the course of a year, also reported no differences between two types of DMTs, Gilenya (fingolimod) and Tysabri (natalizumab). The study, “…