July 10, 2018 News by Iqra Mumal, MSc RRMS Patients Show High Levels of Satisfaction and Adherence to Gilenya Over 2 Years in Danish Study People with relapsing-remitting multiple sclerosis in Denmark show high rates of adherence to treatment with Gilenya (fingolimod), and give the therapy high marks in terms of satisfaction and quality of life, a long-term study of its use by RRMS patients reports. The study, āHigh treatment adherence, satisfaction, motivation,…
June 13, 2018 News by Vijaya Iyer, PhD Effectiveness of Gilenya and Tecfidera Compared in Real-World Study in Italy Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remittingĀ multiple sclerosis (RRMS), but Gilenya may be of slightly more benefit to those who switch from a previous injectable therapy, according to a real-world study of patients in Italy. The study, “…
June 12, 2018 News by Vijaya Iyer, PhD Gilenya Seen to Particularly Benefit Young Adults with Higher Relapse Rates, Trial Data Show Young adults withĀ multiple sclerosis (MS) have higher relapse rates and respond better to Gilenya treatment compared to the overall MS population, data from a post hoc analysis of three separate trials show. The study, āRelapse Rate and MRI Activity in Young Adult Patients With Multiple…
May 24, 2018 News by Ashraf Malhas, PhD 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…
May 16, 2018 News by Janet Stewart, MSc Complications from Gilenya Treatment Managed Successfully, Case Report Says A case study reported the successful management of a multiple sclerosis (MS) patient who developed a rare condition in the brain ā progressive multifocal leukoencephalopathyĀ (PML) ā due to treatment with Novartis Pharmaceuticalās Gilenya (fingolimod). The study, titled āFingolimod-associated PML with mild IRIS in MS: A…
May 15, 2018 News by Alice MelĆ£o, MSc Gilenya Approved by FDA as First DMT for Children, Ages 10 and Older, with Relapsing MS Gilenya (fingolimod) has become the first disease-modifying therapy approved by the U.S. Food and Drug Administration (FDA) to treat children and adolescents with relapsing forms of multiple sclerosis (MS). This expanded approval allows Gilenya, previously indicated for adults patients 18 or older, to be used to treat pediatric relapsing MS…
May 9, 2018 Columns by Cathy Chester The Agony of Decision-making when It’s Time to Switch MS Medications Iām agonizing over an important decision and it’s driving me crazy. Iām usually a quick decision-maker, but this one is tough. I have my analytical hat on, trying to look at my choices from a scientific standpoint. Unfortunately, my anxiety kicks in, and my hat…
April 25, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Review of Phase 3 Trial Data Supports Gilenya as Treatment for Pediatric MS An additional analysis of data collected during the Phase 3 PARADIGMS trial found GilenyaĀ (fingolimod)Ā can prevent the progression of disability and control multiple sclerosis (MS) activity in pediatric patients. Results of the analysis were the subject of an oral presentation Tuesday at the 2018Ā American Academy of Neurology…
February 21, 2018 News by Iqra Mumal, MSc Gilenya Continues to Demonstrate Effectiveness as Therapy for RRMS Patients in Study Gilenya (fingolimod) is an effective treatment forĀ 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…
February 8, 2018 Columns by Tamara Sellman The MS Alphabet: Plaquenil, PML, Prevalence, and Other ‘P’ Words (Part 6 of 7) Editorās 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) isnāt an actual symptom of MS,…
February 6, 2018 News by Alice MelĆ£o, MSc #ACTRIMS2018 – Prior Therapies Don’t Affect Gilenya’s Benefits, Study Shows 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…
January 24, 2018 News by Alice MelĆ£o, MSc 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, āFactors 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 universityās 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. āA higher ARR [annualized relapse rate] is the major contributory factor toward development of SDR,ā the researchers wrote. āPatients 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 āplasmapheresis [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
January 2, 2018 News by Patricia Inacio, PhD Gilenya Halts Brain’s Gray Matter Atrophy in RRMS Patients, Study Suggests 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 HospitalĀ have found. Their report, āA two-year study using cerebral gray matter volume to assess the response to fingolimod therapy in multiple sclerosis,ā appeared in the…
December 20, 2017 News by Alice MelĆ£o, MSc FDA Gives Fingolimod a Breakthrough Therapy Designation for Relapsing MS in Children The U.S. Food and Drug Administration has givenĀ fingolimodĀ a Breakthrough Therapy designation as a treatment for children 10 years and older and adolescents with relapsing multiple sclerosis. NovartisĀ is marketing it in the United States under the brand name GilenyaĀ for adults with relapsing MS. It has yet to approved…
December 8, 2017 News by Patricia Inacio, PhD Novartis’ Gilenya Improves Cognition, Reduces Relapses and MS Lesions, Phase 4 Trial Shows Ā 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 ā areas where a protein coating that protects nerve cells has deteriorated, researchers found.
November 8, 2017 News by Patricia Silva, PhD Global Phase 3 Trial of Oral Ponesimod Plus Tecfidera Enrolling Relapsing MS Patients 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)Ā in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartisā Gilenya (fingolimod) ā making immune…
October 30, 2017 News by Patricia Silva, PhD #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…
October 30, 2017 News by Alice MelĆ£o, MSc #MSParis2017 ā Gilenya Seen to Reduce Relapses in Children with Active MS Gilenya (fingolimod) was seen to significantly reduce relapses in children and teenagers with multiple sclerosis (MS), according to data from a Phase 3 study ā the first successfully conducted in pediatric patients. Novartis, the therapy’s developer, is preparing to file requests for Gilenya to be approved to…
October 26, 2017 News by Patricia Silva, PhD #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…
September 7, 2017 News by Jose Marques Lopes, PhD #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.
June 29, 2017 Columns by Tamara Sellman The MS Alphabet: Foot Drop, Flexion, Fingolimod, and More ‘F’ Terms (Editorās note: Tamara Sellman continues her occasional series on the MS alphabet with this first of two columns about terms starting with the letter āF.ā) When it comes to multiple sclerosis, mastering an understanding of the disease means you need to mind your Ps and…
May 22, 2017 News by Alice MelĆ£o, MSc 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…
April 25, 2017 News by Patricia Silva, PhD Real-world Data of Gilenya Treatment Validates Slowed Brain Shrinkage as Disease Progression Measure 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 theĀ American Academy of…
February 15, 2017 News by Joana Fernandes, PhD 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, āSphingosine 1-Phosphate Receptor Modulation Suppresses Pathogenic Astrocyte Activation and Chronic Progressive CNS Inflammation,ā appeared in the…
February 6, 2017 News by Ćzge Ćzkaya, PhD Switching From Gilenya to Lemtrada Seen to Trigger Disease Activity in Some MS Patients 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.
February 2, 2017 News by admin 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, āLong-term efficacy and safety of fingolimod in…
October 31, 2016 News by Patricia Silva, PhD 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…
October 28, 2016 News by Joana Fernandes, PhD Relapses in MS Patients Using Gilenya May Be Result of Changes Within T-Cells, Study Reports 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 toĀ a study published in the journal Scientific Reports. The study, āAltered T Cell Phenotypes Associated With Clinical Relapse Of Multiple Sclerosis Patients Receiving…
October 6, 2016 News by Patricia Inacio, PhD 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, āThe Efficacy of Natalizumab versus Fingolimod for Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review, Indirect…
September 21, 2016 News by Patricia Silva, PhD #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…