November 26, 2018 News by Ana Pena PhD FDA Warns of Rare Risk of Severe Worsening in MS Disability After Stopping Gilenya Use The U.S. Food and Drug Administration (FDA) has issued a safety alert, warningĀ that people with relapsingĀ multiple sclerosis (MS)Ā who stop usingĀ Gilenya (fingolimod) may experience disease worsening beyond that when starting the medicine or while taking it. Reported cases of such increases in MS disability upon stopping treatment are…
November 26, 2018 News by Jose Marques Lopes, PhD Gilenya-induced Changes in Heart Rate May Predict Degree of Drop in Lymphocytes, Study Reports Assessing changes in a person’s heart rate can help to predict the degree to which lymphocyte numbers will decrease in relapsing-remitting multiple sclerosis (RRMS) patients usingĀ Gilenya (fingolimod), according to a small study. The research, āFingolimod-induced decrease in heart rate may predict subsequent decreasing degree of…
October 17, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Blood Level of Neurofilament Light Chain May Predict Brain Atrophy in Progressive MS, Study Suggests Measuring the blood level of neurofilament light chain (NfL) may predict brain shrinkage in primary progressive (PPMS) and secondary progressive multiple sclerosis (SPMS), according to a new study. The findings also show that NfL levels are associated with brain lesion load in these patients. The research, ā…
October 16, 2018 News by Ana Pena PhD #ECTRIMS2018 – Shifting from Gilenya to Lemtrada Doesn’t Increase Risk of MS Reactivation, Study Says Shifting from treatment with Gilenya (fingolimod) to Lemtrada (alemtuzumab), and doing a short washout period between the two therapies, does not seem to increase the risk of disease reactivation in patients with multiple sclerosis (MS), an Italian study shows. Lemtrada, marketed by…
October 16, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Study Examines Relapses When Stopping Gilenya During, After Pregnancy Up to half of women with multiple sclerosis (MS) who stop treatment with Gilenya (fingolimod) when planning to become pregnant will experience a relapse during pregnancy, according to a new study. The findings also revealed relapses over the first six months after giving birth in a quarter of…
October 15, 2018 News by BioNews Staff #ECTRIMS2018 ā As Siponimod Awaits FDA Decision, Mouse Work Helps in Understanding Benefits Seen in SPMS Mouse studies ofĀ siponimod ā a potential progressive multiple sclerosis (MS) treatment that’s up for approval in the U.S. and EU ā were among presentations given by NovartisĀ at the 34th European Committee for Treatment and Research in Multiple SclerosisĀ (ECTRIMS), held Oct. 10-12 in Berlin. Animal work might seem…
October 15, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Plasma Neurofilament Light Levels Linked to Treatment Effects in RRMS, Study Finds Levels of proposed biomarker neurofilament light chain (NfL) are associated with therapeutic effects of disease-modifying treatments (DMTs) inĀ relapsing-remitting multiple sclerosisĀ (RRMS) patients, according to a real-world study. Study findings also revealed that treatment with either Lemtrada (alemtuzumab, marketed byĀ Sanofi Genzyme),Ā Gilenya (fingolimod, marketed by Novartis), Tecfidera (dimethyl fumarate, marketed…
October 11, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Rituximab for MS Does Not Increase Cancer Risk Compared to Gilenya and Tysabri, Swedish Study Finds Treatment of multiple sclerosis (MS) patients with rituximab does not increase breast cancer risk in women, and is not associated with a higher risk for malignant cancer of any type in men or women, when compared to Gilenya (fingolimod) orĀ Tysabri (natalizumab), according to a nationwide study in…
October 10, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Switching to Tysabri Leads to Fewer Relapses and Disability than Gilenya, Study in RRMS Patients Finds Patients with relapsing-remitting multiple sclerosis (RRMS) who switch to Tysabri (natalizumab) after relapses on first-line treatment with other medications show greater relapse reduction and less disability progression than those switching to Gilenya (fingolimod), according to a real-world study. The research, āComparative effectiveness of switching…
October 4, 2018 News by BioNews Staff #ECTRIMS2018 – Emerging MS Treatments, from Cannabinoids to Diet, Among Highlights at Conference Thousands of scientists, doctors, pharmaceutical company executives and others ā representing about 100 countries ā will meet for three days to discuss and debate the latest developments in multiple sclerosis (MS) at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, best known as…
September 24, 2018 News by Jose Marques Lopes, PhD CHMP Favors Approving Gilenya to Treat Children and Teenagers with RRMS in Europe The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended thatĀ Gilenya (fingolimod) be approved to treat children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS). If the CHMP opinion is accepted, Gilenya ā marketed by…
September 17, 2018 News by Patricia Inacio, PhD Gilenya More Effective Than Avonex in Lowering Relapse Rates, New Lesions in Children with Relapsing MS, Phase 3 Trial Shows Two years of treatment with oral GilenyaĀ (fingolimod) significantly reduced the rate of relapses when compared toĀ AvonexĀ (interferon beta-1a) intramuscular injections in children and adolescents with relapsing forms of multiple sclerosis (RMS), according to Phase 3 clinical trial results. Additionally, Gilenya (marketed by Novartis) decreased the number of central nervous…
August 30, 2018 News by Marta Figueiredo, PhD Tecfidera, Gilenya Equally Effective, But More MS Patients Stop Tecfidera, Real-World Study Shows TecfideraĀ (dimethyl fumarate) and GilenyaĀ (fingolimod) are equally effective in treating multiple sclerosis (MS),Ā but Tecfidera shows higher rates of discontinuation, according to a real-world study. The study, āDiscontinuation and comparative effectiveness of dimethyl fumarate and fingolimod in 2 centers,ā was published in the journal Neurology Clinical…
August 27, 2018 News by Joana Carvalho, PhD Small Vesicles Involved in MS Seen to Be Affected by Gilenya, Suggesting Potential as Biomarker Gilenya (fingolimod) influences the release and function of small membrane particles, called extracellular vesicles, that are involved in the development of multiple sclerosisĀ ā and these vesicles may serve a biomarker of treatment effectiveness in people with relapsing MS, researchers report. Extracellular vesicles (EVs) may also work…
August 23, 2018 News by Stacy Grieve, PhD Case Study Suggests Need for New Treatment Strategy When Switching from Gilenya to Rituximab Discontinuing Gilenya (fingolimod) treatment and starting on rituximab therapy may be more complicated than originally thought. A new report chronicles the medical journey of a man with multiple sclerosis (MS) treated with these drugs, and proposes a new treatment regimen. Both Gilenya (an approved MS therapy marketed by…
August 21, 2018 News by Janet Stewart, MSc Consecutive Use of Gilenya and Lemtrada Causes Disease Activity in MS Patient, Case Report Suggests Multiple sclerosis (MS) patients may experience severe disease exacerbation after switching fromĀ NovartisāĀ Gilenya (fingolimod) to Sanofi Genzymeās LemtradaĀ (alemtuzumab), a case report suggests. This unexpected high disease activity raises questions about managing MS through the consecutive use of immunotherapies. The case report, āUnexpected high multiple…
July 30, 2018 News by Jose Marques Lopes, PhD African-Americans Show Better Adherence and Satisfaction with Gilenya Than Injectable DMTs, Phase 4 Study Finds African-Americans with relapsingāremitting multiple sclerosis (RRMS) show higher adherence and greater satisfaction when treated with oralĀ Gilenya (fingolimod, by Novartis) than with injectable therapies, according to a new study. The research, āTreatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A…
July 23, 2018 News by Ana Pena PhD Shorter Washout Period Lessens Relapse Risk When Switching from Tysabri to Gilenya in RRMS, Study Finds Shortening the washout period to four weeks when switching from Biogenās Tysabri to Novartisā Gilenya is safe and reduces the chances of experiencing a disease flare in patients with relapsing-remitting multiple sclerosis (RRMS), a small Swiss study found. A four-week washout reduced the risk of having a disease relapse or an increase in disease activity, compared with an eight-week washout period, for two years after switching from Tysabri to Gilenya. Although TysabriĀ effectively slows worsening of MS symptoms and the appearance of disease flares, its use is under a strict risk management plan as it heightens the risk of developing a rare and life-threatening brain infection called progressive multifocal leukoencephalopathy, also known as PML. Some patients may switch to Gilenya, an alternative disease-modifying therapy for RRMS. Gilenya has been associated with a lower risk of PML infection and seen to reduce relapses, disability worsening, and the appearance of new brain lesions on clinical trials. It also is the only therapy approved by the U.S. Food and Drug Administration for children with MS as young as 10. When switching from Tysabri to Gilenya, it is important to consider the washout period, which is the period when the patient is taken off medications. If too long, it may lead to disease reactivation, which can be even stronger than before starting Tysabri. There is little evidence about the optimal length of washout periods, but a Phase 3 trial showed that an eight-week washout between Tysabri and Gilenya was beneficial compared with longer washouts of 12 or 16 weeks. The eight-week washout enabled more RRMS patients to become free from relapses and lowered disease activity. To study if a shorter washout period of four weeks further reduced the risk of MS reactivation, researchers conducted an open-label, observational study at the University Hospital, Basel, Switzerland. The study enrolled 25 RRMS patients who were appointed to switch from Tysabri to Gilenya. Participants were assigned to either a four-week or an eight-week washout period, and were followed for two years after switching to Gilenya. Although patients were older in the four-week washout group, disease activity and disability scoreswere not significantly different between groups at the beginning of the study. Relapses, disability scores, and disease activity on magnetic resonance imaging scans were recorded at baseline and weeks 8, 12, 16, 20 32, 56, and 108. In the first year (week 56) the proportion of patients with disease flare-ups or disease activity on MRI was not significantly different between the two washout groups, affecting 55.6% and 62.5% of the patients who had a four-week and an eight-week washout, respectively. However, at the end of the two-year follow-up (week 108), recurrent event analysis showed that patients who were on the four-week washout group were 77% less likely to experience relapses. The combined risk for relapse or disease activity on MRI also was 58% lower in the four-week group,Ā compared with those who had an eight-week washout. In addition, researchers found that patients who had flares more frequently in the year before discontinuing Tysabri also had a nearly four times higher risk of experiencing relapses in the first year after switching to Gilenya. ThisĀ suggests that the number of relapses before switching from Tysabri can predict disease reactivation once on other disease-modifying therapies. Both washout periods were deemed safe, with no serious adverse side effects or cases of opportunistic infections, including PML, being reported. Researchers emphasized, however, that the findings need to be confirmed in larger studies.
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 20, 2018 News by Patricia Inacio, PhD #EAN2018 – Levels ofĀ Neurofilament Light Chain Can Predict Disease Progression in RRMS, Study Shows Levels ofĀ neurofilament light chain are a reliable predictor of disease worsening and progression in relapsing-remitting MS (RRMS) patients, a new study shows. Moreover, treatment withĀ GilenyaĀ (fingolimod), marketed by Novartis, can reduce the levels ofĀ NfL for up to 10 years. These findings were shared recently in the presentation ā…
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…
June 5, 2018 News by Alice MelĆ£o, MSc #CMSC2018 ā Advances Made in Care of Children with MS, but Challenges Remain, Expert Says While the treatment and care of children and teenagers with multiple sclerosis (MS) has seen many developments in recent years, there are still many challenges to overcome, according to a presentation given by Brenda Banwell, MD. Banwell, who is the chief of child neurology at the Childrenās Hospital…
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…
April 23, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Neurofilament Light Blood Levels Can Help Define Disease Activity in RRMS, Study Shows Analysis of a potential blood biomarker linked to brain cell damage can help define disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). Results of a study showed that determining blood levels of neurofilament light chain, or NfL, could help in establishing āno evidence of disease activity,ā or NEDA, status…
February 27, 2018 Columns by Ed Tobias What’s Hot and What’s Not Among MS Therapies? The newest kids on the MS block, disease-modifying therapies (DMT) such as Genentech’s Ocrevus (ocrelizumab) and Sanofi Genzyme’s Lemtrada (alemtuzumab), are attracting a lot of interest these days. But, some DMTs that have been around for more than two decades are still being prescribed by a lot of neurologists.