March 18, 2020 News by Patricia Inacio, PhD Gilenya Linked to Slightly Increased Cancer Risk in MS, Swedish Study Suggests The risk of invasive cancer may be slightly higher in multiple sclerosis (MS) patients treated with GilenyaĀ (fingolimod) compared with those treated with rituximab, and with people from the general population, a Swedish study suggests. The study, āCancer Risk for Fingolimod, Natalizumab, and Rituximab…
February 17, 2020 Columns by Ed Tobias MS News that Caught My Eye Last Week: Report on Ocrevus Use, Cognitive Decline in MS, Gold Nanocrystals and Remyelination Study Ocrevus Use Rises Among New Starters with RRMS, Loses Ground to Other Therapies in PPMS Ocrevus (ocrelizumab) bolted out of the starting gate after it was approved for use in the U.S. about three years ago. However, though its use by people with relapsing forms of multiple sclerosis continues…
February 12, 2020 News by Steve Bryson, PhD Gilenya Works to Treat RRMS by Specifically Targeting B-cells and T-helper Cells, Study Finds Treating people with relapsing-remitting multiple sclerosis (RRMS) for one year with the immune-modulating therapy Gilenya (fingolimod)Ā reduced the numbers of antibody-producing B-cells and of T helper cells, a study finds.Ā While the…
January 6, 2020 News by Patricia Inacio, PhD Brain Regeneration Impaired in Progressive MS, Unaffected By DMTs, Study Reports Regeneration in the brain is reduced in people with primary progressive multiple sclerosis (PPMS), but enhanced during disease activity in those with relapsing-remitting MS (RRMS), a study reports. The results also show that regeneration is unaffected by treatment with disease-modifying therapies (DMTs), as shown by the levels…
December 6, 2019 News by Joana Carvalho, PhD FDA Approves Three Generic Versions of Novartis’ Gilenya for Treating Relapsing MS The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS). A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the…
November 18, 2019 News by Iqra Mumal, MSc Mayzent Approved in Australia as First Treatment for Secondary Progressive MS Novartisās MayzentĀ (siponimod) has been approved by Australiaās Therapeutic Goods Administration (TGA) for the treatment of secondary progressive multiple sclerosis (SPMS), making it the first therapy to be approved for this use in Australia. SPMS is a form of MS that develops after the onset of…
November 7, 2019 News by Patricia Inacio, PhD Generic Version of Gilenya, pms-Fingolimod, Now Available for RRMS Patients in Canada PharmascienceĀ recently launched pms-Fingolimod, a generic version of NovartisāĀ GilenyaĀ (fingolimod),Ā to treat adults with relapsing-remitting multiple sclerosisĀ (RRMS) in Canada. The new generic is now available in that country, and has demonstrated efficacy and safety similar to Gilenya. GenericĀ medicines are chemically identical to the original branded therapy, but carry a…
November 4, 2019 News by Iqra Mumal, MSc Teva-Fingolimod, Generic and Bioequivalent Version of Gilenya, Available in Canada Teva Canada announced that Teva-Fingolimod 0.5 mg capsules, a bioequivalent generic version ofĀ Novartisā Gilenya (fingolimod), are now available in Canada and approved by the country’s national health system calledĀ Health Canada. GenericĀ medicines are chemically identical to the original branded therapy, but carry a significantly lower cost. Canadian…
November 1, 2019 News by Ana Pena PhD Interferons Superior to Glatiramer Acetate, and Tysabri More Effective than Gilenya for RRMS, Real-world Study Finds Interferon therapy (brand names Avonex, Betaseron, and others) is more effective than glatiramer acetate (sold as Copaxone, Glatopa and other generics) for reducing relapses…
October 22, 2019 News by Joana Carvalho, PhD Long-term Gilenya Treatment Safe and Effective for Relapsing MS Patients, Phase 3 Trial Shows Long-term treatment with Gilenya (fingolimod) in patients with relapsing forms of multiple sclerosis (MS) is safe and effective, results from a Phase 3 trial show. Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in…
October 17, 2019 News by Iqra Mumal, MSc Interleukin-22 May Be Biomarker to Monitor How Well RRMS Patients Respond to Therapy The levels of the inflammatory molecule interleukin-22 (IL-22) may be used as a potential biomarker to evaluate disease severity and the effectiveness of treatments in patients with relapsing-remitting multiple sclerosis (RRMS), a new study shows. The study, āImpact of interferon Ī²-1b, interferon Ī²-1a and fingolimod therapies on serum…
September 20, 2019 Columns by Ed Tobias Neuros Say that Flu Shots and Other Vaccines Are OK for Those with MS This is the time of year when my wife and I start thinking about getting our flu shots. We’ve already had the pneumonia and the older shingles vaccine and hope to soon update with the new shingles vaccine, Shingrix (recombinant zoster vaccine). These vaccines are OK with my neurologist and…
August 30, 2019 Columns by Ed Tobias Another Study Shows That Costs of Disease-modifying Therapies Are Zooming It probably comes as no surprise to you that the costs of some of the most popular MS medications have been soaring. A new study by researchers at the University of Pittsburgh reports that their list prices have more than quadrupled in a decade. And out-of-pocket costs rose even more.
August 28, 2019 News by Jose Marques Lopes, PhD Mavenclad Cost-Effective Treatment for At-risk RRMS Patients Compared to Other DMTs, Dutch Study Finds Treating at-riskĀ relapsing-remitting multiple sclerosis (RRMS) patients is most cost-effective withĀ MavencladĀ (cladribine) tablets when compared to Gilenya (fingolimod), Lemtrada (alemtuzumab) or Tysabri (natalizumab),Ā according to a study in Dutch patients. The study, āCost Effectiveness of Cladribine Tablets for the Treatment of Relapsing-Remitting Multiple Sclerosis in…
August 21, 2019 News by Ana Pena PhD Gilenya, Aubagio, Tysabri, Tecfidera Dominate MS Therapy Switches in Europe, Spherix Survey Finds Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘sĀ Aubagio (teriflunomide), andĀ BiogenāsĀ TysabriĀ (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…
August 2, 2019 Columns by Ed Tobias Using the Floodlight App to Track My MS Over the past several weeks, I’ve been using an app called Floodlight to track my ability to live with my multiple sclerosis (MS). It measures things such as my balance, finger dexterity, walking speed, and cognitive ability. It even knows if I’m keeping myself shuttered in my apartment or…
July 29, 2019 News by Patricia Inacio, PhD Early Gilenya Treatment Lessens Disability Progression and Disease Activity in Young RRMS Patients, Study Shows Early and continuous treatment with Gilenya (fingolimod) in youngĀ people ā those ages 30 years or younger ā with relapsing-remitting multiple sclerosis (RRMS) decreases the risk of disability progression, and lowers annual relapse rates and brain lesions, new analysis from the FREEDOMS and FREEDOMS II trials show. The…
July 23, 2019 News by Patricia Inacio, PhD Gilenya Approved in China for Adults and Children with Relapsing MS Gilenya (fingolimod) has been approved in China as a disease-modifying therapy to treat adults and children, ages 10 and older, with relapsing forms of multiple sclerosis (MS). Gilenya,Ā marketed byĀ Novartis, is an oral disease-modifying treatment for relapsing MS. It acts by binding and modulating receptors…
June 3, 2019 News by Joana Carvalho, PhD Mavenclad May Surpass Gilenya as DMT of Choice for Treatment of MS in Canada Mavenclad (cladribine) may surpass Gilenya (fingolimod) in the category of oral disease-modifying therapy (DMT) of choice for the treatment of multiple sclerosis (MS) in Canada, according to a press release. The Canadian healthcare market for MS has grown considerably over the past two years. In November…
May 16, 2019 News by Jose Marques Lopes, PhD #AANAM – Gilenya at 0.5 mg Superior to Copaxone at Lowering Relapses, Phase 3 Trial Shows Oral Gilenya (fingolimod) taken daily at a 0.5 mg dose is superior toĀ Copaxone (glatiramer acetate) injections at lowering relapses and disease activity over one year in patients with relapsing-remitting multiple sclerosis (RRMS), according to results of a Phase 3b trial. The research, āEfficacy and Safety…
May 6, 2019 News by Marisa Wexler, MS #AANAM – IV Therapy May Be More Effective Than Oral Treatment in Younger RRMS Patients, Research Suggests Infusible disease-modifying treatment ā that is, therapies given intravenously ā might have greater benefits for younger people with multiple sclerosis (MS) than oral ones, new research suggests. The research was presented at the ongoing American Academy of Neurology (AAN)’s annual meeting (May 4-10) by Brandi Vollmer,…
April 10, 2019 News by Jose Marques Lopes, PhD Different Ways of Working Tailor Mayzent for Early SPMS Patients, Novartis Says The effectiveness of MayzentĀ (siponimod) in both the brain and the body make it an oral therapy tailored for people with early secondary progressive multiple sclerosisĀ (SPMS), according to Dan Bar-Zohar, MD, top executive with Novartis, the treatmentās developer. Mayzent was recentlyĀ approvedĀ by the U.S. Food and Drug Administration…
March 19, 2019 Columns by Ed Tobias DMT Choice for Your MS Is Your Decision About 15 disease-modifying therapies (DMTs) are available to treat MS these days. So, choosing which to use can be daunting. I’ve been treated with four DMTs since I was first prescribed Avonex (interferon beta-1a) back in 1996. Each time I’ve switched treatments, my neurologist has suggested a number of…
February 18, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Misdiagnosing MS, Gilenya Relapse Study, Ocrevus in England, Estimate of Americans with MS Doubles Almost 1 in 5 People Wrongly Diagnosed with MS at Two Specialized Centers in US, Study Finds We know that MS is a difficult disease to diagnose, but is it really possible that 20 percent of the MS diagnoses are wrong? Apparently so. This study reports that…
February 15, 2019 News by Jonathan Grinstein Neurofilament Light Chain Levels in Blood of Value as Biomarker of MS Activity and Treatment Response, Study Finds Blood levels of a nerve cell-derived component known as neurofilament light chain (NfL) could be used as a biomarker of disease severity and treatment response in patients with relapsing-remitting multiple sclerosis (RRMS), a new study shows. The research article, āBlood neurofilament light chain as a biomarker of MS…
February 14, 2019 News by Santiago Gisler Continuous Use of Gilenya for Up to 3 Years Can Lead to 50% Drop in Annual Relapse Rates, Real-world Study Says Multiple sclerosis patients who began treatment withĀ Gilenya and stayed with it continuously showed a more than 50 percent reduction in annual relapse rates, a real-world study following these people for up to three years found. Gilenya,Ā marketed by Novartis, is an oral disease-modifying treatment forĀ relapsing-remitting multiple sclerosis , approved in 2010. It acts by binding and modulating receptors ā called sphingosine-1-phosphate receptor ā on lymphocytes (adaptive immune cells). By binding to these receptors, Gilenya prevents lymphocytes from leaving the lymph nodes and reaching the brain and spinal cord, and so lower lymphocyte-induced inflammation and damage. Although several clinical trials have reported reduced annualized relapse rates (ARRs) upon treatment with Gilenya, few long-term real-life studies have examined the relapse rate reductions over a long term. A team, led by Novartis researchers and a scientist atĀ Central Texas Neurology Consultants,Ā collected MS patient data from the MarketScan database, a U.S. claims database including medical and pharmacy claims (bills submitted to health insurance providers), between 2009 and 2016. Among 9,312 MS patients in the database with at least one filled Gilenya prescription, 1,599 adults (mean age, 46) met the study's inclusion criteria, including having at least one inpatient or two outpatient claims, and a total of four years of continuous health plan enrollment. Among theseĀ 1,599 patients, all usedĀ Gilenya for one year (cohort 1), 1,158 (72.4%) took Gilenya continuously up to the start of year two (cohort 2), and 937 (58.6%) used the therapy up to the start of year three (cohort 3). Baseline analysis ā measures taken at the study's start ā showed that the most common MS-linked symptoms were disorders of the optic nerve and visual pathways (reported in 22-24%), followed by fatigue/malaise (20-21%). Hypertension (20-21%) and depression (15-16%) were the most common physical and mental comorbidities, respectively. The mean annualized relapse rates (AARs) at baseline in these three groups of patients ā cohorts 1 to 3 ā ranged between 0.48 and 0.51. A consistent reduction in ARRs was seen in all three groups: cohort 1 had a 0.25 ARR at the close of the first year, for a 51% reduction from the baseline rate; cohort 2 a 0.22 ARR at the start of year two, for a Ā 54% lowering in relapse rates from baseline; and cohort 3 had 0.23 ARR at the third year, amounting to a 53% reduction. As expected, when researchers calculated ARRs among patients with continuous Gilenya use over these three years, they found a greater reduction in annual relapse rates. Mean ARRs in continuous-use patients were 0.19 (a 61% reduction) during the first year, 0.18 (a 62% reduction) during the second year, and 0.18 (a 61% reduction) at the start of the third year. āThis retrospective claims database study found that patients with MS who received fingolimod [Gilenya] therapy experienced a durable and sustained reduction in relapse rates over a 3-year period,ā the researchers wrote, with findings representingĀ āa durable reduction in relapse rates by [more than] 50%.ā Reasons that some patients discontinued treatment were not a focus of this study, they added.
January 30, 2019 News by Jonathan Grinstein Canadian RRMS Patients Less Likely to Discontinue Treatment with Oral Gilenya, Compared to Injectable or Infusible Therapies Multiple sclerosisĀ (MS) patients in Canada are more likely to comply with their treatment plan and less likely to discontinue the use of the oral disease-modifying treatment Gilenya (fingolimod), compared to injectable or infusible treatment options, new research shows. The research article with that finding, āA…
January 29, 2019 Columns by Ed Tobias New Study Supports Hitting MS Fast and Hard The question of how quickly to start a disease-modifying therapy (DMT) after a multiple sclerosis (MS) diagnosis is one that I frequently see when I browse online. It goes hand in hand with questions about which DMT is best to start with. There are many things to consider when…
January 29, 2019 News by Patricia Inacio, PhD Gilenya Better at Lowering Relapse Rate than Tecfidera or Aubagio, Study Suggests Gilenya is linked to significantly lower annualized relapse rates in relapsing-remitting multiple sclerosis (RRMS) patients compared to Tecfidera orĀ Aubagio, a study suggests. All three therapies showed similar effects on disability outcomes. Oral immunotherapies ā including Novartisā Gilenya, Biogenās Tecfidera, and Sanofi Genzymeās Aubagio ā are currently standard therapies for RRMS treatment. But while these therapies are highly effective at modulating MS activity, studies comparing their efficacy on relapse and disability are missing. This is an important point for MS patients, so that if a change in oral therapies is needed (due to lack of tolerance, for example), the decision on a more suitable therapy is based on scientific evidence. To address this matter, a group of researchers used the MsBase, an international observational MS cohort study, to identify RRMS patients who had been treated with Gilenya, Tecfidera, or Aubagio for at least three months. The team compared Tecfidera versus Aubagio, Gilenya versus Aubagio, and Gilenya versus Tecfidera, specifically for the therapyās impact on relapse activity, six-month disability worsening or improvement, and persistence of treatment. Relapse was defined as the occurrence of new symptoms or exacerbation of existing ones for a period of over 24 hours, at least 30 days after a previous relapse. Disability was assessed using the Expanded Disability Status Scale (EDSS); the six-month disability worsening or improvement were defined as an increase or a decrease by one value in EDSS. The study included 614 patients treated with Aubagio, 782 with Tecfidera, and 2,332 with Gilenya. Patients were followed over a median of 2.5 years. Patientsā characteristics at baseline differed among the three groups. Aubagio-treated patients tended to be older, with longer periods of disease, fewer relapses, and lower EDSS scores compared to the other two groups. Patients treated with Gilenya had higher EDSS and more relapses during the prior year, compared to those treated with Tecfidera. The majority of the patients had been treated with other immunotherapies prior to being given one of these three oral treatments. Results showed that Gilenya-treated patients had significantly lower annualized relapse rates than those treated with Tecfidera (0.20 versus 0.26) or Aubagio (0.18 versus 0.24), while patients taking either Tecfidera or Aubagio had a similar rate. However, during the 2.5-year period analyzed, researchers found no differences in disability accumulation or disability improvement among the three therapies. Regarding treatment persistence, Tecfidera and Aubagio were more likely to be discontinued than Gilenya. Overall, the results suggest that treatment with Gilenya may have a greater impact on relapse frequency in RRMS patients compared to Tecfidera and Aubagio, although the "effect of the three oral therapies on disability outcomes was similar during the initial 2.5 years on treatment," researchers said. āChoosing a therapy in individual patients remains a complex task that requires thorough and individualized evaluation of disease prognosis, and the corresponding risks and benefits of the increasing number of available therapies,ā they concluded.
January 17, 2019 News by Jose Marques Lopes, PhD Fewer RRMS Patients Relapse, Discontinue Treatment with Gilenya, Study Finds Relapsing-remitting multiple sclerosis (RRMS) patients on Gilenya (fingolimod) have fewer relapses and stay on treatment longer than those takingĀ Tecfidera (dimethyl fumarate) or Aubagio (teriflunomide), according to a new study. The research, āComparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis,ā was published…