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…
April 17, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Siponimod Reduces Disease Activity Biomarker in SPMS Patients Novartis‘ siponimod (BAF312) can reduce blood levels of a biomarker of nerve cell damage in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. Researchers will present the latest results of the ongoing trial at the 2018 annual meeting of the American Academy…
March 27, 2018 News by Alice MelĆ£o, MSc Siponimod Reduces Risk of SPMS Patients’ Disability Worsening, Phase 3 Trial Shows Siponimod (BAF312) reduces the risk of disability progression in patients withĀ secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. An article about theĀ NovartisĀ therapy’s trial resultsĀ appeared in the journal The Lancet. The title is āSiponimod versus placebo in secondary progressive multiple sclerosis…
March 15, 2018 News by Patricia Inacio, PhD New Spherix Report Finds PPMS Treatment Increased Significantly in Past Year Since Genentech‘sĀ OcrevusĀ was approvedĀ a year ago, the treatment rate of primary progressive multiple sclerosis (PPMS)Ā has increased significantly. However, a closer look at the data shows that other disease-modifying therapies (DMTs) are equally responsible for this increase. The findings were reported byĀ Spherix Global InsightsĀ in their new study…
March 7, 2018 News by Diogo Pinto Novartis, Pear Collaborating on Digital Therapeutics to Treat MS, Schizophrenia Novartis and Pear Therapeutics are joining forces to develop novel prescription digital therapeutics to treat patients with schizophrenia and multiple sclerosis (MS). Digital therapeutics are software applications designed to treat diseases and improve clinical outcomes for patients.Ā Combining Novartisā expertise in biomedical research and clinical development with Pearās…
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.
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 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 23, 2018 Columns by Ed Tobias Who Are You to Tell Me What MS Therapy I Need? I’m used to seeing insurance companies here in the United States make decisions about MS therapies, including refusing to pay for certain treatments unless other, less expensive ones are tried first. These, of course, are decisions that should be made between patients and their doctors, not by insurers.
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 22, 2017 News by Catarina Silva Britain’s National Health Service Likely to Cover the Multiple Sclerosis Therapy Extavia Britain’sĀ National Health ServiceĀ should cover the multiple sclerosis therapy Extavia, the National Institute for Health and Care ExcellenceĀ (NICE) has recommended. The health service usually follows the institute’s recommendations. So NICE’s endorsement means there is a good chance the health service will begin covering the Extavia prescriptions that…
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 15, 2017 News by Patricia Silva, PhD Ocrevus’ Use Continues Rising, with RRMS Patients Receiving the Most Attention U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global InsightsĀ 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.
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 28, 2017 News by Patricia Silva, PhD European Neurologists Ready to Use Both Mavenclad and Ocrevus, Survey Shows Mavenclad has become the multiple sclerosis therapy of choice for one in five neurologists in Germany and the United Kingdom,Ā according to a Spherix Global InsightsĀ survey. Meanwhile, many European neurologists are looking forward to the continent's approval of Ocrevus, particularly as a treatment for primary progressive multiple sclerosis, or PPMS. The United States approved the therapy in March of 2017. European neurologists are using Mavenclad for both relapsing-remitting multiple sclerosis, or RRMS, and secondary progressive multiple sclerosis, SPMS. The report that Spherix issued on European neurologists' treatment choices is calledĀ "RealTime Dynamix: Multiple Sclerosis EU."Ā It was based on a survey of 261 neurologists, who were asked about thei disease-modifying drugs they prescribed and the way they manage MS, according toĀ a press release. The survey focused on Merck KGaAās Mavenclad, whichĀ the European Union approved in August 2017, and Genentechās Ocrevus, which the European Commission is expected to approve soon. The European Medicines Agency paved the way for approval byĀ recommending its authorization earlier this month. Mavenclad is the first disease-modifying therapy that most of the patients who are on it have tried, according to the survey. Spherix analysts said this indicates that Mavenclad may expand the proportion of MS patients using disease-modifying drugs. But while Mavencladās label allows patients to use it as a first-line therapy, the survey revealed that many neurologists are not comfortable prescribing it as an initial treatment. This suggests that the Mavenclad-treated population may later include more patients who switched treatments, Spherix said. Mavenclad reduces MS relapses by resetting the immune system, studies have shown. Neurologists who prescribe it as a first-line treatment appear to endorse the idea of induction therapy. This approach involves more potent therapies being used from the onset of the disease.Ā British neurologists in particular appear to favor the induction approach, the report revealed. Patients who had been on previous treatments have switched mainly from Copaxone (glatiramer acetate), interferons, or Novartis' Gilenya, the report showed. Many neurologists' lack of familiarity with Mavenclad may be limiting its use, the report said. It noted that two out of five neurologists had not received a detailed briefing on the drug, and more than one-third had not attended any launch activities. Limited market access was the second most common obstacle to Mavenclad prescription, the report indicated. Interestingly, those who had participated in Mavenclad launch activities said these consisted mostly of independent research or discussions with colleagues, rather than activities organized by Mavencladās developer Merck KGaA. Spherixās survey was done just before the European Medicines Agency recommended Ocrevus' approval in mid-November. Even before the endorsement, the survey indicated, Ocrevus was by far the MS drug in development that most neurologists looked forward to using. The reasons, the neurologists said, were its beneficial effectiveness-safety profile, its new mechanism of action, the fact that it only needs to be given once every six months, and a treatment label that includes PPMS. It is the first disease-modifying drug ever approved for PPMS patients. Twice as many neurologists said they look forward to using Ocrevus as a first-line treatment for PPMS as those saying they wanted to use it as a first-line treatment for relapsing MS. And neurologists estimated that twice as many PPMS patients as RRMS patients are appropriate candidates for Ocrevus treatment. In a report in October about U.S. neurologists' treatment preferences, Spherix said those doctors estimated the number of PPMS Ocrevus candidates at three times that of RRMS patients. Nonetheless, about equally as many PPMS and RRMS patients had tried Ocrevus four months after its launch, the survey showed. The European situation may evolve in a similar manner, since the European Medicines Agency recommended a specific use of Ocrevus in PPMS patients. It specified that the drug be used in PPMS patients who show āimaging features characteristic of inflammatory activity."Ā This makes it likely that only a subgroup of PPMS patients will receive the treatment. The use of Biogen's Tysabri, Gilenya, and Rituxan (rituximab), also made by Roche'sĀ Genentech subdivision, will be most impacted by Ocrevus' introduction. Despite this, neurologists believe rituximab's use will grow in the next six months, because Ocrevus is still not available, while lower-cost rituximab biosimilars are.
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 27, 2017 News by Patricia Silva, PhD #MSParis2017 ā Early High-Efficacy Treatment Reduces Disability Accumulation in Young MS Patients 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…
October 26, 2017 News by Patricia Silva, PhD #MSParis2017 – Siponimod Leads to Dramatic Drop in MS Lesions, Phase 3 Trial Shows Novartis’Ā SiponimodĀ led to a dramatic drop in the number of inflammation patches in the brains and spinal cords of secondary progressive multiple sclerosis patients, according to a Phase 3 clinical trial. Robert Fox of the Cleveland Clinic’sĀ Mellen Center for Treatment and Research in Multiple SclerosisĀ presented the findings…
October 18, 2017 News by Patricia Silva, PhD #MSParis2017 – Progressive MS Research Among ECTRIMS Highlights, National MS Society Says The 7th Joint ECTRIMS-ACTRIMS Meeting, taking place in Paris this month, is one of the largest scientific conferences focused solely on multiple sclerosis (MS), and the National Multiple Sclerosis Society will be among the many interested parties attending. To get a feeling for meeting highlights and presentations the…
September 14, 2017 Columns by Laura Kolaczkowski Thereās an App (Maybe Too Many) for That! How many hours do the pharmaceutical companies think we have in our day? I ask because almost all of them have come up with very slick tools to use, particularly mobile apps, to help us improve our daily lives with MS. Not coincidentally, these apps also provide their…
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.
August 25, 2017 Columns by Ed Tobias How’s Your MS? Ask This App I’ve just added an app to my iPhone that’s designed to track how I’m doing day-to-day with my MS. Not only can the data it collects be useful to me and to researchers, the app also is fun to use. The app is called elevateMS. It’s…
August 24, 2017 News by Patricia Inacio, PhD MS Patients Can Use Smartphone to Take Part in Novartis Study of Movement Performance and Symptoms A multiple sclerosis study will collect information about patients' movement performance and symptoms from their smartphones, Novartis has reported. The study is aimed at evaluating in real time the daily challenges of people living with MS. The results may help researchers develop new ways to measure treatments' effectiveness, the company said. Novartis is partnering on what it has dubbed the elevateMS study with Sage Bionetworks. The non-profit research organization is developing new predictors of disease to accelerate health research. A cellphone application will allow MS patients to send information about their situation from anywhere. The app will use sensors to gather information on patients' movements. It will also assess functional performance tasks that participants engage in. Patients can also fill out questionnaires with the app. A division of Apple called the Apple ResearchKit platform developed the app. Those interested in participating in the study can download it here. The elevateMS app allows a smartphone user to register important features of their disease. It includes a symptom tracker tool that allows users to record their overall wellness. They can also get an overview of what's been happening to them on an activity dashboard. Patients, neurologists and disease advocates gave Apple's app team input that helped with the design. "As physicians, we always want to know how our patients with MS are doing on the treatments we prescribe," Dr. Stanley Cohan, medical director of the Providence Multiple Sclerosis Center in Portland, Oregon, said in a press release. "With the elevateMS app, study participants can frequently document their symptoms in a personal health story," said Cohan, one of the scientific advisors to the study. "In turn, this data may provide researchers with new ways to look at disease progression and treatment effectiveness." The elevateMS study is open to MS patients 18 years old or older in the United States who own a smartphone. Additional information about it is available at www.elevatems.org.
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…
April 17, 2017 News by Joana Fernandes, PhD Genentech, Novartis, Sanofi Genzyme Support Nationwide 2017 ‘Walk MS’ Events Genentech, NovartisĀ and Sanofi Genzyme are sponsoring this yearās Walk MS, an annualĀ event to raise funds for multiple sclerosis (MS) and the National Multiple Sclerosis Society (NMSS). Genentech, a division of Roche, returns as an MS Walk sponsor for the second year and will promote the āMS Voiceā…