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 22, 2018 Columns by Tamara Sellman The MS Alphabet: Remyelination, RRMS, Quadrantanopia, and Other ‘Q’ and ‘R’ Terms Editorās note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letters “Q” and “R.” Symptoms of MS Quadrantanopia This eye-related symptom of MS refers to the compromising of vision in one of the quarters of the visual field,…
March 16, 2018 Columns by John Connor Into the Woods Well, I’m usually fairly upbeat, but this time, it’s going to be beyond me. We’ve all had relapses ā I think I’m in the fitting clichĆ© of being on my last legs. I can, on a good day, transfer on my own from the bed to my trusty…
March 9, 2018 News by Patricia Inacio, PhD Merck’s MS Therapy Evobrutinib Significantly Reduces Brain Lesions, Phase 2 Trial Shows Merck KGaA’sĀ evobrutinib led to significant reductions in relapsing multiple sclerosis patients’ brain and spinal cord lesions, compared with a placebo, a Phase 2b clinical trial showed. Researchers measured the number of lesions at weeks 12, 16, 20 and 24. Evobrutinib, also known as M2951, is an oral inhibitor of…
March 1, 2018 News by Alice MelĆ£o, MSc Argentina Approves Mavenclad for Active Relapsing MS Argentina has become the first country in Latin America to approve MavencladĀ (cladribine) as a treatment for adults with highly active relapsing multiple sclerosis. The Argentinian Administration of Medicines, Food and Medical Technology's approval coveredĀ Merckās cladribine tablet formulation. Merck expects to make the treatment available in the country in the next few months. Mavenclad has already been approved in Canada, Australia, Israel, and Europe. Merck is seeking approval in the United States and other countries. "Having a new MS treatment approved in Argentina is very motivating," Dr. Jorge Correale of the Institute for Neurological Research Dr. RaĆŗl Carrea said in a press release. "Mavenclad allows the patient's immune system to go through a selective immune reconstitution, similar to a reset, and the treatment mechanism is simple because it does not require frequent administration or monitoring," said Correale,Ā head of the institute's neuroimmunology and demyelinating diseases department. Mavenclad is designed to target the immune T- and B-cells that trigger relapsing MSĀ without suppressing the entire immune system. With a maximum of 20 days' treatment over two years, the oral drug promotes long-term inhibition of harmful immune cells, reconstituting the immune system. MS is an autoimmune disease, or one in which the immune system attacks normal tissue as well as invadors. Argentine regulators based their approval on the results of five clinical trials. These were the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS studies, the Phase 2 ONWARD study, and the long-term PREMIERE study. These trials involved more than 2,700Ā patients with relapsing MS, some of whom researchers followed for more than 10 years. The trials showed that Mavenclad can significantly reduce MS relapse rates, disability progression and brain atrophy. The treatment is recommended for patients who fail to respond adequately, or are unable to tolerate, other therapies. "We are pleased the Argentinian Administration of Medicines, Food and Medical Technology has approved Mavenclad," said Rehan Verjee, the chief marketing and strategy officer of Merck's biopharma business. "Our goal is to ensure fast access to patients who may benefit from this innovative therapy, and we will be working with payers on obtaining reimbursement as a next step."
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 14, 2018 News by Patricia Inacio, PhD Italian Study Examines Tysabri and Risk for Miscarriage and Birth Defects Pregnant women with multiple sclerosis (MS) exposed to Tysabri (natalizumab) in the first trimester had higher rates of miscarriage and major birth defects in their babies, than women left untreated or treated with interferon beta, a study shows. Although higher, these rates were similar to those in the general…
February 9, 2018 News by Patricia Inacio, PhD #ACTRIMS2018 ā Third Course of Lemtrada Improves Relapse, Disability in MS Patients, CARE-MS II Trial Shows Multiple sclerosis (MS) patients who experience a relapse after two courses ofĀ Lemtrada (alemtuzumab)Ā treatment showed improvements inĀ relapse rate and disability after aĀ third Lemtrada course, according to results of the CARE-MS II trial extension. The poster reporting the findings, titled āEfficacy of Alemtuzumab Retreatment in Patients Who Experienced Disease Activity after…
February 8, 2018 News by Jose Marques Lopes, PhD #ACTRIMS2018 – Ozanimod Reduces MS Relapses and Brain Deterioration, Phase 3 Trial Shows Celgene’sĀ Ozanimod reduces relapsing multiple sclerosis patients’ relapses, brain lesions, and brain volume loss, a Phase 3 clinical trial shows. The company presented the results of the SUNBEAM trial atĀ theĀ ACTRIMS Forum 2018Ā convention in San Diego, Feb. 1-3. The presentation was titled āOzanimod Demonstrates Efficacy and Safety…
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 Patricia Inacio, PhD MS Patients’ High Osteopontin Protein Levels Make It a Potential Biomarker for the Disorder, Study Reports Multiple sclerosis patients have high levels of a protein called osteopontin in their cerebrospinal fluid and blood, making it a potential tool for diagnosing the disease and predicting its course, a study suggests. The research, āOsteopontin (OPN) as a CSF and blood biomarker for multiple sclerosis: A systematic review and meta-analysis,ā was published in the journal PLOS One. Researchers wanted to know if levels of osteopontin inĀ cerebrospinal fluid and bloodĀ could be a reliable biomarker for MS. To arrive at answer, they āconducted a systematic review and meta-analysis" of studies that had measured the protein's levels in cerebrospinal fluid and blood "in MS patients and controls." The team searched for studies in three databases ā PubMed, Web of Science and Scopus. Out of 27 that met their criteria, they used 22 in the meta-analysis. All four types of MS were represented in the studies ā clinically isolated syndrome, relapsing-remitting MS, secondary progressive MS, and primary progressive MS. There were three types of controls in the articlesĀ ā healthy people, people with non-inflammatory neurological disorders, and people with inflammatory neurological disorders. Researchers' first observation was that all of the MS patients had higher levels of osteopontin than controls. The protein's levels were significantly higher in relapsing-remitting MS patients than in those with clinically isolated syndrome, the group with the lowest osteopontin levels. Levels were similar in the other types of MS. Patients with an active disease had significantly higher levels of the protein in their cerebrospinal fluid than those with a stable disease. The results supported previous studies' findings that osteopontin levels are higher than normal in the cerebrospinal fluid and blood of MS patients, strengthening the notion that it could be used as a biomarker for MS. āGiven the fact that OPN [osteopontin] levels are higher during relapses, we think that by monitoring this biomarker, Ā we might be able to predict the disease course," the team wrote. "We propose that developing drugs modulating OPN concentration may be a new treatment strategy for MS."
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
December 19, 2017 News by Patricia Inacio, PhD Additional Diseases Increase Risk of MS Relapses, Canadian Study Shows Multiple sclerosis patients with additional diseases, high cholesterol levels or a history of migraine headaches are more likely to experience relapses than other patients, a Canadian study shows. The report, āComorbidity increases the risk of relapse in multiple sclerosis,ā was published in the journal Neurology. Researchers…
December 11, 2017 News by Alice MelĆ£o, MSc Australia Approves Shorter Mavenclad Treatment Regimen for Relapsing-Remitting MS Australia has approved a shorter treatment regimen ofĀ MerckāsĀ MavencladĀ for relapsing-remitting multiple sclerosis. The Therapeutic Goods Administration authorized 20-day courses of the cladribine tablet form of the medication once a year for two years. The regimen reduces relapse rates and the progression of the disease for up to four years, Merck said. The new approval came after Merck submitted additional clinical trial findings on theĀ therapy. Health CanadaĀ andĀ the European CommissionĀ approved Mavenclad earlier this year. Merck continues to seek its regulatory approval in the United States and other countries. "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS,ā Bill Carroll, clinical professor of neurology at the University of Western Australia and the Perron Institute, said in a press release. āAs an oral therapy taken in two short courses over a two-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional," added Carrol, a neurology consultant at the Sir Charles Gairdner Hospital as well as president-elect of the World Federation of Neurology. Mavenclad targetsĀ immune cells that trigger relapsing MS.Ā Multiple sclerosis is an autoimmune disease, or one in which the immune system attacks healthy cells. Mavenclad inhibitsĀ harmful immune T- and B-cells without suppressing the entire immune system. Australia based its approval of the drug on the findings of a number of clinical trials, including the Phase 3 CLARITY, CLARITY EXTENSION and ORACLE-MSĀ studies, the Phase 2 trial ONWARD study, and the long-term PREMIERE studies. The trials involved more than 2,700 RRMS patients, some of whom were followed more than 10 years. The trials showed that Mavenclad can significantly reduce relapse rates, disability progressionĀ and brain atrophy. Doctors recommended the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments. "We are pleased the Therapeutic Goods Administration has updated the product Information for Mavenclad in Australia to reflect additional clinical data," said Simon Sturge, chief operating officer of Merck's biopharma business. "Our next step is to work closely with the Australian government to bring this treatment advance to patients as quickly as possible."
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.
December 6, 2017 News by Alice MelĆ£o, MSc Health Canada Approves Merck’s Mavenclad to Treat RRMS Canadians with relapsing-remitting multiple sclerosis can now receiveĀ Merckās Mavenclad, now thatĀ Health CanadaĀ has approved Mavenclad as a therapy to reduce the frequency of MS exacerbations and delay disease progression. Merck expects the drug to be commercially available by early January 2018 throughout Canada, which has the world's highest MS rate. This follows the drugās approval by the European Commission in August, making Mavenclad Europe's first approved highly efficient, oral short-course therapy for relapsing MS. Merck said it would seek regulatory approval of Mavenclad in other countries, including the United States. Mavenclad was designed to selectively target immune cells that trigger relapsing MS, while resetting the immune system. With two annual courses of treatment for a maximum of 20 days over two years, the oral drug promotesĀ long-term inhibition of harmful immune T- and B-cells, without continuous suppression of the immune system. Researchers evaluated Mavenclad in five clinical trials: Phase 3 trials CLARITY, CLARITY EXTENSION and ORACLE-MS; the Phase 2 trial ONWARD study ; and the long-term study PREMIERE. These involved more than 2,700 RRMS patients, some of whom were observed for more than 10 years. Clinical data showed that Mavenclad can significantly reduce disability progression, annualized relapse ratesĀ and brain atrophy. The treatment is generally recommended for patients who failed to respond adequately, or are unable to tolerate, one or more MS therapies.
December 4, 2017 News by Ashraf Malhas, PhD Analysis Suggests Oral Steroids Better Than Intravenous Ones for Treating Relapsing MS Oral steroids may be cheaper, more convenient and less invasive alternatives than intravenous steroids in treating relapses in multiple sclerosis (MS) patients, suggests an analysis of five randomized trials. Glucocorticoids are recommended as the first line of treatment for MS relapses. Yet recent studies have shown no significant difference between…
November 27, 2017 News by Patricia Inacio, PhD Vegetable-rich Diet Promotes Bacteria That Fights Inflammation in MS, Study Shows A diet rich in vegetables and low in protein reduced inflammation in multiple sclerosis (MS) patients by modulating the gut microbiome and promoting bacteria that helps control a hyper-reactive immune system. The study reporting the findings, āImmunological and Clinical Effect of Diet Modulation of the Gut…
November 2, 2017 News by Ashraf Malhas, PhD #MSParis2017 – Almost Half of MS Patients Fail to Report Relapses, Two Surveys Show Nearly half of multiple sclerosis patients do not always report their relapses to healthcare providers, two surveys indicate. MallinckrodtĀ sponsored the surveys to betterĀ understand patients’ experience with relapses, whichĀ are sudden episodes of new symptoms or worsening of existing symptoms. The company presented the survey results at the 7th joint meeting…
October 30, 2017 News by Alice MelĆ£o, MSc #MSParis2017 – RADIANCE Trial Data Shows Ozanimod’s Potential Over Interferon Beta-1a for Relapsing MS Celgene‘s investigative drug ozanimod has been shown to be more efficient thanĀ an intramuscular injection of interferon beta-1a (marketed as AvonexĀ by Biogen) in reducing relapses and disease progression in patients with relapsing multiple sclerosis (MS), according to results of the two-year Phase 3 RADIANCE trial. The findings were…
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 27, 2017 News by Patricia Silva, PhD #MSParis2017 ā Phase 3 Trial Data Show Ozanimod Safe, Effective in MS Patients Ozanimod (RPC1063) was seen to lower relapse rates and reduce brain and spinal cord lesions among patients with relapsing multiple sclerosis (MS) participating in a Phase 3 study of the treatment. Giancarlo Comi,Ā from theĀ Vita-SaluteĀ San RaffaeleĀ University, in Italy, announced the results in a presentation during the ongoing…
October 27, 2017 News by Patricia Silva, PhD #MSParis2017 – Researchers Suggest Best Time to Stop Tysabri During Pregnancy Babies born to women who are treated with Tysabri (natalizumab) during pregnancy are more likely to develop abnormal blood cell counts if the treatment continues beyond week 30 of pregnancy. Since more relapses occurred in women who quit the treatment before this time, researchers from the Ludwig Maximilian University…
October 27, 2017 News by Alice MelĆ£o, MSc #MSParis2017 ā Anti-inflammatory Therapies May Be More Beneficial for Younger SPMS Patients, Study Suggests Older patients with secondary progressive multiple sclerosis (SPMS) have reduced risk of experiencing disease relapse, according to a study presented at theĀ 7th Joint ECTRIMS-ACTRIMS Meeting, being held Oct. 25-28, in Paris, France. The study, āRelapses in patients with secondary progressive MS: a matter of disease duration…
October 2, 2017 News by Patricia Silva, PhD Long-term Lemtrada Treatment Benefits Demonstrated in Extension Study A five-year study demonstrated that Sanofi-Genzymeās Lemtrada (alemtuzumab) provides long-term benefits forĀ relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease. Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions. The study,…
September 19, 2017 News by Patricia Silva, PhD TG Therapeutics Recruiting Patients for Two Phase 3 Trials of Relapsing MS Therapy TG-1101 TG TherapeuticsĀ is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab)Ā as a treatment for relapsing forms of multiple sclerosis. ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, aĀ glycoengineered monoclonal antibody, with Genzyme’sĀ Aubagio…
September 12, 2017 News by Patricia Silva, PhD Swedish Study Suggests Stem Cell Transplants as Possible Treatment for Aggressive RRMS Autologous hematopoietic stem cell transplants for relapsing-remitting multiple sclerosis (RRMS) are superior to currently approved disease-modifying drugs,Ā according to a Swedish studyĀ published in the Journal of Neurology, Neurosurgery & Psychiatry. In addition, says the review, the procedure’s safety profile has improved in the last decade, and is now just…
September 8, 2017 Columns by Ed Tobias When Do MS Symptoms Become a Relapse? Am I having an MS relapse? I saw that question asked the other day on one of the social sites I follow. At first, I thought, “Gee, doesn’t everyone with MS know when they’re having a relapse?” Then I realized thatĀ for several years after I was diagnosed, I…
September 7, 2017 News by Patricia Silva, PhD Merck Extension Study Confirms Mavencladās Long-term Benefits in Relapsing MS Patients Three-fourths of relapsing multiple sclerosis patients who took two short courses of Mavenclad over two years remained relapse-free for four years, according to newly published data from the medication's Phase 3 extension trial. Moreover, patients who took Mavenclad during the first two years and then a placebo for the next two years fared similarly to those who took Mavenclad for the entire four-year period. The European Commission on Aug. 25 approved Mavenclad ā developed by Merck KGaA (known as EMD in North America) ā to treat relapsing forms of MS in Europe. It based that approval on data from the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS trials, as well as the Phase 2 ONWARD trial, and the ongoing long-term PREMIERE study. Besides showing the long-term impact of two short courses of Mavenclad ā patients took tablets for a maximum of 20 days over two years ā this latest study showed that continuing treatment into the third or fourth year offered no additional benefits. This finding supports Merckās earlier studies, which suggested that Mavenclad resets the immune system. This is a stark contrast in treatment approach to most approved MS drugs which work by suppressing either T- or B- immune cells over the long term. Researchers also deemed safety to be similar in the two groups. Most adverse events were mild or moderate, and most patients who had their B-cells and T-cells depleted in the first part of the study had normal, or nearly normal, levels at the end of the extension. Shingles were most common in patients who received the highest cumulative dose of the drug, affecting 4.8 percent of participants. But in the remaining treatment groups, rates of the viral infection were similar at 1.1 to 2 percent, researchers said. Besides Merck's own studies, an independent study recently demonstrated that Mavenclad also improves patientsā quality of life. As such, the company plans to file regulatory approval for Mavenclad in the United States and elsewhere.