August 14, 2020 Columns by John Connor Relapse, Relapse, Relapse, Profanity, Relapse Maybe I should have called this one “Short and Sharp 2.” Yes, I’ve had another relapse, following my last one in May. I can no longer clean my own tail, and the present regime is literally to “s**t the bed!” I’m using a lot of exclamation points here,…
July 30, 2020 News by Marta Figueiredo, PhD Healthy Diet May Lower Risk of Relapse After 1st Myelin Attack, Study Suggests A “prudent” diet rich in fresh fruit, non-fried fish, whole grains, vegetables, and nuts may lower the likelihood of a relapse in people with a first demyelinating event, a major risk factor forĀ multiple sclerosis (MS), a study in Australia suggests. While the researchers did not find a strong link…
July 9, 2020 News by Patricia Inacio, PhD Disability Builds in Relapsing MS in Ways Not Tied to Relapses, Analysis Finds Disability appears to mostly accumulate in people with relapsing forms of multiple sclerosis (MS) in a progressive manner ā rather than being due to relapses, a pooled analysis of patients in two Ocrevus (ocrelizumab) clinical trials shows. These findings, indicating that disease progression underlies relapsing MS as well,…
July 7, 2020 News by Marta Figueiredo, PhD Study: Mavenclad Shows Long-term Effectiveness at Preventing MS Relapses, Disease Progression MavencladĀ (cladribine) prevents relapses and disease progression in more than half of patients with relapsing forms of multiple sclerosis (MS) for at least five years after the last dose, according to a real-life study from Italy. These findings, based on real-world data from Italian MS patients previously treated…
June 29, 2020 News by Marisa Wexler, MS Tecfidera Safe and Effective Over Years of Use, RRMS Study Finds Tecfidera (dimethyl fumarate) is safe and effective as a long-term treatment for relapsing-remitting multiple sclerosis (RRMS), a study of clinical trial data covering up to 11 years of treatment suggests. The study, “Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis:…
April 14, 2020 Columns by Jessie Ace An April Fools’ Joke that Wasn’t Very Funny “I canāt move my head,” I thought.Ā It was 5 a.m. on April 1, and the realization of my full bladder prompted my wakening. But I soon realized I had a more significant issue that only became apparent when I tried to get up and couldn’t. What on…
March 20, 2020 News by Marisa Wexler, MS Janssen Seeks FDA Approval for Oral Ponesimod for Treating Relapsing MS Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) asking for ponesimodĀ to be approved as an oral treatment for adults with relapsingĀ multiple sclerosis (MS). Ponesimod, formerly ACT-128800, is an experimental treatment that targets the proteinĀ sphingosine-1-phosphate…
March 2, 2020 News by Patricia Inacio, PhD #ACTRIMS2020 – Acthar Gel Ably Treats MS Relapses, Topline Data Show Acthar GelĀ (repository corticotropin injection) leads to significant improvements after two months of use in people with multiple sclerosis (MS) still having acute relapses despite treatment, and who failed to respond to other high-dose corticosteroids, topline data from an observational study show. The gel’s developer, Mallinckrodt Pharmaceuticals, also…
February 28, 2020 News by Patricia Inacio, PhD #ACTRIMS2020 – Depression in MS Linked to Worsening Neurological Function Multiple sclerosis (MS) patients with depression are more likely to have worsening neurological function compared with those who do not have the mood disorder, results from a real-world study show. The findings were presented Feb. 27 by Jenny Feng, MD, in an oral presentation ā titled “…
February 24, 2020 News by David Melamed, PhD MS Patients Switching from Tysabri to Other Therapies May Risk Disease Activity Multiple sclerosis (MS) patients switching from Tysabri (natalizumab) to other disease-modifying therapies may have an increased risk of disease activity, though the risk is lower if the switch is limited to three months, a study found. The results were published in an article, “Effect of…
January 21, 2020 News by Marta Figueiredo, PhD Mayzent Approved in Europe as First Oral Treatment for Active Secondary Progressive MS TheĀ European CommissionĀ has approvedĀ Novartis‘s MayzentĀ (siponimod) as the first oral treatment for adults with active secondary progressive multiple sclerosisĀ (SPMS). Active SPMS is defined by the presence of evident relapses or the detection of inflammatory activity in brain lesions on imaging scans. āAs the only indicated oral therapy proven for…
November 20, 2019 News by Marta Figueiredo, PhD Pregnancy Does Not Change Long-term Course of MS, New Data Suggest Pregnancy does not lead to long-term changes in the disease course ofĀ multiple sclerosisĀ (MS), new research suggests. This work, which emphasizes the importance of careful data analysis, supports studies disputing previous beliefs that pregnancy worsened or lessened the long-term disease course of MS. The findings were presented by Mar Tintore,…
September 20, 2019 News by Ana Pena PhD #ECTRIMS2019 – Mayzent’s Benefits from a Patient Perspective a ‘Key Question,’ Says EXPAND’s Principal Investigator The most recent data continue to support Mayzent‘s (siponimod) benefits and provide more insights on how this therapy can make a difference for those with relapsing forms of multiple sclerosis (MS) ā in particular, data showing the therapy lowers the risk of becoming wheelchair-dependent. New results from…
August 1, 2019 News by Joana Carvalho, PhD Rutgers Health Leading Program to Support MS Children Rutgers Health is leading the Pediatric Multiple Sclerosis and Demyelinating Diseases Program, the only program in the state of New Jersey designed specifically to support children with multiple sclerosis (MS). The support program seeks to promote children’s access to cutting-edge therapies and clinical trials, and to educate…
July 31, 2019 News by Steve Bryson, PhD Surgery with Anesthesia Does Not Raise Person’s Risk of MS Relapse, Study Finds No excessive relapse risk appears to exist for people with multiple sclerosisĀ who undergo surgery that requires anesthesia, researchers report, challenging long-held assumptions associated with MS and surgery. Their single-site study, āMultiple sclerosis relapse risk in the postoperative period: Effects of…
July 30, 2019 News by Ana Pena PhD Ponesimod Fares Well in Phase 3 Trial for Relapsing MS, Janssen Announces JanssenĀ has announced positive, top-line results from its Phase 3 OPTIMUM study, testing the effectiveness and safety of ponesimod tablets, compared to Sanofi‘s Aubagio (teriflunomide), in adults with relapsing forms of multiple sclerosis (MS). The study met its primary goal ā a reduction in the…
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…
June 5, 2019 News by Mary Chapman 12-part Video Series, ‘Understanding Multiple Sclerosis,’ Available Online In partnership with @Point of Care, the Multiple Sclerosis Association of America (MSAA) is offering a comprehensive educational video series about multiple sclerosis (MS). The concise, 12-part series ā titled āUnderstanding Multiple Sclerosisā ā Ā features neurologist and MS expert Michelle T. Fabian, MD, and covers…
June 4, 2019 News by Patricia Inacio, PhD Vumerity’s Safety, Effectiveness Bolstered by New Data from EVOLVE-MS-1 Trial Vumerity (diroximel fumarate), taken as a 462 milligram (mg) tablet twice daily, significantly decreases disease activity in patients withĀ relapsing-remitting multiple sclerosisĀ (RRMS), and leads to low rates of gastrointestinal side effects, new interim data of Phase 3 trial EVOLVE-MS-1 show. The findings were presented at the 2019 Consortium…
May 21, 2019 News by Ana Pena PhD Fibrinogen-containing Vesicles in Blood May Play Key Role in MS Relapses, Mouse Study Suggests Vesicles in the blood that contain a protein called fibrinogen important for blood clotting were found to be “sufficient and required” for the occurrence of spontaneous disease relapses in mouse models of multiple sclerosis (MS), a study reports. In mice, these vesicles were associated with immune cell infiltration, inflammation,…
May 13, 2019 News by Patricia Inacio, PhD #AANAM – Aubagio at Higher Dose Shows Long-term Efficacy in Variety of Patients, Trial Data Show AubagioĀ taken as 14 milligram (mg) tablet once daily significantly reduces the risk of relapse in people with relapsing multiple sclerosis (MS) over time irrespective of their prior treatment history, a pooled analysis of Phase 2 and Phase 3 trial results show. The findings were presented at the 2019…
May 10, 2019 Columns by John Connor I Survived a Marathon Comedy Festival Exactly one year ago on this day of writing, I was down and out. This year, I’m not exactly fighting fit, but the same set of circumstances has pushed me the distance. But it didn’t floor me. OK, OK, I’ll stop with the pugilistic metaphors ā it’s not exactly…
April 11, 2019 News by Patricia Inacio, PhD TecfideraĀ Better at Preventing Relapses than Aubagio, Real-world Study Suggests TecfideraĀ (dimethyl fumarate) is more efficient at preventing relapses, and has a lower discontinuation rate than AubagioĀ (teriflunomide), according to a Danish study. The study āComparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort studyā was published in the journal Neurology. Aubagio (marketed byĀ Sanofi Genzyme)Ā and Tecfidera…
April 2, 2019 News by Alice MelĆ£o, MSc Analysis of TWEAK Protein Levels May Help Identify Active Inflammation in MS Patients, Study Suggests High blood levels of a signaling protein known as TWEAK are associated with active neuroinflammation in patients with multiple sclerosis (MS), a study shows. This finding suggests that TWEAK may be a valuable biomarker to assess ongoing inflammation and overall MS activity, and potentially help optimize patient care. The…
March 27, 2019 News by Jose Marques Lopes, PhD Celgene Seeking FDA Approval for Ozanimod to Treat Adults With Relapsing MS An application has been submitted to approveĀ ozanimod as an oral treatment for adults with relapsing forms of multiple sclerosis in the U.S., according to its developer,Ā Celgene. āNew oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,ā Jay Backstrom, MD, Celgeneās chief medical officer, said in a press release. Celgene'sĀ New Drug Application has been submitted to the U.S. Food and Drug Administration. Earlier this month, the companyĀ submitted a marketing authorization application to the European Medicines Agency covering the treatment of adults with relapsing-remitting MS. āWith concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of (relapsing MS) in 2020,ā Backstrom said. Ozanimod is designed to cause the retention of immune cells in lymphoid tissues, thereby blocking their migration to the central nervous system ā brain and spinal cord ā and preventing damage to nerve fibers and their protective layer, called myelin. The investigational therapy selectively binds to S1P receptor subtypes S1P1 and S1P5. The NDA application is based on positive findings from two multicenter, double-blind, Phase 3 trials calledĀ SUNBEAM andĀ RADIANCE part B. Both studies demonstrated that ozanimod reduced the number of relapses and brain lesions. In theĀ SUNBEAMĀ Phase 3 trial, 1,346 participants with relapsing MSĀ were randomized to one daily dose of 0.92 or 0.46 mg of ozanimod ā equivalent to 1 mg and 0.5 mg of the therapyās HCI formulation ā orĀ AvonexĀ (interferon beta-1a, marketed byĀ Biogen) for at least 12 months. Results showed that treatment with ozanimod led toĀ fewer relapsesĀ and brain lesions, as well as clinically meaningful improvements in processing speed compared with Avonex. In the Phase 2/3 RADIANCE trial, patients were divided in two parts: in part A, participants received either one daily dose of ozanimod (0.5 mg or 1.0 mg) or a placebo for 24 weeks; in part B, a 96-week open-label extension study completed by 223 patients, those initially on placebo switched to ozanimod. As in the SUNBEAM trial, results of part A of the RADIANCE trial revealed a reduction in the number of brain lesions from weeks 12 to 24, as well as less frequent relapses compared with a placebo. Treatment with ozanimod was safe and well-tolerated. Findings of part B of the studyĀ included an increased percentage of patients free of T1 lesions on MRI (magnetic resonance imaging) scans ā which refer to areas of active inflammation and disease activity ā after two years of treatment, from 58.5ā69.0% of patients in part A to 86.5ā94.6% of patients in part B. T2 lesions, a measure of the total amount of MRI lesions ā both old and new ā and relapse rate remained low in patients maintained on ozanimod (more significantly with the higher dose of 1.0 mg), and dropped in those who switched from a placebo. The scientists also analyzed ozanimodās benefits usingĀ data from the SUNBEAM and RADIANCE part B trials, which covered 2,659 patients treated over one to two years. Compared with Avonex, ozanimod reduced the annualized relapse rates ā the number of relapses per year ā by 42% in the higher dose group and 26% in the lower dose group. Treatment with ozanimod also lessened the relapse rate requiring steroid treatment or hospitalization by 43% (in the 1 mg dose group) and 26% (in the 0.5 mg dose group) compared with Avonex treatment. In addition to MS, ozanimod is also being developed for patients with ulcerative colitis and Crohn's disease, two inflammatory bowel diseases.
March 12, 2019 News by Jose Marques Lopes, PhD #AANAM ā Risk of MS Relapses Not Increased Right After Giving Birth, Study Suggests Women with multiple sclerosis (MS) do not experience more relapses right after giving birth, as previously believed, according to a preliminary study. The study also revealed that mothers with MS who breastfeed their babies have a lower relapse risk compared with those who do not breastfeed. The data, ā…
March 5, 2019 News by Patricia Inacio, PhD #ACTRIMS2019 – TG Therapeutics’ Investigational Therapy Ublituximab Posts Positive Data in MS Phase 2 Clinical Trial Full results of a Phase 2 clinical trial testing TG Therapeuticsā lead candidate ublituximab (TG-1101) for relapsingĀ multiple sclerosisĀ (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…
February 26, 2019 News by Iqra Mumal, MSc Switching from Tysabri to Aubagio Can Help Lower Relapse Risk in MS Patients, Phase 4 Trial Shows Stable patients with multiple sclerosis (MS) who transition from Tysabri (natalizumab) treatment toĀ Aubagio (teriflunomide) have a lower relapse risk, a new study shows. The study, āReducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy,ā…
February 22, 2019 Columns by John Connor Relapse, Relapse, Relapse Relapses can be sneaky. They can scythe you down. I’ve been dealing with multiple sclerosis (MS) since 2006 and I only consciously remember two relapses. The first relapseĀ was two years after I had been diagnosed with sclerosis. There was the possible hope from my first neurologist that nothing…
February 22, 2019 News by Jonathan Grinstein Aubagio, Tecfidera Show Comparable Effectiveness in Relapsing MS, Real-world Phase 4 Trial Finds Aubagio (teriflunomide)Ā seems to be superior to Tecfidera (dimethyl fumarate)Ā in slowingĀ whole brain shrinkage in patients withĀ relapsing multiple sclerosis (MS), a new Phase 4 clinical trial shows. However, Aubagio and Tecfidera have similar beneficial effects in achieving other clinical goals and magnetic resonance imaging (MRI) parameters,…