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Julie Roberts, a country music singer and multiple sclerosis (MS) patient advocate, will perform at the upcoming Consortium of Multiple Sclerosis Centers (CMSC)’s annual meeting, the association announced Roberts, diagnosed with MS while making her second recording in 2005, will also attend CMSC sessions to learn more about…

Curatio and BioScript Solutions recently launched a mobile patient engagement platform designed to provide multiple sclerosis (MS) patients with a way to connect, share experiences, and gain new knowledge. The private, free social network app was introduced at the recent HLTH conference, which took place May 6-9…

The science underlying our understanding of multiple sclerosis — through to new technologies that might expand that understanding in ways “never imagined” — was the focus of a recent educational webinar titled “The Evolving Science of Multiple Sclerosis (MS).” Kottil Rammohan, MD, a professor of clinical neurology and director of the…

Lemtrada (alemtuzumab) can sustain reduced activity and prevent progression of relapsing-remitting multiple sclerosis (RRMS) for more than seven years, clinical data from the CARE-MS extension trial shows. Findings were recently presented in four poster presentations at the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles. Lemtrada, marketed by Sanofi Genzyme, is an approved MS therapy that, according to its label, should generally be reserved for patients who have had an inadequate response to two or more other therapies. But the use of the word "generally" opens a window of opportunity “to use Lemtrada as a second-line therapy and potentially first-line therapy,” Barry Singer, MD, director of the MS Center for Innovations in Care at Missouri Baptist Medical Center, said in an email response to questions from Multiple Sclerosis News Today. The treatment was initially tested in two pivotal clinical trials in comparison with a high-dose under-the-skin injection of Rebif (interferon beta-1a) in RRMS patients. Participants were either new to treatment (CARE-MS I, NCT00530348) or had not responded to prior therapies (CARE-MS II, NCT00548405). During these trials, patients received 12 mg of Lemtrada for three or five consecutive days in two annual courses — at the beginning of the study and again one year later. After completing this treatment period, they had the opportunity to participate in a four-year extension study (NCT00930553) during which they could receive the therapy as needed to control their disease. Patients completing the extension could enroll in the five-year TOPAZ trial (NCT02255656) for further evaluation. To date, 80% of the participants (299 patients) from CARE-MS I and 73% from CARE-MS II (317 patients) have completed seven years of long-term follow-up. After completing two initial courses of Lemtrada, 59% of patients from CARE-MS I and 47% from CARE-MS II did not require additional treatment courses with Lemtrada or other disease-modifying therapies during the next six years. Two-thirds of  CARE-MS II patients who required a third Lemtrada course also experienced disability stabilization one year after the last treatment. During the seven years of follow-up, reported annualized relapse rates remained low, and 37% of patients from CARE-MS 1 and 44% from CARE-MS II experienced confirmed improvements in disability. In fact, during this period, only 26% from CARE-MS 1 and 31% from CARE-MS II showed disability worsening. The treatment also had a sustained effect on slowing brain volume loss by the seventh year, with a median yearly brain volume loss of 0.20% or less from the third to seventh year. This effect was found to be even better than that reported during the initial two years of treatment in the pivotal studies (0.59% in the first year and 0.25% in the second year in CARE-MS I, and 0.48% in year one and 0.22% in year two in CARE-MS II). Additionally, evaluation by magnetic resonance imaging (MRI) showed no signs of disease activity during the seven years of follow-up. “The extension study data being presented at AAN illustrate that more than two-thirds of patients did not experience confirmed disability worsening at year seven after initiating treatment with Lemtrada,” Singer said in a press release. “In addition, consistent effects were maintained over time across relapses and MRI outcomes including brain volume loss, even though the majority of patients did not receive any additional treatment over the prior six years.” During the extension studies, the frequency of adverse events was similar to that reported during the pivotal studies. In seven years, three deaths occurred, none of which was considered to be treatment-related. Thyroid adverse events were reported to be more frequent by the third year, but declined thereafter. As Singer noted, "the serious risks of Lemtrada, including serious infusion reactions, serious infections, thyroid disease, kidney disease, low platelets and potential malignancies, must always be discussed with the patient." All patients should also be carefully monitored on a monthly basis for four years after the last treatment course “to screen for autoimmune complications, including low platelet counts, thyroid disease, and kidney disease,” he said. Lemtrada’s long-term effects were shared at the AAN annual meeting in these presentations: “Active RRMS Patients Treated with Alemtuzumab Experience Durable Reductions in MRI Disease Activity and Slowing of Brain Volume Loss: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study)” “Durable Clinical Outcomes With Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study)” “Durable Reduction in MRI Disease Activity and Slowing of Brain Volume Loss in Alemtuzumab-Treated Patients With Active RRMS: 7-Year Follow-up of CARE-MS I Patients (TOPAZ Study)” “Durable Clinical Efficacy of Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS I Patients (TOPAZ Study) Lemtrada is approved in more than 60 countries, and has additional marketing applications under review by regulatory authorities worldwide.

Treatment with Ocrevus (ocrelizumab) is linked to a reduced immune response to vaccinations in patients with relapsing multiple sclerosis (MS), according to a Phase 3 trial. These results were recently presented at the 2018 American Academy of Neurology (AAN) Annual Meeting in Los Angeles in a presentation titled, “Effect of Ocrelizumab on Vaccine Responses in Patients With Multiple Sclerosis.” Genentech’s Ocrevus is an approved MS therapy that targets the CD20 protein located on the surface of B-cells, targeting the cells for destruction. B-cells are immune system cells involved, for example, in the production of antibodies necessary to fight off infection. At the AAN meeting, researchers reported that in MS patients, treatment with Ocrevus decreased the ability of B-cells to activate other immune cells, improving the rate of MS attacks. Penn Medicine neurologist Amit Bar-Or, MD, presented these findings, which showed that interactions between different classes of immune cells, such as B- and T-cells, promote MS attacks. Vaccination against infections is an important part of the management of patients with MS. So, in a second study (NCT02545868), researchers investigated the impact treatment with Ocrevus has on patient response to vaccines. They recruited 102 patients with relapsing MS and randomized them in two groups. In group A, 68 people received a single dose of 600 mg Ocrevus (administered into the blood); in group B, 34 patients received no disease-modifying therapy or interferon-beta. All patients were then administered vaccines for tetanus, seasonal flu, and pneumococcus. Patients in group A received the vaccines 12 weeks after they were treated with Ocrevus, while group B patients received the vaccines on day one. Researchers also tested patients’ response to a novel protein (an antigen) never "seen" by their immune system, called keyhole limpet hemocyanin (KLH) neoantigen. The vaccinations led to an immune system response in all patients, but the level of response in patients treated with Ocrevus was lower. A positive response to the tetanus vaccine at eight weeks after treatment was 23.9% in group A (Ocrevus) compared with 54.5% in group B (no treatment); the response to pneumococcus vaccination was 71.6% in group A and 100% in group B. After four weeks of treatment, the levels of antibodies against the different strains of the flu virus were lower in Ocrevus-treated patients than in the control group, ranging from 55.6% to 80.0% in the Ocrevus group compared with 75.0% to 97.0% in the controls. The immune response to the neoantigen KLH was also decreased in the Ocrevus group. "This study shows that while people with MS treated with ocrelizumab [Ocrevus] can still mount vaccine responses, it's not nearly as strong as prior to treatment," Bar-Or said in a press release. "While antibody responses were reduced in the ocrelizumab treated patients, they still responded to a certain level," he said. "This is valuable information in terms of seasonal vaccines such as the flu — it appears safe for patients taking ocrelizumab to get vaccinated and vaccination is likely to provide them with at least some protection from such infections." These findings correlate with standard guidelines that advise patients to undergo vaccinations six weeks before they start treatment with Ocrevus.

A new American Academy of Neurology (AAN) guideline recommends that multiple sclerosis (MS) patients in general be counseled to start treatment with disease-modifying therapies (DMTs) as early as possible. Considerations on switching and stopping treatments are also presented in the guideline. The report, “Practice guideline recommendations…

Autologous hematopoietic stem cell transplantation, also known as aHSCT, has been shown to be safe and highly effective to treat patients with "aggressive" multiple sclerosis. Tested in 19 patients, transplantation of stem cells was found to induce clinically meaningful improvements in disability. These findings were shared at the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles, California. aHSCT uses a patient’s own healthy bone marrow stem cells, in combination with a much less aggressive chemotherapy and/or radiation regimen, to prepare the patient for the transplant. Previous studies have suggested that aHSCT is an effective strategy to treat patients with highly active relapsing-remitting MS (RRMS) who do not respond to available disease-modifying therapies (DMTs), and international guidelines advocate for its use in patients with "aggressive" MS. To further demonstrate the potential of aHSCT as a treatment for "aggressive" MS, a research team evaluated its safety and effectiveness in MS patients who had not been treated previously with DMTs. A total of 19 patients were treated across several clinical centers: seven patients were from Sheffield, U.K., seven from Uppsala, Sweden, four from Ottawa, Canada, and one patient was from Florence, Italy. All patients received aHSCT between May 2004 and May 2017. In addition to aHSCT, patients were treated with BEAM (carmustine, etoposide, cytarabine, melphalan) chemotherapy plus antithymocyte globulin (ATG) to reduce transplant rejection, or with Cytoxan (cyclophosphamide) with ATG, or the triple combination of Cytoxan, ATG, plus busulfan as conditioning regimens. Patients had a median age of 33 years at diagnosis and received the aHSCT by a median time of nine years after symptom onset. They had a median disability score of 6.5 before the treatment, as determined by the Expanded Disability Status Scale (EDSS). After a median follow-up period of 30 months, patients had a median EDSS score of 2.0, which represented a median improvement of 2 points (the higher the score, the worse the patient's disability level). None of the patients had clinical relapse following the transplant of stem cells. Only three patients developed new brain lesions detectable by magnetic resonance imaging (MRI) at the first six-month follow-up evaluation, but no additional new lesions were detected in the following scans. The adverse effects reported during the study were comparable to those previously observed in similar treatments. No deaths related to the treatment were reported. Based on these preliminary results, the researchers concluded that aHSCT is “safe and highly effective in inducing rapid and sustain remission” in highly active MS, and "was associated with a significant improvement of [patient’s] level of disability.” “aHSCT should be considered as first line therapy in patients with ‘aggressive’ MS,” the team concluded. Another study presented at the AAN 2018 meeting further supports these findings, demonstrating the superior effectiveness of aHSCT over conventional DMTs for RRMS.

Cladribine treatment leads to a selective depletion of memory B-cells in patients with relapsing-remitting multiple sclerosis (RRMS), researchers report. The results are in the presentation “Cladribine for the Effective Control of Multiple Sclerosis via Memory B Cell Depletion” being given Friday, the final day of the 2018 Annual Meeting of the …

Multiple sclerosis in African-Americans progresses much faster than in Caucasian patients, new research reports, suggesting that blacks would benefit from a more aggressive treatment approach. Led by researchers at Johns Hopkins University and presented at the American Academy of Neurology (AAN) annual meeting taking place in Los Angeles through…

Celgene’s oral treatment candidate ozanimod can effectively reduce relapse rates in multiple sclerosis (MS) patients with mild to moderate disability, results of two Phase 3 trials show. The company will present data on the SUNBEAM (NCT02294058) and RADIANCE (NCT02047734) trials in two presentations at the…

Treatment with Ocrevus (ocrelizumab) shows sustained efficacy and an ability to improve cognition in patients with relapsing multiple sclerosis (MS), according to data being presented by Genentech, the drug’s developer. The company will detail these findings in a series of oral and poster sessions at the 2018 American Academy…

Research that points to a potential blood biomarker of multiple sclerosis (MS) severity, relates cognitive difficulties to patients’ employment and other measures of socioeconomic status, and one-year results of an ongoing clinical trial are among data presentations planned by Biogen for the annual meeting of the American Academy of Neurology (AAN). This year’s…

Beginning treatment early with disease-modifying therapies is the most effective approach to prevent multiple sclerosis (MS) progression in patients, a large-scale study suggests. Data from the Danish study will be presented at the 2018 Annual Meeting of the American Academy of Neurology (AAN), taking place April 21-27…

Genentech’s Ocrevus (ocrelizumab) reduces levels of cerebrospinal fluid biomarkers that denote nerve cell damage in multiple sclerosis patients, a Phase 3 clinical trial shows. Researchers will present the results at the American Academy of Neurology’s annual meeting in Los Angeles, April 21-27. The presentation will be titled “Interim Analysis of the…

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…

When and how to best use disease-modifying therapies (DMTs) in multiple sclerosis depends on key treatment decisions that, partly because the number of DMTs available, can be as challenging for clinicians as they are for patients. DMTs and their optimal use will be covered in the closing lecture of the…

The Consortium of Multiple Sclerosis Centers (CMSC) is partnering with a number of organizations during Multiple Sclerosis Awareness Month in March to provide education, research and services to the MS community. CMSC is a non-profit organization that provides educational programs and resources to MS professionals, healthcare providers, researchers and the…

American TV personality Montel Williams, who uses medical cannabis to manage his multiple sclerosis symptoms, will speak at the 5th annual Cannabis World Congress and Business Exposition in New York City, May 30 to June 2. A prominent medical cannabis advocate, Williams will discuss its legalization and acceptance, a movement that has…

The Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) has awarded five young investigators for their research work on multiple sclerosis (MS). The awards were presented at the ACTRIMS Forum 2018, held Feb. 1-3 in San Diego,…

Multiple sclerosis (MS) patients who experience a relapse after two courses of Lemtrada (alemtuzumab) treatment showed improvements in relapse rate and disability after a third Lemtrada course, according to results of the CARE-MS II trial extension. The poster reporting the findings, titled “Efficacy of Alemtuzumab Retreatment in Patients Who Experienced Disease Activity after…

Celgene’s 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 at the ACTRIMS Forum 2018 convention in San Diego, Feb. 1-3. The presentation was titled “Ozanimod Demonstrates Efficacy and Safety…

Ampyra (dalfampridine), approved to treat walking difficulties in multiple sclerosis (MS) patients, also helps with cognition and movement in the upper and lower extremities, according to a recent scientific presentation. These findings were reported at the 3rd Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 in…

MedDay Pharma’s MD1003 leads to long-lasting improvements in progressive multiple sclerosis patients’ disability, a Phase 3 clinical trial follow-up study shows. Researchers presented the results at the third Annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum in San Diego, Feb. 1-3. The poster presentation was titled “…

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…

Extending the dosing periods of Tysabri (natalizumab) treatment may help reduce the risk of progressive multifocal leukoencephalopathy, or PML, in multiple sclerosis (MS) patients infected with the JC virus, a study suggests. The study, “Natalizumab Extended Interval Dosing Is Associated with a Reduction in Progressive Multifocal Leukoencephalopathy…

Ocrevus improved vision among relapsing multiple sclerosis patients who participated in the Phase 3 clinical trials of the treatment, according to updated analyses recently presented at the ACTRIMS Forum 2018. While Ocrevus-treated patients improved their ability to read low-contrast letters over the course of the two trials, people who received Rebif (interferon beta-1a) did not. Laura J. Balcer, a neurologist at New York University Langone Medical Center, shared the data in a presentation titled, “Effect of Ocrelizumab on Visual Outcomes in Patients with Baseline Visual Impairment in the OPERA Studies in Relapsing Multiple Sclerosis.” Balcer had earlier shared data on the visual outcomes of relapsing patients in the OPERA I and OPERA II Phase 3 clinical trials of Ocrevus at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, last year. The two studies — sponsored by Ocrevus developer Genentech, a member of the Roche group —  compared Ocrevus and Rebif in patients with relapsing MS. This time, her presentation focused only on patients who had visual impairment when they enrolled in the trials. Among a total of 1,656 participants, 375 of those treated with Ocrevus and 373 in the Rebif group had visual impairment. Researchers tested vision using a low-contrast letter acuity test. The test is similar to an ordinary vision test, with letters of different sizes on a chart. But the low-contrast test uses gray letters — instead of black — on a white background. Researchers included charts with two shades of gray to test different contrast levels. These tests can detect reduced visual function. At the beginning of the trials, both groups performed in a similar manner — correctly identifying about 35 letters on a chart with somewhat higher contrast. After 96 weeks, those receiving Ocrevus identified on average 3.4 more letters, while Rebif-treated patients worsened by 0.5 letters — a significant difference, Balcer said. Researchers tested vision every 12 weeks. At the end of the trials, they found that 39 percent more patients in the Ocrevus groups had a cumulative improvement of at least 10 letters, compared to those treated with Rebif. At this time, 26.4 percent of Ocrevus-treated patients improved 10 letters or more, compared to 19.8 percent in the Rebif group. The difference between the groups for at least seven letters was 54 percent, with Ocrevus-treated patients performing better. Researchers believe that a seven-letter change is the minimal clinically important difference for the test. Based on the results, researchers believe that the findings demonstrate Ocrevus’ ability to reverse visual impairment in relapsing MS. The ACTRIMS Forum 2018 is being held in San Diego, California, Feb. 1–3.

Oryzon Genomics has enrolled the first multiple sclerosis patient in its Phase 2a SATEEN clinical trial investigating the therapy ORY-2001. The Spanish company will also present new results from preclinical models of MS treated with ORY-2001 at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018, set for Feb. 1-3 in San Diego. ORY-2001 is an epigenetic therapy, meaning it targets the expression and activity of genes. The drug inhibits two particular molecules, LSD1 and MAOB, and was previously shown to reduce cognitive impairment and neuroinflammation in preclinical models, including in a mouse model of MS — the experimental autoimmune encephalomyelitis (EAE) model. The therapy was also shown to have neuroprotective effects. During ACTRESS 2018, Oryzon's chief scientific officer, Tamara Maes, will present a poster, "ORY-2001 reduces inflammatory cell infiltration in the Theiler’s murine encephalomyelitis virus model and highlights the epigenetic axis in MS.” “In previous reports we showed that ORY-2001 reduces the clinical score, lymphocyte egress, immune cell infiltration and inflammation protecting the spinal cord from demyelination in a murine MS-EAE model,” Maes said in a press release. “Here we provide data on the efficacy of ORY-2001 in the Theiler’s murine encephalomyelitis virus model for multiple sclerosis." In a second poster, "ORY-2001 in multiple sclerosis: first clinical trial of a dual LSD-1/MAOB inhibitor,” Roger Bullock, Oryzon's chief medical officer, will detail the Phase 2a trial, SATEEN, testing ORY-2001 in patients with relapsing-remitting or secondary progressive MS over a 36-week period, followed by an open-label extension. “Our first patient enrolled in SATEEN signals a new landmark for the clinical development of this drug in different neurological indications,” said Bullock. “This is the first epigenetic approach in this disease, and we hope that it will contribute to enlarge and improve the therapeutic options for patients afflicted by MS."

Registrations are now open for the 32nd Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), set for May 30-June 2 at the Music City Center in Nashville, Tennessee. The CMSC Annual Meeting is the nation’s largest educational conference and professional development event for healthcare practitioners, researchers and…

Research teams from Canada, Portugal and the United States, each with projects focused on predicting and defining characteristics of multiple sclerosis (MS) , will share this year’s 1 million euro ($1,165,700) Grant for Multiple Sclerosis Innovation (GMSI), announced by Merck at the 7th Joint ECTRIMS-ACTRIMS meeting in Paris, France,…

Nearly half of multiple sclerosis patients do not always report their relapses to healthcare providers, two surveys indicate. Mallinckrodt sponsored the surveys to better understand patients’ experience with relapses, which are sudden episodes of new symptoms or worsening of existing symptoms. The company presented the survey results at the 7th joint meeting…