May 3, 2018 Columns by Laura Kolaczkowski Ocrevus Shows Promise for Cognitive Function in Relapsing MS One thing weāve all hoped for with our disease-modifying therapies (DMT) is a treatment that will improve our multiple sclerosis (MS) and not just keep it from worsening. The latest studies presented on Ocrevus (ocrelizumab) hold promise that this treatment may have finally arrived. According to recent reports,…
May 2, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Lemtrada Sustains Long-Term Benefits for RRMS Patients, TOPAZ Study Shows 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 āto use Lemtrada as a second-line therapy and potentially first-line therapy,ā Barry Singer, MD, director of the MS Center for Innovations in Care at Missouri Baptist Medical Center, said in an email response to questions fromĀ 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 ā 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 Ā 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, andĀ 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. āThe 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,ā Singer said in a press release. āIn 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.ā 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 āto screen for autoimmune complications, including low platelet counts, thyroid disease, and kidney disease,ā he said. Lemtradaās long-term effects were shared at the AAN annual meeting in these presentations: āActive 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)ā āDurable 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)ā āDurable 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)ā āDurable 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.
May 1, 2018 News by Patricia Inacio, PhD #AAN2018 ā Ocrevus Lowers Immune Response to Vaccines in Relapsing MS, Phase 3 Trial Shows Treatment with Ocrevus (ocrelizumab)Ā is linked to a reduced immune response to vaccinations inĀ patients with relapsingĀ multiple sclerosis (MS), according to a Phase 3 trial. These results were recently presented at the 2018 American Academy of Neurology (AAN) Annual MeetingĀ in Los Angeles in a presentation titled, āEffect of Ocrelizumab on Vaccine Responses in Patients With Multiple Sclerosis.ā GenentechāsĀ 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,Ā 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.Ā 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 patientsā 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%Ā 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 ā 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.
April 30, 2018 Columns by Ed Tobias MS News that Caught My Eye This Week: aHSCT Studies, MS Progression in African-Americans, Gilenya for Pediatrics #AAN2018 ā Stem Cell Transplant is Effective Treatment for āAggressiveā MS, Study Shows I like the fact that a study shows that stem cell transplant treatment is effective for aggressive MS. I love the fact that the efficacy was dramatic, reducing theĀ Expanded Disability Status Scale (EDSS) levels…
April 30, 2018 News by Jose Marques Lopes, PhD #AAN2018 – New AAN Guideline Favors Advising Patients to Use DMTs Early in Disease Course 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, āPractice guideline recommendations…
April 27, 2018 Columns by Ed Tobias New DMT Guidelines Are Good for MS Patients The American Academy of Neurology (AAN) has just released some new guidelines about when to begin, change, and end disease-modifying therapies (DMTs) that are used to treat MS patients. The guidelines, published on April 23, encourage aggressive treatment when symptoms of MS first appear. They’re also patient-centric. And…
April 27, 2018 News by Jose Marques Lopes, PhD #AAN2018 – Siponimod Lessens Risk of SPMS Progression Independent of Relapses, Trial Data Show Novartisā investigational oral treatmentĀ siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a new analysis of Phase 3 trial results show. Using what the company describes as more accurate methods to assess siponimod effect’s on progression risk, necessary because the…
April 27, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Stem Cell Transplant is Effective Treatment for ‘Aggressive’ MS, Study Shows 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 patientās 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 āsafe and highly effective in inducing rapid and sustain remissionā in highly active MS, and "was associated with a significant improvement of [patientās] level of disability.ā āaHSCT should be considered as first line therapy in patients with āaggressiveā MS,ā 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.
April 26, 2018 News by Patricia Inacio, PhD #AAN2018 – CladribineĀ Injections Deplete Number of Memory B-cells in RRMS, Study Shows CladribineĀ treatment leads to a selective depletion of memory B-cells in patients with relapsing-remittingĀ multiple sclerosisĀ (RRMS), researchers report. The results are in the presentation āCladribine for the Effective Control of Multiple Sclerosis via Memory B Cell Depletionā being given Friday, the final day of the 2018 Annual MeetingĀ of theĀ …
April 26, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā MS Progresses Quickly in African-Americans and May Warrant Aggressive Treatment 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 UniversityĀ and presented at the American Academy of Neurology (AAN) annual meeting taking place in Los Angeles through…
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 25, 2018 News by Patricia Inacio, PhD #AAN2018 ā ALKS 8700Ā Shows Promise as RRMS Therapy, Phase 3 Trial Interim Results Suggest A one-year analysis of the ongoing Phase 3 EVOLVE-MS-1 trial of ALKS 8700Ā as a therapy for relapsing remitting multiple sclerosis (RRMS) supports the experimental therapy’s effectiveness, with the treatment significantly reducing the number of MS lesions. Interim results from the trial were presented Tuesday at the…
April 24, 2018 News by Patricia Inacio, PhD #AAN2018 – High Fish Consumption Linked to Lower MS Risk A diet rich in fish consumption and supplemented with omega-3 polyunsaturated fatty acidsĀ (PUFAs) is linked to a reduction of 45 percent in the risk of developing multiple sclerosis, a study shows. The results confirming previous research will be shared April 26 at theĀ 2018 Annual MeetingĀ of theĀ American Academy of…
April 24, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Celgene to Present Latest Data on Ozanimod’s Safety and Effectiveness Celgeneās 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…
April 23, 2018 News by Patricia Inacio, PhD #AAN2018 – Blood Stem Cell Transplant Superior to DMDs in Highly Active RRMS, MIST Trial Shows Autologous non-myeloablative hematopoietic stem cell transplant was found to be significantly better at reducing risks for disability in relapsing-remitting multiple sclerosis (RRMS) patients compared to disease-modifying drug (DMD) therapies, interim results of the MIST clinical trial show. The results will be shared at the 2018 Annual MeetingĀ of theĀ American…
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 20, 2018 News by Jose Marques Lopes, PhD #AAN2018 – Ocrevus Data Support Sustained Efficacy, Ability to Aid Cognition in RMS Patients 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 byĀ Genentech, the drug’s developer. The company will detail these findings in a series of oral and poster sessions at the 2018 American Academy…
April 20, 2018 News by Patricia Inacio, PhD #AAN2018 – Switching from Rebif to Ocrevus Improves MS, Extension Study Shows Continuous treatment with Ocrevus (ocrelizumab) or switching from Rebif (interferon beta-1a)Ā to Ocrevus leads to aĀ significant long-term reduction in relapsing multiple sclerosis activity, a two-year extension study shows. Ocrevus’s maker, Genentech,Ā drew the results from anĀ open-label extension of the Phase 3 OPERA trials. Researchers will present the findings at…
April 19, 2018 News by Patricia Inacio, PhD #AAN2018 – Biogen Data Covers Work into an MS Blood Biomarker, Cognition and Life Quality Research that points to aĀ potential blood biomarker ofĀ 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 byĀ BiogenĀ for theĀ annual meeting of the American Academy of Neurology (AAN). This year’s…
April 19, 2018 News by Patricia Inacio, PhD #AAN2018 ā Investigational Therapy Ibudilast Slows Brain Atrophy in Phase 2 Trial for Progressive MS Investigational therapyĀ ibudilastĀ leads to a significant reduction of brain atrophy, supporting its potential to effectively treat progressive multiple sclerosis (MS), new data from a Phase 2 clinical trial show. These results will be shared at the upcoming 2018 Annual MeetingĀ of theĀ American…
April 18, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Levels of Protein Derived from Brain Cell Damage Can Mirror Severity of MS, Study Finds Levels of a protein stemming from brain cell damage can mirror the severity and symptoms of multiple sclerosis, an analysis of combined data from three trials showed. Researchers will present this and related findingsĀ at the annual meeting of the American Academy of NeurologyĀ in Los Angeles, April 21-27. The…
April 18, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Early Treatment Delays MS Disease Progression But Does Not Affect Death Rate, Study Suggests 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…
April 18, 2018 News by Patricia Inacio, PhD #AAN2018 – Ocrevus Decreases Biomarkers of MS Patients’ Nerve Cell Damage, Phase 3 Trial Shows Genentech’sĀ Ocrevus (ocrelizumab)Ā 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 theĀ American Academy of Neurology’s annual meetingĀ in Los Angeles, April 21-27. The presentation will be titled āInterim Analysis of the…
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…