March 29, 2018 News by Ana Pena PhD Ocrevus Outperforms Rebif in Preventing Relapsing MS Activity, Analysis Shows Ocrevus (ocrelizumab) was more effective thanĀ RebifĀ (interferon beta-1a) at preventing relapsing multiple sclerosis activity, according to an analysis that covered two Phase 3 clinical trials. The comparison dealt with the therapies’ ability to generate and maintain a condition known as no evidence of disease activity,…
March 28, 2018 News by Larry Luxner Ocrevus a Year After Approval: Views of Some MS Experts A year after U.S. regulators approved Genentech’sĀ Ocrevus (ocrelizumab)Ā as the first treatment for both the relapsing and progressive forms of multiple sclerosis, a prominent neurologist involved in the Phase 3 clinical trials that led to its authorization says it has been beneficial for some MS patients. But itās simply…
March 26, 2018 Columns by Debi Wilson My Unique Primary Progressive MS Diagnosis I have lived with the diagnosis of primary progressive multiple sclerosis (PPMS)Ā for almost eight years. For many years prior to that diagnosis, I was confused by what could be causing my abnormal gait, extreme fatigue, blurred vision,Ā and trouble concentrating. During that time, I completed many diagnostic tests, dealt…
March 23, 2018 Columns by Ed Tobias It Shouldn’t Be This Hard to Get Our MS Medications I got a phone call from my MS One to One nurse, Lynn, today. One to One is the patient support service provided by Sanofi Genzyme for patients on the biotech company’s MS disease-modifying therapies (DMTs) Lemtrada (alemtuzumab) and Aubagio (teriflunomide). Lynn called to ensure that all…
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…
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 26, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Mediterranean Diet, Medical Marijuana, Ocrevus, Myelin Repair Pilot Study Is Testing Whether Mediterranean Diet Can Help MS Patients There’s been a good deal of news recently about the possibility that bacteria in our stomachs have an impact on our MS. There’s also been talk, for a long time, about whether certain diets can improve…
February 19, 2018 News by Patricia Inacio, PhD New Ocrevus Data, Post-FDA Approval, Supports Range of Benefits, Genentech’s Hideki Garren Says OcrevusĀ (ocrelizumab), GenentechāsĀ humanized anti-CD20 monoclonal antibody, continues to show clear evidence that it helps to slow disease progression and enable better function ā including in the hands and limbs ā ofĀ relapsing multiple sclerosis (MS)Ā and primary progressive multiple sclerosis (PPMS), latest data reveals. TheĀ first FDA-approved therapy ā in March…
February 16, 2018 News by Alice MelĆ£o, MSc Health Canada Approves Ocrevus to Treat Early Stage PPMS Patients with Active Disease Primary progressive multiple sclerosis (PPMS) patients in Canada in the earlier stages of this disease can now be treated with Ocrevus (ocrelizumab), followingĀ Health Canada‘s decision to approve its use with restrictions. Roche/Genentechās Ocrevus can be prescribed to adults with early-stage PPMS and characteristic signs of…
February 8, 2018 Columns by Tamara Sellman The MS Alphabet: Plaquenil, PML, Prevalence, and Other ‘P’ Words (Part 6 of 7) Editorās note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letter “P.” This post comes sixth in a series of seven. Symptoms of MS Progressive multifocal leukoencephalopathy (PML) Though progressive multifocal leukoencephalopathy (PML) isnāt an actual symptom of MS,…
February 5, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Testosterone and MS, Ocrevus in the UK, Enhanced MRI Technology, Ublituximab Trial Results Researchers Identify Testosterone-triggered Molecule That Protects Men From MS This finding is an extension of research that has already indicated that a higher testosterone level reduces the chance of a person developing multiple sclerosis (MS). This new research focuses on a testosterone-related molecule that,Ā these…
February 2, 2018 News by Patricia Silva, PhD #ACTRIMS2018 – Relapsing MS Patients With Impaired Vision Improved on Ocrevus, Updated Trial Data Show 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 ACTRIMSĀ 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, āEffect of Ocrelizumab on Visual Outcomes in Patients with Baseline Visual Impairment in the OPERA Studies in Relapsing Multiple Sclerosis.ā 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 āĀ sponsored by Ocrevus developer Genentech, a member of the Roche group ā Ā 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 lettersĀ ā instead of black ā 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 āĀ 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 ā 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 Ocrevusā ability to reverse visual impairment in relapsing MS. The ACTRIMS Forum 2018 isĀ being held in San Diego, California, Feb. 1ā3.
February 2, 2018 News by Alice MelĆ£o, MSc MS Trust Seeking PPMS Patients’ Views on Ocrevus as It Tries to Obtain British Coverage Britain’sĀ Multiple Sclerosis TrustĀ is asking patients to help them getĀ the National Health ServiceĀ to cover Ocrevus (ocrelizumab) as a treatment forĀ primary progressive multiple sclerosis, or PPMS. The key step is trying to persuade the National Institute for Health and Care ExcellenceĀ to recommend that the health service…
January 22, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Ocrevus in the EU, Salt and Cognitive Problems, Searching for Myelin, Tecfidera Tolerance European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU This is a biggie. It’s been nearly a year since the FDA approved the use of Ocrevus here in the U.S. Finally, it’s been given the green light in Europe. Canada, Australia, Switzerland, and various countries in…
January 19, 2018 Columns by Ed Tobias Heavy-hitting MS Therapies Now Being Used Sooner for Some Patients I’m sitting in Florida and the start of spring training is only about six weeks from now, so please forgive a baseball analogy: The heavy-hitters of the MS-fighting treatments, the monoclonal antibodiesĀ (mAbs), are moving up in the lineup. Five treatments currently are in the mAbs class:Ā Ocrevus,…
January 15, 2018 News by Patricia Silva, PhD European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU The European Commission has approved Roche’sĀ Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union. The commissionās move ā Ā nearly 10 months after the U.S. Food and Drug Administration (FDA)Ā approvedĀ Ocrevus in March 2017 ā makes it the first approved PPMS…
January 11, 2018 Columns by Laura Kolaczkowski My Ocrevus Treatments: The Next Round Is Delayed By now, I had planned to give you an update on my current multiple sclerosis disease-modifying therapyĀ Ocrevus (ocrelizumab). But one thing living with multiple sclerosis teaches us is to not count on plans always working out as we had hoped. Timing really is everything…
January 5, 2018 News by Patricia Silva, PhD Top 10 Multiple Sclerosis Articles of 2017 Multiple Sclerosis News Today brought you daily coverage of important discoveries, treatment developments, clinical trials, and other events dealing with multiple sclerosis throughout 2017. We look forward to providing more news to MS patients, family members, and caregivers during 2018. As a reminder of what mattered most to you in…
January 3, 2018 Columns by Mike Knight Turning Corners with MS: Ocrevus, Biotin, and 2018 Like a lot of people with MS, I took part in the āGreat Ocrevus Rush of 2017,ā with the fanfare surrounding the release of the first therapy in the United States known to have some ability to stem the advancement of primary and secondary progressive MS.
December 21, 2017 Columns by Tamara Sellman The MS Alphabet: Optic Neuritis, Occupational Therapy, and Other ‘O’ Words Editorās note: Tamara Sellman continues her occasional series on the MS alphabet with this column referencing terms starting with the letter “O.” Symptoms of MS Optic neuritis This is a common symptom of MS, though not everyone who experiences optic neuritis…
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.
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 14, 2017 News by Alice MelĆ£o, MSc Europe’s CHMP Urges Approval of Ocrevus in EU to Treat Relapsing, Primary Progressive MS Europeans with relapsing multiple sclerosis (MS) andĀ earlyĀ primary progressive MS are one step closer to accessingĀ Ocrevus, now that the European Medicines Agency has urged the European Union to approve the therapy. The positive opinion ā announced inĀ a press release issued Nov. 10 by the EMAās Committee for Medicinal Products for Human UseĀ ā is an intermediary step required in the regulatory pathway to allow patient access to a new drug. The European Commission will now make a final decision on whetherĀ OcrevusĀ should be granted marketing authorization in all 28 EU member states. This decision will take the CHMP recommendation into consideration. If approved, Ocrevus will become the first disease-modifying medicine available throughout Europe for patients with PPMS. Once this happens,Ā any decisions on price or insurance reimbursements will be the responsibility of each member state. OcrevusĀ wonĀ U.S. approval earlier this year. It was alsoĀ recentlyĀ approved in Switzerland for both relapsing MS and PPMS. Ocrevus is an anti-CD20 antibody developed by Genentech, a division ofĀ Roche. It blocks immune B-cells, preventing them from attacking nerve cells and their myelin protective sheath, as well as inhibiting other pro-inflammatory immune signals involved in MS. CHMP based its positive recommendation on data from three pivotal Phase 3 clinical trials: the OPERA I and II trials in relapsing MS patients, and the ORATORIO trial in PPMS patients. Results from the OPERA clinical studies demonstrated that treatment with Ocrevus for up to 96 weeks could reduce the annualized relapse rate by 46.4 percent compared with EMD Seronoās approved drug Rebif (interferon beta-1a) in relapsing MS patients. The ORATORIO trial showed that Ocrevus could reduce by 24 percent the risk of 12-week confirmed disability progression compared to placebo in PPMS patients. Data from the trial further supported the drug's therapeutic benefit in early-stage PPMS patients. Additional studies are warranted to better evaluate the therapeutic potential of Ocrevus for patients with more advanced stages of the disease. The most common treatment-associated adverse effects reported wee infusion-related reactions and infections.
November 9, 2017 Columns by Laura Kolaczkowski Ocrevus Q&A, Part 2 Editor’s note: This is the second of a two-part series on readers’ comments about Ocrevus (ocrelizumab). Read part one here. Last week, I responded to a few comments on columns regarding my personal experience with Ocrevus (ocrelizumab). Here are more reader comments and my answers.
November 2, 2017 Columns by Laura Kolaczkowski Ocrevus Q&A, Part 1 Editor’s Note: First in a two-part series on readers’ comments about Ocrevus (ocrelizumab). I switched disease-modifying therapies and began treatment with Ocrevus (ocrelizumab)Ā in June. I previously wrote about my reasons for switching, my experiences with the first two doses, and more recently, about any…
October 31, 2017 News by BioNews Staff #MSParis2017 ā Ocrevus Trial Data May Lead to Key Biomarkers of Chronic Inflammation, Genentech Says Potential new ways of capturing disease progression in multiple sclerosis (MS) patients ā including those with chronic as opposed to active inflammation ā are coming to the fore as analyses continue into the huge amounts of data collected during pivotal clinical trials that led to Ocrevus’ approval, a leadingĀ GenentechĀ researcher…
October 31, 2017 News by Patricia Silva, PhD #MSParis2017 – T-cell vs. B-cell Debate More Meeting of Minds Than ‘Rumble in the Jungle’ News commentary One particular session on Day 2 of the four-day 7th Joint ECTRIMS-ACTRIMS Meeting ā which drew 10,000 researchers, doctors, industry representatives, and patient advocates to hear about advances in multiple sclerosis (MS) treatment and understanding ā attracted so much interest that all seats were taken in the…
October 31, 2017 News by Patricia Silva, PhD #MSParis2017 – Scant Difference Seen in Inflammatory Response to Ocrevus or Rituxan in Small Study Both Ocrevus (ocrelizumab) and Rituxan (rituximab) trigger a similar release of inflammatory mediators after a first infusion, with little difference seen in infusion reactions among a small group ofĀ multiple sclerosis (MS) patients treated with either therapy, said researchers from the Rocky Mountain MS Center at the University of…
October 27, 2017 News by Patricia Silva, PhD #MSParis2017 – Ocrevus Improves Relapsing MS Patients’ Vision Better Than Interferon, Trials Show Genentech’sĀ Ocrevus (ocrelizumab) improved the vision of people with relapsing multiple sclerosis better than the widely used therapyĀ interferon beta-1a, according to clinical trial findings presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris. Dr. Laura Balcer of the department of neurology atĀ New York UniversityĀ made the presentation, titledĀ āEffect…
October 23, 2017 Columns by Ed Tobias MS News That Caught My Eye Last Week: Mavenclad, Tecfidera, Ublituximab, Ocrevus The giant ECTRIMS/ACTRIMS MS conference begins in Paris on Wednesday, Oct. 25, and this column focuses on several of the presentations on which Multiple Sclerosis News Today will be reporting during the week. #MSParis2017 ā Mavenclad Reduces Relapses, Prevents New Lesions in Many RRMS Patients, Presentations Will…