May 9, 2018 Columns by Cathy Chester The Agony of Decision-making when It’s Time to Switch MS Medications Iām agonizing over an important decision and it’s driving me crazy. Iām usually a quick decision-maker, but this one is tough. I have my analytical hat on, trying to look at my choices from a scientific standpoint. Unfortunately, my anxiety kicks in, and my hat…
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 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 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 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 Larry Luxner 5 MS Patients Across US Talk About How Ocrevus Has Changed Their Lives Itās been a little over a year since U.S. regulators approved GenentechāsĀ Ocrevus (ocrelizumab)Ā as the first treatment for both relapsing and progressive forms of multiple sclerosis (MS) ā a disabling neurological diseaseĀ now believed to affect nearly one million Americans. While the juryās still outĀ regarding the therapyās…
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 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…
March 5, 2018 News by Jose Marques Lopes, PhD MS Progression Focus of MSAA Events, ‘Ask Experts’ Sessions for Awareness Month Understanding multiple sclerosis (MS) progression will be the focus of theĀ Multiple Sclerosis Association of AmericaāsĀ (MSAA) campaign for MS Awareness Month 2018. March has been recognized asĀ MS Awareness MonthĀ since 2003. Across the U.S., MSAA events aim to raise public awareness about the disease, and increase involvement in…
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 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 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…