Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports I’m not surprised at reports that the use of Mavenclad (cladribine) and Ocrevus (ocrelizumab) is increasing in Europe, or that the use of injectable disease-modifying therapies appears to be declining there. Mavenclad and Ocrevus are approved…
Ocrevus
Prescriptions of two multiple sclerosis (MS) treatments — Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) — have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…
In this week’s column, I’ve changed the format a little to focus on one subject: rituximab. This is an approved cancer medication that some U.S. neurologists use as an off-label treatment for multiple sclerosis (MS). Rituximab is similar to Ocrevus (ocrelizumab). When the latter disease-modifying therapy (DMT) became available in…
For the last few months, urinary tract infections (UTIs) have been the main subject of this column. My current disease-modifying therapy, Ocrevus (ocrelizumab), has had a significant impact on my multiple sclerosis (MS). The only downside is that Ocrevus attacks B-cells in the body, increasing the risk…
Editor’s note: This is the third story in a three-part report examining the question, “Is rituximab a reasonable alternative treatment for MS?”, which was a topic discussed at this year’s Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Here, we take an in-depth look…
Two years after the approval of Ocrevus (ocrelizumab), the latest data continue to support the benefits of the so-called “game-changing” therapy in multiple sclerosis (MS), while new insights highlight its neuronal protective effects and safety. Multiple Sclerosis News Today had the opportunity to speak with Hideki Garren,…
Monthly under-the-skin injections of ofatumumab are superior to Aubagio (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), leading to over 50% reduction in relapse rates, and more than a 90% reduction in active brain lesions, compared with Aubagio, results from ASCLEPIOS I…
#ECTRIMS2019 – Early Ocrevus Use Slows Disability in PPMS, Including Risk of Wheelchair Reliance
Early and continuous treatment with Ocrevus (ocrelizumab) leads to a greater and more durable slowing of disability progression — seen for up to 6.5 years — in people with primary progressive multiple sclerosis (PPMS), according to long-term data on its use in PPMS patients in a Phase 3…
Treating relapsing multiple sclerosis (MS) patients with Ocrevus (ocrelizumab) is not associated with retinal thinning — unlike treatment with Rebif (interferon beta-1a), according to two Phase 3 trials. The findings also showed a link between retinal thinning and brain volume loss. The study, “…
Treatment for more than six years with Ocrevus (ocrelizumab) is linked to lower levels of blood antibodies among people with primary progressive multiple sclerosis (PPMS) and relapsing MS, but rates of serious infections also remain low, an analysis of data from three Phase 3 trials show. Dropping below a certain…
I knew nothing about multiple sclerosis (MS) before 2012, including the cause, the cure, or any other details. I had so many unanswered questions about how I would live with MS when I was diagnosed. I had never heard of treatment for MS and was unsure of the…
Relapsing-remitting multiple sclerosis (RRMS) patients treated with Lemtrada (alemtuzumab) may develop additional (secondary) autoimmune reactions. Anti-CD20 therapies, including rituximab or Ocrevus (ocrelizumab), are a potential treatment for Lemtrada-associated autoimmune complications in patients who fail to respond to other conventional immunotherapies, according to a case report about two women in…
Users of the disease-modifying therapy Ocrevus (ocrelizumab) share a common complaint: the length of time the infusions take. It may seem petty, but an Ocrevus infusion consumes nearly an entire day. My typical infusion involves checking into the clinic, being screened by the infusion nurse for any changes, taking…
The loss of immune B-cells, and the resulting changes in the profile of immune T-cells, is a major mechanism of action for the beneficial effects seen with ublituximab treatment in multiple sclerosis (MS) patients, a study suggests. B-cells are a type of immune cell best known for producing…
What the Falck Is Going On?
Stranded. Not on a desert island but in an empty hospital ward. Earlier, it had been filled with fellow MSers getting their Ocrevus (ocrelizumab) infusions. I write “fellow,” but as ever, we blokes were in the minority — there were only two of us. Research indicates that more…
#AANAM – Biogen Offers Update on Development Plans for MS Therapies The pharma company that brought you Tysabri (natalizumab) is investigating a new process for treating multiple sclerosis. The treatment looks for something called neurofilament light chain (NfL), a potential biomarker that’s released from damaged neurons.
Treatment with Ocrevus (ocrelizumab) decreases the levels of neurofilament light chain (NfL) and immune B-cells in the serum and central nervous system of patients with relapsing multiple sclerosis (MS), according to results from a Phase 3 trial. The research, “Ocrelizumab treatment reduced levels of neurofilament light chain and…
After first rejecting it due to cost-effectiveness concerns, the National Institute for Health and Care Excellence (NICE) has now approved the use of Ocrevus (ocrelizumab) for people in the U.K. with early, inflammatory primary progressive multiple sclerosis (PPMS). This means that PPMS patients living in the…
Early, one-year data from the Phase 3 CHORDS study show that Ocrevus effectively prevents relapses and disease progression in relapsing-remitting multiple sclerosis (RRMS) patients who have had poor responses to other disease-modifying therapies. These interim results were presented at the 2019 annual meeting of the American Academy of Neurology (AAN) in…
Higher exposure to Ocrevus (ocrelizumab) is associated with greater immune B-cell depletion in the blood, and lessened risk of disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive disease (PPMS), according to new research. The study supporting that finding, “Pharmacokinetics, Pharmacodynamics and…
This year’s John Dystel Prize for Multiple Sclerosis Research is being awarded to Anne H. Cross, a neurologist and MS chair in the department of neuroimmunology at Washington University School of Medicine in St. Louis, for her research into the role of immune B-cells in multiple sclerosis attacks and new imaging…
Most healthy people probably don’t have to worry about a fungus called Candida auris, or simply C. auris. But if your immune system is compromised, it’s a different story. Health officials say C. auris should be of special concern to people whose immune systems are not at full strength,…
Roche and pan-Canadian Pharmaceutical Alliance Finalize Ocrevus Negotiations for RRMS and Early PPMS
Roche Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) have completed negotiations ultimately aiming to obtain public funding for Ocrevus (ocrelizumab) as a first-line treatment for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, and as management strategy for patients with early primary progressive MS…
Ocrevus (ocrelizumab) was shown to be a highly effective therapy for people with multiple sclerosis (MS) in real-world clinical practice, according to Brandon Moss, MD, from the Cleveland Clinic. The data was presented in a poster session Feb. 28, at the Americas Committee…
Almost 1 in 5 People Wrongly Diagnosed with MS at Two Specialized Centers in US, Study Finds We know that MS is a difficult disease to diagnose, but is it really possible that 20 percent of the MS diagnoses are wrong? Apparently so. This study reports that…
More than 21,000 people have signed a petition calling for Ocrevus (ocrelizumab) to be made available by the National Health Service (NHS) in England for people with primary progressive multiple sclerosis (PPMS). According to an MS Trust press release, the…
Blood Stem Cell Transplant Better than DMTs at Reducing Risk of Disease Progression in RRMS Here’s more evidence that hematopoietic stem cell transplant (HSCT) works better than some disease-modifying therapies (DMTs) at reducing multiple sclerosis (MS) progression. In this study, only three of 52 patients in the…
Treatment with Ocrevus (ocrelizumab) has superior or comparable effectiveness and a similar safety profile to other available disease-modifying treatments (DMTs) for treating relapsing multiple sclerosis (MS), according to a new review study. The research, “Systematic review and network meta-analysis comparing ocrelizumab with other treatments for…
Treatment with a single dose of Ocrevus (ocrelizumab) depleted a subset of immune T-cells within two weeks in patients with relapsing multiple sclerosis (MS) or primary progressive MS (PPMS), according to a study. The study, “Ocrelizumab Depletes CD20+ T Cells in Multiple Sclerosis Patients,” was published in the journal Cells. Autoreactive immune T-cells, which attack the body’s own tissues, have been regarded as the primary mediator of MS; however, this view has been challenged by the effectiveness of therapies targeting immune B-cells that contain the CD20 cell surface protein in reducing disease activity. One such therapy is Genentech’s Ocrevus, an anti-CD20 monoclonal antibody, which was first approved in the U.S. in 2017 for patients with relapsing MS or PPMS. Because CD20 is mainly expressed by B-cell precursors and mature B-cells, Ocrevus is often considered to selectively deplete CD20-containing B-cells. However, CD20 is also expressed by highly activated T-cells with the CD3 protein marker, characterized by the increased production of proinflammatory molecules, or cytokines. These T-cells are found in the blood, cerebrospinal fluid — the liquid surrounding the brain and spinal cord — and chronic brain lesions of MS patients, and show an elevated expression of the CD8 and CD45 markers. Off-label use of rituximab (marketed as Rituxan in the U.S. and MabThera in Europe), a lymphoma and rheumatoid arthritis treatment that also targets CD20, has been associated with the depletion of CD20-containing T-cells in MS patients. Therefore, targeting this T-cell subtype has been hypothesized as an additional mechanism for rituximab’s clinical effectiveness. However, scientists did not know whether Ocrevus, which is different from rituximab in terms of CD20 binding and cell toxicity, also depletes CD20-positive T-cells. To address this unknown, a team from Hannover Medical School in Germany analyzed blood samples of MS patients through a technique called multicolor flow cytometry prior to the first dose of Ocrevus and after two weeks, immediately before the second dose. They intended to evaluate the characteristics of the patients’ peripheral blood mononuclear cells, which include T-cells, B-cells, monocytes, and macrophages. A total of 21 patients (13 women) were included, with a median age of 43 years (range 22-65 years). Of the participants, 17 had the relapsing form of the disease for a median of 14.6 years, while four had PPMS for a median of 5.6 years. The analysis found T-cells containing CD20 and CD3 in all patients. These cells accounted for 2.4% of all CD45-expressing lymphocytes — white blood cells that include T- and B-cells — and for a significant proportion (18.4%) of all CD20 cells. Evaluation of the cells’ fluorescence intensity revealed that CD20 levels were significantly lower on T-cells than on B-cells also expressing this marker. Treatment with one dose of Ocrevus substantially lowered the levels of CD20-positive T- and B-cells within two weeks, reflected by a frequency of 0.04% and an absolute cell count decrease from 224.9 to 0.57/microliter. “Our results demonstrate that treatment with [Ocrevus] does not exclusively target B-cells, but also CD20+ T-cells, which account for a substantial amount of CD20-expressing cells,” the researchers wrote. “These findings suggest that CD20+ T-cells might play a pivotal role in the pathogenesis of MS, and we speculate that depletion of CD3+CD20+ cells by anti-CD20 monoclonal antibodies might contribute to the efficacy of anti-CD20 therapy,” they added. However, they also emphasized that the findings need to be confirmed in studies with larger groups of MS patients.
Pretreating multiple sclerosis patients with antihistamines more extensively and with hydration can significantly reduce — by 60% — the likelihood of infusion-associated reactions that are the most common side effect of Ocrevus (ocrelizumab) use, a pilot study reported. Data also found that older and male MS patients are less likely to have…
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