ocrelizumab

Ocrevus Use Rises Among New Starters with RRMS, Loses Ground to Other Therapies in PPMS Ocrevus (ocrelizumab) bolted out of the starting gate after it was approved for use in the U.S. about three years ago. However, though its use by people with relapsing forms of multiple sclerosis continues…

The medical profession must be sick and tired of patients diagnosing themselves via the wonders of the internet. But as a patient who’s sick and tired, you eventually have to. Medicine is full of orthodoxies that are incredibly hard to shake. When you find yourself at the edge of these…

People with multiple sclerosis have been waiting for this: A full-scale clinical trial testing the effectiveness of stem cell transplantation as an MS treatment. The trial is being conducted by the U.S. National Institutes of Health, and it’s enrolling people with MS at several centers in the United States and…

Ocrevus (ocrelizumab) has been approved in Scotland as a treatment for early, inflammatory primary progressive multiple sclerosis (PPMS). The Scottish Medicines Consortium (SMC) has advised that Ocrevus can be prescribed by the National Health Service (NHS) for people with PPMS who have had symptoms for less than 15…

I rolled onto the neurology ward of the hospital that has been dealing with my disease from the beginning. The nurses, whom I’ve met innumerable times, opened with their normal jolly, “How are you?” I can never resist, “Well, I have got MS!” It was 8 in the morning. I’d…

I remember a time without televised ads promoting medication. We had access to information through our physician or a card catalog. Pharmaceuticals are now a mainstay on our airwaves. And although prevalent, these ads previously had been inapplicable to me. Until now. An ad for Ocrevus (ocrelizumab) aired a…

#ECTRIMS2019 – Are Injectables Inappropriate for Active Relapsing MS Treatment? Injectable disease-modifying therapies (DMTs) have been around for a long time. I took part in a Phase 3 clinical trial for Avonex (interferon beta-1a) in the mid-1990s. These treatments were the only game in town back then, and…

Ofatumumab, an investigational B-cell therapy being developed by Novartis, demonstrated encouraging results in lowering relapse rates and active brain lesions in people with relapsing multiple sclerosis (MS) enrolled in the ASCLEPIOS trials. For Stephen L. Hauser, MD, an investigator in the ASCLEPIOS trials, these results represent a…

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…

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…

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…

Editor’s note: This is the second 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,…

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…

Treatment with rituximab — sold as Rituxan in the U.S. by Roche and Biogen, and as MabThera by Roche in Europe — reversed disease course in a “dramatic fashion,” leading to complete remission in a 12-year-old boy with aggressive relapse-remitting multiple sclerosis (RRMS), a case report states. The report, “…

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…

Last Thursday was the hottest day ever recorded in U.K. history at 101.6 degrees F. Heat sensitivity is enough to reduce me to the puddle I described last week. But it doesn’t explain the shaking of my body and the extreme pain in my right arm Thursday night. Not…

Over the past several weeks, I’ve been using an app called Floodlight to track my ability to live with my multiple sclerosis (MS). It measures things such as my balance, finger dexterity, walking speed, and cognitive ability. It even knows if I’m keeping myself shuttered in my apartment or…

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…

Cyxone Launches Phase 1 Trial Assessing T20K for MS This trial caught my eye because even though it’s a small, early trial, T20K is a medication derived from a plant. Animal studies have shown that the treatment can inhibit cytokines, substances that mediate inflammation. Cyxone launched the first-in-human Phase…

I worked up a little sweat when I was exercising the other day. It was just a tiny bit on my forehead, but it was something I hadn’t felt in many years. I’ve lived with MS since 1980, and before now, I can’t remember the last time I felt sweaty.

I remember the day like it was yesterday: Sept. 20, 2012. I was fortunate to receive a swift diagnosis — following a couple of tests, my neurologist told me that I have multiple sclerosis (MS). At the time I thought, “Well, let the journey begin.” My name is Stephanie…

#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.

Although the use of highly effective disease-modifying treatments (HETs) in patients with relapsing-remitting multiple sclerosis (RRMS) has increased, they still represent a minority among the treatment strategies used, according to a study. The study, “Trends in the use of Highly Effective Disease Modifying Treatments in Multiple Sclerosis…

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…

I spend a great deal of time in my head. I think. A lot. Perhaps I do so more than I should, but then again, it is a haven at times. My thoughts run the gamut from the serious to the inane. Today my thoughts…

When the U.S. Food and Drug Administration approved the disease-modifying therapy Mayzent for relapsing types of multiple sclerosis, it specified in its label that the treatment was for people with clinically isolated syndrome, relapsing-remitting MS, and — importantly — secondary progressive MS provided they have "active" disease. The approval is good news, an MS researcher and physician said to Multiple Sclerosis News Today in an interview, but "surprising" in that the FDA's decision was largely based on a trial that didn't involve CIS patients and wasn't focused on responses among particular types of SPMS. “It's the first time that I've seen in the MS field that regulators made an approval designation — active secondary progressive MS — based on an underpowered subgroup analysis,” said Robert Fox, MD, a neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. Novartis' medication, as a first oral therapy approved in the U.S. for a form of SPMS, is a big step forward in MS treatment, he said. But details of the FDA's decision caught him off guard. Fox served on the steering committee for the EXPAND Phase 3 clinical trial , on which the FDA decision was largely based. His clinic was also one of the sites treating and evaluating patients in this pivotal study. Results of the EXPAND trial showed that Mayzent could reduce the risk of disability progression at three months (the trial’s primary endpoint, or goal) by 21% in treated SPMS patients, compared to those given a placebo. Among those with active SPMS (meaning with relapses), a 33% reduction was observed. The treatment, an S1P modulator that works in part to keep lymphocytes from entering the brain to trigger inflammation, also decreased the annualized relapse rate by 55% and improved cognitive processing speed in all treated patients.  “What was found, and I think quite clearly found in a large-size study, was that siponimod in patients with secondary progressive MS clearly slowed the progression of clinical disability over the course of the trial,” Fox said. “It's a statistical concept — obviously patients either progress or they don't progress — but on an overall basis there was a 21% slowing in the rate of progression of clinical disability.” The FDA’s decision is particularly important for SPMS patients. While Ocrevus (ocrelizumab) also treats all relapsing MS forms and people with primary progressive disease (PPMS), it's an intravenous therapy given every six months. Mavenclad (cladribine), approved for relapsing patients in the U.S. just days after Mayzent, is another oral and active disease therapy. To Fox, Mayzent seemed to reach beyond only those secondary progressive patients with clinically active disease. “Really, this is the only drug that's been found to be effective in secondary progressive MS," he said. “To that degree, it stands alone.” That's why two points in the FDA's decision surprised him. The first is the label's specific mention of clinically isolated syndrome. CIS is defined as the first clinical presentation of this disease — a neurological episode that lasts at least 24 hours, and is characterized by inflammatory demyelination (the loss of myelin, the protective coat surrounding neurons).   For clinicians like Fox, CIS is a first manifestation of MS — a kind of "mono sclerosis." Since there’s only one documented attack, it can’t yet be considered multiple sclerosis, “as the multiple hasn't happened,” Fox said, but many "in the field consider CIS to be … an early stage of MS." “If the patient has a whole bunch of lesions on their brain [as seen on an MRI scan] and they had a single clinical event, ah, probably, they have MS,” he said. Regulatory bodies like the FDA, however, have historically considered CIS to be its own separate entity. That makes this decision doubly surprising, according to Fox, since the EXPAND trial only enrolled patients with SPMS, not CIS.   “It's the first time I've seen them approve for CIS specifically when there wasn't a trial in CIS,” Fox said. “I agree with it — I don't have a problem with it — it just surprised me that the regulators were so progressive in their appreciation of MS.” The second — and far more unsettling — surprise was the FDA’s decision to only approve Mayzent for “active” SPMS patients, instead of all SPMS patients. This decision didn’t come out of nowhere, he noted, but it remains puzzling in the context of the EXPAND trial.  In compiling trial results, investigators did a subgroup analysis — as they often do, almost as an aside for research reasons — and found more favorable responses to Mayzent treatment in patients with active inflammation before the trial's start, those it determined to be with "active" disease.   “There was a third of patients who had a relapse in the two years prior to enrollment, and those patients actually had a 30% slowing in disability progression, compared to the 21% overall,” Fox said. This certainly does suggest that Mayzent can be more effective in people with active disease — but there's a catch. The trial itself was not designed to make such a distinction. It enrolled SPMS patients regardless of activity, and its priority goal was changes in disease progression across all who were treated with Mayzent or given a placebo.   “What's important is that the trial was powered for the overall outcome. It was not powered for subgroup analysis,” Fox said, considering this a crucial point.  In clinical studies, being “powered” refers to the enrolling of whatever specific number of participants a study needs to ensure its results will reach statistical significance. More people are redundant and, as such, an unnecessary cost; fewer could mean that trial's conclusions cannot be supported by rigorous scientific measures.  In other words, Fox said, the only conclusions that can be drawn from the EXPAND study reliably — with rigor — are based on data drawn from all its SPMS patients, not a subgroup with active disease. This trial “followed over 1,600 patients for the clinical disability. These are purposely powered so that you're not following twice as many people as you need to … you're powered for that primary outcome,” he said. “So, how could they [the FDA] look at a subgroup analysis and make an approval decision based on a subgroup analysis that was underpowered?” The neurologist gave as examples other subgroup differences found in trial analyses that didn't affect regulatory approval — but to his mind, equally could have. One was an analysis finding female SPMS patients responded to the therapy better than males, showing lesser disease progression. "So why didn't they just approve it for the females and not the males?" Fox asked. But, when asked, Fox did not think the label to necessarily be an error. "My point is the absurdity of it," he said. "How could they make the regulatory approval based on a subgroup analysis that wasn't powered for conclusions?" He was also particularly troubled because the FDA “didn't define what ‘active’ means — is it just a relapse, or is it MRI disease activity?"  For many clinicians, “active” SPMS refers to ongoing inflammation that can be observed on MRI (magnetic resonance imaging) scans. In EXPAND, however, the active subgroup was defined as patients with clinical relapses within two years of being enrolled in the trial. Fox worries about this apparent lack of a regulatory definition of "active" SPMS, since “obviously, the insurance companies are going to seize upon that, and they're going to look for every way they can to avoid covering it for patients.” Mayzent, Fox agreed, is likely to be expensive. The therapy is reported to carry a U.S. list price of $88,500 a year. “I always have a concern about the cost of these drugs. They're all fearfully expensive,” he said, noting he treats SPMS patients. His focus now is on working to ensure that possible regulatory and financial hurdles won’t pose too much of an obstacle for patients, especially those with SPMS. “I don't know what the insurance companies are going to do with this, but I'm hoping that it is available for my patients, and I say that as their clinician,” Fox concluded.

National organizations that represent patients with multiple sclerosis (MS) welcome the U.S. Food and Drug Administration’s March 26 approval of Novartis’ oral therapy Mayzent (siponimod) — but they complain that, at $88,500 per year, the treatment is overpriced. The Multiple Sclerosis Society of America (MSSA) is clearly upbeat about the…