Author Archives: Larry Luxner

TV Personality Montel Williams Launches ‘My MS: Second Act’

A little over 20 years ago, Montel Williams learned once and for all that he had multiple sclerosis (MS). But that determination should have happened long before then, said the well-known TV personality — who’s made fighting the neurodegenerative disease his life’s mission. Williams, 63, was the star attraction…

Newly Published NMSS Study Confirms Nearly 1 Million Americans Have MS

It’s finally official: Around 900,000 Americans and quite possibly more than that have multiple sclerosis (MS) — easily double the long-accepted figure of 400,000. Since MS News Today first reported on this finding in November 2017, the National Multiple Sclerosis Society (NMSS) study, which reached that conclusion, has…

5 MS Patients Across US Talk About How Ocrevus Has Changed Their Lives

It’s been a little over a year since U.S. regulators approved Genentech’s Ocrevus (ocrelizumab) as the first treatment for both relapsing and progressive forms of multiple sclerosis (MS) — a disabling neurological disease now believed to affect nearly one million Americans. While the jury’s still out regarding the therapy’s…

Ocrevus a Year After Approval: Views of Some MS Experts

A year after U.S. regulators approved Genentech's Ocrevus 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 a godsend for certain subsets of patients. But it’s simply too early to tell if the infusion therapy is the game changer its developers predicted it could be for the MS population in general, he said. The neurologist, Dr. Robert Lisak, who is past president of the Consortium of Multiple Sclerosis Centers (CMSC), teaches immunology and biology at Detroit’s Wayne State University School of Medicine. The U.S. Food and Drug Administration approved Ocrevus on March 28, 2017 — a milestone, considering that MS is now believed to affect nearly one million people in the U.S., according to the CMSC. In clinical trials, Ocrevus — which is administered as an intravenous infusion once every six months — slowed MS progression. This has given hope to the thousands who suffer from primary progressive multiple sclerosis and the more common relapsing-remitting (RRMS) form of the disease. About 15 percent of all MS patients are believed to have PPMS, which in general is more difficult than RRMS to diagnose and treat. People with PPMS also tend to have more difficulty walking, and usually require more assistance with everyday activities. Dr. Robert Lisak estimates that 500 to 600 of the several thousand MS patients being treated at his Detroit clinic are receiving Ocrevus. But he points out that “you don’t really know how a therapy is doing in an individual patient unless they were doing terribly and are now doing very well, or they’re now doing poorly. "With in-between patients, it’s difficult to know whether you’re getting a partial response,” he said. “The patient who seems to be stable may have a mild attack every two or three years, or no new [brain] lesions. In that case, you don’t know what they would have done had you not put them on any new therapy,” Lisak said. “Suppose you had decided to switch them off Rebif. If they do spectacularly well, then Ocrevus has been a big improvement. But if they were doing OK on Rebif or Copaxone, and you then switch them to Ocrevus and they’re still doing the same or a little better, you can’t tell.” Brain lesions are areas where the myelin sheath that protects nerve cells has deteriorated. It's a hallmark of MS. Another group of patients that have done well on Ocrevus are those who were previously doing well with Tysabri, but switched because of concerns with or evidence of JC virus, which can lead to a potentially fatal brain inflammation known as progressive multifocal leukoencephalopathy (PML). Tysabri treatment is known to increase the risk of PML. Insurance not a major problem  Lisak said access to the $65,000-a-year Ocrevus varies according to a patient’s insurance company, but most insurers have covered it after other therapies failed. “The only problem we’ve had occasionally is when a patient has such active disease and such poor indicators that you’d like to put them on Ocrevus or Tysabri right from the beginning,” he said. “We have had a lot of resistance from insurance companies. But as a second- or third-line treatment, when a patient has failed or doesn’t tolerate another drug, we’ve done pretty well.” “Knock on wood,” was Lisak’s response when asked about safety issues linked to Ocrevus. “So far, there have been no tumors or opportunistic infections, but it’s only a year,” he said. “You don’t know you’re out of the woods yet. The extension study of ORATORIO and OPERA 1 and 2 have looked reasonably good, but you don’t know what’s going to come five years out.” The biggest worry, he said, is a possibly heightened risk of breast cancer among women on Ocrevus. In clinical trials, half a percent of patients with relapsing MS and 2.3 percent of PPMS patients developed cancer. Genentech urges women on therapy to undergo routine breast cancer screening based on age and family history of cancer. “It’s a concern until we see statistics one way or another,” Lisak said, noting that none of the patients on a placebo during the Ocrevus trials developed the disease. “Unless you think placebo prevents breast cancer, you’ve got to worry about it,” he said. “We have a lot of patients who, when they hear that there’s a risk and they have a family history, they shy away from it. So you’re sort of self-selecting out the patients who might be more likely to get breast cancer.” Twice-a-year infusions and stability Lori Mayer is director of medical research at Central Texas Neurology Consultants in Austin. A registered nurse, she was involved in clinical trials of Ocrevus. She works with Edward Fox, a top neurologist studying MS. “I think the efficacy data speaks for itself in that what you see in the clinical trials is what we see in real life,” Mayer said. “Many are patients who were on treatments maybe every day — either a pill or an injectable — or maybe a couple of times a week.” The infusion method of delivery causes some patients to feel as if they’re not doing anything to fight their disease, she said. But Ocrevus is effective for six months. “Patients have to readjust their mindset that they’re still doing something for their MS, but that they don’t have to think about it for six months. It’s kind of psychological, but it’s a very important component,” Mayer said. “Every MS patient has his or own variety of symptoms, and these fluctuate from day to day, from morning to night, and from month to month. There’s no continuity of anything. "What I see with these patients on Ocrevus is that they don’t [have to] deal with this,” she said. “They have more stability, and for them, that makes a significant difference. When patients don’t need to think about their MS on a daily basis, their whole life changes.” That translates into an improved quality of life for that patient, Mayer said. About 200 of the 1,400 patients being treated at her clinic are receiving Ocrevus. “The PPMS population is small, compared to RRMS, but those progressive patients that are on Ocrevus are really excited because there hasn’t been a disease-modifying therapy available for them in the past. This is the first FDA-approved treatment for progressive MS.” She said the four-hour infusion required for Ocrevus is tolerated “really well,” and that its disadvantages are limited. “There is some concern about breast cancer issues, since so many of our patients are women,” she said, echoing Lisak’s concerns. “That’s where your long-term safety evaluations really come in, and we need to follow them over time.” Mayer said her clinic recommends that women follow the American College of Obstretricians and Gynecologists' mammogram advice, and tells patients that vaccines need to be done at least six weeks before an Ocrevus treatment begins. The CMSC will soon issue specific guidelines to patients considering this therapy, she added.

Nearly 1 Million Americans Have Multiple Sclerosis, NMSS Prevalence Study Finds

An estimated 947,000 people in the U.S. have multiple sclerosis — more than double the long-accepted figure of 400,000 — according to a newly completed study organized and funded by the National Multiple Sclerosis Society. “This is definitely not what we expected,”  Nicholas G. LaRocca, vice president of healthcare delivery and policy research at the New York-based NMSS, said in an interview with Multiple Sclerosis News Today. The nonprofit organization presented its poster, “The Prevalence of Multiple Sclerosis in the United States: A Population-Based Healthcare Database Approach,” at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, the world’s largest MS research gathering. Now under peer review, these findings are considered tentative until that review is complete and the study is published in a scientific journal, possibly next year. LaRocca, who’s headed the MS Prevalence Initiative since its 2014 launch, said the dramatic jump seen in prevalence has more to do with methodology than an actual rise in the number of MS cases — though he doesn’t discount that possibility. “In the past, prevalence was looked at as the number of people diagnosed with a given disorder at a particular point in time,” LaRocca said. “But people with a given condition don’t necessarily have the sort of contact with the healthcare system that would appear to generate a valid diagnostic report. In order to get an accurate estimate, you can’t look at one point in time or even a year or two, but several years. That really opened up the possibility that the numbers would be much greater than we anticipated.” June Halper, CEO of the Consortium of Multiple Sclerosis Centers in Hackensack, N.J., was not surprised by the new data. “Here in New Jersey alone, we have tens of thousands of cases,” she said. “MS now seems to be occurring all over the world, in areas you wouldn’t expect it to occur.” Kathy Costello, a registered nurse and associate vice president for clinical care at NMSS, also welcomed the new estimate. “Over the years, lots of numbers have been thrown around. I myself, in my own practice, thought it had to be much greater than 400,000,” Costello said in a video interview at ECTRIMS 2017. “But we’ve been using that number for 25 years because it’s very difficult to get that those kinds of statistics. This has a whole lot of meaning, for treatments, for health economics and for everyone to know what the number really is.” The latest NMSS study cost $1 million and involved a working group of 15 to 20 epidemiologists, statisticians and neurologists meeting virtually every week. It drew on data culled from five national databases — Optum, Truven Health Market Scan, Department of Veterans Affairs, Medicare and Medicaid — and one regional database, Kaiser Permanente of Southern California. Collectively, these six databases provided information on more than 100 million people — or well over a third of the U.S. population — with the rationale that “nearly all persons with MS, except the uninsured, would be captured in one of these programs.” Among its limitations, the NMSS study excludes children, Native Americans, undocumented residents and prisoners, as well as people who seek treatment at alternative medical clinics rather than the healthcare insurance system. The study showed an overall MS prevalence of 402.8 cases per 100,000 inhabitants — up from 58 per 100,000 in 1976 and 85 per 100,000 for the period 1989-94.

Dancing Doodle

Did you know some of the news and columns on Multiple Sclerosis News Today are recorded and available for listening on SoundCloud? These flash briefings give our readers an alternative option for accessing information important for them.

Listen Here

Survey Icon

Video