An approved lymphoma treatment, rituximab was found to be effective and safe for relapsing-remitting multiple sclerosis (RRMS) patients whose active disease has failed to respond to immunosuppressive therapies, a retrospective French study reports. Published in the Multiple Sclerosis Journal in an article titled, “Efficacy of…
Drug information
Mavenclad Effective in Treating Highly Active MS, New CLARITY Analysis Shows Mavenclad isn’t approved for use in the U.S. but it is approved in Canada, Europe, and other parts of the world. Here’s another positive study of the therapy. Hopefully, it won’t be much longer before Americans…
Biogen, a pharmaceutical company that markets half a dozen MS therapies, is accused of paying doctors to prescribe its medications. A former Biogen employee claimed that the company paid fake consulting and speaking fees to doctors who prescribed Avonex (interferon beta-1a) and Tysabri (natalizumab) in 2009 and 2010. The company…
An additional analysis of data from the CLARITY study confirmed the long-term benefits of treatment with Mavenclad (cladribine tablets) for patients with highly active relapsing forms of multiple sclerosis (MS). The post-hoc analysis, “Efficacy of Cladribine Tablets in high disease activity subgroups of patients…
Lemtrada (alemtuzumab) can sustain reduced activity and prevent progression of relapsing-remitting multiple sclerosis (RRMS) for more than seven years, clinical data from the CARE-MS extension trial shows. Findings were recently presented in four poster presentations at the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles. Lemtrada, marketed by Sanofi Genzyme, is an approved MS therapy that, according to its label, should generally be reserved for patients who have had an inadequate response to two or more other therapies. But the use of the word "generally" opens a window of opportunity “to use Lemtrada as a second-line therapy and potentially first-line therapy,” Barry Singer, MD, director of the MS Center for Innovations in Care at Missouri Baptist Medical Center, said in an email response to questions from Multiple Sclerosis News Today. The treatment was initially tested in two pivotal clinical trials in comparison with a high-dose under-the-skin injection of Rebif (interferon beta-1a) in RRMS patients. Participants were either new to treatment (CARE-MS I, NCT00530348) or had not responded to prior therapies (CARE-MS II, NCT00548405). During these trials, patients received 12 mg of Lemtrada for three or five consecutive days in two annual courses — at the beginning of the study and again one year later. After completing this treatment period, they had the opportunity to participate in a four-year extension study (NCT00930553) during which they could receive the therapy as needed to control their disease. Patients completing the extension could enroll in the five-year TOPAZ trial (NCT02255656) for further evaluation. To date, 80% of the participants (299 patients) from CARE-MS I and 73% from CARE-MS II (317 patients) have completed seven years of long-term follow-up. After completing two initial courses of Lemtrada, 59% of patients from CARE-MS I and 47% from CARE-MS II did not require additional treatment courses with Lemtrada or other disease-modifying therapies during the next six years. Two-thirds of CARE-MS II patients who required a third Lemtrada course also experienced disability stabilization one year after the last treatment. During the seven years of follow-up, reported annualized relapse rates remained low, and 37% of patients from CARE-MS 1 and 44% from CARE-MS II experienced confirmed improvements in disability. In fact, during this period, only 26% from CARE-MS 1 and 31% from CARE-MS II showed disability worsening. The treatment also had a sustained effect on slowing brain volume loss by the seventh year, with a median yearly brain volume loss of 0.20% or less from the third to seventh year. This effect was found to be even better than that reported during the initial two years of treatment in the pivotal studies (0.59% in the first year and 0.25% in the second year in CARE-MS I, and 0.48% in year one and 0.22% in year two in CARE-MS II). Additionally, evaluation by magnetic resonance imaging (MRI) showed no signs of disease activity during the seven years of follow-up. “The extension study data being presented at AAN illustrate that more than two-thirds of patients did not experience confirmed disability worsening at year seven after initiating treatment with Lemtrada,” Singer said in a press release. “In addition, consistent effects were maintained over time across relapses and MRI outcomes including brain volume loss, even though the majority of patients did not receive any additional treatment over the prior six years.” During the extension studies, the frequency of adverse events was similar to that reported during the pivotal studies. In seven years, three deaths occurred, none of which was considered to be treatment-related. Thyroid adverse events were reported to be more frequent by the third year, but declined thereafter. As Singer noted, "the serious risks of Lemtrada, including serious infusion reactions, serious infections, thyroid disease, kidney disease, low platelets and potential malignancies, must always be discussed with the patient." All patients should also be carefully monitored on a monthly basis for four years after the last treatment course “to screen for autoimmune complications, including low platelet counts, thyroid disease, and kidney disease,” he said. Lemtrada’s long-term effects were shared at the AAN annual meeting in these presentations: “Active RRMS Patients Treated with Alemtuzumab Experience Durable Reductions in MRI Disease Activity and Slowing of Brain Volume Loss: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study)” “Durable Clinical Outcomes With Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS II Patients (TOPAZ Study)” “Durable Reduction in MRI Disease Activity and Slowing of Brain Volume Loss in Alemtuzumab-Treated Patients With Active RRMS: 7-Year Follow-up of CARE-MS I Patients (TOPAZ Study)” “Durable Clinical Efficacy of Alemtuzumab in Patients With Active RRMS in the Absence of Continuous Treatment: 7-Year Follow-up of CARE-MS I Patients (TOPAZ Study) Lemtrada is approved in more than 60 countries, and has additional marketing applications under review by regulatory authorities worldwide.
Here in the U.S., the price we pay for medications is complicated. The usual process is for a pharmaceutical company to set a high price for a medication when it first hits the market. But, like buying a car, that “sticker” price is negotiable. Health plans use pharmaceutical benefit…
Part two in a series. Read part one here. In the last column, I discussed gadolinium’s role in contrasted MRI procedures and a December 2017 warning by the U.S. Food and Drug Administration that the body can retain gadolinium in its tissues and brain for years. I also shared my personal experience with…
#AAN2018 – Stem Cell Transplant is Effective Treatment for ‘Aggressive’ MS, Study Shows I like the fact that a study shows that stem cell transplant treatment is effective for aggressive MS. I love the fact that the efficacy was dramatic, reducing the Expanded Disability Status Scale (EDSS) levels…
A new American Academy of Neurology (AAN) guideline recommends that multiple sclerosis (MS) patients in general be counseled to start treatment with disease-modifying therapies (DMTs) as early as possible. Considerations on switching and stopping treatments are also presented in the guideline. The report, “Practice guideline recommendations…
The American Academy of Neurology (AAN) has just released some new guidelines about when to begin, change, and end disease-modifying therapies (DMTs) that are used to treat MS patients. The guidelines, published on April 23, encourage aggressive treatment when symptoms of MS first appear. They’re also patient-centric. And…
Novartis’ investigational oral treatment siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a new analysis of Phase 3 trial results show. Using what the company describes as more accurate methods to assess siponimod effect’s on progression risk, necessary because the…
Extending the time between standard doses of Tysabri (natalizumab) from four weeks to up to 12 weeks is linked to a significant decrease in the risk of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients infected with what’s known as the JC virus, according to a recent analysis of data from…
Cladribine treatment leads to a selective depletion of memory B-cells in patients with relapsing-remitting multiple sclerosis (RRMS), researchers report. The results are in the presentation “Cladribine for the Effective Control of Multiple Sclerosis via Memory B Cell Depletion” being given Friday, the final day of the 2018 Annual Meeting of the …
Celgene’s oral treatment candidate ozanimod can effectively reduce relapse rates in multiple sclerosis (MS) patients with mild to moderate disability, results of two Phase 3 trials show. The company will present data on the SUNBEAM (NCT02294058) and RADIANCE (NCT02047734) trials in two presentations at the…
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 by Genentech, the drug’s developer. The company will detail these findings in a series of oral and poster sessions at the 2018 American Academy…
With apologies to Edgar Allan Poe, quoth the Lemmie, “Nevermore.” As I write this, the final brown bag of Lemtrada (alemtuzumab) has just begun to drip into a vein in my left arm. If all goes “as advertised,” this will be the final disease-modifying therapy I’ll ever receive.
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…
Novartis‘ siponimod (BAF312) can reduce blood levels of a biomarker of nerve cell damage in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. Researchers will present the latest results of the ongoing trial at the 2018 annual meeting of the American Academy…
Acute Acalculous Cholecystitis Linked to Lemtrada Use in RRMS Patients, FDA Reports The makers of Lemtrada have added the possibility of another serious side effect to the warning carried on the therapy’s label. The addition follows a Food and Drug Administration review that discovered a potentially serious…
Higher rates of adverse effects have a negative impact on a patient’s perspective about treatment with Ocrevus (ocrelizumab), according to a survey conducted by the multiple sclerosis community GeneFo. About half of the 840 patient responses surveyed so far have reported improvements from Ocrevus. Those reporting none had a higher rate…
Acute acalculous cholecystitis (AAC) is a rare but potentially life-threatening adverse effect linked to treatment with Lemtrada (alemtuzumab) in patients with relapsing-remitting multiple sclerosis (RRMS), according to a U.S. Food and Drug Administration review. The study, “Acute acalculous cholecystitis — A new safety risk for…
A large group study showed that first-generation disease-modifying therapies (DMTs) do not increase the infection risk in multiple sclerosis (MS) patients. Many of the DMTs used to reduce the risk of relapse in MS target the immune system and cause a suppression of the inflammatory response. Although helpful in…
Mylan and Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapy Copaxone (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…
As you read this, I likely will be in the middle of, or finished with, my second round of Lemtrada (alemtuzumab). Hopefully, this will be the final round of this disease-modifying therapy (DMT), and the final MS treatment of any kind, for me. Though some have required more,…
Ocrevus (ocrelizumab) was more effective than Rebif (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,…
Siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. An article about the Novartis therapy’s trial results appeared in the journal The Lancet. The title is “Siponimod versus placebo in secondary progressive multiple sclerosis…
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…
Fatigue. That No. 1 symptom that a large majority of people with multiple sclerosis are affected by. MS fatigue. It can be crushing, numbing, and stop the hardiest person in their tracks. I know MS fatigue all too well because it affects me all the time. Combating MS…
As we all know, the cost of prescription medications can be outrageous. Disease-modifying therapies aside, even with insurance, the medications we get from a pharmacy can take quite a bite out of a budget. Though many people don’t know it, there are times when it can actually be…
Editor’s note: Tamara Sellman continues her series on the “MS alphabet” with this column referencing terms starting with the letter “S.” Fourth in a series of five. Symptoms of MS Scotoma Scotoma describes a vision problem in which the presence of “blind spots” or other partial vision…