February 5, 2019 Columns by Ed Tobias Have You Joined Our MS Forums Yet? It’s been about nine months since we created the MS Forums section on the Multiple Sclerosis News Today website. It’s a placeĀ designed to host conversations about our MS experiences and to find some answers from reliable sources when you have a question. You can even begin your own…
January 29, 2019 Columns by Ed Tobias New Study Supports Hitting MS Fast and Hard The question of how quickly to start a disease-modifying therapy (DMT) after a multiple sclerosis (MS) diagnosis is one that I frequently see when I browse online. It goes hand in hand with questions about which DMT is best to start with. There are many things to consider when…
January 25, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: HSCT vs. DMTs, Mindfulness for MS, Ocrevus and T-cells, Pregnancy Guidelines 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…
December 5, 2018 News by Ana Pena PhD Lemtrada Linked to Bleeding in Lungs in Case Report, 1 of 5 MS Cases Worldwide, Study Says AĀ potentially life-threatening case of bleeding in the lungs has been reported and attributed toĀ treatment with Lemtrada (alemtuzumab) by a woman withĀ relapsing-remitting multiple sclerosis. Her medical team foundĀ diffuse alveolar hemorrhageĀ in this patient ā which resolved in about a week without treatment. The scientists advised that clinicians be alert…
December 3, 2018 News by Ana Pena PhD Lemtrada’s Use Carries Rare But Serious Risk of Stroke and Artery Tears, FDA Warns The U.S. Food and Drug Administration (FDA)Ā has issued a safety alert, warning about a rare but life-threatening risk of stroke and artery rupture in patients with relapsing forms of multiple sclerosis (MS)Ā being treated with Lemtrada (alemtuzumab). Since Lemtrada’s approval in 2014 to treat relapsing MS, 13…
November 19, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: New Thinking About MS Development, Rhythm to Improve Walking, UK Nurse Shortage, B-cells MS-specific Lineage of Oligodendrocytes May Provide New Hints on MS Development Our immune system, according to this study, may not be the only thing playing a role in the development of our MS. The same cells that produce the myelin that coats our nerves may also be…
October 5, 2018 Columns by Ed Tobias Could Government Probe Threaten Pharma Patient Assistance Programs? Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened. A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong…
September 28, 2018 Columns by Ed Tobias Serious DMTs Need Serious Care Coordination Ocrevus (ocrelizumab) is a serious disease-modifying therapy. It has the potential to deliver a major blow to a patient’s MS, but it also carries the possibility ofĀ severe side effects. The protocol for Ocrevus requires different doses on different infusion dates, following a specific treatment schedule. It’s also…
September 10, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: B- and T-cells, Tysabri, Sexual Silence How B-cells Work to Promote T-cell Attacks on Myelin That Lead to MS Detailed in Study I keep a close eye on reports about B-cells and T-cells because they’re the targets of Lemtrada, which is my current disease-modifying therapy. (The DMT Ocrevus targets B-cells alone). So, this…
August 21, 2018 News by Janet Stewart, MSc Consecutive Use of Gilenya and Lemtrada Causes Disease Activity in MS Patient, Case Report Suggests Multiple sclerosis (MS) patients may experience severe disease exacerbation after switching fromĀ NovartisāĀ Gilenya (fingolimod) to Sanofi Genzymeās LemtradaĀ (alemtuzumab), a case report suggests. This unexpected high disease activity raises questions about managing MS through the consecutive use of immunotherapies. The case report, āUnexpected high multiple…
August 16, 2018 News by Iqra Mumal, MSc Lemtrada Can Lower Number of B-cells Infiltrating Nervous System and Forming Clumps, Animal Study Shows Treating mice in a model of multiple sclerosis with Lemtrada (alemtuzumab)Ā prevented the formation of B-cell aggregates in the animals’ central nervous system and disrupted already existing ones, researchers report. The treatment alsoĀ reduced disease activity when administered at the peak of disease. The study, āAnti-CD52 antibody treatment depletes B…
July 27, 2018 Columns by Ed Tobias A Fall, a Scratch, and an MS Lesson Learned In mid-July, the woman who writes the Multiple ExperienceS blog had a little fall. As Jamie explains, her rollator went forward, but her feet didn’t. The fall left a small cut on her knee. Over the next few days, Jamie’s knee swelled, and a trip to her doctor,…
June 6, 2018 News by Patricia Inacio, PhD #CMSC2018 – Gains in Functional Abilities Seen in Lemtrada-treated MS Patients Over Six Years, CARE-MS II Extension Study Shows Patients with active relapsing-remitting multiple sclerosis (MS) continue to show improvement ā lesser functional disability across a variety of measures ā and often without the need for continuous treatment after takingĀ LemtradaĀ for two years, according to six-year results from the CARE-MS II extension study. These results were shared in a…
May 2, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Lemtrada Sustains Long-Term Benefits for RRMS Patients, TOPAZ Study Shows 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 āto use Lemtrada as a second-line therapy and potentially first-line therapy,ā Barry Singer, MD, director of the MS Center for Innovations in Care at Missouri Baptist Medical Center, said in an email response to questions fromĀ 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 ā 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 Ā 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, andĀ 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. āThe 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,ā Singer said in a press release. āIn 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.ā 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 āto screen for autoimmune complications, including low platelet counts, thyroid disease, and kidney disease,ā he said. Lemtradaās long-term effects were shared at the AAN annual meeting in these presentations: āActive 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)ā āDurable 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)ā āDurable 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)ā āDurable 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.
April 27, 2018 Columns by John Connor Tricks of the Trade I saw my neurologist a few weeks ago for what was effectively an emergency meeting. I’d had the customary two rounds of Lemtrada (alemtuzumab) and still had a relapse. We discussed weighty subjects and there seemed,Ā surprisingly, to still be some hope. It depends on the outcome of an MRI;…
April 13, 2018 News by Patricia Inacio, PhD Acute Acalculous Cholecystitis Linked to Lemtrada Use in RRMS Patients, FDA Reports Acute acalculous cholecystitis (AAC) is a rare but potentially life-threatening adverse effect linked to treatment with Lemtrada (alemtuzumab)Ā in patients with relapsing-remitting multiple sclerosis (RRMS), according to a U.S. Food and Drug Administration review. The study, āAcute acalculous cholecystitis ā A new safety risk for…
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 9, 2018 News by Patricia Inacio, PhD #ACTRIMS2018 ā Third Course of Lemtrada Improves Relapse, Disability in MS Patients, CARE-MS II Trial Shows Multiple sclerosis (MS) patients who experience a relapse after two courses ofĀ Lemtrada (alemtuzumab)Ā treatment showed improvements inĀ relapse rate and disability after aĀ third Lemtrada course, according to results of the CARE-MS II trial extension. The poster reporting the findings, titled āEfficacy of Alemtuzumab Retreatment in Patients Who Experienced Disease Activity after…
February 8, 2018 Columns by Tamara Sellman The MS Alphabet: Plaquenil, PML, Prevalence, and Other ‘P’ Words (Part 6 of 7) Editorās note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letter “P.” This post comes sixth in a series of seven. Symptoms of MS Progressive multifocal leukoencephalopathy (PML) Though progressive multifocal leukoencephalopathy (PML) isnāt an actual symptom of MS,…
October 27, 2017 News by BioNews Staff #MSParis2017 ā Lemtrada Shows Good Safety and Lasting Efficacy Over 7 Years, Doctor Says in Interview Lemtrada (alemtuzumab) remains a “game-changer” of a treatment for relapsing multiple sclerosis (MS), with benefits continuing and no new side effects seen in a study of its use that now goes out seven years, Aaron Boster, a neuroimmunologist at Ohio Health, said in an interview atĀ the…
October 27, 2017 News by Patricia Silva, PhD #MSParis2017 ā Early High-Efficacy Treatment Reduces Disability Accumulation in Young MS Patients While early use of high-efficacy treatments lowers relapse rates among patients with relapsing-remitting multiple sclerosis (MS) compared to lower-efficacy ones, starting these therapies earlier may only impact the accumulation of disability among young patients, according to data presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France. Earlier treatment…
October 26, 2017 Columns by Tamara Sellman MS Alphabet: Lesion, LP, Leukocytes, and Other ‘L’ Words Editorās note: Tamara Sellman continues her occasional series on the MS alphabet with this first of two columns about terms starting with the letter L. Symptoms of MS Lesion Lesions are a defining feature of MS. They also are referred to as scars or plaques. These areas of damage…
October 26, 2017 News by Patricia Silva, PhD #MSParis2017 – Lemtrada and Tysabri More Efficient Than Older Injectables in Preventing SPMS Onset, Study Finds Sanofi Genzyme‘s Lemtrada (alemtuzumab) and Biogen’s Tysabri (natalizumab) are more effective in preventing conversion to secondary progressive multiple sclerosis (SPMS) compared to older injectable drugs, researchers from the University of Cambridge in the U.K. reported at the 7th Joint ECTRIMS-ACTRIMS MeetingĀ Oct. 25-28 in Paris. The…
October 23, 2017 News by Patricia Silva, PhD #MSParis2017 – Sanofi to Present Long-term Data on Lemtrada and Aubagio Use New data on how Lemtrada and Aubagio perform in a real-world setting will be the focus of Sanofi Genzyme when the company showcases its research at the upcoming 7th Joint ECTRIMS-ACTRIMS Meeting in Paris this week. Researchers will also share information about the safety of a new investigational therapy, GLD52 (GZ402668), currently in a Phase 1 safety study. The TOPAZ study is one of the main data sources for the upcoming presentations. The study, which follows relapsing MS patients who participated in the CARE MS-I and CARE MS-II extension study , is a rich source of information on long-term outcomes. Researchers will share various aspects of disease outcomes and magnetic resonance imaging (MRI) data from patients followed up to seven years, with some presentations focusing solely on those who switched from treatment with interferon beta-1a. Among the Lemtrada highlights are findings demonstrating that Lemtrada does not appear to trigger birth defects. Another presentation compared Lemtrada to Genentechās Ocrevus using a model that evaluated both the cost and effectiveness of the two drugs. The analysis suggests that Lemtrada more effectively treated relapsing MS and was also linked to lower costs over a 20-year period. Aubagio studies also focused on long-term patient data, including in people with progressive forms of relapsing MS. Data from the Phase 3 TEMSO , TOWER , and the TEMSO extension showed that Aubagio stabilized disability progression in these patients over nearly a decade. Other presentations homed in on Aubagioās ability to slow brain tissue loss and improve cognitive outcomes. Finally, Sanofi Genzyme shared initial data on its investigational antibody GLD52. The treatment is an updated form of Lemtrada, which scientists believe gives rise to fewer and milder infusion-related reactions. Data from the Phase 1 study , so far indicated that this might indeed be the case, as no severe reactions occurred in the 44 progressive MS patients in the trial. For a complete list of Sanofi Genzyme's presentations at the meeting, visit this link.
October 6, 2017 News by Patricia Silva, PhD Lemtrada Prevented Progression of Multiple Sclerosis for Five Years, Study Shows Two short courses of Lemtrada prevented multiple sclerosis from becoming active and progressing for five years, a study reported. Lemtrada's maker,Ā Sanofi-Genzyme,Ā said the study covered the two-year CARE-MS II Phase 3 clinical trialĀ (NCT00548405) and a long-term extension (NCT00930553) trial of people with relapsing-remitting MS. In addition to demonstrating Lemtrada's effectiveness, the study showed that it was safe, researchers said. The Phase 3 trial participants had had an active disease, with at least two relapses in the two years before the study and an inadequate response to earlier treatment. The trial compared Lemtrada's effectiveness with that ofĀ Rebif. The Lemtrada group receivedĀ 12-mg doses for five consecutive days at the start of the study and three consecutive days a year later. Ninety-three percent of the 435 patients who completed the trial enrolled in the extension, which followed patients for another three years. Remarkably, 60 percent of patients required no additional treatment after the two years of the Phase 3 study. Among the 376 patients who required more treatment, 30 percent had one additional Lemtrada course, 10.4 percent had two, and 1.6 percent had three. A small proportion of patients also received other disease-modifying treatments. The most common reason for additional treatment was relapse. Nevertheless, Lemtrada reduced annualized relapse rates to only 0.18 of patients by the fifth year. In addition, during the five years, 75 percent of patients experienced no worsening of their disability over six-month cycles. And 49Ā percent of patients' disability improved. Researchers also tracked patients' scores on the NEDA ā or No Evidence of Disease Activity ā index. The composite measure takes into account relapses, disease activity detected in MRI scans, and disability progression. In year five, 58 percent of patients achieved NEDA, slightly more than the 53 percent in year three. Another important finding was that patients' loss of brain tissue slowed in the first two years, and dropped further during the extension. Researchers also noted that adverse events dropped during the extension trial. Ninety-six percent were mild or moderate, and no patient left the study because of side effects. The rate of infusion-associated reactions was lower in the extension study than in the Phase 3 study. Patients who did have a reaction most often experienced headache, fever, or rash. Infections did not become more common with accumulating Lemtrada doses and, again, were less common in the extension trial. Patients most often developed colds or urinary tract infections. Autoimmune reactions against the thyroid gland were relatively common, however. Thirty-eight percent of patients developed them over the five years. Most were moderate in severity. Four patients developed various types of cancers. Researchers also examined Lemtrada in the CARE-MS I clinical trial and its extension trial. TheyĀ reportedĀ long-term outcomes and safety findings similar to those in the latest study. Overall, the newest results demonstrated that Lemtrada slowed disease progression over five years inĀ relapsing-remitting MSĀ patients who failed to respond to previous therapy.
October 2, 2017 News by Patricia Silva, PhD Long-term Lemtrada Treatment Benefits Demonstrated in Extension Study A five-year study demonstrated that Sanofi-Genzymeās Lemtrada (alemtuzumab) provides long-term benefits forĀ relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease. Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions. The study,…
July 21, 2017 Columns by Ed Tobias Do MS Patients in the UK Get the Right Treatment Quickly Enough? About two years ago, a report by the European Multiple Sclerosis Platform stated that only 21% of MS patients in the United Kingdom were receiving any kind of disease-modifying therapy. This is compared to 40% in France and 69% in Germany. Now, the U.K. branch of pharmaceutical giant Sanofi has published a report of its own, "The Missing Pieces." The report tries to answer, "Why is this so?" Here are some of the answers that were received online from a small group of healthcare professionals and MS patients: Nearly three-quarters of U.K. healthcare professionals think that people with MS face delays in starting on disease-modifying treatments (DMTs). Nearly one-quarter of MS patients there reported being unaware of some treatments that could help delay the onset of disability. Only half of people with MS say disability was discussed with their healthcare professional when they were first diagnosed, yet 69% of the healthcare professionals say it was discussed. Only a third of those patients say that "disability" is discussed in their regular MS appointments. Two-thirds of people with MS say that maintaining independence is their main treatment goal, followed by reducing relapses. The report also says that healthcare professionals believe the primary reason that DMTs are slow to be prescribed is lack of access in the U.K. to neurologists who specialize in MS. And, it says, 62% of MS specialist nurses and 47% of MS specialists thought this delay is also because of a shortage of healthcare facilities needed to deliver DMTs. Now, it needs to be noted that this survey involved only 100 MS specialist healthcare professionals and 120 MS patients in the U.K. And, as mentioned earlier, the survey was conducted by Sanofi, which claims to be the fourth largest pharmaceutical company in the world. Sanofi makes two big-time MS drugs: Aubagio (teriflunomide) and Lemtrada (alemtuzumab). Naturally, it has a vested interest in seeing that MS patients are treated with DMTs. (Full disclosure: I recently was compensated by Sanofi Genzyme to attend a meeting of "digital influencers" that the company held at its U.S. headquarters.) But drug sales aside, a case certainly can be made for treating MS patients with DMTs quickly after patients are diagnosed, and many drugs currently on the market have shown that they are able to modify the course of MS. And there's a case to be made about a need for better patient-healthcare provider communication. So, my question is: How do MS patients in the U.K. feel about access to DMTs? And to MS care, in general? Is this small report correct about the lack of knowledge by patients about their treatment options? Is it correct about the lack of MS specialists and resources in the U.K.? Do MS patients outside of the U.K. have similar concerns?
June 26, 2017 News by Joana Fernandes, PhD RRMS Patients at Risk of PML Can Safely Switch from Tysabri to Lemtrada Lemtrada (alemtuzumab) may be an effective option for relapsing-remitting multiple sclerosis (RRMS) patients withdrawing from prior treatment with Tysabri (natalizumab), an Italian study shows. The study, āHigh-Risk PML Patients Switching from Natalizumab to Alemtuzumab: an Observational Study,ā appeared in the journal Neurology and Therapy. Tysabri, an antibody with…
June 13, 2017 News by Patricia Silva, PhD Unpublished Data May Point to Link Between Lemtrada and Other Autoimmune Diseases in MS Patients Previously unpublished results of clinical trials of Lemtrada (alemtuzumab) appears to contain key information as toĀ why many multiple sclerosis patients who use it develop other autoimmune diseases. Researchers looked at the immune cell mix after Lemtrada depleted many of those cells. They discovered that certain B-cells repopulate the body earlier…
May 31, 2017 News by Patricia Inacio, PhD #CMSC17 – Lemtrada’s 2 Year Therapy in RRMS Sustains Efficacy for Over 6 Years Without Additional Treatment Taking Lemtrada (alemtuzumab) for two years inhibitedĀ magnetic resonance imaging (MRI) disease activity in patients with relapsing-remitting multiple sclerosis (RRMS) for more than six years, theĀ CARE-MS I clinical trial extension study found. Researchers presented their study,Ā āDurable Efficacy of Alemtuzumab on MRI Disease Activity Over 6 Years in Treatment-Naive RRMS Patients With…