August 26, 2019 News by Jose Marques Lopes, PhD Link Between Lemtrada, Mortality More Common Than Previously Reported Treatment with Lemtrada (alemtuzumab) is associated with the death of patients with relapsing-remitting multiple sclerosis (RRMS) more often than previously reported and appears to be most common during the first month, according to a European review. The study, āAdverse events with fatal outcome associated…
August 7, 2019 News by Patricia Inacio, PhD Autoimmune Complications Associated with Lemtrada Solved Using Anti-CD20 Therapies, Case Studies Suggest Relapsing-remitting multiple sclerosisĀ (RRMS) patients treated with LemtradaĀ (alemtuzumab) may develop additional (secondary) autoimmune reactions. Anti-CD20 therapies, including rituximabĀ 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…
June 24, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Plant Medication Trial, B-cell Depletion Study, MS App Award, DMTs’ Cancer Risk 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. CyxoneĀ launched the first-in-human Phase…
June 19, 2019 News by Patricia Inacio, PhD Lemtrada Lowers Levels of Nerve Damage Biomarker Better Than Rebif, Trial Data Show Treatment with Sanofi GenzymeāsĀ LemtradaĀ (alemtuzumab) for up to two years lowers the levels of serum neurofilament light chain (sNfL), a proposed biomarker of nerve damage, in relapsing-remitting multiple sclerosisĀ (RRMS) patients to levels comparable to those seen in healthy people, data from the CARE-MS I study shows. Lemtradaās effectiveness…
June 18, 2019 Columns by Ed Tobias Some Neuros Make DMT Choice Harder than It Should Be More than 15 disease-modifying therapies (DMTs) are available in most high-income countries to treat multiple sclerosis (MS). DMTs come in the form of injectables, infusions, and pills. Some are new, others have been around for more than 20 years. Some have a greater possibility of serious side effects than others. Some DMTs are highly effective at slowing or stopping disease progression; others, not so much. It's a difficult choice to make. So, why are some neurologists making it harder? These doctors are handing their patients a medication "shopping list" and telling them to pick one. I see this topic discussed regularly in social media MS groups. Recently, a woman who needs to switch DMTs wrote that her neuro gave her a "handful of (medication) brochures" and told her to go home and decide which medication she wanted. Really? DMT selection shouldn't be do-it-yourself I've been using DMTs for more than 20 years. I've been on Avonex (interferon beta-1a), Tysabri (natalizumab), Aubagio (teriflunomide), and Lemtrada (alemtuzumab). I always had the final say on which med I wanted to use, but I never had to make that decision alone without guidance from my neuro. That's the way a doctor-patient relationship should work. While the final DMT decision should always rest with the patient, your neurologist has the responsibility to use his or her knowledge of the meds and of you to guide you in your choice. Some factors that you both need to consider are: Is the disease progressing quickly or slowly? Your lifestyle: Do you work full time? Do you have a good support system and reliable transportation? If an injectable DMT is in the mix, can you handle injecting yourself monthly, three times a week, or every day? How much possible risk are you willing to accept in exchange for the potential of a better result? An additional and criticial consideration is whether you can afford the treatment. My impression is that cost is rarely thought of or talked about before most physicians prescribe a medication. I see nothing wrong with asking your doctor how much you can expect to pay out-of-pocket. (Or, for the doctor's office to ask this of your insurance company). If you feel your neurologist doesn't know all of these things about you I suggest that you be proactive and fill in any blanks. The final choice is yours With all of that knowledge, you can probably narrow down the most appropriate DMT candidates for you to three or four. Then it's time for your neuro to clearly explain why those are the best choices and to review the pros and cons of each. Then, and only then, it's time for you to make the final choice. And your decision might be not to use any medication. That wouldn't be my choice, but it might be yours. After all, you're the one who'll be living with whatever choice you make. What has been your experience? Was your neurologist helpful when selecting a DMT or were you given "a handful of brochures" and told to do-it-yourself? How did you choose? You're invited to visit my personal blog at www.themswire.com.
June 13, 2019 News by Marisa Wexler, MS Elevated Blood Pressure May Predict Brain Bleeding in RRMS Patients Treated with Lemtrada, Study Suggests New research suggests that rising blood pressure might be predictive of intracranial hemorrhage ā bleeding in the brain, a serious and sometimes fatal condition ā in people with multiple sclerosis (MS) who are receiving treatment with Lemtrada (alemtuzumab). The study, titled “Intracerebral haemorrhage during…
June 7, 2019 Columns by Ed Tobias My MS Has Been No Sweat. Has Yours, Too? 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.
May 14, 2019 News by Jose Marques Lopes, PhD #AANAM ā Use of Highly Effective Treatments for RRMS Increasing but Still Limited, Study Says 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, āTrends in the use of Highly Effective Disease Modifying Treatments in Multiple Sclerosis…
May 10, 2019 News by Ana Pena PhD #AANAM – RRMS Patients Switching to Lemtrada Report Greater Satisfaction with Treatment and Improvements in Quality of Life Patients with relapsing-remitting multiple sclerosis (RRMS) who switched to infusions with Sanofi Genzymeās Lemtrada (alemtuzumab) report increased satisfaction with treatment and improvements in health-related quality of life, according to…
April 18, 2019 News by Joana Carvalho, PhD EMA Reviewing Safety Data for Lemtrada After Reports of Serious Treatment Side Effects The European Medicines Agency (EMA) is reviewing safety data for Sanofi Genzyme‘sĀ LemtradaĀ (alemtuzumab) following new reports of serious treatment side effects. Lemtrada is a humanized monoclonal antibody used to slow disease progression in adult patients with relapsing-remitting multiple sclerosis (RRMS). It works by blocking the activity of…
March 18, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Non-contrast MRIs, Stem Cell Study Seeks Subjects, Postpartum Relapses, Which DMT? Non-contrast MRI Effective in Monitoring Progression of MS, Study Shows There’s been increased interest in the risks versus the benefits of using gadolinium to make lesions more visible on an MRI. The U.S. Food and Drug Administration issued an advisory last year raising the level of…
February 22, 2019 Columns by Ed Tobias My Lemtrada Journey and a 90-minute School Bus Ride My wife and I joined our son and his family on a tour of a Southwest Florida nature preserve today. It required riding on an old school bus-swamp buggy for a little over an hour and a half. There were plenty of gators, wild hogs, egrets, and storks in…
February 20, 2019 News by Patricia Inacio, PhD Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports Multiple sclerosis (MS) patients given intensive disease-modifying therapies early in their disease course have more favorable long-term outcomes than those treated with an escalating regimen, real-world data shows. The study, āClinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,ā was published in the journalĀ …
February 8, 2019 Columns by Ed Tobias DMT Approvals for Medicare Users Decline While Costs Rise, Study Shows This probably won’t come as a surprise to you if you’re on Medicare: It’s getting harder to obtain approval for many of the disease-modifying therapies (DMTs) prescribed for people with multiple sclerosis (MS). I see complaints about this all the time on social media. Now, research reported in…
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 7, 2018 Columns by John Connor The Right Hand of Lightness There’s a joy in going on a long journey in which I get the luxury of sleeping through the whole thing. It’s practically magical. Or scientifically, like teleportation. I was there and now I’m here without any effort! I’ll never be able to afford a first-class bed on a…
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 16, 2018 News by Ana Pena PhD #ECTRIMS2018 – Shifting from Gilenya to Lemtrada Doesn’t Increase Risk of MS Reactivation, Study Says Shifting from treatment with Gilenya (fingolimod) to Lemtrada (alemtuzumab), and doing a short washout period between the two therapies, does not seem to increase the risk of disease reactivation in patients with multiple sclerosis (MS), an Italian study shows. Lemtrada, marketed by…
October 15, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Plasma Neurofilament Light Levels Linked to Treatment Effects in RRMS, Study Finds Levels of proposed biomarker neurofilament light chain (NfL) are associated with therapeutic effects of disease-modifying treatments (DMTs) inĀ relapsing-remitting multiple sclerosisĀ (RRMS) patients, according to a real-world study. Study findings also revealed that treatment with either Lemtrada (alemtuzumab, marketed byĀ Sanofi Genzyme),Ā Gilenya (fingolimod, marketed by Novartis), Tecfidera (dimethyl fumarate, marketed…
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.