Lemtrada

Treatment with Sanofi Genzyme’s Lemtrada (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 sclerosis (RRMS) patients to levels comparable to those seen in healthy people, data from the CARE-MS I study shows. Lemtrada’s effectiveness…

New research suggests that rising blood pressure might be predictive of intracranial hemorrhage — bleeding in the brain, a serious and sometimes fatal condition — in people with multiple sclerosis (MS) who are receiving treatment with Lemtrada (alemtuzumab). The study, titled “Intracerebral haemorrhage during…

#AANAM – RRMS Patients Switching to Lemtrada Report Greater Satisfaction with Treatment and Improvements in Quality of Life I’m a self-proclaimed secondary progressive, rather than a remitting, multiple sclerosis (MS) person. But a year after round two of Lemtrada (alemtuzumab), I can agree with this report. Several of my…

Patients with relapsing-remitting multiple sclerosis (RRMS) who switched to infusions with Sanofi Genzyme’s Lemtrada (alemtuzumab) report increased satisfaction with treatment and improvements in health-related quality of life, according to…

There’s been a lot of social media chatter following the recent decision by the European Medicines Agency (EMA) to initiate a safety review of Lemtrada (alemtuzumab). The EMA has restricted use of the medication within the European Union (EU) while the review is underway. That’s worrying some people who are…

Study Will Explore Benefits of Tai Chi, Meditation on MS Patients’ Balance I’ve tried yoga to help with my balance and flexibility and found it useful. But tai chi scares me a little — it seems too difficult. Maybe, if the results of this study are very positive, I’ll…

The European Medicines Agency (EMA) is reviewing safety data for Sanofi Genzyme‘s Lemtrada (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…

Most healthy people probably don’t have to worry about a fungus called Candida auris, or simply C. auris. But if your immune system is compromised, it’s a different story. Health officials say C. auris should be of special concern to people whose immune systems are not at full strength,…

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…

Initial treatment of relapsing-remitting multiple sclerosis (RRMS) with Gilenya (fingolimod), Tysabri (natalizumab), or Lemtrada (alemtuzumab) is associated with a lower risk of conversion to secondary progressive multiple sclerosis (SPMS), compared with interferon beta or Copaxone (glatiramer acetate), a study reports. Findings also showed that…

Use of Hospital Palliative Care by MS Patients in US Rose 30-fold Between 2005-14, Study Finds Palliative care emphasizes prevention and relief of a patient’s suffering. Its goal is to improve the quality of life of that patient and his or her family. It’s usually thought of…

A potentially life-threatening case of bleeding in the lungs has been reported and attributed to treatment with Lemtrada (alemtuzumab) by a woman with relapsing-remitting multiple sclerosis. Her medical team found diffuse alveolar hemorrhage in this patient — which resolved in about a week without treatment. The scientists advised that clinicians be alert…

The U.S. Food and Drug Administration (FDA) 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) being treated with Lemtrada (alemtuzumab). Since Lemtrada’s approval in 2014 to treat relapsing MS, 13…

I’m coming up on the second anniversary of my Lemtrada (alemtuzumab) treatment. My first infusion round was the first week of December 2016. Round 2, delayed by four months, was done last April. So, it’s time to update my Lemtrada journey for you. Lemtrada, in case you’re not…

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…

Levels of proposed biomarker neurofilament light chain (NfL) are associated with therapeutic effects of disease-modifying treatments (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients, according to a real-world study. Study findings also revealed that treatment with either Lemtrada (alemtuzumab, marketed by Sanofi Genzyme), Gilenya (fingolimod, marketed by Novartis), Tecfidera (dimethyl fumarate, marketed…

Multiple sclerosis (MS) patients may experience severe disease exacerbation after switching from Novartis’ Gilenya (fingolimod) to Sanofi Genzyme’s Lemtrada (alemtuzumab), a case report suggests. This unexpected high disease activity raises questions about managing MS through the consecutive use of immunotherapies. The case report, “Unexpected high multiple…

Lemtrada Can Lower Number of B-cells Infiltrating Nervous System and Forming Clumps, Animal Study Shows I usually stay away from recommending articles about mice studies, but this article does a nice job of explaining how Lemtrada works and the role of B-cells in multiple sclerosis (MS). As…

Treating mice in a model of multiple sclerosis with Lemtrada (alemtuzumab) prevented the formation of B-cell aggregates in the animals’ central nervous system and disrupted already existing ones, researchers report. The treatment also reduced disease activity when administered at the peak of disease. The study, “Anti-CD52 antibody treatment depletes B…

I’m now three months past my second round of Lemtrada treatments, so it’s time for an update. I began Lemtrada (alemtuzumab) in December 2016, hoping it will be the last disease-modifying therapy that I’ll ever need to use. I’ve had peaks and valleys since this treatment began, thus…

Patients with active relapsing-remitting multiple sclerosis (MS) continue to show improvement — lesser functional disability across a variety of measures — and often without the need for continuous treatment after taking Lemtrada for two years, according to six-year results from the CARE-MS II extension study. These results were shared in a…

National Nurses Week was earlier this month. I’m a little late saying it, but, “Thank you, nurses.” And doctors. I’m really a lucky guy. Lucky to have had fabulous nurses. Lucky to have had a couple of top-notch neurologists. My luck began in August 1980 with Dr. Stanley…

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.

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.

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…

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…

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,…

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…

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.

#ACTRIMS2018 – Third Course of Lemtrada Improves Relapse, Disability in MS Patients, CARE-MS II Trial Shows The normal treatment regimen with Lemtrada is a series of two treatment courses, with the second infusion course given 12 months after the first. A “selling point” for this disease-modifying therapy (DMT) is…