November 30, 2018 Columns by Ed Tobias My Lemtrada Journey: Round 2, Plus 7 Months I’m coming up on the second anniversary of my Lemtrada (alemtuzumab) treatment. My first infusion round was the first week of DecemberĀ 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…
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 16, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Two European Studies Compare Tecfidera, Aubagio Effectiveness Treatment of relapsing-remitting multiple sclerosis (RRMS) patients with Tecfidera (dimethyl fumarate)Ā is associated with fewer new brain lesions at two years, lower relapse rates, increased time to first relapse, and reduced treatment discontinuation than with Aubagio (teriflunomide), according to a nationwide study from France and a real-world, population-based…
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 12, 2018 Columns by Ed Tobias MS Patients Capture the Ear of a Pharma Company People with multiple sclerosis (MS) rarely get the opportunity to talk to the people who design their medications. But a new collaboration is providing that opportunity to a few of us. The Accelerated Cure Project for Multiple SclerosisĀ (ACP) and pharmaceutical manufacturer EMD Serono have begun working together…
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…
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…
June 15, 2018 Columns by Ed Tobias Getting Help Paying for Your MRIs It’s not unusual for someone with MS to have an annual MRI exam. Sometimes it’s even semiannual. And it’s not cheap. According to the website Healthcare Bluebook, an MRI of the brain, with and without contrast, can cost you anywhere from $826 to $4,780, depending on where youĀ live…
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 17, 2018 Columns by Ed Tobias I Hope My MS Treatments Are Done for Good 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.
April 16, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: New Lemtrada Side Effect, MS Cooling Vests, and Drug Infection Risks 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…
April 5, 2018 News by Mary Chapman MS Path 2 Care Program Aims to Empower Patients to Be Active in Healthcare Journey In the first year after being diagnosed with multiple sclerosis (MS) inĀ 1997, Ann Borsellino basically withdrew from life, rarely even leaving her bedroom. Knowing little about the disease, she assumed its relapses would soon rob her of any control over her body. They didn’t, and now Borsellino is involved with…
March 23, 2018 Columns by Ed Tobias It Shouldn’t Be This Hard to Get Our MS Medications 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…
March 8, 2018 News by Patricia Silva, PhD Can Do MS Launches ‘MS Path 2 Care’ to Help Patients Be Equal Partners in Care Can Do MSĀ has launched an MS Path 2 CareĀ initiative that aims to help people affected by MSĀ be more active partners in their healthcare experience. A national non-profit organization based in Avon, Colorado, Can Do MS delivers health and wellness education programs focused on exercise, nutrition, symptom…
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…
December 15, 2017 News by Patricia Silva, PhD Ocrevus’ Use Continues Rising, with RRMS Patients Receiving the Most Attention U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global InsightsĀ reports. Another good sign for Genentech is that, in just three months, neurologists have increased by 50 percent their estimate of the numbers of relapsing-remitting MS patients who could benefit from Ocrevus.
November 13, 2017 News by Patricia Silva, PhD Sanofi and Principia Join to Develop Potential B-Cell-targeting Oral MS Treatment Sanofi Genzyme and Principia BiopharmaĀ have entered into a license agreement to advance the clinical development of PRN2246, an oral drug candidate for the treatment of multiple sclerosis and other diseases of the central nervous system. PRN2246 is an inhibitor of the Brutonās tyrosine kinase, an enzyme encoded by the BTK gene that plays a crucial role in B-cell development and the B-cell signaling pathway. B-cells are known to be involved in the development of autoimmune diseases that affect the nervous system, including multiple sclerosis. PRN2246 is an orally available therapy designed to easily access the central nervous system (brain and spinal cord) by crossing the blood-brain barrier, and impact the signaling of immune cells and brain cells involved in autoimmunity and inflammatory processes. The drug is designed to safely and effectively modulate B-cell function without depleting these cells. A Phase 1 clinical trial is now testing the drug's safety in healthy volunteers. Under the agreement, which is expected to close shortly, Principia will grant Sanofi an exclusive, worldwide license to develop and commercialize PRN2246. Principia, in return, will receive $40 million in upfront payments from Sanofi, and future milestone payments could reach $765 million. Principia will retain the option to co-fund the treatment's Phase 3 development in exchange for other royalties in the United States. Principia has developed a novel way toĀ design and develop better and safer therapies based on oral small molecules. The company uses its proprietaryĀ Tailored Covalency technologyĀ to develop its drug candidates, which are, according to the company's website, safer, and more selective, potent and durable than other available treatments. The terms of this licensing agreement are still subject to customary regulatory approval.
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 27, 2017 News by Patricia Silva, PhD #MSParis2017 – MS Therapy Aubagio Does Not Appear to Cause Birth Defects, Study Reports Sanofi Genzyme’sĀ multiple sclerosis therapyĀ Aubagio (teriflunomide) does not appear to cause birth defects in humans as it does in laboratory animals, researchers concluded after studying more than 100 pregnant women with MS. Their research indicated that birth-defectĀ findings in rats and rabbits do not translate to humans. The team presented its…
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 16, 2017 News by Patricia Silva, PhD Multiple Sclerosis Therapy Aubagio May Cause Nail Loss, Researchers Report Aubagio (teriflunomide) may lead to reversible nail loss, researchers at Italy'sĀ University of BolognaĀ reported after reviewing the case of a 55-year-old woman with relapsing-remitting multiple sclerosis. They described what happened to a patient who was referred to an MS clinic after experiencing acute optic neuritis ā or inflammation of the optic nerve ā three months earlier.Ā Their report, āNail loss after teriflunomide treatment: A new potential adverse event,āĀ was published in the journal Multiple Sclerosis and Related Disorders. Doctors had been treating the woman with intravenous methylprednisolone. Physicians had judged her slightly disabled, with an Expanded Disability Status Scale (EDSS) score of 3, but had not diagnosed her with MS. When she was diagnosed a few months later, she began receiving interferon beta-1a. It did not work, so doctors switched her to Sanofi Genzyme'sĀ Aubagio. At first, she tolerated the treatment well, having only slight nausea after taking the medication. Physicians did not detect signs of liver toxicity or high blood pressure, which are relatively common side effects of Aubagio. Roughly three months after starting the medication, however, the woman began having more trouble walking problems and had mild hair loss. Two and a half months later, she said her nails had started falling out in the past month. When doctors examined her, she had lost two nails, while others appeared to have stopped growing. They were thinner than normal and some had detached from the nail bed. In addition, her hair loss continued. She had not started using other drugs, new cosmetics, or changed her diet. A dermatologist excluded the possibility that the condition was the result of fungus, psoriasis, or other conditions that could cause nails to fall off. Because doctors suspected that Aubagio could be the cause of the nail loss, they recommended that she stopped taking it. The patient switched to Biogen'sĀ Tecfidera (dimethyl fumarate) after a couple of weeks, and her nails started to grow again. This supported doctorsā idea that Aubagio had caused the nail loss, and that it was reversible. Nail growth is similar to that of hair, researchers said. The patientās reaction could be an unusual version of the same process that makes people lose their hair when taking Aubagio, they said. Since nail loss is not described as a side effect of Aubagio on the medication's label, researchers urged MS specialists to consider the possibility if they see patients with the problem. Ā
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,…
September 15, 2017 Columns by Ed Tobias My Lemtrada Journey: At 9 Months, a Cane Tells a Tale Back in May, when I updated everyone about my Lemtrada treatment at six months post-infusion, I began with a question my wife asked: “Do you think you’re walking better?” And, I thought IĀ was. Maybe. Just a little. I was walking a bit more smoothly, my left foot…
July 18, 2017 News by Patricia Silva, PhD Quarter of MS Patients in UK Not Aware of Disease-modifying Treatments, Online Survey Reports A recent patient survey reveals that almost one in four people with multiple sclerosis in the U.K. are not aware of available treatments that could help delay the onset of disability, even though a clear majority put disability as a chief worry. TheĀ report, fundedĀ byĀ Sanofi Genzyme,Ā was conducted by Adelphi…
June 16, 2017 Columns by Ed Tobias My Opportunity to Speak with ‘Big Pharma’ I was in Boston last week at the headquarters of Sanofi Genzyme. Yes, the big drug company. They brought together several people they consider to be “digital influencers” to pick their brains about what’s on the minds of people like you, who read what we write. Sanofi…
May 26, 2017 News by Patricia Silva, PhD #CMSC17 – Relapse After First Lemtrada Course No Indication of Poor Long-Term Outcome, Study Finds Multiple sclerosis (MS) patients who experienced a relapse between their first and second rounds of Lemtrada (alemtuzumab) had good treatment outcomes over the long run, according to a Phase 3 clinical trial. Those who relapsed after their first round ended up with annual relapse rates similar to those who didn’t…
April 28, 2017 News by Patricia Silva, PhD Lemtrada Might Outperform Ocrevus in Preventing MS Relapses, Italian Researchers Say Lemtrada (alemtuzumab) may be more effective in preventing relapses in multiple sclerosis patients than the newly approved Ocrevus (ocrelizumab), according to a study presented April 28Ā atĀ the American Academy of Neurology (AAN) 2017 Annual MeetingĀ in Boston. TheĀ study, supported by Sanofi Genzyme and Bayer HealthCare Pharmaceuticals, compared…