December 7, 2018 News by Alberto Molano, PhD Tysabri Seen as Superior to IFN-Ī² in Preventing Relapses, Easing Disability in Small Study Tysabri (natalizumab) was found to be superior to interferon beta (IFN-Ī²) in a small, 12-month study with relapsing-remitting multiple sclerosis (RRMS) patients, significantly decreasing their disability levels, its researchers report. A vast majority ā 90 percent ā of Tysabri-treated patients experienced no relapses during the study period,…
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 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…
September 6, 2018 News by Marta Figueiredo, PhD Tysabri Seen to Improve Cognition in RRMS Patients Over 2 Years in Retrospective Study TysabriĀ (natalizumab) was reported in a small retrospective study to significantly improve cognitive abilities in people with relapsing-remitting MS patients (RRMS)Ā over two years of use. The study, āImprovement in Cognitive Function as Measured by NeuroTrax in Patients with Relapsing Multiple Sclerosis Treated with Natalizumab: A 2-Year…
August 7, 2018 News by Stacy Grieve, PhD Smoking Increases Relapse Rate in RRMS Patients on Tysabri, Study Suggests Smoking increases the relapse rate in patients with relapsing-remitting multiple sclerosis being treated with Tysabri , an observational study suggests. Multiple sclerosis is a multifactorial disease associated with both genetic and environmental risk factors.Ā Smoking, in particular, has been linked to numerous aspects of MS, including its development and progression. In a previous study, the research team looked at how smoking influences the relapse rate in RRMS patients being treated with interferon beta. From more than 800 patients, they found that smoking one pack per day (about 20 cigarettes) essentially interfered with the positive effect of the IFN-beta treatment and increased the relapse rate by 27%. The researchers then questioned whether the same was true for other treatments. Tysabri, developed by Biogen, is a monoclonal antibody that targets the alpha-4 integrin protein. By interfering with this molecule, the therapy prevents white blood cells from moving into the central nervous system, suppressing the immune reaction that contributes to MS symptoms. In the study, 355 Tysabri-treated RRMS patients from the Danish Multiple Sclerosis Centre were assessed. To gather information on smoking habits and body mass index, the patients filled out a 100-question survey. Data was collected between the start of the treatment and a two-year follow-up visit. Results showed that smoking one pack of cigarettes per day increases the relapse rate by 38% in RRMS patients on Tysabri. This increase in relapse rate takes into account both sex and age at the start of treatment, since ageĀ can affect the relapse rate. For example, an increase in age by one year raises the number of relapses by 2%. The researchers also looked at the relationship between smoking and the presence of two immune-related alleles:Ā HLA-DRB1*15:01 andĀ HLA-A*02:01. Previous studies showed that HLADRB1*15:01Ā is associated with an increased risk ofĀ developing MS, whileĀ HLA-A*02:01 is linked to a decreasedĀ risk. Although previous studies reported a link between smoking and these two alleles in MS patients, the current study did not find an association between smoking and carrying either of these alleles. Based on the results, the researchers concludedĀ that smoking significantly increases the relapse rate in RRMS patients receiving Tysabri. According to the team, the results "add important informationĀ that hopefully will sharpen the focus on the overallĀ harmful effects of smoking in MS patients."
July 23, 2018 News by Ana Pena PhD Shorter Washout Period Lessens Relapse Risk When Switching from Tysabri to Gilenya in RRMS, Study Finds Shortening the washout period to four weeks when switching from Biogenās Tysabri to Novartisā Gilenya is safe and reduces the chances of experiencing a disease flare in patients with relapsing-remitting multiple sclerosis (RRMS), a small Swiss study found. A four-week washout reduced the risk of having a disease relapse or an increase in disease activity, compared with an eight-week washout period, for two years after switching from Tysabri to Gilenya. Although TysabriĀ effectively slows worsening of MS symptoms and the appearance of disease flares, its use is under a strict risk management plan as it heightens the risk of developing a rare and life-threatening brain infection called progressive multifocal leukoencephalopathy, also known as PML. Some patients may switch to Gilenya, an alternative disease-modifying therapy for RRMS. Gilenya has been associated with a lower risk of PML infection and seen to reduce relapses, disability worsening, and the appearance of new brain lesions on clinical trials. It also is the only therapy approved by the U.S. Food and Drug Administration for children with MS as young as 10. When switching from Tysabri to Gilenya, it is important to consider the washout period, which is the period when the patient is taken off medications. If too long, it may lead to disease reactivation, which can be even stronger than before starting Tysabri. There is little evidence about the optimal length of washout periods, but a Phase 3 trial showed that an eight-week washout between Tysabri and Gilenya was beneficial compared with longer washouts of 12 or 16 weeks. The eight-week washout enabled more RRMS patients to become free from relapses and lowered disease activity. To study if a shorter washout period of four weeks further reduced the risk of MS reactivation, researchers conducted an open-label, observational study at the University Hospital, Basel, Switzerland. The study enrolled 25 RRMS patients who were appointed to switch from Tysabri to Gilenya. Participants were assigned to either a four-week or an eight-week washout period, and were followed for two years after switching to Gilenya. Although patients were older in the four-week washout group, disease activity and disability scoreswere not significantly different between groups at the beginning of the study. Relapses, disability scores, and disease activity on magnetic resonance imaging scans were recorded at baseline and weeks 8, 12, 16, 20 32, 56, and 108. In the first year (week 56) the proportion of patients with disease flare-ups or disease activity on MRI was not significantly different between the two washout groups, affecting 55.6% and 62.5% of the patients who had a four-week and an eight-week washout, respectively. However, at the end of the two-year follow-up (week 108), recurrent event analysis showed that patients who were on the four-week washout group were 77% less likely to experience relapses. The combined risk for relapse or disease activity on MRI also was 58% lower in the four-week group,Ā compared with those who had an eight-week washout. In addition, researchers found that patients who had flares more frequently in the year before discontinuing Tysabri also had a nearly four times higher risk of experiencing relapses in the first year after switching to Gilenya. ThisĀ suggests that the number of relapses before switching from Tysabri can predict disease reactivation once on other disease-modifying therapies. Both washout periods were deemed safe, with no serious adverse side effects or cases of opportunistic infections, including PML, being reported. Researchers emphasized, however, that the findings need to be confirmed in larger studies.
July 20, 2018 News by Iqra Mumal, MSc Tysabri Treatment Lessens Sexual Dysfunction in MS Patients, Study Finds Treatment with Tysabri (natalizumab)Ā can help lessen sexual dysfunction in patients with multiple sclerosis (MS), a new study shows. The study, āPatient perceived changes in sexual dysfunction after initiation of natalizumab for multiple sclerosis,ā was published in the Multiple Sclerosis Journal ā Experimental, Translational and Clinical. MS is…
April 27, 2018 News by Patricia Inacio, PhD #AAN2018 – Extending Time Between Tysabri Doses Linked to Lower PML Risk, Analysis Suggests Extending the time between standard doses ofĀ TysabriĀ (natalizumab)Ā 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…
April 12, 2018 News by Stacy Grieve, PhD First Generation Disease-modifying Therapies Pose Low Infection Risk in MS, Study Finds 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…
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 19, 2018 Columns by Ed Tobias MS News that Caught My Eye Last Week: Stem Cell Trial, Medical Marijuana, Myelin Repair, Tysabri Study Stem Cell Treatment Benefits Three-fourths of MS Patients in Phase 1 Trial This is encouraging news for MS patients hoping to see some action in the stem cell area. A Phase 1Ā mesenchymal stem cell trial is reporting positive results, and a Phase 2 trial is underway in…
February 14, 2018 News by Patricia Inacio, PhD Italian Study Examines Tysabri and Risk for Miscarriage and Birth Defects Pregnant women with multiple sclerosis (MS) exposed to Tysabri (natalizumab) in the first trimester had higher rates of miscarriage and major birth defects in their babies, than women left untreated or treated with interferon beta, a study shows. Although higher, these rates were similar to those in the general…
February 9, 2018 News by Alice MelĆ£o, MSc #ACTRIMS2018 ā Combo Can Stop Tysabri-related PML Infection from Worsening, Case Study Shows A combination of an anti-viral therapy and the anti-depressive mirtazapine can stop the worsening of an infection linked to the multiple sclerosis therapyĀ Tysabri (natalizumab), a case study suggests. The infection, John Cunninghan polyomavirus, can cause a potentially fatal brain infection known as Ā progressive multifocal leukoencephalopathy, or PML. Both…
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,…
February 5, 2018 News by Patricia Inacio, PhD #ACTRIMS2018 ā Extending Tysabri Treatment Intervals May Reduce PML Risk, TOUCH Registry Data Suggest Extending the dosing periods of Tysabri (natalizumab) treatment may help reduce the risk of progressive multifocal leukoencephalopathy, or PML, in multiple sclerosis (MS) patients infected with the JC virus, a study suggests. The study, āNatalizumab Extended Interval Dosing Is Associated with a Reduction in Progressive Multifocal Leukoencephalopathy…
December 28, 2017 News by Patricia Inacio, PhD Zinbryta Fails to Prevent RRMS from Worsening After Patient Gets Off Tysabri, Case Study Shows Zinbryta (daclizumab) may not be the best follow-up therapy for relapsingāremitting multiple sclerosis patients who stop taking Tysabri (natalizumab) for safety reasons, a case study suggests. An article on the 25-year-old patient’s case, titled āDisease reactivation after switching from natalizumab to daclizumab,ā was published in…
December 14, 2017 Columns by Tamara Sellman The MS Alphabet: Neurogenic Bladder, Neuropsychologist and More Words That Start With ‘N’ (Editorās note: Tamara Sellman continues her occasional series on the MS alphabet with this column referencing terms starting with the letter “N.”) Symptoms of MS Neurogenic bladder Many people with MS experience problems with the bladder. A neurogenic…
October 27, 2017 News by Patricia Silva, PhD #MSParis2017 – Researchers Suggest Best Time to Stop Tysabri During Pregnancy Babies born to women who are treated with Tysabri (natalizumab) during pregnancy are more likely to develop abnormal blood cell counts if the treatment continues beyond week 30 of pregnancy. Since more relapses occurred in women who quit the treatment before this time, researchers from the Ludwig Maximilian University…
October 26, 2017 News by Patricia Silva, PhD #MSParis2017 – Tysabri Did Improve Walking and Hand Function in Failed SPMS Trial, Researchers Say While Tysabri (natalizumab) failed to slow worsening disability in people with secondary progressive multiple sclerosis (SPMS) in a Phase 3 trial, researchers now suggest that the treatment did improve walking and arm function in people with advanced disability. Researchers presented new analyses of data from the ASCEND trial (…
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…
August 31, 2017 News by Alice MelĆ£o, MSc Tecfidera Shows Promise as Replacement MS Therapy for Tysabri, Study Shows Tecfidera (dimethyl fumarate) can be a suitable replacement therapy whenĀ Tysabri (natalizumab) is discontinued, keeping low levels of disease activity in patients with relapsing-remitting multiple sclerosis (RRMS), according to a report published in theĀ Journal of Neurology, Neurosurgery & Psychiatry. Several studies have demonstrated the effectiveness and…
August 7, 2017 Columns by Ed Tobias MS News That Caught My Eye This Week: Resistance Training, Tysabri Report, Cognigram, and Depression Resistance Training Can Slow MS Patientsā Brain Shrinkage, Clinical Trial Indicates Over the years, studies have shown the benefits of various types of exercise in improving MS symptoms. But here,Ā Alice MelĆ£o reports about a small…
August 1, 2017 News by Jose Marques Lopes, PhD Long-term Tysabri Treatment Improved Quality of Life and Satisfaction with Therapy in Relapsing MS Patients, Study Finds Long-term Tysabri (natalizumab) treatment of relapsing multiple sclerosis (RMS) improves physical and mental health and leads to greater satisfaction with therapy, new research shows. The study, āLong-term natalizumab treatment is associated with sustained improvements in quality of life in patients with multiple sclerosis,ā appeared in the journal…
July 6, 2017 Columns by Laura Kolaczkowski Ocrevus and Me Iāve done it! I made the treatment switch that so many people with multiple sclerosis are talking about: I said goodbye to Tysabri (natalizumab) and am now on Ocrevus (ocrelizumab) as my disease-modifying therapy (DMT). I went through 56 monthly infusions (or maybe more, I’ve…
June 30, 2017 News by Patricia Silva, PhD Link Between MS Therapy Tysabri and Melanoma Possible, an Adverse Reactions Watchdog Group Says The multiple sclerosis therapy Tysabri could trigger melanoma, the Southern Network on Adverse Reactions (SONAR) has warned. Although its investigation failed to demonstrate that melanoma is more common among Tysabri-treated MS patients than in the general population, unusual features among the patients raise concerns about a possible link, the organization said. Contending that current monitoring efforts are inadequate, it suggested improvements that could generate a better understanding of the relationship between Tysabri treatment and cancer. The organization's report, published in the journal Cancer Medicine, was titled āMelanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions, also known as SONAR." SONAR is an organization that was formed in the Southern United States in 2010 to investigate adverse drug reactions that regulators might not be aware of. Its goal is to reduce the time it takes between detecting an adverse reaction and have regulators act on it. A case that a SONAR investigator came across led to the group investigating possible links between Tysabri and melanoma. A 43-year-old woman developed melanoma in her urethra, the tubing that drains urine from the bladder, after being treated with Tysabri for about two years. Melanoma is most often a skin cancer that is related to sun exposure, but the woman had no skin lesions. After extensive surgery, she relapsed and died when the cancer spread to other parts of her body. She had declined anti-cancer treatment. The case prompt SONAR to look for similar cases. Its investigators found seven studies that involved Tysabri-treated MS patients developing melanoma. In addition, they looked through the U.S. Food and Drug Administrationās Adverse Event Reporting System (FAERS) and the Tysabri Safety Surveillance Program. The surveillance program is part of the Tysabri Outcomes Unified Commitment to Health (TOUCH) database run by Tysabri's developer, Biogen, The research team found 137 cases in the FAERS database through April 1, 2014. The patients' average age was 45. Seventeen percent of the group developed tumors in locations not exposed to the sun, and nine died. The researchers said the database contained only about half the information it should have, such as tumor site, patients' family history of cancer, and earlier immunosuppressive treatment. Fifteen percent of the cases in the FAERS database were based entirely on information from the TOUCH database. Seventy-three percent were cases initially reported to FAERS but with TOUCH information added. Thirteen percent of the FAERS cases contained no additional information. Importantly, there was even less patient information in the TOUCH database than in the FAERS database. Out of eight items researchers believe a database should contain, TOUCH had information on two, on average. āThe existence of the TOUCH Safety Surveillance Program, an FDA-mandated program, did not improve melanoma reporting,ā the team wrote. This shortage of data stymies research into possible links between Tysabri treatment and melanoma, the researchers said. As an example, although the death rates in the databases were low, there was no information about survival in many cases, which could lead to flawed survival estimates. The investigation noted that patients received a wide range of Tysabri doses before they were diagnosed with melanoma. While some received only one or a few injections, others had been treated for a long time. These observations do not seem to support a link between Tysabri and melanoma, the team said. āA longer therapy duration would be expected if natalizumab caused melanoma via an immunologic pathway, unless existing nevi [lesions of the skin or mucus tissue] were already premalignant lesions,ā the researchers wrote. But other information the team found seemed to suggest a Tysabri-melanoma link. For example, the average age of melanoma patients was much lower than that reported in the National Cancer Instituteās Surveillance, Epidemiology and End Results (SEER) database. The average age in the institute's database is 63, compared with 45 in the FAERS database and 41 in cases in academic journals. In addition, many patients developed tumors in unusual places not exposed to sunlight. Finally, the low melanoma death rate in Tysabri-treated patients differed from that seen in the general population. All these factors suggest that melanoma after Tysabri treatment could differ from other types of melanoma, the researchers argued. While the molecular workings of Tysabri might promote melanoma growth, studies so far have not found a relationship between the drug and this cancer. In fact, some studies suggest that MS patients, in general, have a lower risk of melanoma than others. The team said more information on patients could give researchers a better understanding of the potential relationship between Tysabri and melanoma. The implication was that the standard of reporting in the FAERS and TOUCH databases could improve. To minimize the risk of patients who receive Tysabri developing melanoma, the researchers offered a number of suggestions for IV centers, physicians, patients, and educational programs. For instance, they suggested that all patients should have a skin examination before the start of treatment, and regular physical and skin exams while receiving Tysabri. While noting that risk of infection and the development of tumors can occur with all immunosuppressive treatments, the team said more studies are needed to explore the risk of Tysabri-treated patients developing melanoma.
June 27, 2017 News by admin Tysabri Shows Long-term Safety, Efficacy in Japanese RRMS Patients, Study Shows A recentĀ study has found Tysabri (natalizumab) treatment for two years to beĀ efficient and safe in Japanese patients with relapsing-remitting multiple sclerosis (RRMS). The study, āSafety and Efficacy of Natalizumab in Japanese Patients with Relapsing-Remitting Multiple Sclerosis: Open-Label Extension Study of a Phase 2 Trial,ā appearedĀ in the journal…
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…
May 26, 2017 News by Patricia Inacio, PhD #CMSC17 – Tysabri Improves Mental Outlook for Patients with Secondary Progressive Multiple Sclerosis Long-term therapy with Tysabri (natalizumab) significantly improved the mental state of people withĀ secondary progressive multiple sclerosis (SPMS), according to results of a Biogen-supported study with patients taking the drugĀ for almost two years. Biogen presented the study,Ā āThe Impact of Natalizumab on Health-Related Quality of Life in Patients with Secondary Progressive…
May 25, 2017 News by Patricia Silva, PhD PML Found in Ocrevus-Treated Patient Who Had Used Tysabri for 3 Previous Years A multiple sclerosis (MS) patient treated in Germany withĀ Ocrevus (ocrelizumab)Ā has developed the dreaded brain infection progressive multifocal leukoencephalopathy (PML).Ā But it is not clear whether the recently approvedĀ Genentech/Roche-developed treatmentĀ is the cause. The patient took the last dose of a three-year course of Tysabri (natalizumab)Ā in February. Tysabri is…
April 25, 2017 News by Patricia Silva, PhD Latest Tecfidera and Tysabri Data Suggest Treatments Improve MS Outcomes When Used Early Real-world data of treatment with Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) in relapsing multiple sclerosis (MS) patients suggest that treatment at early disease stages improves outcomes and prevents disability development. The studies, presented by Biogen at the American Academy of Neurology 2017 Annual MeetingĀ in Boston, might challenge the…