MS relapse

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…

Growing up in a spiritual family, I can remember hearing the words “we are not going to claim it.” These were words of comfort, hope, and support when a catastrophic event was impending. The dictum was to pray, believe in what you pray for, and to “not claim” whatever…

New results from a Phase 2 trial evaluating TG Therapeutics’ ublituximab continue to support the therapy’s efficacy in treating relapsing forms of multiple sclerosis (MS). This investigative infusion therapy is now moving into a Phase 3 study. Treatment with 450 mg of ublituximab delivered intravenously in a rapid fashion…

Until about a week ago, no medication was approved in the U.S. to treat patients with pediatric-onset MS (POMS). Now there is one. The Food and Drug Administration (FDA) has given its OK to use Gilenya (fingolimod) to treat relapsing MS in children and adolescents starting at…

Quality healthcare is imperative when living with a disease such as multiple sclerosis. While the operational definition of “quality” varies from person to person, I find it to be contingent on the same variable: the doctor/patient relationship. A relationship between a doctor and a patient is symbiotic. Any healthcare…

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, surprisingly, to still be some hope. It depends on the outcome of an MRI;…

Autologous hematopoietic stem cell transplantation, also known as aHSCT, has been shown to be safe and highly effective to treat patients with "aggressive" multiple sclerosis. Tested in 19 patients, transplantation of stem cells was found to induce clinically meaningful improvements in disability. These findings were shared at the 2018 Annual Meeting of the American Academy of Neurology (AAN) in Los Angeles, California. aHSCT uses a patient’s own healthy bone marrow stem cells, in combination with a much less aggressive chemotherapy and/or radiation regimen, to prepare the patient for the transplant. Previous studies have suggested that aHSCT is an effective strategy to treat patients with highly active relapsing-remitting MS (RRMS) who do not respond to available disease-modifying therapies (DMTs), and international guidelines advocate for its use in patients with "aggressive" MS. To further demonstrate the potential of aHSCT as a treatment for "aggressive" MS, a research team evaluated its safety and effectiveness in MS patients who had not been treated previously with DMTs. A total of 19 patients were treated across several clinical centers: seven patients were from Sheffield, U.K., seven from Uppsala, Sweden, four from Ottawa, Canada, and one patient was from Florence, Italy. All patients received aHSCT between May 2004 and May 2017. In addition to aHSCT, patients were treated with BEAM (carmustine, etoposide, cytarabine, melphalan) chemotherapy plus antithymocyte globulin (ATG) to reduce transplant rejection, or with Cytoxan (cyclophosphamide) with ATG, or the triple combination of Cytoxan, ATG, plus busulfan as conditioning regimens. Patients had a median age of 33 years at diagnosis and received the aHSCT by a median time of nine years after symptom onset. They had a median disability score of 6.5 before the treatment, as determined by the Expanded Disability Status Scale (EDSS). After a median follow-up period of 30 months, patients had a median EDSS score of 2.0, which represented a median improvement of 2 points (the higher the score, the worse the patient's disability level). None of the patients had clinical relapse following the transplant of stem cells. Only three patients developed new brain lesions detectable by magnetic resonance imaging (MRI) at the first six-month follow-up evaluation, but no additional new lesions were detected in the following scans. The adverse effects reported during the study were comparable to those previously observed in similar treatments. No deaths related to the treatment were reported. Based on these preliminary results, the researchers concluded that aHSCT is “safe and highly effective in inducing rapid and sustain remission” in highly active MS, and "was associated with a significant improvement of [patient’s] level of disability.” “aHSCT should be considered as first line therapy in patients with ‘aggressive’ MS,” the team concluded. Another study presented at the AAN 2018 meeting further supports these findings, demonstrating the superior effectiveness of aHSCT over conventional DMTs for RRMS.

April is my month. The weather gets warmer, the world gets greener, and everything just generally lightens up. I was born in April. My wife and I were married in April. My favorite holiday is April Fools’ Day. I love…

Celgene’s oral treatment candidate ozanimod can effectively reduce relapse rates in multiple sclerosis (MS) patients with mild to moderate disability, results of two Phase 3 trials show. The company will present data on the SUNBEAM (NCT02294058) and RADIANCE (NCT02047734) trials in two presentations at the…

Online training in  meditation based on mindfulness can improve the quality of life for multiple sclerosis (MS) patients while easing depression, anxiety, and sleep problems, a study conducted in Italy reports. These findings add to the growing body of evidence that interventions able…

A certain type of pain-relief treatment during childbirth does not increase the risk that women with multiple sclerosis will have relapses after delivering, a European study reports. The research involved treatments called neuraxial analgesia, so the scientists titled their study “Neuraxial analgesia is not associated with an increased risk of…

Ocrevus (ocrelizumab) was more effective than Rebif (interferon beta-1a) at preventing relapsing multiple sclerosis activity, according to an analysis that covered two Phase 3 clinical trials. The comparison dealt with the therapies’ ability to generate and maintain a condition known as no evidence of disease activity,…

For years, my wife and I have disagreed about smells. She smells something and I don’t. I tell her that her nose is too sensitive. She tells me to get out the air freshener. Over the 37 years since my MS diagnosis, this conversation has happened thousands of times.

People with multiple sclerosis (MS) can indeed have a poorer-than-usual sense of smell, with problems possibly starting at early diseases stages, a small Turkish study reports. This work supports previous research noting olfactory problems in MS patients. It also argues that longer disease duration and more relapses are associated…

Understanding multiple sclerosis (MS) progression will be the focus of the Multiple Sclerosis Association of America’s (MSAA) campaign for MS Awareness Month 2018. March has been recognized as MS Awareness Month since 2003. Across the U.S., MSAA events aim to raise public awareness about the disease, and increase involvement in…

The U.S. Food and Drug Administration has asked Celgene to add more information to its New Drug Application for ozanimod as a treatment for relapsing forms of multiple sclerosis. Celgene said it plans to meet with FDA officials to make sure it understands exactly what new information the agency…

I fell out of sight in February, thanks to a case of the flu. Influenza B and its lingering side effects took me out of action from almost everything except sleeping, but I’ll save those details for another story. As I come out of my flu-induced fog, I see…

Something is! I had to be carted off to the hospital in an ambulance on Thursday of last week. It was either an infection my home-visiting doctor couldn’t spot or the dreaded relapse. She couldn’t diagnose any illness. At the hospital, they used the words “atypical infection.” One of…

#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…

Multiple sclerosis (MS) patients who experience a relapse after two courses of Lemtrada (alemtuzumab) treatment showed improvements in relapse rate and disability after a third Lemtrada course, according to results of the CARE-MS II trial extension. The poster reporting the findings, titled “Efficacy of Alemtuzumab Retreatment in Patients Who Experienced Disease Activity after…

Celgene’s Ozanimod reduces relapsing multiple sclerosis patients’ relapses, brain lesions, and brain volume loss, a Phase 3 clinical trial shows. The company presented the results of the SUNBEAM trial at the ACTRIMS Forum 2018 convention in San Diego, Feb. 1-3. The presentation was titled “Ozanimod Demonstrates Efficacy and Safety…

Ocrevus improved vision among relapsing multiple sclerosis patients who participated in the Phase 3 clinical trials of the treatment, according to updated analyses recently presented at the ACTRIMS Forum 2018. While Ocrevus-treated patients improved their ability to read low-contrast letters over the course of the two trials, people who received Rebif (interferon beta-1a) did not. Laura J. Balcer, a neurologist at New York University Langone Medical Center, shared the data in a presentation titled, “Effect of Ocrelizumab on Visual Outcomes in Patients with Baseline Visual Impairment in the OPERA Studies in Relapsing Multiple Sclerosis.” Balcer had earlier shared data on the visual outcomes of relapsing patients in the OPERA I and OPERA II Phase 3 clinical trials of Ocrevus at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, last year. The two studies — sponsored by Ocrevus developer Genentech, a member of the Roche group —  compared Ocrevus and Rebif in patients with relapsing MS. This time, her presentation focused only on patients who had visual impairment when they enrolled in the trials. Among a total of 1,656 participants, 375 of those treated with Ocrevus and 373 in the Rebif group had visual impairment. Researchers tested vision using a low-contrast letter acuity test. The test is similar to an ordinary vision test, with letters of different sizes on a chart. But the low-contrast test uses gray letters — instead of black — on a white background. Researchers included charts with two shades of gray to test different contrast levels. These tests can detect reduced visual function. At the beginning of the trials, both groups performed in a similar manner — correctly identifying about 35 letters on a chart with somewhat higher contrast. After 96 weeks, those receiving Ocrevus identified on average 3.4 more letters, while Rebif-treated patients worsened by 0.5 letters — a significant difference, Balcer said. Researchers tested vision every 12 weeks. At the end of the trials, they found that 39 percent more patients in the Ocrevus groups had a cumulative improvement of at least 10 letters, compared to those treated with Rebif. At this time, 26.4 percent of Ocrevus-treated patients improved 10 letters or more, compared to 19.8 percent in the Rebif group. The difference between the groups for at least seven letters was 54 percent, with Ocrevus-treated patients performing better. Researchers believe that a seven-letter change is the minimal clinically important difference for the test. Based on the results, researchers believe that the findings demonstrate Ocrevus’ ability to reverse visual impairment in relapsing MS. The ACTRIMS Forum 2018 is being held in San Diego, California, Feb. 1–3.

Multiple sclerosis patients with high relapse rates but less physical impairment before starting on  Novartis’ Gilenya (fingolimod) are likely to experience a surge in disease activity if they stop the treatment, researchers in Turkey report. The study, which dealt with patients with relapsing forms of MS, referred to the surge as "severe disease reactivation," or SDR. Researchers published their article, “Factors Predictive of Severe Multiple Sclerosis Disease Reactivation After Fingolimod Cessation,” in the journal The Neurologist. Studies have shown that Gilenya, which the U.S. Food and Drug Administration approved in 2010, can benefit adults with relapsing MS. It reduces annualized relapse rates and prevents more brain lesions from forming, compared with standard interferon treatments. Lesions are damaged nerve cell areas. Despite its benefits, Gilenya is not recommended for patients with heart or liver problems, low levels of white blood cells, severe herpes virus infections or other infections. Also, patients who do not respond to Gilenya and women who are planning to become pregnant are advised to stop the treatment. Discontinuing Gilenya can lead to a return to pretreatment disease activity, or severe disease reactivation, in some patients. It is unclear why this happens and why it affects only some patients. To better understand what risk factors could be associated with reactivation, a team at Istanbul University compared the demographic and disease features of patients who developed SDR after stopping treatment with Gilenya. SDR was defined as including these elements within 6 months of Gilenya discontinuation: more than 5 gadolinium-enhanced lesions or a tumefactive demyelinating lesion detectable by magnetic resonance imaging, the disease progressing to the point that additional treatment with methylprednisolone or plasma exchange was required, and progressive physical disability reflected by a 1-point or more increase in patients' scores on the Expanded Disability Status Scale, or EDSS, Thirty-one patients at the university’s MS clinic who had discontinued Gilenya were included in the study. Eight experienced SDR and 11 relapses. The mean time for SDR patients' reactivation to occur was 2.6 months, researchers said. Patients had significantly higher levels of lymphocytes — white blood cells involved in autoimmunity — than during Gilenya treatment. When the team compared the disease features of SDR and non-SDR patients, they found that SDR patients had significantly higher annualized relapse rates before starting Gilenya and lower EDSS scores. “A higher ARR [annualized relapse rate] is the major contributory factor toward development of SDR,” the researchers wrote. “Patients who had higher ARRs before fingolimod [Gilenya] treatment must be closely followed up both clinically and radiologically in terms of the early signs of severe reactivation,” they wrote. About 38 percent of the SDR patients failed to respond to steroid treatment. They received a plasma exchange, which led to moderate improvement in their condition. Based on this finding, the researchers suggested that “plasmapheresis [plasma exchange] must be considered in patients exhibiting steroid-refractory SDR.” "In conclusion, SDR may be observed within the first 3 months after cessation of fingolimod," the team wrote. "This may be explained by the rapid influx of lymphocytes into the CNS [central nervous system]. Patients with higher annualized relapse rates and lower Expanded Disability Status Scale scores before commencing fingolimod treatment were more likely to exhibit SDR."  

Editor’s note: Tamara Sellman continues her occasional series on the “MS alphabet” with this column referencing terms starting with the letter P. This post comes third in a series of seven. Symptoms of MS Pseudoexacerbation Sometimes a person with MS may feel they…

Mallinckrodt Pharmaceuticals is seeking 66 participants for a clinical trial to determine the safety and effectiveness of its injected therapy H.P. Acthar Gel as a treatment for acute relapses in people with relapsing-remitting multiple sclerosis (RRMS). MS relapses are flare-ups of central nervous system inflammation that damage the myelin coating that protects nerve cells. The damage disrupts the transmission of impulses between the cells, causing spikes in MS symptoms. For severe relapses that interfere with a person’s mobility, safety or ability to function, most neurologists recommend corticosteroid treatment administered intravenously or taken orally. Steroids can also be administered by injection of a gel under the skin. H.P. Acthar Gel is designed to provide extended release of steroids in the body. The trial will evaluate whether the gel is an effective treatment for RRMS patients who have been unable to recover from a relapse after receiving high-dose intravenous or oral steroids. Researchers will randomly assign participants to receive either H.P. Acthar Gel or a placebo, delivered by injection once a day for 14 days. Follow-up visits will be required at 14, 28 and 42 days. The study's main objective will be seeing whether patients' disability improves. Researchers will use a standard tool for measuring disability known as the Expanded Disability Status Scale.  Other objectives will include seeing how the therapy affects patients' fatigue, quality of life, workplace productivity, and use of healthcare resources. Participants must have a confirmed diagnosis of RRMS, be older than 18 years of age, and have experienced a relapse within 29 days of enrolling in the trial. For more information about enrollment criteria and how to participate in the trial, please contact Valerie Carvajal at (800) 556-3314 or by email at [email protected]. The National Multiple Sclerosis Society announced in an MS trial alert that Mallinckrodt will be  enrolling participants in Tucson; Fort Collins, Colo.; Tampa; Atlanta; Savannah, Ga.; Northbrook, Ill.; Fort Wayne, Ind.; Indianapolis; Kansas City, Kan.; New York; Cleveland; Dayton, Ohio; Dallas; Round Rock, Texas; San Antonio; Salt Lake City; Richmond, Va.; and Tacoma, Wash. Without clinical trial participation there is no way for patients to obtain new medicines or for scientists to ultimately find a cure for MS. The National MS Society encourages participation. It has developed a guide for patients who want to take part in studies called “Participating in Clinical Trials.” It covers the basics of participation, benefits versus risks, patient protection, costs and other important issues about trials.  

A British board that recommends what treatments the National Health Service should cover has advised the system to use only Extavia (interferon beta 1b) as a treatment for MS patients who continue to have relapses. Cost was at the heart of the National Institute for Health and Care…

Zinbryta (daclizumab) may not be the best follow-up therapy for relapsing–remitting 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 “Disease reactivation after switching from natalizumab to daclizumab,” was published in…

Multiple sclerosis patients with additional diseases, high cholesterol levels or a history of migraine headaches are more likely to experience relapses than other patients, a Canadian study shows. The report, “Comorbidity increases the risk of relapse in multiple sclerosis,” was published in the journal Neurology. Researchers…

Chronic and Neuropathic Pain in MS Patients Should Be Routinely Evaluated, Study Says The next time a doctor tells you that there’s no pain associated with MS, point them to this study. Yes, MS can cause chronic pain and, yes, the pain can be caused by nervous system lesions.

You wouldn’t think that a guy who was diagnosed with MS more than 37 years ago would still be able to learn a thing or two about his disease. But that’s exactly what I did while on vacation about a week ago. I guess I really did know…