RRMS

March 29, 2018 News by Patricia Inacio, PhD

GeNeuro-Servier Antibody Limits RRMS Patients’ Brain Shrinkage, Phase 2b Trial Shows

The laboratory-generated antibody GNbAC1 continued to limit brain shrinkage a year after relapsing-remitting multiple sclerosis patients began receiving it, its developers announced. GeNeuro and Servier were reporting on the 12-month results of a Phase 2b clinical trial. GNbAC1 is a monoclonal antibody that destroys a harmful retroviral protein called pHERV-W which scientists have…

March 27, 2018 News by Patricia Inacio, PhD

Smoking Increases Relapses in RRMS Patients Receiving Interferon-beta, Study Suggests

Cigarette smoking increases the relapse rate in patients with relapsing-remitting multiple sclerosis who are being treated with interferon-beta, a study suggests. The findings suggest that RRMS patients who smoke may have fewer relapses if they quit. An article on the results, “Smoking affects the interferon beta treatment response in multiple sclerosis,” appeared in the journal Neurology. A number of studies have looked at the link between environmental and lifestyle factors and the risk of developing MS. These factors include how much sunlight and vitamin D patients get and whether they have an Epstein-Barr virus infection. Cigarette smoking is a well-documented risk factor in MS, but most of the studies on it have focused on the link between smoking and MS, or the link between smoking and the  disease's progression. “Studies that addressed the relationship between smoking and disease activity in RRMS are rarer,” the researchers wrote. The team decided to investigate whether smoking during interferon-beta treatment would affect relapse rates. Previous research had set the stage for the study by showing a link between smoking and gene mutations that make people more susceptible to developing MS. The mutations were in the HLA and NAT1 genes. The team looked at DNA from 834 RRMS patients in the Danish Multiple Sclerosis Biobank who were treated with interferon-beta. Well-known brand names of the treatment include Rebif, Avonex, and Plegridy. There are also other brand names and biosimilar drugs. Researchers also looked at patients’ medical records two years before they started on interferon-beta. Before making any conclusions on possible links between smoking and patients' relapse rate, the team adjusted for patients’ sex, age at the start of treatment, and number of relapses in the two years before treatment began. Their key conclusion was that smoking increased by more than a quarter the number of relapses in patients on interferon-beta therapy. “Each pack of cigarettes more per day during IFN-β [interferon-beta] treatment increased the number of relapses by 27%,” the team wrote. The researchers found no association among smoking, relapses, and mutations of the HLA or NAT1 genes. “Our results confirm that lifestyle factors are important in MS, suggesting that smoking cessation may be associated with a reduction in disease activity,” they wrote. “Although not formally proving that smoking cessation will decrease disease activity in RRMS, the results should encourage physicians to inform patients with MS about the harmful effect of smoking and increase focus on smoking cessation,” they observed.

March 22, 2018 Columns by Jennifer (Jenn) Powell

Navigating Ups and Downs with MS

Today, I ate a dog treat. I was eating cookies from a nearby bowl when I broke a dog treat in half for Abby. Instead of putting the other half in my pocket, I put it in my mouth and chewed. Wondering how the brand could screw up so…

January 17, 2018 News by Patricia Silva, PhD

Trial to Evaluate H.P. Acthar Gel Is Enrolling Patients with Relapsing-remitting MS

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.  

December 11, 2017 News by Alice Melão, MSc

Australia Approves Shorter Mavenclad Treatment Regimen for Relapsing-Remitting MS

Australia has approved a shorter treatment regimen of Merck’s Mavenclad for relapsing-remitting multiple sclerosis. The Therapeutic Goods Administration authorized 20-day courses of the cladribine tablet form of the medication once a year for two years. The regimen reduces relapse rates and the progression of the disease for up to four years, Merck said. The new approval came after Merck submitted additional clinical trial findings on the therapy. Health Canada and the European Commission approved Mavenclad earlier this year. Merck continues to seek its regulatory approval in the United States and other countries. "Mavenclad will be a welcomed treatment option for patients with the relapsing-remitting form of MS,” Bill Carroll, clinical professor of neurology at the University of Western Australia and the Perron Institute, said in a press release. “As an oral therapy taken in two short courses over a two-year period, Mavenclad will be convenient for all eligible patients in Australia, including those who may not live close to their treating healthcare professional," added Carrol, a neurology consultant at the Sir Charles Gairdner Hospital as well as president-elect of the World Federation of Neurology. Mavenclad targets immune cells that trigger relapsing MS. Multiple sclerosis is an autoimmune disease, or one in which the immune system attacks healthy cells. Mavenclad inhibits harmful immune T- and B-cells without suppressing the entire immune system. Australia based its approval of the drug on the findings of a number of clinical trials, including the Phase 3 CLARITY, CLARITY EXTENSION and ORACLE-MS studies, the Phase 2 trial ONWARD study, and the long-term PREMIERE studies. The trials involved more than 2,700 RRMS patients, some of whom were followed more than 10 years. The trials showed that Mavenclad can significantly reduce relapse rates, disability progression and brain atrophy. Doctors recommended the therapy for patients who failed to respond to, or are unable to tolerate, other MS treatments. "We are pleased the Therapeutic Goods Administration has updated the product Information for Mavenclad in Australia to reflect additional clinical data," said Simon Sturge, chief operating officer of Merck's biopharma business. "Our next step is to work closely with the Australian government to bring this treatment advance to patients as quickly as possible."

December 6, 2017 News by Alice Melão, MSc

Health Canada Approves Merck’s Mavenclad to Treat RRMS

Canadians with relapsing-remitting multiple sclerosis can now receive Merck’s Mavenclad, now that Health Canada has approved Mavenclad as a therapy to reduce the frequency of MS exacerbations and delay disease progression. Merck expects the drug to be commercially available by early January 2018 throughout Canada, which has the world's highest MS rate. This follows the drug’s approval by the European Commission in August, making Mavenclad Europe's first approved highly efficient, oral short-course therapy for relapsing MS. Merck said it would seek regulatory approval of Mavenclad in other countries, including the United States. Mavenclad was designed to selectively target immune cells that trigger relapsing MS, while resetting the immune system. With two annual courses of treatment for a maximum of 20 days over two years, the oral drug promotes long-term inhibition of harmful immune T- and B-cells, without continuous suppression of the immune system. Researchers evaluated Mavenclad in five clinical trials: Phase 3 trials CLARITY, CLARITY EXTENSION and ORACLE-MS; the Phase 2 trial ONWARD study ; and the long-term study PREMIERE. These involved more than 2,700 RRMS patients, some of whom were observed for more than 10 years. Clinical data showed that Mavenclad can significantly reduce disability progression, annualized relapse rates and brain atrophy. The treatment is generally recommended for patients who failed to respond adequately, or are unable to tolerate, one or more MS therapies.

November 29, 2017 News by Alice Melão, MSc

Alkermes, Biogen Partnering on Therapy for Relapsing Forms of Multiple Sclerosis

Alkermes and Biogen have begun working together on a compound known as ALKS 8700 as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features than Tecfidera (dimethyl fumarate) — in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris in October. The company is still recruiting participants for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will  be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018.  

November 3, 2017 News by Janet Stewart, MSc

RedHill Awaits US Patent for Antibiotic Combo, RHB-104, as Potential RRMS Therapy

RedHill Biopharma has received a Notice of Allowance for a new patent on RHB-104 its potential therapy for patients with relapsing-remitting multiple sclerosis (RRMS). Once granted by the United States Patent and Trademark Office (USPTO), this patent will be valid until 2032. RHB-104 is a proprietary, orally-administered antibiotic combination with potentially potent intracellular, antimycobacterial…

October 30, 2017 News by Patricia Silva, PhD

#MSParis2017 – Aerobic Exercise Seen to Quickly Strengthen Brain Connections in Patients

Aerobic exercise strengthens brain connections in people with relapsing-remitting multiple sclerosis, Jan-Patrick Stellmann, with University Medical Center Hamburg-Eppendorf in Germany, reported at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris that ran from Oct. 25–28. According to Stellmann, "aerobic exercises are considered to improve mobility, fatigue, depression and cognition in MS," and also to "promote neuroprotective or neuroregenerative mechanisms." For the study, the team used MRI to examine how exercise affected different types of brain connections. They recruited 57 RRMS patients and 30 healthy controls to the study. Women made up more than two-thirds of the patient group, which had a mean age of 39. Patients only had mild disability, with a mean score of 1.5 on the Expanded Disability Status Scale. Researchers randomly assigned about half the group to a supervised and individually adapted aerobic exercise program, consisting of 22 sessions of up to one hour each. Others were assigned to a waiting list — with the intent of taking up exercise after three months — and served as a control group. MRI scans at the study's beginning revealed that patients had more so-called functional connections, but fewer structural ones, than healthy controls. It is known from earlier studies that most RRMS patients show abnormalities in functional connections, but some researchers find increases while others decreases in these connections. Functional and structural connections appear on different types of MRI scans — ones that make use either of blood flow changes or of the properties of water molecules in the white matter of the brain. The deviations were particularly pronounced in highly connected hub regions, the researchers said. After three months, functional connections increased across the entire brain among exercising patients, but decreased in those on the waiting list. Structural connections also increased among patients who exercised, while no change was detected among control patients. Researchers also noted that exercising patients grew more local connections, mostly in hub regions, compared to those who did not exercise. While it is generally accepted that aerobic exercise promotes neuroprotective and regenerative processes within the brain, the study demonstrated that exercise, in only three months, did indeed affect how the brain is wired. "Short-term aerobic exercise increases functional and structural connectivity," Stellmann concluded. "Already after three months, exercise lead to functional and structural reorganization of brain networks." The researcher highlighted the difficulties in obtaining financial support for trials on exercise. And he emphasized that patients should be encouraged by their doctors to exercise regularly.

September 13, 2017 News by Patricia Silva, PhD

Cognitive Impairment Worse Among PPMS Than RRMS Patients, German Study Finds

Patients with primary progressive multiple sclerosis have more severe cognitive impairment than those with relapsing-remitting multiple sclerosis, according to a German study that analyzed published data on the topic. PPMS patients did especially poorly on verbal learning and verbal memory tests, said the study, which suggested that PPMS patients need disease management that specifically focuses on their cognitive difficulties, which do not necessarily correlate with the degree of overall disability. The study gathered data from 47 previously published studies in an attempt to analyze potential differences in cognitive performance between patients with RRMS and PPMS. These studies included 4,460 patients — 3,456 with RRMS and 1,004 with PPMS — and plenty of information about patient and disease features. This allowed researchers to perform a meta-analysis of pooled data from various studies, that is considered the highest level of scientific evidence. Researchers noted that PPMS patients performed worse on cognitive tests, both when considering global scores and tests of specific cognitive domains. Yet both groups scored similarly in levels of anxiety, depression and fatigue. Using statistical analyses, the research team found that differences in sex, education, disease duration, manual dexterity and fatigue could not explain the poorer test results among PPMS patients. On the other hand, PPMS patients were, on average, older than those with relapsing disease, and the team found that this difference accounted for poorer test results in cognitive tests of processing speed and working memory. Yet differences in other cognitive aspects also remained when researchers took age into account. Differences in disability, measured by the Expanded Disability Status Scale, could also not explain why PPMS patients performed worse on the cognitive tests. A detailed look revealed that the largest differences between RRMS and PPMS patients were in verbal learning and verbal memory, along with the age-associated difference in processing speed. Depression and anxiety also brought down processing speed, researchers said, even though the two groups did not differ in their levels of anxiety and depression. The data shows that cognitive impairment in MS is not directly related to the course of the disease. Research may explain differences in other factors including genetics, the degree of brain tissue loss and medications.

August 28, 2017 News by Alice Melão, MSc

RRMS Patients Needed for Phase 3 Trial to Assess Adverse GI Effects of ALKS 8700 Therapy vs. Tecfidera

Alkermes is funding a Phase 3 clinical trial evaluating the effects of its ALKS 8700 therapy on the gastrointestinal tracts of relapsing-remitting multiple sclerosis (RRMS) patients, compared to Tecfidera (dimethyl fumarate), according to a news release by the National Multiple Sclerosis Society. ALKS 8700, an orally administrated form of monomethyl fumarate, is still…

August 17, 2017 News by Patricia Inacio, PhD

Ocrevus Approved in Canada to Treat Relapsing-Remitting MS

Health Canada has approved Ocrevus for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, Roche Canada announced. The approval followed the positive results from the Phase 3 OPERA studies, which evaluated the safety and efficacy of Ocrevus in 825 patients with RRMS. The OPERA 1 and OPERA 2 trials showed that Ocrevus significantly reduced disease activity and disability progression of RRMS patients, with annual relapse rates falling by almost half. Moreover, Ocrevus outperformed Rebif, the standard of care in MS, in slowing worsening of disability and significantly reducing lesions seen on MRI scans over a two-year treatment period. "Ocrevus is a major addition to the treatment options available for MS. The RRMS Ocrevus clinical trial data show a significant reduction in relapses and disease progression, as well as a good safety profile," Daniel Selchen, a neurologist and head of the Division of Neurology at St. Michael's Hospital in Toronto, said in a press release. "For appropriate patients, Ocrevus will be of great value in reducing the burden of MS." The treatment's approval, however, did not extend to — or mention — people with primary progressive MS, in contrast to the U.S. Food and Drug Administration's action in March, which approved Ocrevus for both MS forms. Health Canada did not give address PPMS in its announcement. Estimates are that 100,000 Canadians are currently living with MS, and most have the relapsing form. A number welcomed Ocrevus' arrival for what it offers in their fight against this disease.

August 3, 2017 News by Alice Melão, MSc

Resistance Training Can Slow MS Patients’ Brain Shrinkage, Clinical Trial Indicates

Resistance training like weight lifting can protect or even regenerate the nerve cells of relapsing-remitting multiple sclerosis patients, slowing the progression of the disease, according to a clinical trial. A hallmark of MS is the brain shrinking faster than normal, and findings from this trial indicates that resistance training can slow the shrinking or even make some brain areas grow. Research has shown that physical training benefits MS patients, helping them alleviate many symptoms, including excessive fatigue and balance control problems. Recent studies suggest that exercise can have a disease-modifying role in MS. This means physical activity can be an important adjuvant, or add-on therapy, for standard-of-care regimens. Researchers followed 35 patients with relapsing-remitting MS for 24 weeks. Eighteen patients did resistance training twice a week, consisting of four lower- and two upper-body exercises. The other 17 patients struck with their normal routines. Before and after the 24 weeks, doctors took magnetic resonance imaging scans, or MRIs, to evaluate patients' brain structures. After the 24 weeks, the scans showed less brain shrinkage in those who had resistance training. Some of their cortical brain regions were also thicker — an indication they were growing. It is not clear why exercise benefits MS patients' brains, nor if exercise has the same effect on all patients. Additional studies are needed to clarify its therapeutic effect, the researchers said. That knowledge could help improve current MS therapies.

July 17, 2017 News by Alice Melão, MSc

Copaxone Benefits RRMS Patients in the Long Term by Modulating Immune System Responses, Study Shows

First-line treatment with Copaxone (glatiramer acetate) benefits relapsing-remitting multiple sclerosis (RRMS) patients by boosting the number of anti-inflammatory immune cells and restoring the balance of regulatory immune cells, an Italian study shows. The study, “Biological activity of glatiramer acetate on Treg and anti-inflammatory monocytes persists for more than 10…

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