MS relapse

 Novartis' Gilenya and interferon beta-1b-based therapies stop multiple sclerosis patients' cognitive decline, a Phase 4 clinical trial shows. Gilenya (fingolimod) also reduces patients' relapses and the number of their brain lesions — areas where a protein coating that protects nerve cells has deteriorated, researchers found.

Editor’s Note: Bryan Bickell, a second-round National Hockey League draft for the Chicago Blackhawks in 2004, played his last NHL game as a forward with the Carolina Hurricanes in April 2017, some five months after being diagnosed with relapsing multiple sclerosis. Bickell played on the Blackhawks’ Stanley Cup-winning teams in…

Oral steroids may be cheaper, more convenient and less invasive alternatives than intravenous steroids in treating relapses in multiple sclerosis (MS) patients, suggests an analysis of five randomized trials. Glucocorticoids are recommended as the first line of treatment for MS relapses. Yet recent studies have shown no significant difference between…

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.  

Celgene released the results of two Phase 3 trials showing that patients with relapsing multiple sclerosis (MS) who were treated with ozanimod had lower relapse rates and fewer MRI brain lesions compared to those given a current first-line therapy, Avonex (interferon β-1a). These results will be used to support a request…

Do you have pain? Although prone to subjectivity, I am certain the majority of you silently said yes. I did. I hesitated to write this, as pain, from the definition of it to the management of it, is idiosyncratic. Rather than draw hard and fast lines, I prefer to…

Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate) in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartis’ Gilenya (fingolimod) — making immune…

Nearly half of multiple sclerosis patients do not always report their relapses to healthcare providers, two surveys indicate. Mallinckrodt sponsored the surveys to better understand patients’ experience with relapses, which are sudden episodes of new symptoms or worsening of existing symptoms. The company presented the survey results at the 7th joint meeting…

Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows that ALKS 8700 — an investigative therapy developed by Alkermes to treat relapsing forms of multiple sclerosis — has a good safety and tolerability profile. ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate). Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program, which includes two Phase 3 clinical trials in patients with relapsing-remitting MS. The EVOLVE-MS-1 is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients. Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea. Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment. The EVOLVE-MS-2 trial, being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants. Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.

This comes as no surprise to me and probably not to you. MS patients may not always contact their healthcare providers when they’re having a relapse. This information comes via a pair of surveys that were released at the recent ECTRIMS-ACTRIMS conference in Paris. In the first,…

Celgene‘s investigative drug ozanimod has been shown to be more efficient than an intramuscular injection of interferon beta-1a (marketed as Avonex by Biogen) in reducing relapses and disease progression in patients with relapsing multiple sclerosis (MS), according to results of the two-year Phase 3 RADIANCE trial. The findings were…

Gilenya (fingolimod) lowered relapse rates in children and adolescents with relapsing multiple sclerosis at a “magnitude” — almost 82 percent — never before seen in a scientific study and could be “life changing” for these hard-to-treat patients, a top researcher with Novartis, the treatment’s developer, said in an…

Gilenya (fingolimod) was seen to significantly reduce relapses in children and teenagers with multiple sclerosis (MS), according to data from a Phase 3 study — the first successfully conducted in pediatric patients. Novartis, the therapy’s developer, is preparing to file requests for Gilenya to be approved to…

A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years. John Corboy, with the University of Colorado School of Medicine, presented the study at…

Lemtrada (alemtuzumab) remains a “game-changer” of a treatment for relapsing multiple sclerosis (MS), with benefits continuing and no new side effects seen in a study of its use that now goes out seven years, Aaron Boster, a neuroimmunologist at Ohio Health, said in an interview at the…

Ozanimod (RPC1063) was seen to lower relapse rates and reduce brain and spinal cord lesions among patients with relapsing multiple sclerosis (MS) participating in a Phase 3 study of the treatment. Giancarlo Comi, from the Vita-Salute San Raffaele University, in Italy, announced the results in a presentation during the ongoing…

Genentech’s Ocrevus (ocrelizumab) improved the vision of people with relapsing multiple sclerosis better than the widely used therapy interferon beta-1a, according to clinical trial findings presented at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris. Dr. Laura Balcer of the department of neurology at New York University made the presentation, titled “Effect…

Mavenclad (cladribine tablets), an oral therapy by Merck that’s approved to treat people with active relapsing multiple sclerosis in much of Europe, is a “smart therapy” that is showing real and long-term benefit after a short treatment course, said Gavin Giovannoni, chair of neurology at Barts and The London School of Medicine…

Opicinumab, an investigative treatment aiming to promote remyelination in relapsing multiple sclerosis (MS) patients, will be tested in a new clinical trial —  having failed at an earlier effort, but having shown promise enough in particular patients to be worth a closer look. In fact, the new AFFINITY study “is…

Mavenclad reduced multiple sclerosis relapses by 79 percent and prevented the development of additional inflammatory lesions in 84 percent of patients with high disease activity, according to presentations Merck KGaA will make in Paris next week. The company will share a host of new data at the 7th Joint ECTRIMS-ACTRIMS…

Alkermes will showcase its work in developing a treatment that harnesses the effect of Tecfidera (dimethyl fumarate) for relapsing multiple sclerosis (MS), while lowering the risk of stomach problems at the 7th Joint ECTRIMS-ACTRIMS Meeting this month in Paris. The investigational drug, ALKS 8700, uses the same mechanism of action as Tecfidera. By building the molecule in a different way, however, the company expects it will show better tolerability. Once in the body, dimethyl fumarate turns into monomethyl fumarate (MMF), the molecule that actually impacts MS disease processes. But before giving rise to MMF, dimethyl can cause side effects in users, particularly gastrointestinal. In fact, stomach problem were what caused people in Tecfidera Phase 3 trials to stop the treatment. Alkermes uses a so-called prodrug approach to try to overcome this problem. By attaching a different compound to MMF — which breaks away from the molecule once in the body —  it is possible to deliver MMF with lesser gastrointestinal side effects, Phase 1 study data indicate. At the meeting, the company will present two posters on two clinical trials exploring ALKS 8700 in patients with relapsing-remitting MS. The first presentation, will describe a Phase 3 trial that aims to compare ALKS 8700 to Tecfidera in about 420 patients. The trial is primarily concerned with the drug’s safety, and will measure the occurrence and impact of gastrointestinal side effects in the two treatment groups. The presentation will only include descriptions of patients characteristics and study design, as outcomes are yet to be analyzed. Patients who complete the Phase 3 trial will be eligible to continue in an ongoing open-label, long-term safety study, called EVOLVE-MS-1, covered in the company’s second presentation. By March 3, 2017, the study had enrolled 543 patients. In addition to describing patient characteristics, researchers will present the rates of discontinuation caused by gastrointestinal adverse events within one month of starting the treatment.

By the grace of God, I am a naturally positive individual who lends optimism and hope to even the bleakest of situations. Because of this, it is difficult to find me in a situation when my auspicious nature tires; after all, we find out the most…

Aubagio (teriflunomide) may lead to reversible nail loss, researchers at Italy's University of Bologna 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 — or inflammation of the optic nerve — three months earlier. Their report, “Nail loss after teriflunomide treatment: A new potential adverse event,” 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's 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's Tecfidera (dimethyl fumarate) after a couple of weeks, and her nails started to grow again. This supported doctors’ idea that Aubagio had caused the nail loss, and that it was reversible. Nail growth is similar to that of hair, researchers said. The patient’s 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.  

Diet can play an important role in whether children with relapsing multiple sclerosis have a relapse, researchers at the University of California, San Francisco argue. Their study demonstrated that a diet with a lot of fat increases the risk of a youngster having a relapse by 56 percent, with saturated fat tripling the risk. Eating a lot of vegetables, on the other hand, cuts the risk in half, the team said. Since children with MS tend to have relapses more often than adults, the researchers figured they would be a suitable group to study diet's impact on relapse. They recruited 219 children with relapsing-remitting MS or clinically isolated syndrome from 11 centers across the U.S. Clinically isolated syndrome is a condition that can evolve in MS. The research team use a questionnaire known as the Block Kids Food Screener to analyze what the youngsters ate. They tracked the children an average of almost two years, which was plenty of time for relapses to occur. And, in fact, they did occur in 42.5 percent of the group. It turned out that fat had a particularly devastating effect on the youngsters' relapse rate. For every 10 percent increase in energy intake that came from fat, there was a 56 percent increase in the children's risk of having a relapse. Saturated fats were the biggest driver of risk. When researchers look only at these fats, they discovered that the risk more than tripled. Examples of saturated fats include processed meats such as sausages, ham, and burgers, butter, hard cheeses, and whole milk. Vegetables had the opposite effect on risk, the researchers observed. Using a cup equivalent as a standardized measure, they learned that for every additional cup of vegetables the children ate, the risk of a relapse dropped in half. To exclude the possibility that other factors influenced the results, the team included information about age, sex, ethnicity, duration of disease, body mass index, treatment, and D-vitamin levels in their analyses. This did not influence the results. The team also looked at whether other food components, such as sugar, iron, fruit and fiber, would affect the risk of relapse. They did not find any links. Although the risk associations were strong, the researchers cautioned that the study's observational design meant that it was not able to prove that fat causes relapses. But there are several ways that fat could play a role in disease processes, they argued. For instance, high fat intake triggers the release of inflammation-promoting molecules. It also affectsf gut bacteria that are linked to immune processes. Vegetables lower the risk of inflammation and immune problems, the team said. In an accompanying editorial, Dr. Kathryn Fitzgerald of the Johns Hopkins School of Medicine said the study had important limitations. Researchers gathered information on the children's diet only in the week before they enrolled in the study. This might not adequately capture more long-term dietary patterns, she said. And fat is not simply fat, she pointed out, arguing that fish oil is believed to help MS patients. Although the California research offers insight, she called for long-term studies to define diet's role in MS.

We are familiar with the “why me” moments? I reference this often because it is a recurring subject in the lives of people with chronic illness. As a little girl I’d ask my parents why my heart is sick, and as an adult, I still ask why have I…

I’ve had a cold for two weeks. So, I’ve been more tired than usual. Too tired, in fact, to write the column that was supposed to post last Tuesday. (I apologize to all of you who wait, with bated breath, for the appearance of the MS Wire each…

I was going to write about something else, then my MS got in the way. Intellectually, I know MS is very up-and-down, but often when the down hits, I think the worst has happened. I went to my exercise class this week and struggled. Got home and recovered.

April Hester has MS. She was diagnosed in 1996, just after she turned 20 years old. Like many of us, April has balance and fatigue issues. Her legs can become tired, her foot sometimes drops and she falls a lot. But unlike many of us, April and her…

TG Therapeutics is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab) as a treatment for relapsing forms of multiple sclerosis. ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, a glycoengineered monoclonal antibody, with Genzyme’s Aubagio…

I posted this meme on social media last week with the caption “Current Life Status,” hoping a laugh might help matters. I’m sorry to say things didn’t improve afterward. I’m not a Debbie Downer or a Sad Sack by nature, and I don’t often write about my struggles here…