relapse

Helicopters were whirling in my brain. Turns out, it was a solitary police one. Though it was another hot night, my wife closed my windows in case of a prowler. I’m on the ground floor, after all. It was a dark moment in my life. Another relapse had struck…

Maybe I should have called this one “Short and Sharp 2.” Yes, I’ve had another relapse, following my last one in May. I can no longer clean my own tail, and the present regime is literally to “s**t the bed!” I’m using a lot of exclamation points here,…

Disability appears to mostly accumulate in people with relapsing forms of multiple sclerosis (MS) in a progressive manner — rather than being due to relapses, a pooled analysis of patients in two Ocrevus (ocrelizumab) clinical trials shows. These findings, indicating that disease progression underlies relapsing MS as well,…

Tecfidera (dimethyl fumarate) is safe and effective as a long-term treatment for relapsing-remitting multiple sclerosis (RRMS), a study of clinical trial data covering up to 11 years of treatment suggests. The study, “Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis:…

“I can’t move my head,” I thought.  It was 5 a.m. on April 1, and the realization of my full bladder prompted my wakening. But I soon realized I had a more significant issue that only became apparent when I tried to get up and couldn’t. What on…

Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) asking for ponesimod to be approved as an oral treatment for adults with relapsing multiple sclerosis (MS). Ponesimod, formerly ACT-128800, is an experimental treatment that targets the protein sphingosine-1-phosphate…

Acthar Gel (repository corticotropin injection) leads to significant improvements after two months of use in people with multiple sclerosis (MS) still having acute relapses despite treatment, and who failed to respond to other high-dose corticosteroids, topline data from an observational study show. The gel’s developer, Mallinckrodt Pharmaceuticals, also…

The European Commission has approved Novartis‘s Mayzent (siponimod) as the first oral treatment for adults with active secondary progressive multiple sclerosis (SPMS). Active SPMS is defined by the presence of evident relapses or the detection of inflammatory activity in brain lesions on imaging scans. “As the only indicated oral therapy proven for…

Pregnancy does not lead to long-term changes in the disease course of multiple sclerosis (MS), new research suggests. This work, which emphasizes the importance of careful data analysis, supports studies disputing previous beliefs that pregnancy worsened or lessened the long-term disease course of MS. The findings were presented by Mar Tintore,…

Rutgers Health is leading the Pediatric Multiple Sclerosis and Demyelinating Diseases Program, the only program in the state of New Jersey designed specifically to support children with multiple sclerosis (MS). The support program seeks to promote children’s access to cutting-edge therapies and clinical trials, and to educate…

Janssen has announced positive, top-line results from its Phase 3 OPTIMUM study, testing the effectiveness and safety of ponesimod tablets, compared to Sanofi‘s Aubagio (teriflunomide), in adults with relapsing forms of multiple sclerosis (MS). The study met its primary goal — a reduction in the…

In partnership with @Point of Care, the Multiple Sclerosis Association of America (MSAA) is offering a comprehensive educational video series about multiple sclerosis (MS). The concise, 12-part series — titled “Understanding Multiple Sclerosis” —  features neurologist and MS expert Michelle T. Fabian, MD, and covers…

Vumerity (diroximel fumarate), taken as a 462 milligram (mg) tablet twice daily, significantly decreases disease activity in patients with relapsing-remitting multiple sclerosis (RRMS), and leads to low rates of gastrointestinal side effects, new interim data of Phase 3 trial EVOLVE-MS-1 show. The findings were presented at the 2019 Consortium…

Exactly one year ago on this day of writing, I was down and out. This year, I’m not exactly fighting fit, but the same set of circumstances has pushed me the distance. But it didn’t floor me. OK, OK, I’ll stop with the pugilistic metaphors — it’s not exactly…

Tecfidera (dimethyl fumarate) is more efficient at preventing relapses, and has a lower discontinuation rate than Aubagio (teriflunomide), according to a Danish study. The study “Comparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort study” was published in the journal Neurology. Aubagio (marketed by Sanofi Genzyme) and Tecfidera…

An application has been submitted to approve ozanimod as an oral treatment for adults with relapsing forms of multiple sclerosis in the U.S., according to its developer, Celgene. “New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” Jay Backstrom, MD, Celgene’s chief medical officer, said in a press release. Celgene's New Drug Application has been submitted to the U.S. Food and Drug Administration. Earlier this month, the company submitted a marketing authorization application to the European Medicines Agency covering the treatment of adults with relapsing-remitting MS. “With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of (relapsing MS) in 2020,” Backstrom said. Ozanimod is designed to cause the retention of immune cells in lymphoid tissues, thereby blocking their migration to the central nervous system — brain and spinal cord — and preventing damage to nerve fibers and their protective layer, called myelin. The investigational therapy selectively binds to S1P receptor subtypes S1P1 and S1P5. The NDA application is based on positive findings from two multicenter, double-blind, Phase 3 trials called SUNBEAM and RADIANCE part B. Both studies demonstrated that ozanimod reduced the number of relapses and brain lesions. In the SUNBEAM Phase 3 trial, 1,346 participants with relapsing MS were randomized to one daily dose of 0.92 or 0.46 mg of ozanimod — equivalent to 1 mg and 0.5 mg of the therapy’s HCI formulation — or Avonex (interferon beta-1a, marketed by Biogen) for at least 12 months. Results showed that treatment with ozanimod led to fewer relapses and brain lesions, as well as clinically meaningful improvements in processing speed compared with Avonex. In the Phase 2/3 RADIANCE trial, patients were divided in two parts: in part A, participants received either one daily dose of ozanimod (0.5 mg or 1.0 mg) or a placebo for 24 weeks; in part B, a 96-week open-label extension study completed by 223 patients, those initially on placebo switched to ozanimod. As in the SUNBEAM trial, results of part A of the RADIANCE trial revealed a reduction in the number of brain lesions from weeks 12 to 24, as well as less frequent relapses compared with a placebo. Treatment with ozanimod was safe and well-tolerated. Findings of part B of the study included an increased percentage of patients free of T1 lesions on MRI (magnetic resonance imaging) scans — which refer to areas of active inflammation and disease activity — after two years of treatment, from 58.5–69.0% of patients in part A to 86.5–94.6% of patients in part B. T2 lesions, a measure of the total amount of MRI lesions — both old and new — and relapse rate remained low in patients maintained on ozanimod (more significantly with the higher dose of 1.0 mg), and dropped in those who switched from a placebo. The scientists also analyzed ozanimod’s benefits using data from the SUNBEAM and RADIANCE part B trials, which covered 2,659 patients treated over one to two years. Compared with Avonex, ozanimod reduced the annualized relapse rates — the number of relapses per year — by 42% in the higher dose group and 26% in the lower dose group. Treatment with ozanimod also lessened the relapse rate requiring steroid treatment or hospitalization by 43% (in the 1 mg dose group) and 26% (in the 0.5 mg dose group) compared with Avonex treatment. In addition to MS, ozanimod is also being developed for patients with ulcerative colitis and Crohn's disease, two inflammatory bowel diseases.

Relapses can be sneaky. They can scythe you down. I’ve been dealing with multiple sclerosis (MS) since 2006 and I only consciously remember two relapses. The first relapse was two years after I had been diagnosed with sclerosis. There was the possible hope from my first neurologist that nothing…