relapse

Relapse, Relapse, Relapse, Profanity, Relapse

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,…

Tecfidera Safe and Effective Over Years of Use, RRMS Study Finds

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:…

An April Fools’ Joke that Wasn’t Very Funny

“I canā€™t move my head,” I thought.Ā  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…

#ACTRIMS2020 – Acthar Gel Ably Treats MS Relapses, Topline Data Show

Acthar GelĀ (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…

Mayzent Approved in Europe as First Oral Treatment for Active Secondary Progressive MS

TheĀ European CommissionĀ has approvedĀ Novartis‘s MayzentĀ (siponimod) as the first oral treatment for adults with active secondary progressive multiple sclerosisĀ (SPMS). Active SPMS is defined by the presence of evident relapses or the detection of inflammatory activity in brain lesions on imaging scans. ā€œAs the only indicated oral therapy proven for…

Pregnancy Does Not Change Long-term Course of MS, New Data Suggest

Pregnancy does not lead to long-term changes in the disease course ofĀ multiple sclerosisĀ (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 Leading Program to Support MS Children

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…

I Survived a Marathon Comedy Festival

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 ā€” it’s not exactly…

TecfideraĀ Better at Preventing Relapses than Aubagio, Real-world Study Suggests

TecfideraĀ (dimethyl fumarate) is more efficient at preventing relapses, and has a lower discontinuation rate than AubagioĀ (teriflunomide), according to a Danish study. The study ā€œComparative effectiveness of teriflunomide and dimethyl fumarate: A nationwide cohort studyā€ was published in the journal Neurology. Aubagio (marketed byĀ Sanofi Genzyme)Ā and Tecfidera…

Celgene Seeking FDA Approval for Ozanimod to Treat Adults With Relapsing MS

An application has been submitted to approveĀ ozanimod as an oral treatment for adults with relapsing forms of multiple sclerosis in the U.S., according to its developer,Ā Celgene. ā€œNew oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,ā€ Jay Backstrom, MD, Celgeneā€™s chief medical officer, said in a press release. Celgene'sĀ New Drug Application has been submitted to the U.S. Food and Drug Administration. Earlier this month, the companyĀ submitted a marketing authorization application to the European Medicines Agency covering the treatment of adults with relapsing-remitting MS. ā€œWith 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,ā€ Backstrom said. Ozanimod is designed to cause the retention of immune cells in lymphoid tissues, thereby blocking their migration to the central nervous system ā€” brain and spinal cord ā€” 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 calledĀ SUNBEAM andĀ RADIANCE part B. Both studies demonstrated that ozanimod reduced the number of relapses and brain lesions. In theĀ SUNBEAMĀ Phase 3 trial, 1,346 participants with relapsing MSĀ were randomized to one daily dose of 0.92 or 0.46 mg of ozanimod ā€” equivalent to 1 mg and 0.5 mg of the therapyā€™s HCI formulation ā€” orĀ AvonexĀ (interferon beta-1a, marketed byĀ Biogen) for at least 12 months. Results showed that treatment with ozanimod led toĀ fewer relapsesĀ 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 studyĀ included an increased percentage of patients free of T1 lesions on MRI (magnetic resonance imaging) scans ā€” which refer to areas of active inflammation and disease activity ā€” after two years of treatment, from 58.5ā€“69.0% of patients in part A to 86.5ā€“94.6% of patients in part B. T2 lesions, a measure of the total amount of MRI lesions ā€” both old and new ā€” 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 ozanimodā€™s benefits usingĀ 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 ā€” the number of relapses per year ā€” 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.

#ACTRIMS2019 – TG Therapeutics’ Investigational Therapy Ublituximab Posts Positive Data in MS Phase 2 Clinical Trial

Full results of a Phase 2 clinical trial testing TG Therapeuticsā€™ lead candidate ublituximab (TG-1101) for relapsingĀ multiple sclerosisĀ (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…

Switching from Tysabri to Aubagio Can Help Lower Relapse Risk in MS Patients, Phase 4 Trial Shows

Stable patients with multiple sclerosis (MS) who transition from Tysabri (natalizumab) treatment toĀ Aubagio (teriflunomide) have a lower relapse risk, a new study shows. The study, ā€œReducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy,ā€…

Relapse, Relapse, Relapse

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 relapseĀ was two years after I had been diagnosed with sclerosis. There was the possible hope from my first neurologist that nothing…

Aubagio, Tecfidera Show Comparable Effectiveness in Relapsing MS, Real-world Phase 4 Trial Finds

Aubagio (teriflunomide)Ā seems to be superior to Tecfidera (dimethyl fumarate)Ā in slowingĀ whole brain shrinkage in patients withĀ relapsing multiple sclerosis (MS), a new Phase 4 clinical trial shows. However, Aubagio and Tecfidera have similar beneficial effects in achieving other clinical goals and magnetic resonance imaging (MRI) parameters,…