disability

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,…

Gilenya Better at Lowering Relapse Rate than Tecfidera or Aubagio, Study Suggests

Gilenya is linked to significantly lower annualized relapse rates in relapsing-remitting multiple sclerosis (RRMS) patients compared to Tecfidera orĀ Aubagio, a study suggests. All three therapies showed similar effects on disability outcomes. Oral immunotherapies ā€” including Novartisā€™ Gilenya, Biogenā€™s Tecfidera, and Sanofi Genzymeā€™s Aubagio ā€” are currently standard therapies for RRMS treatment. But while these therapies are highly effective at modulating MS activity, studies comparing their efficacy on relapse and disability are missing. This is an important point for MS patients, so that if a change in oral therapies is needed (due to lack of tolerance, for example), the decision on a more suitable therapy is based on scientific evidence. To address this matter, a group of researchers used the MsBase, an international observational MS cohort study, to identify RRMS patients who had been treated with Gilenya, Tecfidera, or Aubagio for at least three months. The team compared Tecfidera versus Aubagio, Gilenya versus Aubagio, and Gilenya versus Tecfidera, specifically for the therapyā€™s impact on relapse activity, six-month disability worsening or improvement, and persistence of treatment. Relapse was defined as the occurrence of new symptoms or exacerbation of existing ones for a period of over 24 hours, at least 30 days after a previous relapse. Disability was assessed using the Expanded Disability Status Scale (EDSS); the six-month disability worsening or improvement were defined as an increase or a decrease by one value in EDSS. The study included 614 patients treated with Aubagio, 782 with Tecfidera, and 2,332 with Gilenya. Patients were followed over a median of 2.5 years. Patientsā€™ characteristics at baseline differed among the three groups. Aubagio-treated patients tended to be older, with longer periods of disease, fewer relapses, and lower EDSS scores compared to the other two groups. Patients treated with Gilenya had higher EDSS and more relapses during the prior year, compared to those treated with Tecfidera. The majority of the patients had been treated with other immunotherapies prior to being given one of these three oral treatments. Results showed that Gilenya-treated patients had significantly lower annualized relapse rates than those treated with Tecfidera (0.20 versus 0.26) or Aubagio (0.18 versus 0.24), while patients taking either Tecfidera or Aubagio had a similar rate. However, during the 2.5-year period analyzed, researchers found no differences in disability accumulation or disability improvement among the three therapies. Regarding treatment persistence, Tecfidera and Aubagio were more likely to be discontinued than Gilenya. Overall, the results suggest that treatment with Gilenya may have a greater impact on relapse frequency in RRMS patients compared to Tecfidera and Aubagio, although the "effect of the three oral therapies on disability outcomes was similar during the initial 2.5 years on treatment," researchers said. ā€œChoosing a therapy in individual patients remains a complex task that requires thorough and individualized evaluation of disease prognosis, and the corresponding risks and benefits of the increasing number of available therapies,ā€ they concluded.

Fatigue More Common in Progressive MS Patients, Survey Shows

Fatigue is more prevalent among patients with progressive multiple sclerosis (MS), according to a study that surveyed patients on fatigue and factors related to it. In addition, increased fatigue severity correlated with greater physical, cognitive, and psychological impairment, although the strength of this link was largely the same…

Blood Stem Cell Transplant Better than DMTs at Reducing Risk of Disease Progression in RRMS

Autologous hematopoietic stem cell transplant is better than disease-modifying therapies (DMT) at reducing the risk of disease progression in patients with relapsing-remitting multiple sclerosis (RRMS), results from the MIST clinical trial show. The study ā€œEffect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression…

Stem Cell Transplant Lessens Disability and Relapses in RRMS Patients, Phase 2 Trial Shows

Treatment withĀ autologous hematopoietic stem cell transplantĀ (aHSCT) led to a sustained decrease in disability and almost no clinical relapses in patients withĀ relapsing-remitting multiple sclerosisĀ (RRMS)Ā who had failed to respond to prior immunosuppressive therapies, an Australian Phase 2 trial shows. Trial findings were published in the study, ā€œProspective phase…

High Lipid Levels Associated with Increased Disability, Inflammation in RRMS Patients, Study Shows

High levels of certain lipids, or fat, in the blood are linked to increased disability scores and high levels of pro-inflammatory markers inĀ relapsing-remitting multiple sclerosis (RRMS) patients, a small study reports. The study, ā€œLipoprotein markers associated with disability from multiple sclerosis,ā€ was published in the journal Scientific…

#ECTRIMS2018 – Two European Studies Compare Tecfidera, Aubagio Effectiveness

Treatment of relapsing-remitting multiple sclerosis (RRMS) patients with Tecfidera (dimethyl fumarate)Ā is associated with fewer new brain lesions at two years, lower relapse rates, increased time to first relapse, and reduced treatment discontinuation than with Aubagio (teriflunomide), according to a nationwide study from France and a real-world, population-based…

#ECTRIMS2018 ā€” Infections, Severe Disability Complications More Likely Causes of Death in MS Patients, Study Shows

Infections and complications from severe disability are the greatest contributors to mortality amongĀ multiple sclerosis (MS) patients, according to a population-based study in British Columbia, Canada, which also found that that MS is a more common underlying cause of death among younger patients. The study, ā€œCauses that…

#ECTRIMS2018 – Switching to Tysabri Leads to Fewer Relapses and Disability than Gilenya, Study in RRMS Patients Finds

Patients with relapsing-remitting multiple sclerosis (RRMS) who switch to Tysabri (natalizumab) after relapses on first-line treatment with other medications show greater relapse reduction and less disability progression than those switching to Gilenya (fingolimod), according to a real-world study. The research, ā€œComparative effectiveness of switching…

October Is National Disability Employment Awareness Month

Everything can be more challenging when you have a disability, and being part of the workforce can add even more challenges. The month of October is National Disability Employment Awareness Month (NDEAM), and according toĀ the U.S. Department of Laborā€™s website, this year’s theme is ā€œAmericaā€™s Workforce: Empowering All.ā€…

#ECTRIMS2018 – Ublituximab Markedly Reduces Lesions, Promotes B-cell Depletion, Halts Disability Progression in Phase 2 Trial

A 48-week treatment of relapsing multiple sclerosis (MS) with TG Therapeuticsā€™ investigational compound ublituximab led to a marked reduction of brain and spinal cord lesions, massive depletion of relapse-associated immune B-cells, and significantly halted disability progression, according to results from a Phase 2 clinical trial. The data…

Truly ‘Benign MS’ Evident in Only Small Minority of Patients, Large UK Study Reports

Multiple sclerosis (MS)Ā that appears to be "genuinely benign" 15 years after diagnosis is evident in a small number of patients, a large population-based study from the U.K. reports. But, its researchers note, the term ā€œbenignā€ is often not clinically accurate as used, because it is based largely on perceptions of disease impact. The study ā€œHow common is truly benign MS in a UK population?ā€ was published in the Journal of Neurology, Neurosurgery & Psychiatry. The concept of benign MS is controversial, especially among clinicians. Still, long-term epidemiological studies have consistently identified a small fraction of patients whose MS progresses very slowly over a long span of years. Determining the prevalence of this type of MS in the population has been difficult, as estimates can vary significantly depending of the definition of ā€œbenignā€ that is adopted. Researchers sought to determine an accurate estimate of benign MS in the U.K. population, using a rigorous and comprehensive clinical definition of a truly benign disease. This definition included minimal physical disability (EDSS scoreĀ of less than 3), and no significant fatigue, mood disturbance, cognitive impairment or interrupted employment in the absence of treatment with disease-modifying therapies over 15 years or more years after symptom onset. They screened an U.K. population-based registry containing data on 3,062 MS patients to identify those with "unlimited walking ability" 15 or more years after diagnosis. A representative sample of 60 patients Ā from this pool was analyzed (45 women and 15 men, mean age of 57); they had a mean disease duration of 28 years. Nine out of these 60 (15%; 8 women and one men) fulfilled the studyā€™s criteria for truly benign disease. These nine people had a mean age of 27 at symptom onset, a median EDSS disability score of 1.5 (minimal signs of disability), and a mean disease duration of 31 years. "Those nine individuals with truly benign MS all remained in a relapsingā€“remitting state," the study noted. "However, only two out of nine showed disease arrest within the first decade; the remainder all continued to experience relapses well into their second or third decade of MS," but the rates of such relapses were low. MS in the remaining patients was not classified as benign, mostly due to evidence of cognitive difficulties (57%), and the disease's impact on employment status (52%) with many taking early retirement. Based on these results, a population frequency for "benign MS" under the definitions used was estimated at 2.9%. But the researchers noted that a large proportion of patients (65%; 39 patients out of 60) reported their disease as benign, according to a lay definition. Their self-reported status poorly agreed with the clinical assessments done throughout the study. "There is no accepted definition to offer patients when exploring whether they feel their MS is benign; the definition we chose incorporates the fundamental principles of low impact on a person, absence of complications and a favourable outcome and is in line with definitions provided by third-party support groups," the researchers wrote. Many Ā considering themselves with benign disease did so based on their "perception" of their disease, the team added, and one that "appeared to be driven as much by mood, fatigue and bladder function as by physical ability."Ā  ā€œIn conclusion, after detailed clinical assessment, a small minority of people with MS appear genuinely unaffected by symptoms after 15 years,ā€ the researchers added. They also called attention to the fact that EDSS-based definitions of benign MS and the inconsistency between patient and clinician perception of benign MS compromise the use of the term ā€˜benignā€™ in clinical practice. They also emphasize that studying individuals with benign MS ā€œhas the potential to uncover clues to mechanisms underlying favorable outcomes in MS, provide insights into new therapeutic targets and have implications for patient counselling, individual patient management and the construct of clinical trials.ā€