Sanofi Genzyme

Ofatumumab Better at Easing Relapse Rates and Slowing MS Progression Than Aubagio, Phase 3 Data Show

Monthly injections of ofatumumabĀ led to more clinically meaningful reductions in relapse rates and delayed disability progression than did daily treatment withĀ AubagioĀ (teriflunomide) tablets in people with relapsing forms of multiple sclerosisĀ (MS), results from two Phase 3 trials showed. Ofatumumab, formerly known as OMB157, is a potent, self-administered…

Mavenclad Cost-Effective Treatment for At-risk RRMS Patients Compared to Other DMTs, Dutch Study Finds

Treating at-riskĀ relapsing-remitting multiple sclerosis (RRMS) patients is most cost-effective withĀ MavencladĀ (cladribine) tablets when compared to Gilenya (fingolimod), Lemtrada (alemtuzumab) or Tysabri (natalizumab),Ā according to a study in Dutch patients. The study, ā€œCost Effectiveness of Cladribine Tablets for the Treatment of Relapsing-Remitting Multiple Sclerosis in…

Autoimmune Complications Associated with Lemtrada Solved Using Anti-CD20 Therapies, Case Studies Suggest

Relapsing-remitting multiple sclerosisĀ (RRMS) patients treated with LemtradaĀ (alemtuzumab) may develop additional (secondary) autoimmune reactions. Anti-CD20 therapies, including rituximabĀ or Ocrevus (ocrelizumab), are a potential treatment for Lemtrada-associated autoimmune complications in patients who fail to respond to other conventional immunotherapies, according to a case report about two women in…

Aubagio Targets Highly Metabolic Auto-reactive T-Cells, Study Shows

AubagioĀ (teriflunomide), an approved medicine for relapsing forms of multiple sclerosis (MS), specifically targets highly metabolic and more autoreactive T-cells, analysis of the Phase 3 TERI-DYNAMIC clinical trial data shows. The findings, contrary to expectations, support a selective effect of Aubagio on different T-cell populations. The study ā€œTeriflunomide treatment for multiple sclerosis modulates T cell mitochondrial respiration with affinity-dependent effectsā€ was published in the Science Translational MedicineĀ journal. In MS, immune cells, or lymphocytes known as T-cells, attack and destroy myelin, the fat-rich substance that wraps around nerve fibers (axons). Myelin loss creates lesions that affect nerves of the brain and spinal cord. Previous evidence suggested that T-cells, depending on their active or resting state, rely on specific ways of energy production or metabolism. Aubagio, marketed byĀ Sanofi Genzyme, is a well-known inhibitor of a mitochondrial enzyme called dihydroorotate dehydrogenase (DHODH), that is crucial for the activity of T-cells.Ā However, how Aubagio selectively targets the autoreactive T-cells is poorly understood. To shed light on this matter, an internationalĀ group of researchers used data from the TERI-DYNAMIC clinical trial that tested Aubagio in patients with relapsing form of MS to better understand how the therapy inhibited the patients' self-immune responses. The Phase 3, open-label TERI-DYNAMIC trial (NCT01863888) included 70 patients from Belgium, Germany, and The Netherlands, aged 18 to 56. Participants received Aubagio as a 14 milligram (mg) once-daily, oral dose, and researchers assessed the changes in immune cells' profile up to 24 weeks. Results showed that, contrary to what was expected, Aubagio was not generally decreasing T-cell levels in treated patients. Instead, it significantly reduced a particular subset of T-cells, called "Th1 helper cells." Moreover, researchers found that the diversity of T-cell receptors ā€” the surface proteins that can recognize a particular antigen (a protein that can elicit an immune response) ā€” making T-cells specific to a certain target was reduced in MS patients after treatment with Aubagio. These findings suggested that some T-cells were particularly susceptible to Aubagio. Using a mouse model for MS, the experimental autoimmune encephalomyelitis (EAE) model, researchers showed that the CD4+Ā T-cells (helper T-cells) and CD8+ T-cells, those that reacted most strongly against self-antigens, were the most sensitive to DHODH inhibition by Aubagio. Moreover, researchers saw that Aubagio was not affecting the production of pro-inflammatory molecules ā€” called cytokines ā€” at the cell level, but their overall decrease probably was due to the reduction in T-cell numbers. In line with these findings, CD4+Ā T-cells that produced the cytokine interferon gamma were significantly reduced with Aubagio treatment, whereas CD4+Ā T-cells that produced interleukin 17A were unchanged. This suggests that Aubagio is able to interfere with specific sub-types of immune cells. When the team compared the metabolic profile of T-cells from healthy subjects with that fromĀ patients with relapsing-remitting MS (RRMS) in both remission and in relapse phases, they found that the metabolism of T-cells from the last group was significantly altered, and thus targetable. Altogether, the results suggested that T-cells with a high-affinity to self-antigens are more susceptible to inhibition of the DHODH enzyme by Aubagio. ā€œTherapeutic targeting of metabolic alterations might represent an attractive concept in MS, and might represent an as yet unrecognized key mechanism of teriflunomide-mediated immune modulation in this disease,ā€ the researchers concluded.

My MS Has Been No Sweat. Has Yours, Too?

I worked up a little sweat when I was exercising the other day. It was just a tiny bit on my forehead, but it was something I hadn’t felt in many years. I’ve lived with MS since 1980, and before now, I can’t remember the last time I felt sweaty.

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…

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€…

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,…

Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports

Multiple sclerosis (MS) patients given intensive disease-modifying therapies early in their disease course have more favorable long-term outcomes than those treated with an escalating regimen, real-world data shows. The study, ā€œClinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,ā€ was published in the journalĀ …

4 Things I’ve Learned About Paying for MS Medications

Are you having trouble paying for MS medications? If so, you’re not alone. People change or lose their insurance, and plans change the medications they cover from year to year. Your neurologist may change your medication without realizing that moving you from an injection to an oral med may…

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.

Lemtrada Linked to Bleeding in Lungs in Case Report, 1 of 5 MS Cases Worldwide, Study Says

AĀ potentially life-threatening case of bleeding in the lungs has been reported and attributed toĀ treatment with Lemtrada (alemtuzumab) by a woman withĀ relapsing-remitting multiple sclerosis. Her medical team foundĀ diffuse alveolar hemorrhageĀ in this patient ā€” which resolved in about a week without treatment. The scientists advised that clinicians be alert…

How Worried Should We Be About MS Medication Side Effects?

Over the past couple of weeks, two warnings have been issued about side effects of multiple sclerosis (MS) medications. First, the U.S. Food and Drug Administration warned about a slight risk of seriously worsening MS symptoms if someone who is using the disease-modifying therapy (DMT) Gilenya (fingolimod) stops using…