Disease modifying therapies (DMT)

Treating at-risk relapsing-remitting multiple sclerosis (RRMS) patients is most cost-effective with Mavenclad (cladribine) tablets when compared to Gilenya (fingolimod), Lemtrada (alemtuzumab) or Tysabri (natalizumab), according to a study in Dutch patients. The study, “Cost Effectiveness of Cladribine Tablets for the Treatment of Relapsing-Remitting Multiple Sclerosis in…

Rituximab Leads to ‘Dramatic’ Recovery in Boy with Aggressive RRMS, Case Study Reports I dislike using adjectives such as “dramatic” when describing treatment results. I think they frequently blow things out of proportion. However, after reading about how this young boy in Greece responded to Rituximab as a “rescue…

Choosing which MS medication to use is one of the most difficult decisions for someone with MS and their neurologist. After 39 years with MS, and with four disease-modifying therapies (DMTs) on my medical chart, I’m definitely on the hit-it-fast, hit-it-hard side of that treatment decision. So, I was…

Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘s Aubagio (teriflunomide), and Biogen’s Tysabri (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…

When it comes to initial treatment selection for relapsing-remitting multiple sclerosis (RRMS), there is one question that has yet to be answered: Is it better to start with potentially safer moderately effective disease-modifying treatments (DMTs) or to hit the disease immediately with a high-efficacy DMT that may be…

Medications for treating certain rare and chronic conditions,  including multiple sclerosis (MS), are now available from the specialty and home delivery pharmacy AllianceRx Walgreens Prime, the company announced. The newly included specialty medications are all limited distribution drugs (LDDs), which means the drug manufacturers have signed agreements giving very…

Autoimmune Complications Associated with Lemtrada Solved Using Anti-CD20 Therapies, Case Studies Suggest One of the concerns about the disease-modifying therapy (DMT) Lemtrada (alemtuzumab) is that it may raise the patient’s risk of developing a secondary autoimmune disease within seven years post-treatment. This small study suggests that the abnormal proliferation…

Relapsing-remitting multiple sclerosis (RRMS) patients treated with Lemtrada (alemtuzumab) may develop additional (secondary) autoimmune reactions. Anti-CD20 therapies, including rituximab 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…

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…

Gilenya (fingolimod) has been approved in China as a disease-modifying therapy to treat adults and children, ages 10 and older, with relapsing forms of multiple sclerosis (MS). Gilenya, marketed by Novartis, is an oral disease-modifying treatment for relapsing MS. It acts by binding and modulating receptors…

Obesity may increase the risk for the development and progression of multiple sclerosis (MS) in children and teens, and it may prevent first-line MS therapies from working. Those findings were reported in the study “Association of Obesity With Multiple Sclerosis Risk and Response to First-line Disease…

Convelo Therapeutics has announced a collaboration with Genentech, a member of the Roche Group, to work toward the development of new remyelination therapies for multiple sclerosis (MS) and other myelin disorders. “We are excited to be working with Genentech to…

Treating people with relapsing forms of multiple sclerosis (MS) with opicinumab and Avonex (interferon beta-1a) for 72 weeks did not lead to a dose-dependent reduction in disability,  results of a Phase 2 trial show. However, an ongoing study is evaluating opicinumab in a subgroup with better clinical responses.

Does your doctor consider what you’ll have to pay when prescribing your medications? A few months ago, I wrote that some people are skipping doses of their meds because they can’t afford their out-of-pocket costs. In that column, one of the suggested solutions was to talk to your doctor…

NervGen wants to advance the development of NVG-291, its lead investigational therapy for spinal cord damage, as a potential remyelination treatment for multiple sclerosis (MS), the company announced. Following preclinical data showing that NVG-291 promotes myelin repair and regeneration of damaged nerves in animal models of…

While neurologists favor Novartis‘ Mayzent (siponimod) for people with active secondary progressive multiple sclerosis (SPMS) and transitioning relapsing-remitting MS (RRMS), EMD Serono‘s Mavenclad (cladribine) could serve as a first option for patients with RRMS who failed initial therapy, Spherix Global Insights says in its…

Users of the disease-modifying therapy Ocrevus (ocrelizumab) share a common complaint: the length of time the infusions take. It may seem petty, but an Ocrevus infusion consumes nearly an entire day. My typical infusion involves checking into the clinic, being screened by the infusion nurse for any changes, taking…

Cyxone Launches Phase 1 Trial Assessing T20K for MS This trial caught my eye because even though it’s a small, early trial, T20K is a medication derived from a plant. Animal studies have shown that the treatment can inhibit cytokines, substances that mediate inflammation. Cyxone launched the first-in-human Phase…

The loss of immune B-cells, and the resulting changes in the profile of immune T-cells, is a major mechanism of action for the beneficial effects seen with ublituximab treatment in multiple sclerosis (MS) patients, a study suggests. B-cells are a type of immune cell best known for producing…

Treatment with Sanofi Genzyme’s Lemtrada (alemtuzumab) for up to two years lowers the levels of serum neurofilament light chain (sNfL), a proposed biomarker of nerve damage, in relapsing-remitting multiple sclerosis (RRMS) patients to levels comparable to those seen in healthy people, data from the CARE-MS I study shows. Lemtrada’s effectiveness…

More than 15 disease-modifying therapies (DMTs) are available in most high-income countries to treat multiple sclerosis (MS). DMTs come in the form of injectables, infusions, and pills. Some are new, others have been around for more than 20 years. Some have a greater possibility of serious side effects than others. Some DMTs are highly effective at slowing or stopping disease progression; others, not so much. It's a difficult choice to make. So, why are some neurologists making it harder? These doctors are handing their patients a medication "shopping list" and telling them to pick one. I see this topic discussed regularly in social media MS groups. Recently, a woman who needs to switch DMTs wrote that her neuro gave her a "handful of (medication) brochures" and told her to go home and decide which medication she wanted. Really? DMT selection shouldn't be do-it-yourself I've been using DMTs for more than 20 years. I've been on Avonex (interferon beta-1a), Tysabri (natalizumab), Aubagio (teriflunomide), and Lemtrada (alemtuzumab). I always had the final say on which med I wanted to use, but I never had to make that decision alone without guidance from my neuro. That's the way a doctor-patient relationship should work. While the final DMT decision should always rest with the patient, your neurologist has the responsibility to use his or her knowledge of the meds and of you to guide you in your choice. Some factors that you both need to consider are: Is the disease progressing quickly or slowly? Your lifestyle: Do you work full time? Do you have a good support system and reliable transportation? If an injectable DMT is in the mix, can you handle injecting yourself monthly, three times a week, or every day? How much possible risk are you willing to accept in exchange for the potential of a better result? An additional and criticial consideration is whether you can afford the treatment. My impression is that cost is rarely thought of or talked about before most physicians prescribe a medication. I see nothing wrong with asking your doctor how much you can expect to pay out-of-pocket. (Or, for the doctor's office to ask this of your insurance company). If you feel your neurologist doesn't know all of these things about you I suggest that you be proactive and fill in any blanks. The final choice is yours With all of that knowledge, you can probably narrow down the most appropriate DMT candidates for you to three or four. Then it's time for your neuro to clearly explain why those are the best choices and to review the pros and cons of each. Then, and only then, it's time for you to make the final choice. And your decision might be not to use any medication. That wouldn't be my choice, but it might be yours. After all, you're the one who'll be living with whatever choice you make. What has been your experience? Was your neurologist helpful when selecting a DMT or were you given "a handful of brochures" and told to do-it-yourself? How did you choose? You're invited to visit my personal blog at www.themswire.com.

DELIVER-MS Trial Recruiting RRMS Patients to Help Improve Treatment Decision-making What’s the best way to attack multiple sclerosis when it’s first diagnosed? Do you hit it hard and fast using the most effective disease-modifying therapy (DMT), or do you start with a lower efficacy DMT and slowly ramp up?…

The relative risk of developing cancer was found to be higher in multiple sclerosis (MS) patients who more frequently switched between disease-modifying treatments, according to a study. In addition, researchers found an increased incidence of cancer in male MS patients from 20 to 50 years old, and in female…

Aubagio (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 “Teriflunomide treatment for multiple sclerosis modulates T cell mitochondrial respiration with affinity-dependent effects” was published in the Science Translational Medicine 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 by Sanofi Genzyme, is a well-known inhibitor of a mitochondrial enzyme called dihydroorotate dehydrogenase (DHODH), that is crucial for the activity of T-cells. However, how Aubagio selectively targets the autoreactive T-cells is poorly understood. To shed light on this matter, an international 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 — the surface proteins that can recognize a particular antigen (a protein that can elicit an immune response) — 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+ 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 — called cytokines — at the cell level, but their overall decrease probably was due to the reduction in T-cell numbers. In line with these findings, CD4+ T-cells that produced the cytokine interferon gamma were significantly reduced with Aubagio treatment, whereas CD4+ 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 from 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. “Therapeutic 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,” the researchers concluded.

FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS Another disease-modifying therapy (DMT) is a step closer to gaining approval for use both in the U.S. and in Europe. And that’s good news. The discouraging news, however, is that once again, the approval is being…

Mavenclad (cladribine) may surpass Gilenya (fingolimod) in the category of oral disease-modifying therapy (DMT) of choice for the treatment of multiple sclerosis (MS) in Canada, according to a press release. The Canadian healthcare market for MS has grown considerably over the past two years. In November…

#AANAM – Biogen Offers Update on Development Plans for MS Therapies The pharma company that brought you Tysabri (natalizumab) is investigating a new process for treating multiple sclerosis. The treatment looks for something called neurofilament light chain (NfL), a potential biomarker that’s released from damaged neurons.

At the 2019 annual meeting of the American Academy of Neurology (AAN), Multiple Sclerosis News Today sat down with Bernd Kieseier, MD, global head of multiple sclerosis at Biogen, to discuss the company’s portfolio, latest data, and therapeutic development plans in the field of multiple sclerosis (MS). Kieseier said…

Two ongoing clinical trials may help doctors better understand which type of disease-modifying therapy — those considered highly effective or those with low-to-moderate efficacy used in an escalating treatment approach — would be best for people in the early stages of  relapsing-remitting multiple sclerosis (RRMS), according to a  …

Although the use of highly effective disease-modifying treatments (HETs) in patients with relapsing-remitting multiple sclerosis (RRMS) has increased, they still represent a minority among the treatment strategies used, according to a study. The study, “Trends in the use of Highly Effective Disease Modifying Treatments in Multiple Sclerosis…