September 17, 2019 News by Ana Pena PhD #ECTRIMS2019 – Early Ocrevus Use Slows Disability in PPMS, Including Risk of Wheelchair Reliance Early and continuous treatment with Ocrevus (ocrelizumab) leads to a greater and more durable slowing of disability progression ā seen for up to 6.5 years ā in people with primary progressive multiple sclerosis (PPMS), according to long-term data on its use in PPMS patients in a Phase 3…
September 12, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – No Retinal Thinning with Ocrevus in Relapsing MS Patients, Phase 3 Trials Show Treating relapsing multiple sclerosis (MS) patients with Ocrevus (ocrelizumab) is not associated with retinal thinning ā unlike treatment with Rebif (interferon beta-1a), according to two Phase 3 trials. The findings also showed a link between retinal thinning and brain volume loss. The study, ā…
September 12, 2019 News by Patricia Inacio, PhD #ECTRIMS2019 – 6 Years of Ocrevus Use Tied to Low Rates of Serious Infections Treatment for more than six years with OcrevusĀ (ocrelizumab) is linked to lower levels of blood antibodies among people withĀ primary progressive multiple sclerosis (PPMS) and relapsing MS, but rates of serious infections also remain low, an analysis of data from three Phase 3 trials show. Dropping below a certain…
August 23, 2019 News by Ana Pena PhD Rituximab Leads to ‘Dramatic’ Recovery in Boy with Aggressive RRMS, Case Study Reports Treatment with rituximabĀ ā sold as RituxanĀ in the U.S. by RocheĀ and Biogen, and asĀ MabThera byĀ Roche in Europe ā reversed disease course in a “dramatic fashion,” leading to complete remission in a 12-year-old boy with aggressiveĀ relapse-remitting multiple sclerosis (RRMS), a case report states. The report, “…
August 21, 2019 Columns by Stephanie Towler The Clinical Trial I Participated in Was a Positive Experience I knew nothing about multiple sclerosis (MS) before 2012, including the cause, the cure, or any other details. I had so many unanswered questions about how I would live with MS when I was diagnosed. I had never heard of treatment for MS and was unsure of the…
August 21, 2019 News by Ana Pena PhD Gilenya, Aubagio, Tysabri, Tecfidera Dominate MS Therapy Switches in Europe, Spherix Survey Finds Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘sĀ Aubagio (teriflunomide), andĀ BiogenāsĀ TysabriĀ (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…
August 7, 2019 News by Patricia Inacio, PhD 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…
August 2, 2019 Columns by John Connor Hell Week: Record Heat Teams Up with a Sneaky Infection Last Thursday was the hottest day ever recorded in U.K. history at 101.6 degrees F.Ā Heat sensitivity is enough to reduce me to the puddle I described last week. But it doesn’t explain the shaking of my body and the extreme pain in my right arm Thursday night. Not…
August 2, 2019 Columns by Ed Tobias Using the Floodlight App to Track My MS Over the past several weeks, I’ve been using an app called Floodlight to track my ability to live with my multiple sclerosis (MS). It measures things such as my balance, finger dexterity, walking speed, and cognitive ability. It even knows if I’m keeping myself shuttered in my apartment or…
June 27, 2019 Columns by Laura Kolaczkowski Could Shortened Infusion Times for Ocrevus Become a Reality? 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…
June 24, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Plant Medication Trial, B-cell Depletion Study, MS App Award, DMTs’ Cancer Risk 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. CyxoneĀ launched the first-in-human Phase…
June 7, 2019 Columns by Ed Tobias 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.
June 5, 2019 Columns by Stephanie Towler I Am a Millennial with Multiple Sclerosis I remember the day like it was yesterday: Sept. 20, 2012. I was fortunate to receive a swift diagnosis ā following a couple of tests, my neurologist told me that I have multiple sclerosis (MS). At the time I thought, “Well, let the journey begin.” My name is Stephanie…
June 3, 2019 News by Joana Carvalho, PhD Mavenclad May Surpass Gilenya as DMT of Choice for Treatment of MS in Canada 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…
May 20, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: MS Biomarker, Best RRMS Early Treatment, Ocrevus Study, Out-of-Pocket Costs #AANAM ā 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.
May 14, 2019 News by Jose Marques Lopes, PhD #AANAM ā Use of Highly Effective Treatments for RRMS Increasing but Still Limited, Study Says 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, āTrends in the use of Highly Effective Disease Modifying Treatments in Multiple Sclerosis…
May 14, 2019 News by Jose Marques Lopes, PhD #AANAM ā Ocrevus Lowers Markers of Inflammation, Damage in Relapsing MS Patients, Phase 3 Trial Shows Treatment with Ocrevus (ocrelizumab) decreases the levels of neurofilament light chain (NfL) and immune B-cells in the serum and central nervous system of patients with relapsing multiple sclerosis (MS), according to results from a Phase 3 trial. The research, āOcrelizumab treatment reduced levels of neurofilament light chain and…
May 13, 2019 News by Joana Carvalho, PhD Ocrevus Approved in UK as First NHS Treatment for PPMS After firstĀ rejecting it due to cost-effectiveness concerns, the National Institute for Health and Care Excellence (NICE) has now approved the use of Ocrevus (ocrelizumab) for people in the U.K. with early, inflammatory primary progressive multiple sclerosis (PPMS). This means that PPMS patients living in the…
May 13, 2019 News by Marisa Wexler, MS #AANAM – Ocrevus Effective in RRMS Patients with Poor Responses to Other DMTs, Early Trial Data Suggest Early, one-year data from theĀ Phase 3 CHORDS study show that OcrevusĀ effectively prevents relapses and disease progression inĀ relapsing-remitting multiple sclerosis (RRMS) patients who have had poor responses to other disease-modifying therapies. These interim results were presented at the 2019 annual meeting of the American Academy of NeurologyĀ (AAN) in…
May 9, 2019 News by Jose Marques Lopes, PhD #AANAM – Greater Exposure to Ocrevus Means Less Risk of Disability Progression in MS Patients, Study Contends Higher exposure to Ocrevus (ocrelizumab) is associated with greater immune B-cell depletion in the blood, and lessened risk of disability progression in patients with relapsing multiple sclerosis (MS) and primary progressive disease (PPMS), according to new research. The study supporting that finding, āPharmacokinetics, Pharmacodynamics and…
April 18, 2019 Columns by Jennifer (Jenn) Powell The DMT Decision: Tried and True or Shiny and New? I spend a great deal of time in my head. I think. A lot. Perhaps I do so more than I should, but then again, it is a haven at times. My thoughts run the gamut from the serious to the inane. Today my thoughts…
April 15, 2019 News by Jose Marques Lopes, PhD Anne Cross, Neurologist with Pioneering Work into B-cells and MS, Awarded John Dystel Prize This year’sĀ John Dystel Prize for Multiple Sclerosis ResearchĀ is being awarded toĀ Anne H. Cross, a neurologist and MS chair in the department of neuroimmunology atĀ Washington University School of Medicine in St. Louis, for herĀ research into the role of immune B-cells in multiple sclerosisĀ attacks and new imaging…
April 3, 2019 News by Marisa Wexler, MS Cleveland Clinic Neurologist Applauds Mayzent’s FDA Approval, But Surprised by Those It May Not Treat When theĀ U.S. Food and Drug Administration approvedĀ the disease-modifying therapy Mayzent forĀ relapsing types of multiple sclerosis, itĀ specified in its label that the treatment was for people withĀ clinically isolated syndrome, relapsing-remitting MS, and ā importantly āĀ secondary progressive MSĀ provided they have "active" disease. The approval is good news, an MS researcher and physician saidĀ toĀ Multiple Sclerosis News TodayĀ in an interview, but "surprising" in that the FDA's decision was largely based on a trial that didn't involve CIS patients and wasn't focused on responses among particular types of SPMS. āIt's the first time that I've seen in the MSĀ field that regulatorsĀ made an approval designation ā activeĀ secondary progressive MS ā based on an underpowered subgroupĀ analysis,ā saidĀ Robert Fox, MD, a neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic. Novartis'Ā medication, as a first oral therapy approved in the U.S. forĀ a form ofĀ SPMS,Ā is a big step forward in MS treatment, he said. But details of the FDA's decisionĀ caughtĀ him off guard. Fox served on the steering committee for the EXPAND Phase 3 clinical trial ,Ā on which the FDA decision was largely based.Ā His clinic was also one of the sites treating and evaluating patients in this pivotal study. Results of the EXPAND trial showed thatĀ Mayzent could reduce the risk of disability progression at three months (the trialās primary endpoint, or goal) by 21% in treatedĀ SPMS patients, compared to those given aĀ placebo. Among those with active SPMS (meaning with relapses), a 33% reduction was observed. The treatment, an S1P modulator that works in part to keep lymphocytes from entering the brain to trigger inflammation,Ā alsoĀ decreased the annualized relapse rate by 55% and improved cognitive processing speed in all treated patients.Ā āWhat was found, and I think quite clearly found in a large-size study, was that siponimod in patients with secondary progressive MS clearly slowed the progression of clinical disability over the course of the trial,ā Fox said. āIt's a statistical concept ā obviously patients either progress or they don't progress ā but on an overall basis there was a 21% slowing in the rate of progression of clinical disability.ā The FDAās decision is particularly important for SPMS patients. While Ocrevus (ocrelizumab) alsoĀ treats all relapsing MS forms and people with primary progressive disease (PPMS), it's an intravenous therapy given every six months. Mavenclad (cladribine), approved for relapsing patients in the U.S. just days after Mayzent, is another oral and active disease therapy. To Fox, Mayzent seemed to reach beyond only those secondary progressive patients with clinically active disease. āReally, this is the only drug that's been found to be effective in secondary progressive MS," he said. āTo that degree, it stands alone.ā That's why two points in the FDA's decisionĀ surprised him. The firstĀ is the label's specific mention of clinically isolated syndrome. CISĀ is defined asĀ theĀ first clinical presentationĀ of this diseaseĀ ā aĀ neurological episode that lasts at least 24 hours, and is characterized by inflammatory demyelination (the loss of myelin, the protective coat surrounding neurons). Ā For clinicians like Fox, CIS is a first manifestation of MS ā a kind of "mono sclerosis."Ā Since thereās only one documented attack, it canāt yet be considered multiple sclerosis, āas the multiple hasn't happened,ā Fox said, but many "in the field consider CIS to be ā¦ an early stage of MS." āIf the patient has a whole bunch of lesions on their brain [as seen on an MRI scan] and they had a single clinical event, ah, probably, they have MS,ā he said. Regulatory bodies like the FDA,Ā however,Ā have historically considered CIS to be its own separate entity. That makes this decision doubly surprising, according to Fox, since the EXPAND trial only enrolled patients with SPMS, not CIS. Ā āIt's the first time I've seen them approve for CIS specifically when there wasn't a trial in CIS,āĀ Fox said. āI agree with it ā I don't have a problem with it ā it just surprised me that the regulators were so progressive in their appreciation of MS.ā The second ā and far more unsettling ā surpriseĀ wasĀ the FDAās decision toĀ only approve Mayzent for āactiveā SPMS patients, instead of all SPMS patients. This decision didnāt come out of nowhere, he noted, but it remains puzzling in the context of the EXPAND trial.Ā InĀ compiling trial results, investigators did a subgroup analysis ā as they often do, almost as an aside for research reasons ā and found more favorableĀ responses to Mayzent treatmentĀ in patients with active inflammation beforeĀ the trial's start, those it determined to be with "active" disease. Ā āThere was a third of patients who had a relapse in the two years prior to enrollment, and those patients actually had a 30% slowing in disability progression, compared to the 21% overall,ā Fox said. This certainly does suggest that Mayzent can be more effective in people with active disease ā but there's a catch. The trial itself was not designed to make such a distinction. It enrolled SPMS patients regardless of activity, and its priority goal was changes in disease progression across all who were treated with Mayzent or given a placebo. Ā āWhat's important is that the trial was powered for the overall outcome. It was not powered for subgroup analysis,ā Fox said,Ā considering this a crucial point.Ā In clinical studies, being āpoweredā refers to theĀ enrollingĀ of whatever specific number of participants a study needs to ensureĀ itsĀ results will reach statistical significance. More people are redundant and, as such, an unnecessary cost; fewer could mean that trial's conclusions cannot be supported by rigorous scientific measures.Ā In other words, Fox said, the only conclusions that can be drawn from the EXPAND study reliably ā with rigor ā are based on data drawn from all its SPMSĀ patients, not aĀ subgroup with active disease. This trial āfollowed over 1,600 patients for the clinicalĀ disability. These are purposely powered so that you're not following twice as many people as you need toĀ ā¦ you're powered for that primary outcome,ā he said. āSo, how could they [the FDA] look at a subgroupĀ analysis and make an approval decision based on a subgroupĀ analysis that was underpowered?ā The neurologist gave as examplesĀ other subgroup differences found in trial analyses that didn't affect regulatory approval ā but to his mind, equally could have.Ā One was an analysis findingĀ female SPMS patients respondedĀ to the therapy better than males,Ā showing lesser disease progression. "So why didn't they just approve it for the females and not the males?" Fox asked. But, when asked, Fox did not think the labelĀ toĀ necessarily be an error. "My point is the absurdity of it," he said. "How could they make the regulatory approval based on a subgroupĀ analysis that wasn't powered for conclusions?" He was also particularly troubled becauseĀ the FDAĀ ādidn't define what āactiveā means āĀ is it just a relapse, or is it MRI disease activity?"Ā For many clinicians, āactiveā SPMS refers to ongoing inflammation that can be observed on MRI (magnetic resonance imaging) scans. In EXPAND, however, the active subgroup was defined as patients with clinical relapses within two years of being enrolled in the trial. Fox worries about this apparent lack of a regulatory definition of "active" SPMS, since āobviously, the insurance companies are going to seize upon that, and they're going to look for every way they can to avoid covering it for patients.ā Mayzent, Fox agreed,Ā is likely to be expensive. The therapy is reported to carry a U.S. list price ofĀ $88,500 a year. āI always have a concern about the cost of these drugs. They're all fearfully expensive,ā he said, noting he treats SPMS patients. His focus now is on working to ensure that possible regulatory and financial hurdles wonāt pose too much of an obstacle for patients, especially those with SPMS. āI don't know what the insurance companies are going to do with this, but I'm hoping that it is available for my patients, and I say that as their clinician,ā Fox concluded.
March 28, 2019 News by Larry Luxner MS Patient Groups React Favorably to Mayzent Approval, But Question Therapyās Price Tag National organizations that represent patients with multiple sclerosisĀ (MS) welcome the U.S. Food and Drug Administration’s March 26 approvalĀ of Novartis’Ā oral therapy MayzentĀ (siponimod) ā but they complain that, at $88,500 per year, the treatment is overpriced. The Multiple Sclerosis Society of AmericaĀ (MSSA) is clearly upbeat about the…
March 21, 2019 News by Jose Marques Lopes, PhD Roche and pan-Canadian Pharmaceutical Alliance Finalize Ocrevus Negotiations for RRMS and Early PPMS Roche Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) have completed negotiations ultimately aiming to obtain public funding for Ocrevus (ocrelizumab) as a first-line treatment for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, and as management strategy for patients with early primary progressive MS…
March 20, 2019 News by Jose Marques Lopes, PhD SPMS Treatment With Mayzent Better Than Best Supportive Care, ICER Report Says Treatment of secondary progressive multiple sclerosis (SPMS) patients with the investigational oral therapy Mayzent (siponimod) significantly reduced the risk of disability progression and decreased inflammation, compared to best supportive care, according to aĀ preliminary draft evidence reportĀ from the Institute for Clinical and Economic Review (ICER). The report…
March 19, 2019 Columns by Ed Tobias DMT Choice for Your MS Is Your Decision About 15 disease-modifying therapies (DMTs) are available to treat MS these days. So, choosing which to use can be daunting. I’ve been treated with four DMTs since I was first prescribed Avonex (interferon beta-1a) back in 1996. Each time I’ve switched treatments, my neurologist has suggested a number of…
March 18, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Non-contrast MRIs, Stem Cell Study Seeks Subjects, Postpartum Relapses, Which DMT? Non-contrast MRI Effective in Monitoring Progression of MS, Study Shows There’s been increased interest in the risks versus the benefits of using gadolinium to make lesions more visible on an MRI. The U.S. Food and Drug Administration issued an advisory last year raising the level of…
March 5, 2019 Columns by Ed Tobias Two Different Approaches to Providing Online MS Help I received an email recently from the National Multiple Sclerosis Society in the U.S. promoting a searchable database of “credible doctors and resources.” A few days later, I happened to run across another online multiple sclerosis (MS) information service hosted by the HealthCare Journey website. They call it…
March 1, 2019 News by Jonathan Grinstein #ACTRIMS2019 ā Use of Ocrevus at Cleveland Clinic Backs Phase 3 Trial Data Ocrevus (ocrelizumab) was shown to be aĀ highly effective therapy for people with multiple sclerosis (MS) in real-world clinical practice, according to Brandon Moss, MD, from theĀ Cleveland Clinic. The data was presented in a poster session Feb. 28, atĀ the Americas Committee…