NeurologyLive® Staff

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Months after announcing positive phase 3 data, AbbVie has 

submitted a supplemental new drug application

 (sNDA) to the FDA to expand atogepant’s (Qulipta) indication to include the preventive treatment of chronic migraine. If approved, the medication would be the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved as a preventive treatment for both episodic and chronic migraine.Results from the PROGRESS trial (NCT03855137), a double-blind, placebo-controlled, parallel-group study assessing 60-mg once daily (QD) and 30-mg twice-daily (BID) doses of atogepant, were the basis for the submission. In that study, those in the 60-mg QD and 30-mg BID arms experienced statistically significant reductions of 6.88 and 7.46 in mean monthly migraine days (MMDs), respectively, compared with patients in the placebo arm, who had a decrease of 5.05 MMDs. Atogepant, 

 as the first and only oral CGRP receptor for the preventive treatment of episodic migraine, continued to show a safe profile in PROGRESS as well. Constipation and nausea were among the most commonly reported (>5%) adverse events (AEs) in the trial.

 showed that semorinemab (AC Immune SA/Genentech), a humanized IgG4 monoclonal antibody, was safe and well-tolerated among patients with prodromal to mild Alzheimer disease (AD), but did not slow the rate of cerebral tau accumulation or clinical decline in a 73-week treatment period.The modified intent-to-treat (mITT) cohort, which included 422 individuals aged 50 to 80 years with prodromal to mild AD, showed similar increases on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) for those on semorinemab at multiple doses. To the study authors’ knowledge, this was the first published phase 2 data of an antitau monoclonal antibody in prodromal to mild AD. Lead investigator Edmond Teng, MD, PhD, senior medical research, Genentech, and colleagues concluded that “nevertheless, while the specific role of tau in AD pathogenesis remains uncertain, it remains a compelling target. Additional studies of monoclonal antitau antibodies that target other tau epitopes and/or different stages of AD will help determine whether this mechanistic approach remains viable or whether other antitau strategies should be prioritized for future clinical drug development.”

 StrivePD software ecosystem, an application that collects data on symptoms of patients with Parkinson disease (PD) using an Apple Watch, with the intention of improving care management and clinical trial design. Patients using the app can track and log their symptoms, thus enabling greater control of their disease. The clearance opens the door for thousands of patients already using the tool to participate in clinical trials that could have significant impacts on future therapeutics. Additionally, the hope is that StrivePD may help locate and facilitate patients with prodromal PD, the stage at which individuals do not fulfill the diagnostic criteria for PD but do exhibit signs and symptoms. As part of an existing partnership with Medtronic, the StrivePD app will be utilized for clinicians interpreting data on patients who use Medtronic’s Percept PC Deep Brain Stimulation (DBS) device, 

. The two companies announced the collaboration in November 2021, which uses Rune’s proprieatary software platform to integrate, analyze, and display data captured from the neurostimulator, along with data from the StrivePD application and other sources.

For more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.

Videos

Neurology News Network for the week ending June 25, 2022. [WATCH TIME: 4 minutes]

AbbVie Submits sNDA for Atogepant in Chronic Migraine, Semorinemab Fails in Phase 2 Prodromal Alzheimer Study, StrivePD Software Gets FDA Greenlight

's Friday 5! Every week, the staff compiles 5 highlights of 

's widespread coverage in neurology, ranging from newsworthy study findings and FDA action to expert interviews and peer-to-peer panel discussions.

1: Multiple Sclerosis DMT Waste Is Staggering, New Study Shows

More than $5.2 million in new, unused DMTs were collected from patients with MS over the course of 1 year—from only 1 neuroimmunologist. Watching the phenomenon first-hand, investigators led by Darin T. Okuda, MD, set out to quantify just how much DMT waste was occurring and why.

2: Achieving Greater Diversity in Dementia Research: A Call to Action

, guest editor-in-chief R. Scott Turner, MD, PhD, writes that achieving greater diversity in study populations is a focus of increasing scrutiny, priority, and funding in all medical research, including studies enrolling individuals on the continuum of prodromal Alzheimer disease, mild cognitive impairment, and Alzheimer disease.

3: NeuroVoices: Ruth Benca, MD, PhD, on the Importance of Maintaining Quality Sleep and Lowering Alzheimer Disease Risk

The professor and chair of Psychiatry & Human Behavior at Wake Forest School of Medicine discussed the major talking points regarding sleep quality, sleep disorders, and late-life neurocognitive issues.

4: Improving Post-Stroke Rehabilitation Through Primseq Digital Tool: Heidi Schambra, MD

The associate professor at the North Carolina Agricultural and Technical State University discussed a newfound initiative that helps encourage more professionals in multiple sclerosis and across the breadth of neurology.

5: The ATMRD Congress and Importance of Accessibility as a Clinician: Jill Farmer, DO, MPH

The director of the Parkinson’s Disease and Movement Disorder Program at Global Neuroscience Institute spoke about her time at the 2022 ATMRD Congress and how successful communication between patients and providers is rooted in accessibility. 

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Articles

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending June 24, 2022.

NeurologyLive® Friday 5 — June 24, 2022

 staff prepares this preview of what to expect from our coverage. This week on 

, there are a number of hot topics that we will be posting on the website. As always, our weekly coverage extends beyond just these topics, so make sure to check out the rest of the site!

Click through the slides below to see what you can expect from our team this week:

This Week on NeurologyLive — June 20, 2022

Here's what is coming soon to NeurologyLive®.

This Week on NeurologyLive® — June 20, 2022

 (NCT03828539), a comparator trial between erenumab (Aimovig; Amgen) and topiramate (Topamax; Janssen), showed that patients with migraine on erenumab performed better on patient reported outcomes, including Headache Impact Test (HIT-6) and Short Form 36 Health Survey Questionnaire, version 2 (SF-36 v2). The study compared adult patients with migraine who were randomized 1:1 to subcutaneous monthly erenumab 70 mg or 140 mg (n = 389), the first FDA approved calcitonin gene-related peptide (CGRP) inhibitor, or topiramate oral daily 50 to 100 mg (n = 388). In total, 72.2% of those on erenumab achieved relevant improvement on HIT-6, as shown by reductions of at least 5 points (

<.001). On SF-36 v2 scores, 47.7% and 25.3% of those in the erenumab group demonstrated at least 5-point improvements on PCS and MCS, respectively, compared with 37.4% and 16.8% of those on topiramate.

Atogepant (Qulipta; AbbVie), an oral, calcitonin gene-related peptide (CGRP) receptor antagonist FDA-approved for the prevention of migraine, was found to be associated with 

, according to new post-hoc data from the phase 3 ADVANCE study. Presented at the 

2022 American Headache Society (AHS) Annual Meeting

, June 9-12, in Denver, Colorado, the results showed a least square (LS) mean percentage change in body weight of +0.37 in the placebo group after 12 weeks compared with +0.14 (

<.0001), in the atogepant 10-, 30-, and 60-mg groups, respectively. Atogepant is a relatively young drug within the field, gaining the FDA greenlight in September 2021 and becoming the second overall member of the gepant class to receive approval.In ADVANCE, 3.2% of those on placebo demonstrated at least 7% weight loss compared with 4.1%, 2.7%, and 5.7% for the atogepant 10-, 30-, and 60-mg groups, respectively. In contrast, weight gains of at least 7% were found in 2.3%, 1.8%, and 0.0% of those in the respective atogepant groups and 2.7% of those on placebo.

After the FDA first extended its review by an additional 3 months, the agency approved Alnylam’s investigational subcutaneous RNA interface therapy vutrisiran, marketed as Amvuttra, for the 

.The RNAi therapeutic administered once every 3 months was approved based on positive 9-month results from the 

 (NCT03759379). Results from the study showed that the treatment met the primary end point of change from baseline in the modified Neuropathy Impairment Score (mNIS+7) at 9 months (

<.001). Additionally, vutrisiran achieved statistically significant results (

<.001) on secondary measures such as the Norfolk Quality of Life Questionnaire–Diabetic Neuropathy (Norfolk QoL-DN) and timed 10-meter walk test (10-MWT) as compared with historical placebo results. HELIOS-A was a global, open-label, multicenter study that evaluated 164 patients with hATTR amyloidosis who were randomized 3:1 to either 25 mg of vutrisiran (n = 122) or 0.3 mg/kg of patrisiran (Onpratto; Alnylam) (n = 42) via intravenous infusion once every 3 weeks for 18 months.

Neurology News Network for the week ending June 18, 2022. [WATCH TIME: 3 minutes]

Erenumab Outperforms Topiramate in PROs, Atogepant Dose-Dependent With Weight Changes, Vutrisiran FDA-Approved for ATTR Amyloidosis

1: The Aducanumab Saga and the Future of Antiamyloid Monoclonal Antibodies

David S. Knopman, MD, writes on the journey of aducanumab (Aduhelm; Biogen) from development to the FDA—a tortured one. But, its path may serve to teach the Alzheimer disease field valuable lessons as it strives forward to develop disease-modifying therapies.

2: Mind Moments™ Episode 66: 2022 SLEEP Annual Meeting Highlights

, brings you exclusive interviews with experts in the treatment and management of sleep disorders as a recap of the 2022 SLEEP Annual Meeting.

3: NeuroVoices: Tanuja Chitnis, MD, on Targeting Anti-CD3, Other Biomarkers in Progressive Multiple Sclerosis

The associate neurologist at Brigham and Women’s Hospital discussed the potential of a nasal anti-CD3 monoclonal antibody, foralumab, and its impact on biomarkers specific to patients with progressive multiple sclerosis.

4: Exposing Young Professionals to Multiple Sclerosis Care, Interdisciplinary Teams: Stephanie Teixiera-Poit, PhD

5: New Treatments in Migraine: An In-Depth Review

, write that although new treatments and innovations are a sign of growth in migraine care, it is important to realize that growth comes with a certain amount of pain. In clinical practice, choosing the right treatment option for patients in a time-limited visit is often a dilemma.

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending June 17, 2022.

NeurologyLive® Friday 5 — June 17, 2022

This Week on NeurologyLive — June 13, 2022

This Week on NeurologyLive® — June 13, 2022

 (NCT03689972) showed no significant or clinically meaningful differences in patient-reported outcomes (PRO) or Clinical Global Impression (CGI) rating scores among those with relapsing-remitting multiple sclerosis (MS) treated with natalizumab 300 mg (Tysabri; Biogen) every 4 weeks (Q4W)—the approved regimen—or every 6 weeks. The randomized, controlled, open-label, rater-blinded study looked at several PROs, including the Treatment Satisfaction Questionnaire for Medication (TSMQ), Neurology Quality of Life (NQoL) fatigue questionnaire, Multiple Sclerosis Impact Scale (MSIS-29), and EuroQol 5 Dimensions (EQ-5D-5L) index score.Between the Q6W (n = 247) and Q4W (n = 242) dosing groups, there were no significant differences in least-squares mean change from baseline to week 72 in PROs. Similarly, the odds ratios (ORs) for CGI scores, specifically patient GCI-improvement physician GCI-improvement, and physician CGI-severity, were not meaningfully different between the dosing regimens.

2022 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting

, June 1-4, in National Harbor, Maryland, identified several different factors for patients with multiple sclerosis (MS) and clinicians that 

drive the perception of self-reported cognitive impairment

.In this study, patients with MS took a computerized multidomain cognitive screening battery and reported on several factors, including fatigue, as assessed by Modified Fatigue Impact Scale, depression, assessed using the Beck Depression Inventory-II, and quality of life, using a Likert scale. Physical disability was assessed by the patient’s clinician using the Expanded Disability Status Scale (EDSS), while perceived cognitive deficits among both groups were self-reported using Likert scale. Using hierarchical regression analyses in the cohort of 202 patients with MS, data reported that fatigue (

<.05) scores significantly predicted patient-perceived cognitive deficits, but not depression (

= .213). Clinician-perceived cognitive deficits differed from those with MS, mainly by cognitive scores (

<.05), and self-reported quality of life (

<.05); however, fatigue was not among the significant factors for these deficits.

One-year interim data from a phase 2 study of patients with progressive multiple sclerosis (MS) showed that treatment with 

 (Mapi Pharma), an intramuscularly administered formulation of the approved treatment given every 4 weeks, was safe and effective based on the low rate of adverse events (AEs) and stable Expanded Disability Status Scale (EDSS) scores. The interim data included patients with progressive MS, aged 18 to 65 years with rapid disease progression, demonstrated by at least a 1 point increase per year on EDSS in the year prior to screening. At 1 year, treatment with glatiramer acetate depot was shown to be safe, with 88% of the AEs recorded mild in nature. Injection site reactions and asthenia made up the majority of AEs, with no unexpected AEs reported. Two serious AEs, one related and one unrelated to the study drug, were also reported.

Neurology News Network for the week ending June 11, 2022. [WATCH TIME: 3 minutes]

6-Week Natalizumab Dosing Efficacious, MS Cognitive Perceptions, Glatiramer Acetate Depot Shines in Progressive MS

1: State of Stem Cell Transplantation for Multiple Sclerosis

Jeffrey Cohen, MD, shared his perspective on the current use and study of stem cells for the treatment of multiple sclerosis, which he covered in the CMSC Presidential Lecture at the 2022 annual meeting.

2: Mind Moments™ Special Episode: Aducanumab and Anti-Amyloid-ß, One Year Later

, brings you a special episode recap of aducanumab's journey from discovery to present, ahead of the June 2022 issue's in-depth cover story on the topic.

3: NeuroVoices: Jens Kuhle, MD, on Evobrutinib’s Association With Neurofilament Light Levels

The head of the MS Center at the University of Basel discussed an analysis presented at Consortium of MS Center’s Annual Meeting, focusing on the effects of BTK inhibitor evobrutinib on neurofilament light levels.

4: Peer Exchange: Multidisciplinary Management of OFF Episodes in PD

 Peer Exchange, "Considerations for the Maintenance of ON Time in Parkinson Disease," experts in movement disorders share the importance of multidisciplinary team collaboration for the management of OFF episodes and shared-decision making for treating Parkinson disease.

5: Lingering Challenges With Assessing, Treating Sleep Problems in Alzheimer Disease: Ruth Benca, MD, PhD

The professor and chair of Psychiatry & Human Behavior at Wake Forest School of Medicine discussed the need for improved tools to evaluate and treat sleep disorders in patients with Alzheimer disease.

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending June 10, 2022.

NeurologyLive® Friday 5 — June 10, 2022

This Week on NeurologyLive — June 6, 2022

This Week on NeurologyLive® — June 6, 2022

1: Inaugural Class of Giants of Multiple Sclerosis Announced

The first annual awards ceremony for the Giants of Multiple Sclerosis was held during the Consortium of Multiple Sclerosis Centers Annual Meeting in National Harbor, Maryland, with winners announced in 9 categories plus 2 additional awards.

2: Pilot Study Highlights Outcome Preferences for Adolescents With Chronic Migraine, Their Parents

More than 60% of adolescents felt that it was more important to measure decreases in the frequency and intensity of headaches in terms of severe headaches/spikes rather than total headache days.

3: NeuroVoices: Michael Sughrue, MD, on Using Machine Learning to Build a Better Brain Map

The founder and chief medical officer of Omniscient Neurotechnology discussed how the use of machine learning and big data will be critical in revolutionizing our understanding of the brain and mental illnesses.

4: Raising Awareness for World MS Day, Challenges of Multiple Sclerosis

Emily Harrington, MD, PhD, a physician-scientist at The Ohio State University Wexner Medical Center, provided thoughts on the importance of World MS Day and the issues that plague the MS community.

5: FDA Approves Risdiplam to Treat Presymptomatic Babies Under 2 Months With SMA

Data from the RAINBOWFISH study and a large-scale extension, FIREFISH, were the basis for the expanded indication for risdiplam (Evrysdi; Genentech), which now includes babies with SMA under 2 months old.

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending June 3, 2022.