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The chief executive officer and founder at CureDuchenne discussed efforts to bring specialized physical therapy and infrastructure support to underserved regions to improve care for patients impacted by Duchenne worldwide. [WATCH TIME: 5 minutes]

Helping to Expand Global Care for the Duchenne Muscular Dystrophy Patient Community: Debra Miller

Neurology News Network. for the week ending September 7, 2024. [WATCH TIME: 4 minutes]

Tolebrutinib Shows Promise in Non-Relapsing Secondary Progressive MS, Fenebrutinib Suppresses Relapses in New Data, FDA Accepts Resubmitted NDA for AXS-07

Articles

Take 5 minutes to catch up on NeurologyLive®'s highlights from the week ending September 6, 2024. 

NeurologyLive® Friday 5 — September 6, 2024

Treatment with DYNE-251 revealed dose dependent exon skipping and dystrophin expression as well as improvement in multiple functional end points in both cohorts of the phase 1/2 DELIVER trial.

DYNE-251 Increases Dystrophin Level Expression in Phase 1/2 DELIVER Trial of Duchenne

, has been with the team since October 2019. Follow him on Twitter 

Tanya, a patient who lost her mobility due to undiagnosed spinal issues, discussed her life-saving surgery for spinal meningioma, and the complex surgical process she underwent to regain her strength.

Treating Rare Cases of Spinal Meningioma Using Complex Surgical Tactics

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Imad Najm, MD, PhD. [LISTEN TIME: 22 minutes]

Episode 123: Previewing Cleveland Clinic's Epilepsy Summit

The director of Cleveland Clinic’s Epilepsy Center at the Cleveland Clinic Neurological Institute provided commentary on the future outlook of gene therapies for patients with epilepsy, and some of the knowledge and technical barriers clinicians currently face. [WATCH TIME: 5 minutes]

Promise and Potential Challenges With Gene Therapy in Epilepsy: Imad Najm, MD

The director of neurology and neuromuscular medicine at the Children’s Hospital of the King’s Daughters in Norfolk, Virginia, provided clinical perspective on some of the improvements in the everyday life and care of patients with spinal muscular atrophy.

NeuroVoices: Crystal Proud, MD, on SMA Awareness Month, Advances in Research and Treatments

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Clinical

® Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) clinical focus page is a concentrated place for the latest information on the care and management of patients with CIDP. This page includes podcasts, videos and expert interviews, and news about the latest study and clinical trial findings, FDA actions, and clinical guideline updates.

In a recent analysis, patients with chronic inflammatory demyelinating polyneuropathy who started their initial treatment later experienced a worsening of the disease course.

Early Diagnosis and Treatment Monitoring Key to Preventing Long-Term Disability in CIDP

Findings suggest that autoimmune diseases including neuromyelitis optica spectrum disorder and myasthenia gravis may also benefit from BCMA-CD19 bispecific CAR-T therapy. 

Case Study Shows Efficacy of BCMA-CD19 Bispecific CAR-T Therapy in Refractory CIDP

MoMeNtum will evaluate the efficacy and safety of DNTH103, administered subcutaneously every two weeks over a 17-week period, followed by a 52-week open-label extension to collect additional safety and efficacy data.

FDA Clears Phase 2 MoMeNtum Trial of DNTH103 in Multifocal Motor Neuropathy

Across all studies, including 2 of the largest recorded for CIDP, patients unanimously demonstrated a preference for SCIG over IVIG.

Subcutaneous Immunoglobulin Shows Superiority Over IVIG in Treating CIDP, Meta-Analysis Shows

Patients with CIDP treated with riliprubart reported improved quality-of-life and fatigue measures, as well as reduced neurofilament light levels.

Riliprubart Continues to Show Pronounced Impacts on CIDP at 1 Year

Top stories in neurology, neurological disorders

Neurology News Network

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

 (CRL) to AbbVie's new drug application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson disease (PD). In the CRL, the agency cited observations identified during inspection of a third-party manufacturer listed in the NDA. The inspection at the facility did not involve ABBV-951 or any of the company's medicine. The CRL did not identify any issues in terms of safety, efficacy, or labeling of ABBV-951, including the device. Furthermore, the letter did not request that the company perform additional efficacy and safety studies related to the drug or device-related testing.

Months after being granted priority review designation by the FDA, the agency has 

 pitolisant (Wakix), a selective histamine H3 receptor inverse agonist, for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 years and older with narcolepsy.1 In addition, the agency issued pitolisant a complete response for the treatment of cataplexy in pediatric patients with narcolepsy. Pitolisant's supplemental new drug application was supported by findings from a 

(NCT02611687), which demonstrated significant reductions in EDS and cataplexy in pediatric patients aged 6 to 17 years with narcolepsy treated with 5 mg to 40 mg a day of the therapy. These findings suggested that pitolisant is a safe and effective treatment for children and adolescents with narcolepsy.

 efgartigimod alfa and hiya-luronidase-qvfc (Vyvgart Hytrulo) as a new treatment for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The therapy is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP, and will be available as a once-weekly, 30- to 90-second subcutaneous injection. The therapy was approved based on data from the 

 (NCT04281472) in which treatment with the agent significantly reduced relapse risk compared with placebo. All told, patients treated with Vyvgart Hytrulo had a 61% attenuated risk relative to placebo (

= .00039), with a safety profile that was consistent with previous studies.

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

Neurology News Network. for the week ending June 29, 2024. [WATCH TIME: 3 minutes]

ABBV-951 Gets Another CRL, Pitolisant Approved for Pediatric Narcolepsy, FDA Clears Efgartigimod for CIDP

Richard Lewis, MD, of Cedars-Sinai Medical Center talked about on potential therapies that expand management care options in neuromuscular disease.

A Clinical Preview of 2024 for Neuromuscular Disease: Richard Lewis, MD

“Gene therapy is a promising avenue for various disorders, particularly genetic diseases, where its potential is evident. However, its excitement for immune and inflammatory disorders remains uncertain. The sheer abundance of genetic diseases makes it challenging to predict when specific conditions will benefit from gene therapy. Despite this uncertainty, there is considerable enthusiasm in the scientific community about the potential of gene therapy, and that's truly exciting."

In 2024, those in neuromuscular medicine are anticipating new research updates and pending approvals on potential therapies for certain disorders, including amyotrophic lateral sclerosis, myasthenia gravis, Duchenne muscular dystrophy, chronic inflammatory demyelinating polyneuropathy (CIDP), and others.  Neuromuscular diseases, like CIDP, have experienced challenges in the clinical setting with the diagnosis of subtypes of the diseases and prescribing the most effective therapies for patients that improve outcomes.

CIDP is characterized as progressive weakness and reduction in senses of the arms and legs caused by damage to the fat-based protective covering on nerves.

 Over the recent years, the neuromuscular community has made significant strides to understand the complexities of CIDP, with a greater focus on novel approaches for diagnosis, treatment, and management.

Investigators are continuing their pursuit in 2024 to understand more of the determinants, interactions, and the biological mechanisms of CIDP to discover innovative and improved management strategies. In a recent literature review published in 

, researchers established that the destruction of peripheral nerves and nerve roots typifies CIDP and is an autoimmune disease that influences the myelinating constructions of peripheral nervous system. Although several treatments for CIDP show promising results, researchers recommend that treatment decisions be personalized for each patient’s needs.

, director of the electromyography laboratory and professor of neurology at Cedars-Sinai Medical Center, sat down in an interview with 

 to share his clinical perspective on potential therapies in neuromuscular disease, specifically for patients with CIPD, for 2024. In the conversation, he talked about how neonatal Fc receptor inhibitors and complement inhibition might potentially show promise in CIDP treatment, and some of the challenges they could pose. While gene therapy holds promise for genetic diseases, he also discussed what uncertainties surround its potential effectiveness for immune and inflammatory disorders. Additionally, Lewis talked about how clinicians and patients can navigate the complexity of choices and make informed decisions with the plethora of treatment options available for CIDP.

REFERENCES
1. Patrick MM, Bielling R, Postma G, Trokthi B, Maitland CG. Chronic Inflammatory Demyelinating Polyneuropathy With Reversible Severe Cognitive Impairment and Gastrointestinal Dysfunction. 

. 2023;15(11):e49341. Published 2023 Nov 24. doi:10.7759/cureus.49341
2. Tsoumanis P, Kitsouli A, Stefanou C, et al. Chronic Inflammatory Demyelinating Polyneuropathy and Evaluation of the Visual Evoked Potentials: A Review of the Literature. 

. 2023;59(12):2160. Published 2023 Dec 13. doi:10.3390/medicina59122160

The professor of neurology at Cedars-Sinai Medical Center shared his thoughts on potential therapies that expand management care options for patients with neuromuscular disease, in particularly for chronic inflammatory demyelinating polyneuropathy. [WATCH TIME: 4 minutes] 

Richard Lewis, MD, of Cedars-Sinai Medical Center, shared his clinical perspective on the recent FDA approval of Takeda’s Hyqvia for CIDP.

The Future of Chronic Inflammatory Demyelinating Polyneuropathy Treatment With the FDA Approval of Hyqvia: Richard Lewis, MD

"The announcement that Hyqvia has been approved for CIDP is another piece of ammunition in our ability to treat the patients with this disorder. The advantage of Hyqvia is that you can get a fairly large volume of immunoglobulin in without needing an intravenous, eliminating concerns about venous access. I'm excited that we have this option!"

Patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disorder, typically experience progressive weakness and have a reduction in senses of the arms and legs caused by damage to the fat-based protective covering on nerves. According to the National Institute of Neurological Disorders and Stroke, other symptoms of CIDP include fatigue or feeling tired and unusual feelings in the body.

 Therapies for patients with CIDP may include prescribing steroid medicine and other immune system focused treatments, along with physical therapy.

FDA approved immune globulin (IG) infusion

 10% (human) with recombinant human hyaluronidase (Hyqvia; Takeda Pharmaceuticals), as a maintenance therapy for adults with CIDP.

 The approval was based on the randomized, double-blinded, placebo-controlled ADVANCE-CIDP 1 trial (NCT02549170) and the single-arm, open-label, extension ADVANCE-CIDP 3 study (NCT02955355) that assessed Hyqvia in adults with CIDP. The analysis of the primary end point among 122 patients with CIDP from ADVANCE-CIDP 1 showed a statistical difference between the relapse rates in the Hyqvia group (n = 57; 14.0%) compared with the placebo group (n = 65; 32.3%), which was considered significant (

 to share his reaction. He discussed how the approval marks a significant advancement in the field, especially since it is only FDA-approved combination of IG and hyaluronidase. He also talked about advantages Hyqvia offers over traditional intravenous immunoglobulin treatments for patients with CIDP. Lewis, also a consultant for Takeda, spoke about how the potential shift to a 20% solution might impact the future of CIDP therapy and patient convenience.

REFERENCES
1. National Institute of Neurological Disorders and Stroke. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Accessed January 19, 2024. https://www.ninds.nih.gov/health-information/disorders/chronic-inflammatory-demyelinating-polyneuropathy-cidp
2. U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). News Release. Takeda. Published January 16, 2024. Accessed January 19, 2024. https://www.takeda.com/en-us/newsroom/news-releases/2024/us-fda-approves-takedas-hyqvia-as-maintenance-therapy-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp
3. Takeda presents full data set from phase 3 ADVANCE-CIDP 1 clinical trial investigating Hyqvia as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy at PNS Annual Meeting. News release. June 20, 2023. Accessed January 19, 2024. https://www.takeda.com/en-us/newsroom/news-releases/2023/takeda-presents-full-data-set-from-phase-3-ADVANCE-CIDP-1-clinical-trial-investigating-HYQVIA%C2%AE-as-a-maintenance-therapy-for-chronic-inflammatory-demyelinating-polyneuropathy-CIDP-at-PNS-annual-meeting/

The professor of neurology at Cedars-Sinai Medical Center shared his clinical perspective on the recent FDA approval of Takeda’s immune globulin infusion, Hyqvia, for chronic inflammatory demyelinating polyneuropathy. [WATCH TIME: 5 minutes] 

Expert neurologist Richard Lewis, MD, shares his personal clinical pearls on diagnosing CIDP.

Clinical Pearls for HCPs Diagnosing CIDP

This is a video synopsis/summary of a panel discussion involving Richard Lewis, MD.

The speaker discusses the importance of reaching a definitive diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy) and highlights the guidelines as a crucial tool for clinicians in achieving this goal. While acknowledging the complexity of the guidelines and the challenge of memorizing all aspects, the speaker expresses hope for future web-based or app-based tools to aid clinicians in utilizing the guidelines effectively.

The talk emphasizes the significance of monitoring grip strength, with a notable improvement of 10 to 15 pounds within 3 months considered a positive outcome. The speaker mentions clinical measures that define a clinically significant improvement, but also underscores the value of any improvement within the initial 3-month period as encouraging. This improvement, even if not meeting the clinically significant threshold, is seen as a positive sign, potentially warranting continuation of the current approach for an additional three months.

Overall, the transcript emphasizes the practical application of guidelines in diagnosis, the importance of technological support for clinicians, and the encouraging nature of even modest improvements in grip strength within a defined timeframe.

Video synopsis is AI-generated and reviewed by NeurologyLive editorial staff.

Dr Lewis describes the various investigational therapies that are underway with the potential to change the current treatment landscape of CIDP.

Emerging Agents for Treatment of CIDP

In the presented transcript, the speaker, Richard Lewis, discusses ongoing investigations into potential treatments for CIDP (chronic inflammatory demyelinating polyneuropathy). The focus is on a promising FcRn (neonatal Fc)inhibitor called efgartigimod, highlighted in a recent press release and poster presented at the American Academy of Neuro, Neuromuscular, and Electro Diagnostic Medicine. According to Richard Lewis, MD, this inhibitor demonstrated significant benefits for patients, potentially reducing circulating immunoglobulin G levels by 70% or more, thus impacting the pathophysiology of CIDP.

Dr Lewis expresses enthusiasm about efgartigimod, labeling it a groundbreaking treatment that, if approved, would be the first new CIDP therapy in over 30 years. The drug's subcutaneous administration, aided by hyaluronidase, adds to its appeal, especially considering its efficacy in a relatively short treatment period.

Additionally, Lewis discusses an early-phase study on a complement inhibitor, showing promise in refractory patients. Investigations into B-cell depletion for CIDP treatment also appear encouraging. Dr Lewis anticipates a significant expansion of treatment options for CIDP within the next 3 to 5 years. The challenge ahead lies in determining the most suitable treatment for individual patients, akin to complexities observed in myasthenia. Despite these challenges, Dr Lewis expresses optimism about the evolving landscape of CIDP treatment, with FcRn inhibition, B-cell depletion, and complement inhibition emerging as potential therapeutic avenues.

Expert neurologist Dr Lewis discusses the effect CIDP can have on the quality of life of a patient with CIDP as well as the unmet needs of the disease.

Effects on Quality of Life and Unmet Needs of CIDP

This discussion centers on the significant impact of CIDP (chronic inflammatory demyelinating polyneuropathy) on patients' quality of life and functional abilities. The studies highlighted reveal a marked reduction in the quality of life for CIDP patients, with substantial functional disabilities. A considerable portion, around 20 to 30% of patients, requires wheelchairs, while others rely on various aids like ankle foot orthoses, canes, and walkers. Hand dysfunction poses challenges for daily activities, particularly in the age of widespread computer use.

The emotional toll of dealing with a chronic disease adds another layer of difficulty for individuals affected by CIDP. The speaker emphasizes the multifaceted impact of the disorder, extending beyond neuropathic aspects to become a major life struggle.

Addressing unmet needs, the speaker stresses the necessity for a better understanding of CIDP's pathophysiology and the differences between its variants. Additionally, the challenges of addressing long-term complications, such as axonal destruction or degeneration, are highlighted. The search for treatments with limited risks, ease of use, and high benefits is acknowledged, while recognizing the inherent complexities and potential risks associated with immunosuppressants.

Dr Lewis gives an overview of the current treatment landscape of CIPD, including response rates to available treatments.

Current Treatment Landscape of CIDP

In the discussed transcript, the speaker emphasizes 3 established treatments for a medical condition, avoiding specific drug and medical terminology. These treatments include intravenous immunoglobulin, corticosteroids, and plasma exchange, each exhibiting varying effectiveness and potential drawbacks. Notably, these treatments collectively demonstrate efficacy in approximately 70% of patients. The speaker advises attempting different treatments if one proves ineffective, suggesting a trial-and-error approach.

Furthermore, the speaker mentions immunosuppressive agents like cyclosporine and cyclophosphamide as alternative treatments, acknowledging their slow onset but potential for reducing corticosteroid dosage. Other investigational treatments, such as FcRn (neonatal Fc) receptor inhibitors, complement inhibitors, and B-cell depleting treatments like rituximab, show promise but lack conclusive evidence.

Beyond primary treatments, the transcript highlights the absence of proven secondary treatments, emphasizing the importance of patient-physician discussions in selecting alternative approaches. The speaker stresses the need for a second opinion from specialists when progressing beyond initial treatment, particularly if the current approach fails, underscoring the complexity and individualized nature of managing the condition.

Expert neurologist Dr Lewis reviews the red flag symptoms of CIPD that should prompt a referral your patient.

Red Flag Symptoms of CIDP

The speaker addresses factors that distinguish neuropathies, particularly focusing on when to suspect a condition beyond mild diabetic neuropathy. Key indicators include significant weakness, an unusual loss of reflexes, and multi-focality. These "red flags" prompt further investigation, as they deviate from standard distal symmetric neuropathy definitions.

The aggressiveness of the disorder is emphasized, requiring more than 8 weeks of progression or relapsing to distinguish it from Guillain-Barre syndrome. Persistent symptoms beyond this period, especially if relapsing past 6 weeks, signal potential CIDP (chronic inflammatory demyelinating polyneuropathy). The speaker stresses the need for neurologist involvement and, if necessary, referral to a neuromuscular specialist.

Misdiagnosis challenges are acknowledged, citing research indicating that approximately half of referred CIDP cases did not have the disease. A call for second opinions, especially if initial treatments are ineffective, is encouraged. The CIDP Foundation's Centers of Excellence are recommended for comprehensive evaluations. The speaker highlights the difficulty in CIDP diagnosis and urges seeking additional perspectives when uncertainties arise.

Dr Lewis discusses diagnosis of CIDP, the broad differential diagnosis to keep in mind and common misdiagnosis.

Diagnosing CIDP

The transcript discusses the diagnostic criteria for chronic inflammatory demyelinating polyneuropathy (CIDP). It emphasizes the importance of a clinical presentation fitting the CIDP syndrome, including reflex loss or diminished reflexes. The nerve conduction component is crucial, and new guidelines detail specific criteria for conduction changes, such as motor nerve fibers needing to conduct at least 30 meters per second. The guidelines outline the necessary slowing of 70% below the lower limits of normal, indicating CIDP.

Sensory abnormalities in at least 2 nerves and supportive criteria, including elevated spinal fluid protein and an objective response to treatments like corticosteroids, intravenous immunoglobulin, or plasma exchange, are discussed. The transcript underscores the significance of objective evidence, not subjective reports, in evaluating treatment efficacy. The revised guidelines eliminate the "probable" category, distinguishing between definite CIDP and possible CIDP. The speaker acknowledges the vast differential diagnoses, particularly in different variants of CIDP, emphasizing the need to differentiate nerve disorders from muscle disorders. Additionally, caution is advised in interpreting spinal fluid protein increases, considering age and potential influences from other disorders or surgeries. The transcript concludes with a mention of POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes) syndrome and the importance of testing for vascular endothelial growth factor, with a note on potential limitations when patients are on steroids during testing.

Richard Lewis, MD, talked about efgartigimod as a novel treatment for chronic inflammatory demyelinating polyneuropathy.

Exploring the Efficacy and Evidence of Efgartigimod as a Potential Therapy for CIDP: Richard Lewis, MD

“I think as we get more treatments, the question is: what's the role of each treatment and how do you decide which treatment to use? The fact that there were patients who were ‘not taking medicine before,’ whether truly naive or had been off medicine for a while, suggests that there is a potential for this treatment to be a first line treatment. I think understanding that will be important and again, the long-term efficacy rates will be important but there looks to be a very good effect of this.”

Efgartigimod (Vyvgart; Argenx), a human IgG1 antibody Fc fragment, blocks the neonatal Fc receptor (FcRn) and by doing so, recycling of immunoglobulin G (IgG) and pathogenic IgG autoantibody levels are decreased. Researchers think that this mechanism of IgG may have an important role in the pathogenesis of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Currently, only a limited number of patients with CIDP achieve clinically meaningful benefit from the treatments that are available, which can thus increase long-term safety risks, high costs, and burdensome care.

 (NCT04281472) assessing subcutaneous (SC) efgartigimod PH20 as a treatment for CIDP were presented at the 

American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) meeting

, held November 1-4, in Phoenix, Arizona, by lead author 

, professor of neurology at Cedars-Sinai Medical Center, and colleagues.

In the trial, the primary objectives included investigating evidence of clinical improvement (stage A) and efficacy of efgartigimod PH20 SC compared with placebo based on time to occurrence of clinical deterioration (stage B).

At the AANEM Annual Meeting, Lewis sat down in an interview with 

 to discuss the presented findings from the trial as well as how the rapid reduction of IgG antibodies in patients with CIDP contributes to the potential effectiveness of FcRn inhibitors. He talked about the considerations that healthcare professionals should keep in mind when discussing the use of this novel treatment with patients who live with CIDP, especially in comparison with the existing available therapies. In addition, Lewis spoke about how the presence of antibodies resistant to traditional treatments might influence the global response rate of FcRn inhibitors in CIDP.

Click here for more coverage on AANEM 2023.

REFERENCES
1. Lewis R, Allen J, Dysgaard T, et al. Efficacy, Safety, And Tolerability Of Efgartigimod In Patients With Chronic Inflammatory Demyelinating Polyneuropathy: Results From The Adhere Trial. Presented at: American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) meeting; November 1-4, 2023; Phoenix, AZ. Abstract 143.

The professor of neurology at Cedars-Sinai Medical Center talked about efgartigimod as a novel treatment for chronic inflammatory demyelinating polyneuropathy, with the potential of it being a first-line treatment for patients with the condition. [WATCH TIME: 3 minutes] 

Chronic Inflammatory Demyelinating Polyneuropathy

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