Nemluvio (nemolizumab)

To treat prurigo nodularis

FDA Approval: 8/12/2024

Research Synopsis

  • - Nemluvio (nemolizumab) is a monoclonal antibody that targets the interleukin-31 receptor A (IL-31RA), offering a new approach to treat atopic dermatitis and alleviate pruritus.
  • - Recent research indicates that nemolizumab has shown significant efficacy in reducing itch and severity of eczema in patients with moderate-to-severe atopic dermatitis compared to placebo, with multiple clinical trials supporting its use.
  • - A systematic review highlighted the need for better treatments for chronic prurigo, a condition linked to atopic dermatitis, and indicated that emerging therapies like nemolizumab could play a crucial role.
  • - In a phase 2 trial, nemolizumab demonstrated favorable safety and tolerability profiles, with a significant number of patients completing treatment without serious side effects.
  • - Modeling studies suggest that an optimized dosing regimen for nemolizumab, around 75 mg every 4 weeks, could enhance its therapeutic effects while maintaining safety.
  • - Comparative analyses have positioned nemolizumab alongside other biologics like dupilumab, noting a promising potential for managing difficult-to-treat cases of atopic dermatitis.
  • - Studies emphasize the role of the IL-31 pathway in exacerbating scratching and itching associated with atopic dermatitis, underscoring nemolizumab's mechanism of action.
  • - Ongoing research aims to further validate nemolizumab's efficacy and safety through larger trials and to explore its potential in pediatric populations potentially affected by atopic dermatitis.
  • - As awareness of chronic itch conditions grows, nemolizumab is positioned as a key investigational therapy with the promise of improving the quality of life for patients suffering from severe atopic dermatitis.
  • - Overall, nemolizumab represents a significant advancement in the therapeutic landscape for atopic dermatitis and chronic pruritus, reflecting a shift towards targeting specific inflammatory pathways in dermatological treatments.

Related articles

Research articles about Nemluvio (nemolizumab)

Nemluvio (nemolizumab)

Systemic treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials.

London, UK

2 hours ago

1 Received

  • Atopic dermatitis (AD) is a skin condition that causes inflammation and can be treated in different ways, but it's not always clear which treatments work best.
  • Researchers looked at many studies to compare the benefits and risks of different treatments for AD.
  • They found that some treatments, like high-dose upadacitinib, were very effective but also had more side effects, while others like dupilumab were safer but less powerful.

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The first trial of CIM331, a humanized antihuman interleukin-31 receptor A antibody, in healthy volunteers and patients with atopic dermatitis to evaluate safety, tolerability and pharmacokinetics of a single dose in a randomized, double-blind, placebo-controlled study.

London, UK

2 hours ago

1 Received

  • Interleukin-31 (IL-31) is linked to itchiness in humans, and CIM331 is a monoclonal antibody designed to block its receptor and reduce pruritus associated with atopic dermatitis (AD).
  • A phase I/Ib study tested CIM331 on healthy volunteers and Japanese patients with AD to evaluate its safety, tolerability, and initial effectiveness.
  • Results showed CIM331 was well tolerated without serious side effects and significantly reduced itchiness and sleep disturbances in AD patients, suggesting its potential as a new treatment option.

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Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis.

London, UK

2 hours ago

1 Received

  • The study investigated the efficacy and safety of nemolizumab, an antibody targeting the interleukin-31 receptor A, for treating moderate-to-severe atopic dermatitis in adults inadequately managed by topical treatments.
  • In a 12-week phase 2 trial involving 264 patients, participants received either nemolizumab (at varying doses) or a placebo, with the primary focus on improvement in pruritus measured via a visual-analogue scale.
  • Results indicated significant improvements in pruritus and eczema severity among those receiving nemolizumab compared to placebo, with 82% of participants completing the study, although treatment discontinuation rates were similar between groups.

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Itch in Atopic Dermatitis Management.

London, UK

2 hours ago

1 Received

  • Patients with atopic dermatitis (AD) experience persistent itching that doesn't respond to antihistamines, making effective management crucial.
  • Current treatments include topical anti-inflammatory drugs, moisturizers, phototherapy, and systemic medications for severe cases.
  • Emerging therapies target the central nervous system to help alleviate intractable itch associated with AD, with promising results from clinical trials of medications like dupilumab.

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Itch Management: Treatments under Development.

London, UK

2 hours ago

1 Received

  • Pruritus is a complex symptom linked to various skin, nerve, and systemic issues, and understanding its underlying mechanisms is still a work in progress.
  • Recent studies have improved knowledge about pruritus, leading to the development of new drugs for conditions like inflammatory skin diseases and chronic pruritus.
  • Ongoing clinical trials are testing innovative therapies, but more research is needed to find effective treatments, especially for specific groups like pregnant women and children.

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Therapy with anti-interleukin-31 receptor A antibody for atopic dermatitis.

London, UK

2 hours ago

1 Received

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What progress have we made in the treatment of atopic eczema? Putting the new biological therapies into a wider context.

London, UK

2 hours ago

1 Received

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Interleukin-31 pathway and its role in atopic dermatitis: a systematic review.

London, UK

2 hours ago

1 Received

  • Atopic dermatitis is a common chronic inflammatory skin disease affecting 10-20% of the population, causing significant discomfort mainly due to itching (pruritus).
  • The study focuses on interleukin-31, a newly identified protein linked to pruritus in atopic dermatitis, and looks into potential treatments targeting this pathway.
  • Findings show that interleukin-31 is present on skin cells and its overproduction can lead to symptoms of atopic dermatitis and hair loss; a monoclonal antibody (CIM331) has shown promise in reducing itching in clinical trials.

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Dosage Optimization of Nemolizumab Using Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Modeling and Simulation.

London, UK

2 hours ago

1 Received

  • Nemolizumab is a monoclonal antibody designed to treat atopic dermatitis by targeting the interleukin-31 receptor A, effectively reducing itching (pruritus).
  • The study aimed to optimize dosing regimens for nemolizumab, using population modeling from 299 patients who received varying doses either every 4 weeks or every 8 weeks.
  • Simulations indicated that a flat dose regimen around 75 mg every 4 weeks could be as effective as doses within the 0.5 to 2 mg/kg range, supporting further dose optimization in clinical trials.

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Systemic Therapy of Atopic Dermatitis: Welcome to the Revolution.

London, UK

2 hours ago

1 Received

  • Recent systemic therapies for atopic dermatitis were primarily limited to off-label immunomodulators and systemic corticosteroids, which are now less recommended due to safety concerns.
  • The approval of dupilumab in 2017 represented a significant breakthrough, showing long-term effectiveness in adults with moderate to severe atopic dermatitis and ongoing research for children.
  • Additional biologic agents and "small molecules" are currently in phase 2 or 3 clinical trials, exploring various mechanisms to treat the condition.

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[What's new in dermatological treatment?].

London, UK

2 hours ago

1 Received

  • In 2017, atopic dermatitis emerged as a key focus in dermatology, highlighted by the introduction of dupilumab, the first biologic treatment for the condition.
  • JAK inhibitors were noted for their potential effectiveness in hard-to-treat skin diseases like alopecia areata, but further validation through controlled trials is needed.
  • Monoclonal antibodies targeting IL-23 showed strong results in phase III trials for psoriasis, indicating a successful translation of research into practical treatments for inflammatory skin disorders.

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[Current and upcoming treatments of adult atopic dermatitis].

London, UK

2 hours ago

1 Received

  • Atopic dermatitis (AD) treatment for adults primarily involves topical steroids and emollients; if these fail, alternatives like phototherapy and systemic treatments (e.g., ciclosporin, methotrexate) may be used.
  • New treatments are on the horizon that could significantly change how AD is managed, including topical phosphodiesterase 4 inhibitors and JAK inhibitors, as well as various biotherapies targeting specific interleukins (e.g., dupilumab, tralokinumab).
  • These upcoming therapies aim to provide more effective options for adults who struggle with the condition, enhancing overall management and patient outcomes.

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Cynomolgus monkey model of interleukin-31-induced scratching depicts blockade of human interleukin-31 receptor A by a humanized monoclonal antibody.

London, UK

2 hours ago

1 Received

  • Scratching worsens skin lesions in atopic dermatitis (AD) through the itch-scratch cycle, with IL-31 and its receptor IL-31RA being key players in this process in mice.
  • Researchers found that cynomolgus IL-31 causes scratching behavior in cynomolgus monkeys, establishing a primate model to study itching.
  • A single injection of nemolizumab, an anti-IL-31RA antibody, significantly reduced scratching for about two months, indicating its potential as a treatment for AD.

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Recent advances in atopic dermatitis.

London, UK

2 hours ago

1 Received

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[New aspects in systemic treatment of atopic dermatitis].

London, UK

2 hours ago

1 Received

  • * Emerging evidence supports the effectiveness of other treatments like mycophenolate and ustekinumab, alongside ongoing research exploring genetic factors that may predict treatment response.
  • * In 2017, Dupilumab became the first biologic approved in Europe for moderate to severe AD, targeting specific inflammatory pathways, with additional cytokines and receptors also being studied for future treatments.

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Therapy for pruritus in the elderly: a review of treatment developments.

London, UK

2 hours ago

1 Received

  • Chronic pruritus (CP) is common, especially in people over 65, but managing it is difficult due to additional health issues in older patients.
  • The review covers treatment options for elderly patients with CP, including emollients, topical therapies, phototherapy, and systemic agents.
  • Experts suggest starting with topical treatments and phototherapy, monitoring side effects closely if systemic drugs are required, and personalizing treatment based on individual needs and potential risks.*

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New and developing therapies for atopic dermatitis.

London, UK

2 hours ago

1 Received

  • Atopic dermatitis is a widespread skin condition characterized by inflammation, prompting research into better treatments.
  • Recent insights into the disease's causes have resulted in new drug options, particularly topical agents that can help children avoid long-term use of steroids.
  • Although many mild to moderate cases can be treated effectively with existing topicals, there is a significant demand for new therapies, especially for severe cases that are harder to manage.

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Interleukin-31 and interleukin-31 receptor: New therapeutic targets for atopic dermatitis.

London, UK

2 hours ago

1 Received

  • Atopic dermatitis (AD) is a chronic skin condition marked by itchy, eczematous lesions due to skin barrier issues and an immune response mediated by T helper (Th)2 cells.
  • The cytokine interleukin (IL)-31, mainly produced by Th2 cells, plays a key role in causing itchiness and has been linked to the development of AD-like symptoms in both IL-31 transgenic mice and normal mice treated with IL-31.
  • Recent studies have shown that targeting the IL-31 receptor with an anti-IL-31 receptor antibody can significantly reduce itchiness in patients suffering from AD, highlighting the importance of IL-31 and its receptor in the condition.

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Are Biologics Efficacious in Atopic Dermatitis? A Systematic Review and Meta-Analysis.

London, UK

2 hours ago

1 Received

  • Current treatments for atopic dermatitis (AD) have limited effectiveness and safety concerns, leading researchers to explore biologics as a better option.
  • This study performed a systematic review and meta-analysis on the efficacy and safety of various biologic agents, with dupilumab showing significant EASI-75 response compared to placebo.
  • While dupilumab has strong evidence supporting its use, other biologics like nemolizumab, lebrikizumab, and tralokinumab show potential but require further validation due to the lack of robust evidence.

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