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Medscape
25-07-2025
- Health
- Medscape
Case Reports Describe Itch Relief With Nemolizumab
A recently published case series illustrates how a treatment approved last year for two conditions associated with pruritus could be useful in alleviating itch in patients with a broad variety of other conditions, many of which have a few or no treatment options. In the case series of 70 patients, treatment with nemolizumab — an interleukin (IL)-31 receptor alpha-antagonist approved by the FDA for the treatment of prurigo nodularis (PN) and atopic dermatitis (AD) in 2024 — dramatically reduced itching in a range of additional conditions that cause pruritus. 'Itching causes tremendous suffering,' Jenny Murase, MD, associate clinical professor of dermatology, University of California San Francisco, and one of the authors of the case series, told Medscape Medical News . 'To be unable to sleep and unable to concentrate during the day because the itching is so intense and distracting, to feel like you don't want to live in your own skin — these are incredibly debilitating.' Pruritus, defined as 'an unpleasant sensation that provokes the desire to scratch,' can 'range in intensity from a mild annoyance to an intractable, disabling condition.' Murase, director of Medical Consultative Dermatology and Patch Testing, Palo Alto Medical Foundation, Mountain View, California, said some patients have likened pruritus, which is often accompanied by sensations similar to electric shocks, to being 'tortured.' Many of her patients have tried up to 30 medications, including topical, oral, and injectable agents, receiving minimal if any relief. The multicenter case series examining medical records of 70 patients found nemolizumab dramatically reduced itching in patients with a range of additional conditions that cause pruritus, as measured using the Peak Pruritus Numerical Rating Scale (NRS). The patients described in the report, published in March in the Journal of the American Academy of Dermatology , did not respond to 12 therapies on average. 'The findings of our case review matched my clinical experience using this agent,' Murase said. 'We were excited to uncover the wide range of conditions that responded to it.' In other recently published case reports, authors have described patients with cholestatic pruritus and pruritus of unknown origin who experienced relief from severe pruritus with nemolizumab. In late June, Galderma, the manufacturer of nemolizumab, announced that two clinical trials have been launched to investigate the role of nemolizumab in treating chronic pruritus of unknown origin and systemic sclerosis. Targeting the 'Itch Cytokine' Murase explained that IL-31 is sometimes called the 'itch cytokine.' Because nemolizumab is an IL-31 inhibitor, it works directly on sensory neurons regardless of the underlying cause of the pruritus. In her clinical experience, 'the relief from the itching is extremely fast for the patient after, in some cases, decades of daily itching.' For example, one of her patients with severe pruritus, who was in the case series, did not respond to 30 medications, including JAK inhibitors, IL-4 and IL-13 inhibitors, and neuropathic agents such as pregabalin and gabapentin; was unable to work or sleep; and was forced to quit his job. 'After a single injection of nemolizumab, his symptoms disappeared within 10 days,' Murase said. After 12 days, some mild itching reappeared, 'but his improvements have been largely sustained, and he feels he has his life back for over 8 months now.' Murase and her colleagues were so struck by the potential utility of nemolizumab beyond the two conditions for which it is approved by the FDA that they conducted the case series involving retrospective data collection from medical records of patients who had been treated with nemolizumab for skin diseases associated with pruritus (60 patients) or for burning (10 patients). Conditions affecting these patients included AD, nummular dermatitis, hand dermatitis, dermatographia urticaria, cutaneous mastocytosis, neuropathic itch, subacute prurigo, immunologic eruptions of aging, lymphoma/leukemia, scrotal pruritus, vulvar/anal pruritus, acquired cutaneous brachioradial pruritus, notalgia paresthetica, scabies, post-scabetic Id hypersensitivity, lichen amyloidosis, pernio, and granulomatous dermatitis. Patients experiencing burning had neuropathic skin pain, burning mouth syndrome, neurogenic rosacea, and erythromelalgia. Patients received an initial dose of 60 mg, followed by monthly treatments of 30 or 60 mg, and were followed for an average of 73 days. All 70 patients were considered responders, as defined by a reduction in the NRS score of ≥ 2 and/or a 50% reduction in baseline symptoms, except for one out of two cases of notalgia paresthetica (no response) and acquired cutaneous brachioradial pruritus. Murase noted that the latter patient continued treatment regardless and responded at the 5-month mark after the publication of the case series. Almost all patients (96%) opted to continue taking the medication. 'Many patients started out with an NRS score of 9 or 10, and then their score went to 0 within 2 days. It was truly remarkable,' Murase said in the interview. Investigate Medical Causes Before Prescribing As she and her coauthors noted, Murase expressed a significant concern particularly relevant to patients with no visible cutaneous manifestations such as rash, which could account for their pruritus. In the case series, three patients had leukemia/lymphoma, 20% had renal insufficiency, and 36% had either diabetes or prediabetes. 'All these conditions can predispose patients to have neuropathy and pruritus without a visible rash. Immediately prescribing nemolizumab without thoroughly assessing other potential causes of the itch — especially in lymphoma and leukemia, which can present only with pruritus and no other symptoms — might lead to missed diagnoses of these conditions,' she cautioned. She recounted the story of a male patient in his thirties with dermatographia and no response to an array of previous medications. Murase ordered a hepatitis titer test and a tuberculosis screen, as well as a chest x-ray in preparation to place him on a JAK inhibitor before nemolizumab was available for her to prescribe. She ordered a chest x-ray for an indeterminate QuantiFERON result and diagnosed Hodgkin lymphoma. 'He is alive today because of this,' she commented. 'If I had given him nemolizumab immediately, I would have gotten rid of the only sign that he had lymphoma. The itch reduction is so powerful with the medication that I really want providers to do thorough assessment for malignancy or metabolic conditions before they place their patients on this medication.' Financial Challenges in Prescribing Nemolizumab Murase noted that because nemolizumab is approved only for AD or PN, prescribing it for any other indication is off label, and patients often struggle to get their insurance companies — especially Medicare — to cover the treatment. 'Patients need to have a history of AD, such as a history of rashes in childhood and adulthood, itching, a relapsing and remitting nature, history of hay fever, history of asthma, history of family members with allergies, asthma, and hay fever, to suggest that they could have AD. Or they need to have excoriated lesions for a PN diagnosis.' She noted that these are clinical diagnoses. Murase said that patients in the area where she practices usually have the means to pay out of pocket, and many patients are willing to spend what it takes to obtain the drug because it offers such profound relief. 'I'm hoping that Medicare coverage — and coverage offered by other insurance companies — will improve over time,' she said. Adverse Effects Most patients in the case series experienced no side effects; however, one patient developed facial swelling and erythroderma thought to be caused by discontinuation of abrocitinib. In general, Murase said, nemolizumab has a fairly benign side-effect profile — something she has observed in her own clinical practice. The prescribing information for nemolizumab (Nemluvio) lists the most common adverse reactions (affecting 1% or more of patients) as headache, AD, eczema, and nummular eczema with PN and headache (including migraine), arthralgia, urticaria, and myalgia with AD. A 2025 review of cutaneous adverse events following administration of nemolizumab found an increased incidence of psoriasiform eruptions, AD exacerbations, bullous pemphigoid, nonspecific drug-induced eruptions, fungal infections, urticaria, acne, and contact dermatitis in patients receiving nemolizumab and overall cutaneous adverse events in about 30%-50% of patients. A review and meta-analysis of three studies of nemolizumab for PN encompassing almost 500 patients found no difference between nemolizumab and placebo in the rates of adverse events or serious adverse events. Transforming the Landscape Commenting for Medscape Medical News , Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, DC, said that 'pruritus is not just a symptom; it's a disease in and of itself and one that deserves targeted therapy.' The case series by Murase and colleagues, he said, 'reinforces what we've seen clinically, which is that nemolizumab can provide rapid and profound relief for patients with a wide range of underlying conditions, including those with inflammatory and more difficult-to-manage idiopathic itch.' Nemolizumab has 'transformed the landscape' of PN, an on-label use, Friedman said. He has also prescribed it for itch associated with systemic lupus erythematosus, pruritus associated with various cancer treatments, idiopathic pruritus in older adult patients, and even delusions of parasitosis, 'where traditional antipruritics fall short.' Friedman, also director of translational research and director of supportive oncodermatology at George Washington University, noted that his clinical experience accords with the findings of the case series that nemolizumab 'tends to disappoint' in centrally mediated conditions such as notalgia paresthetica and brachioradial pruritus. And he echoed Murase's caveat that 'diagnostic rigor is critical.' He added that itch is 'very personal,' so clinicians should 'tailor therapy, set expectations, and reassess frequently.' Also commenting for Medscape Medical News , Lauren Ploch, MD, MEd, of Georgia Dermatology & Skin Cancer Center in Augusta and Aiken, South Carolina, agreed that the workup of patients without primary skin lesions should include ruling out medical causes such as renal disease and malignancies, and that patients should be monitored — although some of the newer medications 'do not require strict lab monitoring.' Murase added that nemolizumab can be useful in every medical specialty that treats patients with pruritus. 'For example, vulvar pruritus drives patients crazy. I heard about one patient who was literally sitting on ice throughout the day because her symptoms of itching and burning were so life-altering. Within a few days of treatment [with nemolizumab], her symptoms had abated.' In addition, she said, it is also an option for urologists treating scrotal itch, 'which can be horrific even though there is very little to see on the skin. And one of the most debilitating symptoms of chronic kidney disease is pruritus, which has been shown to sap quality of life in these patients more than other symptoms. Now, nephrologists have something to offer these patients.' Murase and her colleagues are in the process of publishing a post hoc analysis of the rapidity of itch relief with nemolizumab in patients with pruritus. The study received no funding. Murase reported being on the speakers board for Galderma, UCB, Leo Pharma, Eli Lilly, AbbVie, and Sanofi-Regeneron; serving on advisory boards for UCB, Galderma, Arcutis, Eli Lilly, Leo Pharma, Sanofi-Regeneron, and Bristol Myers Squibb; and providing dermatologic consulting services for UCB, Apogee Therapeutics, Galderma, AbbVie, Attovia, Sanofi-Regeneron, and UpToDate. Friedman reported being a speaker, investigator, and consultant for Galderma. Ploch reported having no relevant financial relationships.
National Post
18-06-2025
- Health
- National Post
ICD 2025: New data demonstrate Nemluvio®'s (nemolizumab) favorable safety profile and sustained and clinically meaningful improvements in symptoms of prurigo nodularis up to two years
Article content Sorry, your browser doesn't support embedded videos. Article content An interim analysis of the OLYMPIA long-term extension study to be presented as a late-breaking abstract at the XIV International Congress of Dermatology (ICD) found that Nemluvio was well tolerated and associated with sustained and clinically meaningful improvements in the key signs and symptoms of prurigo nodularis, including both skin lesions and itch, up to two years 1 Results build on data from OLYMPIA – the largest completed pivotal clinical program in prurigo nodularis and the only one assessing long-term safety and efficacy in prurigo nodularis 1-3 This follows the presentation of data from the ARCADIA long-term extension study at the Revolutionizing Atopic Dermatitis (RAD) Conference earlier this month, which showed Nemluvio is well tolerated with sustained and increased improvements in efficacy outcomes in atopic dermatitis patients up to two years 4 Article content Article content ZUG, Switzerland — Galderma (SIX: GALD) today announced data from a new interim analysis of a study investigating the long-term safety and efficacy of Nemluvio in moderate-to-severe prurigo nodularis. The new data show Nemluvio is well tolerated and associated with sustained and clinically meaningful improvements in symptoms including itch and skin lesions, during prolonged treatment up to two years. 1 These new data will be presented as a late-breaking session at ICD, on Saturday, June 21, 2025 at 08:30 AM CET. Article content is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules, which have a substantial impact on patients' quality of life. Article content 5-7 Article content Nemluvio Article content Article content is the first approved monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31. Article content 8,9,10 Article content IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation, skin barrier dysfunction, and fibrosis in prurigo nodularis. Article content 8-11 Article content It is also the first and only biologic approved for prurigo nodularis as well as atopic dermatitis with four-week dosing intervals from the start of treatment. Article content 9,10 Article content The OLYMPIA long-term extension study was designed to assess the safety and efficacy of Nemluvio in patients with prurigo nodularis up to four years and includes 508 patients from the phase II trial or the phase III OLYMPIA 1 and 2 trials. 1 Results show that treatment with Nemluvio is associated with sustained and clinically meaningful improvements in symptoms of prurigo nodularis during prolonged treatment up to two years. 1 At Week 100 in evaluable patients, the interim analysis shows that: Article content More than 90% and 70% achieved at least a four-point improvement in itch, and being itch free or nearly itch free respectively, as measured by the Peak-Pruritus Numerical Rating Scale 1 At least 80% achieved 76‑100% healed pruriginous lesions 1 Approximately 75% reached clearance or almost-clearance of skin nodules when assessed using the Investigator's Global Assessment score 1 Article content Nemluvio was well tolerated in the long-term treatment of prurigo nodularis and no new safety signals were identified in this study to date. 1 'These impressive results give us even more confidence in the value of nemolizumab – a much-needed innovative medicine that has the potential to deeply impact the prurigo nodularis treatment landscape. With this new treatment now approved in multiple markets including the EU and U.S., I'm thrilled to be able to see its meaningful impact in the real world.' This follows presentation of results from the ARCADIA long-term extension study at the RAD Conference earlier this month, which showed that treatment with Nemluvio was well tolerated and associated with sustained and increased improvements in symptoms of atopic dermatitis during prolonged treatment up to two years. 4 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis. 9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. 9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional reviews and submissions are ongoing. Article content Galderma will also host a symposium at ICD, exploring the latest advances in addressing itch in both prurigo nodularis and atopic dermatitis. Separately, the company will share new data from across its Therapeutic Dermatology portfolio in acne, non-melanoma skin cancer, and rosacea. Article content More details on Galderma's scientific presentations at ICD can be found here. Article content Nemluvio Article content Article content was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga Article content ® Article content and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. Article content 12,13 Article content About prurigo nodularis Article content Prurigo nodularis Article content is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas. Article content 5-7 Article content It is an underrecognized and underdiagnosed skin condition, and there are limited studies investigating its prevalence. Article content 11,14,15 Article content About Galderma Article content Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: Article content Ständer S, et a. Nemolizumab long-term efficacy and safety up to 100 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at International Congress of Dermatology; June 18-21, 2025; Rome, Italy. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501679). Available online. Accessed May 2025 Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT04501666). Available online. Accessed May 2025 Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi: 10.1016/ Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi: 10.1111/jdv.14570 Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi: 10.1097/itx.0000000000000042 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Nemluvio European Medicines Agency. Summary of Product Characteristics. Available online. Accessed May 2025 Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555-022-00782-2 Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S, et al. Prevalence of prurigo nodularis in the United States of America: a retrospective database analysis. JAAD Int. 2020;2:28-30. doi: 10.1016/ Huang AH, et al. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. doi: 10.1016/ Article content Article content Article content Article content Article content Contacts Article content For further information: Article content Christian Marcoux, Chief Communications Officer +41 76 315 26 50 Article content Richard Harbinson Corporate Communications Director +41 76 210 60 62 Article content Céline Buguet Franchises and R&D Communications Director +41 76 249 90 87 Article content Emil Ivanov Head of Strategy, Investor Relations, and ESG +41 21 642 78 12 Article content Article content Article content
