Nemluvio (nemolizumab-ilto) / Roche, Maruho, Galderma - LARVOL DELTA

British Society for Skin Care in Immunosuppressed IndividualsOral presentationsBI01 Persistent nonpruritic scabies in a patient on nemolizumab for the treatment of prurigo nodularis. (PubMed, Br J Dermatol) - P3 | "The patient did not respond to monotherapy with topical permethrin 5% (and standard hot wash measures) and required a combination of oral ivermectin and topical permethrin 5% for complete clearance. Allergy 2019; 74: 1727-37). It is important to consider the potential absence of pruritus in patients on nemolizumab when assessing new cutaneous and systemic presentations, particularly in the context of a rising prevalence of scabies in the UK."

Journal • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Prurigo Nodularis • Pruritus • POSTN • TSLP

P052 Nemolizumab elicits rapid itch-free state and sleep improvement in prurigo nodularis. (PubMed, Br J Dermatol) - "As consistently shown in both studies, rapid reduction in itch with nemolizumab translates to improved sleep. This work was sponsored by Galderma SA and Galderma UK."

Clinical • Journal • CNS Disorders • Dermatology • Fibrosis • Immunology • Prurigo Nodularis • Pruritus • Sleep Disorder

Galderma…announced the first patient enrollment for its phase II study investigating the efficacy and safety of nemolizumab in treating patients living with Chronic Pruritus of Unknown Origin (CPUO). (Galderma Press Release)

Trial status • Pruritus

ARCADIA LTE: Long-term Nemolizumab Effective in Adolescents with Atopic Dermatitis (HCPLive) - "Post hoc analyses from ARCADIA LTE 1-year cut-off (NCT03989206). This poster, presented during the 2025 Fall Clinical Dermatology Conference...At the 56-week interim cut-off point, Reich et al included 248 adolescent patients in the analysis (141 NPE and 107 NN). These participants had a mean age of 15 years. After 56 weeks of continuous nemolizumab treatment, the investigative team noted substantial clinical improvements documented in both cohorts. However, responses were generally shown to be higher among participants previously exposed to nemolizumab....IGA scores of 0/1 were shown by the team to have been attained in 72% of participants in the NPE group and 53% of those in the NN group. Additionally, the investigators noted rates of EASI-75 were high in both cohorts, with 86% in NPE and 80% in NN, and EASI-90 responses were attained by 72% and 57%, respectively."

P3 data • Atopic Dermatitis

Response to Letter to the Editor from Dr. Paul et al. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics of Nemolizumab in Adults With Chronic Pruritus of Unknown Origin (CPUO) (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Galderma R&D | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Pruritus

Resolution of Lichen Simplex Chronicus With Nemolizumab: A Case Report. (PubMed, J Drugs Dermatol) - "Lichen simplex chronicus has a significant impairment on quality of life, as it has been linked to anxiety, depression, and poor sleep, underscoring the importance of proper disease management. Current treatment regimens for lichen simplex chronicus are often ineffective. Our observation suggests that nemolizumab may be effective in managing lichen simplex chronicus; larger studies are warranted to confirm these findings."

Journal • CNS Disorders • Depression • Dermatology • Mood Disorders • Pruritus • Psychiatry

Skin and blood proteomic analysis of nemolizumab-treated patients demonstrates suppression of multiaxial inflammatory pathways and improved barrier protein signatures (ISDS 2025) - P3 | "Nemolizumab significantly downregulated inflammatory markers in both skin and blood after 16 weeks of treatment, with changes correlating with clinical improvement. Notably, reductions in ECM remodeling and fibrosis-related proteins suggest nemolizumab may also impact barrier repair in AD."

Clinical • IO biomarker • Omic analysis • Atopic Dermatitis • Dermatitis • Dermatology • Fibrosis • Immunology • Inflammation • Pruritus • CD123 • COL1A1 • CRTAM • CXCL16 • CXCL9 • EPCAM • ICOS • IFNGR1 • IGFBP2 • IL13 • IL16 • IL17A • IL17RA • IL18 • IL1R1 • IL2RA • IL31RA • IL6 • KLK11 • LGALS3 • LGALS8 • MMP1 • PLAU • S100A12 • S100A4 • TNFRSF1B • TSLP

Comparative safety profiles of dupilumab and nemolizumab in prurigo nodularis: an indirect META-analysis to inform clinical decision-making. (PubMed, Front Med (Lausanne)) - "Limitations inherent to indirect methodology - including trial design heterogeneity (endpoint definitions: IGA PN-S vs. PP-NRS; duration:12-24 weeks) and absence of severity-stratified reporting - preclude definitive safety conclusions. All comparisons must be interpreted within the constraint of unmeasured confounding factors potentially influencing indirect estimates."

Journal • Retrospective data • Conjunctivitis • Dermatology • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Prurigo Nodularis

Construction of genetically modified lactic acid bacteria producing an Anti-Interleukin-31 receptor A Single-chain variable fragment. (PubMed, Mol Biol Rep) - "We successfully constructed a novel tool for expressing IL-31Ra scFv designed based on nemolizumab using gmLAB. The scFv produced by gmLAB specifically bound human IL-31Ra and suggesting that it inhibits IL-31/IL-31Ra signaling. Taken together, our results suggest that the gmLAB established in this study may represent an efficient and convenient new tool for administering IL-31Ra scFv, with potential application to pulmonary and respiratory diseases."

Journal • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CD123 • IL31RA

Nemolizumab With Concomitant Topical Therapy in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis (ARCADIA 1 and ARCADIA 2): Results From Two Replicate, Double-Blind, Randomized Controlled Phase 3 Trials. (PubMed, Pediatrics) - No abstract available

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and safety of nemolizumab in paediatric atopic dermatitis: A 24-week real-world case series. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Pruritus

Disproportionality Analysis of Nemolizumab in Patients with Atopic Dermatitis: A Real-World Pharmacovigilance Study. (PubMed, Dermatitis) - "Notably, sleep disorder and eosinophil count emerged as new AEs. These findings provide a comprehensive real-world safety overview of nemolizumab, highlighting both expected and emerging risks to inform clinical monitoring and risk management strategies during patient treatment."

Adverse events • Journal • Real-world evidence • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Hematological Disorders • Immunology • Pain • Pruritus • Sleep Disorder • Urticaria

Basophils in Atopic Dermatitis: Immunologic Roles and Clinical Implications. (PubMed, Ann Allergy Asthma Immunol) - "Additionally, therapies such as dupilumab, tralokinumab, and nemolizumab which target IL-4, IL-13 and IL-31 respectively, likely exert part of their effect by modulating basophil activity. In this review, we summarize the immunologic functions of basophils in AD pathogenesis, discuss their relevance as biomarkers and therapeutic targets, and outline future directions for integrating basophil-focused strategies in the management of patients with AD."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Eosinophilia • Immunology • Inflammation • Pruritus • IL13 • IL4

Long-term IL-31RA inhibition and patient outcomes in atopic dermatitis. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CD123 • IL31RA

The Efficacy and Safety of Nemolizumab in Patients with Prurigo Nodularis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Dermatol Pract Concept) - No abstract available

Journal • Retrospective data • Immunology • Prurigo Nodularis

Dupilumab: an Additional Arrow in the Quiver for Prurigo Nodularis? Data From a Real-Life Setting. (PubMed, Dermatol Pract Concept) - "Our findings reflect the real-world practice of treating PN and support the use of dupilumab as a new effective treatment option, with significant improvements in pruritus, quality of life, and disease severity compared to antidepressant therapy, suggesting its potential as a preferred therapeutic option for PN."

Journal • Dermatology • Immunology • Prurigo Nodularis • Pruritus

Mast cell-neuron axis as a core mechanism in chronic pruritus of atopic dermatitis: from mechanistic insights to therapeutic targets. (PubMed, Front Immunol) - "While IL-31RA antagonists such as nemolizumab have demonstrated clinical efficacy, emerging targets like MRGPRX2 and TRPV1/TRPA1 channels offer additional therapeutic avenues but face challenges in translation and safety...This review provides a comprehensive mechanistic synthesis of the mast cell-neuron axis in AD-associated pruritus, critically evaluates current and investigational therapies, and explores the potential of multi-target interventions, including traditional Chinese medicine (TCM), for axis-level modulation. These efforts support the advancement of precision therapies targeting neuroimmune circuits in chronic inflammatory dermatoses."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • CD123 • IL31RA • TRPA1

Nemolizumab Treatment for Severe Atopic Dermatitis Led to the Simultaneous Improvement of Coexisting Refractory Alopecia Areata: A Case Report. (PubMed, J Dermatol) - No abstract available

Journal • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Cost-Effectiveness of Nemolizumab in the Treatment of Patients With Moderate-to-Severe Prurigo Nodularis in Italy (ISPOR-EU 2025) - "OBJECTIVES: The study objective is to estimate the cost-effectiveness of nemolizumab + BSC (Best Supportive Care), compared to dupilumab + BSC, for the treatment of patients with moderate-to-severe prurigo nodularis from the Italian NHS perspective. The model has a hybrid decision-tree/Markov cohort structure. Nemolizumab shows to be a cost-effective treatment for the Italian NHS. These results support the decision to introduce nemolizumab in routine clinical practice as a cost-effective treatment for patients with moderate-to-severe prurigo nodularis in Italy."

Clinical • Cost effectiveness • HEOR • Immunology • Prurigo Nodularis

Long-term Efficacy and Safety of Nemolizumab up to 2 years in Patients With Moderate-to-Severe Atopic Dermatitis: Pivotal Trial Subgroup Analysis of the ARCADIA LTE (ISAD-RAJKA 2025) - P3 | "Treatment with nemolizumab up to W104 was well tolerated and associated with improvements in pruritus, skin lesions and sleep disturbance."

Clinical • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Pruritus • Sleep Disorder

IL-31/33 Axis in Atopic Dermatitis. (PubMed, Int J Mol Sci) - "Targeting the IL-31/IL-33 axis represents an emerging therapeutic option, e.g., nemolizumab (anti-IL-31RA) significantly reduces pruritus and AD symptoms in clinical trials. However, anti-IL-33/ST2 agents (e.g., etokimab, tozorakimab) demonstrate variable efficacy, highlighting complexity in targeting IL-33. Future research should prioritize biomarker-driven patient stratification to optimize the clinical application of these novel antibody-based therapies."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • CD123 • FLG • IL13 • IL31RA • IL33 • IL4 • IL5

Nemolizumab-induced psoriasiform dermatitis. (PubMed, JAAD Case Rep) - No abstract available

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

The Absence of Recent Systemic Therapy can be a Significant Risk Factor for Nemolizumab-associated Cutaneous Adverse Events in Patients with Prurigo Nodularis: A Single-centre Retrospective Study. (PubMed, Acta Derm Venereol) - No abstract available

Adverse events • Journal • Retrospective data • Immunology • Prurigo Nodularis

Nemluvio’s net sales for the first nine months were 263 million USD, predominantly from the U.S. and prurigo nodularis, although atopic dermatitis started contributing to a greater share of sales in the third quarter. (Galderma Press Release)

Sales • Atopic Dermatitis • Prurigo Nodularis