Long-term Nemolizumab Improves Atopic Dermatitis in Adolescents: Study

Written By : Dr. Shravani Dali |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-11-30T20:45:31+05:30 | Updated On 1 Dec 2025 11:15 AM IST

Researchers have found in a new research that Nemolizumab (30 mg every 4 weeks) combined with topical corticosteroids and/or calcineurin inhibitors significantly improves symptoms of moderate-to-severe atopic dermatitis in adolescents over 56 weeks. Further adolescents previously treated with nemolizumab showed higher response rates compared to treatment-naïve patients and post-hoc analysis confirms the long-term efficacy and safety of nemolizumab in this population.

Atopic dermatitis (AD) is a common, chronic, relapsing, pruritic, neuroimmune skin disease, requiring long-term symptom control. The ARCADIA long-term extension (LTE) study evaluates nemolizumab safety and efficacy in ≥12-year-old patients with moderate-to-severe AD up to 200 weeks. Patients from previous nemolizumab AD trials (Phase 2/3) or newly recruited adolescents with moderate-to-severe AD were enrolled. A background regimen of topical corticosteroids with/without topical calcineurin inhibitors was permitted based on disease control.

Long-term safety was the primary endpoint. Efficacy assessments were secondary endpoints, including the proportion of patients achieving Investigator's Global Assessment (IGA) 0/1 (clear/almost clear), Eczema Area and Severity Index (EASI)-75 (75% improvement from lead-in baseline in EASI), Visual Analogue Scale (VAS) Pruritus and VAS sleep loss ≥4-point improvement from lead-in baseline and quality of life. Observed data up to Week (W) 104 are presented for patients with previous nemolizumab experience (PNE) and no previous nemolizumab experience (NNE) at LTE baseline.

Results: At interim analysis data cut-off (21 July 2024), 1062 of 1901 patients completed W104. Exposure to nemolizumab in this study was equal across cohorts. The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab.

The most common (≥5.0%) TEAEs were COVID-19 (19.6%), nasopharyngitis (19.5%), atopic dermatitis (18.1%), upper respiratory tract infection (12.7%), headache (6.5%) and asthma (5.5%). At LTE baseline, the proportion of PNE and NNE patients was IGA 0/1: 27.1% and 17.1%; EASI-75: 38.8% and 25.8%; VAS Pruritus ≥4-point improvement: 58.7% and 31.6%; and VAS sleep loss ≥4-point improvement: 52.9% and 31.6%, respectively. At W104, this proportion was IGA 0/1: 62.6% and 58.2%; EASI-75: 88.2% and 85.4%; VAS Pruritus ≥4-point improvement: 87.2% and 82.0%; and VAS sleep loss ≥4-point improvement: 70.8% and 68.9%, respectively.

Continuous nemolizumab treatment was well-tolerated through W104 with clinically meaningful improvements in AD signs and symptoms and patient-reported outcomes.

Reference:

Augustin M, Tauber M, Sidbury R, Silverberg JI, Papp KA, Thaçi D, De Bruin-Weller MS, Reich A, Peris K, Barber K, Galus R, Kaszuba A, Zirwas M, Nahm WK, Trullenque G, Maintz L, Alpizar S, Son SW, Laquer V, Gold LS, Cheong SY, Ryzhkova A, Drahos A, Ulianov L, Piketty C. Safety and efficacy of nemolizumab for atopic dermatitis up to 2 years in open-label extension study. J Eur Acad Dermatol Venereol. 2025 Oct 13. doi: 10.1111/jdv.70080. Epub ahead of print. PMID: 41081535.

Pruritusatopic dermatitisnemolizumabadolescent

Source : JEADV | European Academy of Dermatology & Venereology

Dr. Shravani Dali

Dr. Shravani Dali has completed her BDS from Pravara institute of medical sciences, loni. Following which she extensively worked in the healthcare sector for 2+ years. She has been actively involved in writing blogs in field of health and wellness. Currently she is pursuing her Masters of public health-health administration from Tata institute of social sciences. She can be contacted at editorial@medicaldialogues.in.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751