TOPLINE:

Nemolizumab was well tolerated and demonstrated sustained efficacy and safety through 104 weeks in patients with moderate-to-severe atopic dermatitis, with the majority achieving significant skin improvement, a phase 3, long-term extended study reported.

METHODOLOGY:

• Researchers conducted a prospective, multicentre, open-label, phase 3 study across 291 sites in 22 countries and included 1901 patients (mean age, 34 years) with moderate-to-severe atopic dermatitis who received treatment from December 2019, with their safety and efficacy data analysed as available on July 21, 2024.
• This study included up to a 4-week screening period, followed by a 200-week treatment period and an 8-week follow-up phase, with 1062 patients completing the week-104 visit at the interim analysis.
• Patients with previous nemolizumab experience (PNE) received 30 mg subcutaneous nemolizumab and a placebo at the baseline, whereas those with no previous nemolizumab experience (NNE) received a 60-mg loading dose of nemolizumab at the baseline, followed by 30 mg every 4 weeks.
• The primary endpoint was long-term safety, assessed through treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest.
• Secondary endpoints were long-term efficacy assessments, including Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), and SCORing Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) measures for pruritus and sleep loss at week 104.

TAKEAWAY:

• Treatment-emergent AEs were predominantly mild to moderate, with nemolizumab-associated AEs experienced by 22.1% of patients. The most common treatment-emergent AEs 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%).
• Serious AEs were experienced by 8.1% of patients, AEs of infection were experienced by 24.9%, and AEs of peripheral oedema were experienced by 1.8%.
• At week 104, 62.6% of patients with PNE and 58.2% of those with NNE achieved IGA scores of 0/1, indicating clear or almost clear skin; 88.2% of those with PNE and 85.4% of those with NNE achieved a 75% improvement in EASI scores, demonstrating sustained improvement in disease severity.
• VAS pruritus and VAS sleep loss SCORAD subcomponent mean scores were 1.38 and 1.32, respectively, at week 104, showing continued improvement in antipruritic activity and sleep loss over time.

IN PRACTICE:

"The safety data from this interim analysis support the long-term use of nemolizumab for adolescent and adult patients with moderate-to-severe AD [atopic dermatitis]," the authors wrote.

SOURCE:

This study was led by Matthias Augustin, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany. It was published online on October 13, 2025, in the Journal of the European Academy of Dermatology & Venereology.

LIMITATIONS:

This study was limited by its open-label, observed analysis design and non-controlled nature. The concomitant use of topical background therapy and the study's conduct during the COVID pandemic might have influenced the results. Additionally, not all patients reached week 104, which could have affected the interpretation of long-term outcomes.

DISCLOSURES:

This study was funded by Galderma. Five authors reported being employees of Galderma, with one author holding stock or stock options with it. Several authors reported receiving institutional research grants and consulting fees, participating in advisory boards, and receiving honoraria from companies manufacturing drugs for atopic dermatitis, including AbbVie, Almirall, Beiersdorf, Eli Lilly, Galderma, Incyte, LEO Pharma, L'Oréal, Novartis, Pfizer, Regeneron, Roche-Posay, and Sanofi-Genzyme. Full disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.