Trial reportActa dermato-venereologica2026
Efficacy and Safety of Nemolizumab at Week 48: Results from the Maintenance Phase of Two Global Phase 3 Pivotal Studies (ARCADIA 1&2) in Patients with Moderate-to-Severe Atopic Dermatitis.
Trial report in Acta dermato-venereologica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- European Guideline (EuroGuiDerm) on atopic eczema: Living update.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025Guideline
- Update of the evidence- and consensus-based S3 guideline on atopic dermatitis: Systemic therapy with biologics or Janus kinase inhibitors and specific aspects of systemic therapy in pregnancy and lactation.Allergologie select · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nemolizumab with background topical therapy (corticosteroids±calcineurin inhibitors) significantly improved skin lesions, itch and sleep in two global phase 3 trials (ARCADIA 1&2) in adolescents and adults with moderate-to-severe atopic dermatitis through week (W)16. Efficacy and safety of nemolizumab, combined with background topical therapy, were evaluated for an additional 32 weeks (W16-W48) with a focus on maintained skin responses in clinical responders (patients achieving Investigator's Global Assessment [IGA] score of 0/1 [clear/almost clear] or ≥75% improvement in Eczema Area and Severity Index [EASI-75] at W16). At W16, clinical responders (N=507) to nemolizumab every 4 weeks (Q4W) were rerandomized (1 : 1 : 1) to receive nemolizumab 30 mg-Q4W/-Q8W/placebo (nemolizumab-withdrawal) subcutaneously with background topical therapy. At W48, 61.5% (strata-adjusted difference versus nemolizumab-withdrawal group [Δ], 11.8% [95% CI 1.3-22.3]) and 76.3% (Δ, 12.4% [95% CI 2.7- 22.0]) of patients in nemolizumab-Q4W; 60.4% (Δ, 10.7% [95% CI 0.3-21.0]) and 75.7% (Δ, 11.8% [95% CI 2.1-21.5]) in nemolizumab-Q8W; and 49.7% and 63.9% in nemolizumab-withdrawal group maintained response rate for IGA success and EASI-75, respectively. The percentage of patients who experienced ≥1 adverse events were similar across the groups (range: 53.5%-58.3%). Up to W48, skin responses were maintained without notable differences in the safety profile of both nemolizumab dosing regimens.
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