Trial reportAdvances in therapy2025
Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Stapokibart over 52 weeks: A Post Hoc Analysis of a Phase 3 Trial.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05265923 (A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Patients With Moderate-to-severe Atopic Dermatitis), which is not on this map. Cited by 2 papers.
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.
A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Patients With Moderate-to-severe Atopic Dermatitis
Who cites it
2 citing papers in PubMed.
- Real-world Efficacy and Safety of Stapokibart in Children and Adolescents with Moderate-to-severe Atopic Dermatitis: A Retrospective Study.Acta dermato-venereologica · 2026Article
- Targeting the IL-4/IL-4R Axis in Th2 Inflammatory Diseases: A Review of Clinical Efficacy and Safety.Journal of inflammation research · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAtopic dermatitis (AD) significantly impairs quality of life and requires long-term management. This post hoc analysis aimed to evaluate the effect of stapokibart (an anti-IL-4Rα antibody) on patient-reported outcomes (PROs) in adults with moderate-to-severe AD from a phase 3 trial (NCT05265923).
methodsEligible patients were randomized 1:1 to receive stapokibart 300 mg (loading dose 600 mg) (n = 251) or placebo (n = 249) every 2 weeks (Q2W) for 16 weeks. Subsequently, both groups received stapokibart 300 mg Q2W for 36 weeks and were followed-up for 8 weeks. Main PROs analyzed included percentage change from baseline in the Dermatology Life Quality Index (DLQI) and the Patient-Oriented Eczema Measure (POEM) scores, response rates of weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) score ≤ 4 and ≤ 1, DLQI score ≤ 5, and POEM score ≤ 7 over 52-week treatment.
resultsA higher proportion of patients in the stapokibart group achieved weekly average of daily PP-NRS score ≤ 4 compared with the placebo-stapokibart group at week 16 (49.8% vs. 24.2%, p < 0.0001); the proportion at week 52 increased to 84.9% and 80.9%, respectively. Weekly average of daily PP-NRS score ≤ 1 was achieved in 35.2% and 32.1% of patients in stapokibart and placebo-stapokibart groups, respectively, at week 52. The stapokibart group had greater improvements in DLQI and POEM scores compared with the placebo-stapokibart group over weeks 4-16, and the improvements continued during maintenance period in both groups. The proportion of patients achieving DLQI score ≤ 5 was 46.2% versus 28.8% at week 16 (p < 0.0001) and 68.7% versus 73.6% at week 52 in the stapokibart versus placebo-stapokibart groups. POEM score ≤ 7 was achieved in 45.8% versus 22.5% of patients at week 16 (p < 0.0001) and 67.8% versus 62.7% at week 52.
conclusionStapokibart significantly improved PROs in adults with moderate-to-severe AD through 52-week treatment.
trial registrationClinicalTrials.gov identifier, NCT05265923.
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.