ArticleDermatology and therapy2026
Long-Term Safety and Efficacy of Tralokinumab in Patients with Moderate-to-Severe Atopic Dermatitis Treated for up to 6 Years: Final Results from the Open-Label Extension Trial ECZTEND.
Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03587805 (An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials), 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.
An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials
Who cites it
2 citing papers in PubMed.
- Atopic Dermatitis Beyond the Skin Barrier: Precision Medicine Approaches to Immunological Profiling and Therapeutic Innovation.International journal of molecular sciences · 2026Review
- Tralokinumab as a cost-saving treatment option for adults and adolescents with moderate-to-severe atopic dermatitis enrolled in US health insurance plans: a budget impact analysis.Journal of comparative effectiveness research · 2026Article
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAtopic dermatitis (AD) is a chronic inflammatory skin disease often requiring continuous therapy. The objective with the ECZTEND trial was to assess the long-term safety and efficacy of tralokinumab treatment.
methodsECZTEND was a multicountry, open-label, 5-year extension trial conducted from September 2018 to July 2024 in patients (≥ 12 years) with moderate-to-severe AD who had received up to 1 year of tralokinumab treatment in a parent trial. Patients were eligible regardless of previous randomization (tralokinumab or placebo) or treatment response in the parent trial. The primary endpoint was the number of treatment-emergent adverse events (TEAEs) through week 268. Key secondary endpoints were Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) through week 248.
resultsIn total, 1672 patients were enrolled (4466.2 patient-years of exposure; median 2.6 years). Overall, 68.4% of patients (n = 1143) completed the trial period they consented to; 7.1% (n = 117) discontinued owing to lack of efficacy; and 4.2% (n = 72) owing to adverse events. The TEAE incidence rate was 114.3/100 patient-years with a pattern consistent with that observed in the parent trials albeit at lower rates. The majority (> 97%) of TEAEs were nonserious and of mild or moderate severity. Most (> 80%) were assessed as not related to tralokinumab by the investigator and resolved by the end of the trial. Common TEAEs (≥ 5%) included nasopharyngitis, atopic dermatitis, coronavirus infection, upper respiratory tract infection, conjunctivitis, and headache. The proportions of patients with IGA 0/1 and EASI-75/EASI-90 increased during the first 16 weeks and then remained stable through week 248 at ≥ 50% for IGA 0/1 and EASI-90, and ≥ 80% for EASI-75.
conclusionsLong-term tralokinumab treatment for up to 6 years (parent trials plus ECZTEND) in patients ≥ 12 years with moderate-to-severe AD was well tolerated and maintained long-term efficacy. A graphical abstract is available for this article.
trial registrationClinicaltrials.gov listing: NCT03587805 (ECZTEND).
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