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The ECZTEND clinical trial was sponsored by LEO Pharma A/S. Richard B. Warren is supported by the Manchester NIHR Biomedical Research Centre.

Analysis of institutional authors

Herranz, PedroAuthor

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November 29, 2024
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Long-term 2-year safety and efficacy of tralokinumab in adults with moderate-to-severe atopic dermatitis: Interim analysis of the ECZTEND open-label extension trial

Publicated to:JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY. 87 (4): 815-824 - 2022-09-16 87(4), DOI: 10.1016/j.jaad.2022.07.019

Authors: Blauvelt, Andrew; Langley, Richard G; Lacour, Jean-Philippe; Toth, Darryl; Laquer, Vivian; Beissert, Stefan; Wollenberg, Andreas; Herranz, Pedro; Pink, Andrew E; Peris, Ketty; Fangel, Stine; Gjerum, Le; Corriveau, Joshua; Saeki, Hidehisa; Warren, Richard B; Simpson, Eric; Reich, Kristian

Affiliations

Dalhousie Univ, Div Clin Dermatol & Cutaneous Sci, Halifax, NS, Canada - Author
First OC Dermatol, Fountain Valley, CA USA - Author
Guys & St Thomas Hosp, St Johns Inst Dermatol, London, England - Author
Hosp Univ La Paz, Dept Dermatol, Madrid, Spain - Author
LEO Pharma AS, Ballerup, Denmark - Author
LEO Pharma Inc, Madison, NJ USA - Author
Ludwig Maximilians Univ Munchen, Univ Hosp, Dept Dermatol & Allergol, Munich, Germany - Author
Nippon Med Sch, Dept Dermatol, Tokyo, Japan - Author
Oregon Hlth & Sci Univ, Dept Dermatol, Portland, OR 97201 USA - Author
Oregon Med Res Ctr, 9495 SW Locust St,Suite G, Portland, OR 97223 USA - Author
Prob Med Res, Windsor, ON, Canada - Author
Tech Univ Dresden, Dept Dermatol, Dresden, Germany - Author
Univ Cattolica Sacro Cuore, Inst Dermatol, Rome, Italy - Author
Univ Hosp Nice, Dept Dermatol, Nice, France - Author
Univ Manchester, Salford Royal NHS Fdn Trust, Dermatol Ctr, Manchester NIHR Biomed Res Ctr, Manchester, Lancs, England - Author
Univ Med Ctr Hamburg Eppendorf, Inst Hlth Serv Res Dermatol & Nursing, Translat Res Inflammatory Skin Dis, Hamburg, Germany - Author
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Abstract

Background: Additional long-term treatments are needed for moderate-to-severe atopic dermatitis (AD). An ongoing, open-label, 5-year extension trial, ECZTEND (NCT03587805), assesses tralokinumab plus optional topical corticosteroids in participants from previous tralokinumab parent trials (PTs) with moderate-to-severe AD. Objective: To evaluate the safety and efficacy of up to 2 years tralokinumab treatment in a post hoc interim analysis. Methods: Safety analyses included adults from completed PTs enrolled in ECZTEND, regardless of tralokinumab exposure duration. Efficacy analyses included adult participants treated with tralokinumab in ECZTEND for >= 1 year and subgroup analyses of those on tralokinumab for 2 years (1 year from PT, 1 year in ECZTEND). Primary end point was the number of adverse events with additional efficacy end points. Results: Participants on tralokinumab had an exposure-adjusted rate of 237.8 adverse events/100 patient-years' exposure (N = 1174) in the safety analysis set. Exposure-adjusted incidence rates of common adverse events were comparable to PTs, although at lower rates. With 2 years of tralokinumab, improvements in extent and severity of AD were sustained, with Eczema Area and Severity Index (EASI-75) in 82.5% of participants (N = 345). Limitations: Possible selection bias; no placebo arm; some participants experienced treatment gaps between PTs and ECZTEND. Conclusion: Over 2 years, tralokinumab was well tolerated and maintained long-term control of AD signs and symptoms.

Keywords

Atopic dermatitisBiologic therapyEfficacyIl-13Long-termMonoclonal antibodyOpen labelSafetyTralokinumaTralokinumab

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2022, it was in position 1/70, thus managing to position itself as a Q1 (Primer Cuartil), in the category Dermatology. Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 14.81. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

  • Weighted Average of Normalized Impact by the Scopus agency: 13.33 (source consulted: FECYT Feb 2024)
  • Field Citation Ratio (FCR) from Dimensions: 30.44 (source consulted: Dimensions Jul 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-07-26, the following number of citations:

  • WoS: 36
  • Scopus: 40

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-07-26:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 50.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 62 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 26.1.
  • The number of mentions on the social network X (formerly Twitter): 4 (Altmetric).
  • The number of mentions in news outlets: 2 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Canada; Denmark; France; Germany; Italy; Japan; United Kingdom; United States of America.