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Introduction <p>Tralokinumab is approved for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged ≥ 12&#xa0;years. Here, we examined clinical laboratory parameters in adolescents with moderate-to-severe AD who were treated with tralokinumab for up to 1 year.</p> Methods <p>This analysis assessed data from adolescents in the ECZTRA 6 (NCT03526861) phase 3 trial initiated on tralokinumab (150&#xa0;mg or 300&#xa0;mg) or placebo for 16&#xa0;weeks. Additionally, pooled data from tralokinumab-treated patients who continued treatment beyond Week 16 were analyzed regardless of Week 16 response or tralokinumab dosing regimen (i.e., blinded 150&#xa0;mg or 300&#xa0;mg every 2 or 4&#xa0;weeks or open-label tralokinumab 300&#xa0;mg plus optional topical corticosteroids or calcineurin inhibitors).</p> Results <p>Median levels of most laboratory parameters were within respective reference ranges at baseline, Week 16, and Week 52, with comparable values across treatment groups at baseline and Week 16. Baseline levels for eosinophils and immunoglobulin E (IgE) were elevated across treatment groups. Few patients shifted from normal baseline eosinophil levels to moderate eosinophilia by Week 16 (150&#xa0;mg, 3.4%; 300&#xa0;mg, 2.0%; placebo, 0.0%). In tralokinumab-treated patients who continued treatment beyond Week 16, median eosinophil levels at Week 52 (0.48 × 10<sup>9</sup>/L) were similar to baseline levels (<i>P</i> = 0.70). No adverse events of “eosinophilia” or “eosinophil count increased” were reported. IgE levels decreased from baseline to Week 16 in the tralokinumab groups but increased in the placebo group (median change: 150&#xa0;mg, −186&#xa0;IU/mL; 300&#xa0;mg, −105&#xa0;IU/mL; placebo: + 41&#xa0;IU/mL). Among tralokinumab-treated patients, median IgE was significantly lower at Week 52 (1183&#xa0;IU/mL) versus baseline (<i>P</i> &lt; 0.01).</p> Conclusion <p>Similar to previous findings in adults, tralokinumab treatment for up to 1 year did not have any clinically relevant impact on laboratory parameters in adolescents with moderate-to-severe AD, supporting its use without required laboratory monitoring.</p> <p><b>Trial Registration</b>: ClinicalTrials.gov identifier, NCT03526861 (ECZTRA 6); study start date: June 19, 2018; primary completion date: April 15, 2020; study completion date: March 16, 2021.</p>

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Clinical Laboratory Parameters in Adolescents with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab Up to Week 52 in the Phase 3 ECZTRA 6 Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月25日

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  • Amy S. Paller,
  • Michael J. Cork,
  • H. Chih-ho Hong,
  • Weily Soong,
  • Shannon K. R. Schneider,
  • Hannah Lo,
  • Frank Vinther,
  • Patrick Thøgersen,
  • Andreas Wollenberg

摘要

Introduction

Tralokinumab is approved for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged ≥ 12 years. Here, we examined clinical laboratory parameters in adolescents with moderate-to-severe AD who were treated with tralokinumab for up to 1 year.

Methods

This analysis assessed data from adolescents in the ECZTRA 6 (NCT03526861) phase 3 trial initiated on tralokinumab (150 mg or 300 mg) or placebo for 16 weeks. Additionally, pooled data from tralokinumab-treated patients who continued treatment beyond Week 16 were analyzed regardless of Week 16 response or tralokinumab dosing regimen (i.e., blinded 150 mg or 300 mg every 2 or 4 weeks or open-label tralokinumab 300 mg plus optional topical corticosteroids or calcineurin inhibitors).

Results

Median levels of most laboratory parameters were within respective reference ranges at baseline, Week 16, and Week 52, with comparable values across treatment groups at baseline and Week 16. Baseline levels for eosinophils and immunoglobulin E (IgE) were elevated across treatment groups. Few patients shifted from normal baseline eosinophil levels to moderate eosinophilia by Week 16 (150 mg, 3.4%; 300 mg, 2.0%; placebo, 0.0%). In tralokinumab-treated patients who continued treatment beyond Week 16, median eosinophil levels at Week 52 (0.48 × 109/L) were similar to baseline levels (P = 0.70). No adverse events of “eosinophilia” or “eosinophil count increased” were reported. IgE levels decreased from baseline to Week 16 in the tralokinumab groups but increased in the placebo group (median change: 150 mg, −186 IU/mL; 300 mg, −105 IU/mL; placebo: + 41 IU/mL). Among tralokinumab-treated patients, median IgE was significantly lower at Week 52 (1183 IU/mL) versus baseline (P < 0.01).

Conclusion

Similar to previous findings in adults, tralokinumab treatment for up to 1 year did not have any clinically relevant impact on laboratory parameters in adolescents with moderate-to-severe AD, supporting its use without required laboratory monitoring.

Trial Registration: ClinicalTrials.gov identifier, NCT03526861 (ECZTRA 6); study start date: June 19, 2018; primary completion date: April 15, 2020; study completion date: March 16, 2021.