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

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: /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.