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Войти в исследования Dermatology and therapy · 2026
Tralokinumab Versus Dupilumab for the Treatment of Atopic Dermatitis with Moderate-to-Severe Hand Involvement: A Matching-Adjusted Indirect Comparison.
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Armstrong April, Kircik Leon, Metelitsa Andrei, Warren Richard B, Rodriguez Adrian, Volc Sebastian, Issa Naiem, Chovatiya Raj, von Eyben Rie, Festini Teodora, Johansen Pierre, Ehst Benjamin
Аннотация
INTRODUCTION: Both tralokinumab and dupilumab have shown efficacy in atopic dermatitis (AD) with moderate-to-severe hand involvement in double-blind phase 3 trials. As there are no head-to-head studies of tralokinumab and dupilumab, an anchored matching-adjusted indirect comparison (MAIC) was conducted.
METHODS: In the ADHAND trial, adults with AD with moderate-to-severe hand involvement were randomised to tralokinumab 300 mg or placebo every 2 weeks for 16 weeks. In the LIBERTY-AD-HAFT trial, adults and adolescents (≥ 12 years) with moderate-to-severe AD with hand and/or foot involvement were randomised to dupilumab 300 mg or placebo every 2 weeks for 16 weeks. An anchored MAIC was conducted using individual patient data from ADHAND weighted to match aggregate data for age, sex, race, and baseline Hand Eczema Severity Index (HECSI) score from LIBERTY-AD-HAFT, with placebo as the common anchor. Endpoints compared at week 16 were proportions of patients with Investigator's Global Assessment scores of 0/1, HECSI-75 and HECSI-90, and percent reductions in HECSI and the Routine Activity Impairment domain of the Work Productivity and Activity Index. Reductions in itch and pain and proportions of patients with ≥ 4-point itch improvement were also compared.
RESULTS: LIBERTY-AD-HAFT included 133 patients (dupilumab, n = 67, placebo, n = 66) while ADHAND included 235 patients (tralokinumab, n = 156; placebo, n = 79). The effective sample size after matching was 99 (tralokinumab, n = 76, placebo, n = 23). Anchor-adjusted relative treatment differences significantly favoured tralokinumab compared with dupilumab for the proportions of patients achieving HECSI-90 (17.5% [95% CI 0.8, 34.2]; p = 0.040) and decrease in percent routine activity impairment (16.0% [95% CI 4.8, 27.1]; p = 0.005). Relative differences for other endpoints favoured tralokinumab over dupilumab but were not significantly different between treatments.
CONCLUSION: In this anchored MAIC, tralokinumab was associated with a higher placebo-adjusted response than dupilumab, with a higher proportion achieving HECSI-90, and a significantly greater improvement in ability to perform regular daily activities versus dupilumab. Other endpoints were numerically in favour of tralokinumab. Graphical abstract and video abstract available for this article.
CLINICAL TRIAL REGISTRATION: NCT05958407, NCT04417894. Video Abstract (MP4 112997 KB).
METHODS: In the ADHAND trial, adults with AD with moderate-to-severe hand involvement were randomised to tralokinumab 300 mg or placebo every 2 weeks for 16 weeks. In the LIBERTY-AD-HAFT trial, adults and adolescents (≥ 12 years) with moderate-to-severe AD with hand and/or foot involvement were randomised to dupilumab 300 mg or placebo every 2 weeks for 16 weeks. An anchored MAIC was conducted using individual patient data from ADHAND weighted to match aggregate data for age, sex, race, and baseline Hand Eczema Severity Index (HECSI) score from LIBERTY-AD-HAFT, with placebo as the common anchor. Endpoints compared at week 16 were proportions of patients with Investigator's Global Assessment scores of 0/1, HECSI-75 and HECSI-90, and percent reductions in HECSI and the Routine Activity Impairment domain of the Work Productivity and Activity Index. Reductions in itch and pain and proportions of patients with ≥ 4-point itch improvement were also compared.
RESULTS: LIBERTY-AD-HAFT included 133 patients (dupilumab, n = 67, placebo, n = 66) while ADHAND included 235 patients (tralokinumab, n = 156; placebo, n = 79). The effective sample size after matching was 99 (tralokinumab, n = 76, placebo, n = 23). Anchor-adjusted relative treatment differences significantly favoured tralokinumab compared with dupilumab for the proportions of patients achieving HECSI-90 (17.5% [95% CI 0.8, 34.2]; p = 0.040) and decrease in percent routine activity impairment (16.0% [95% CI 4.8, 27.1]; p = 0.005). Relative differences for other endpoints favoured tralokinumab over dupilumab but were not significantly different between treatments.
CONCLUSION: In this anchored MAIC, tralokinumab was associated with a higher placebo-adjusted response than dupilumab, with a higher proportion achieving HECSI-90, and a significantly greater improvement in ability to perform regular daily activities versus dupilumab. Other endpoints were numerically in favour of tralokinumab. Graphical abstract and video abstract available for this article.
CLINICAL TRIAL REGISTRATION: NCT05958407, NCT04417894. Video Abstract (MP4 112997 KB).