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- W4285992481 abstract "In 2 monotherapy phase 3 studies (ECZTRA 1 and 2) of patients with moderate-to-severe atopic dermatitis (AD) treated with tralokinumab, one of the primary endpoints was IGA 0/1 (clear/almost clear) at Week 16. However, in a heterogeneous disease like AD, other important and clinically meaningful parameters include improvement in signs, symptoms, and/or quality of life. We assessed the impact of tralokinumab on AD signs, symptoms, and quality of life in patients with IGA>1 at Week 16. Partial responders, defined as patients with IGA>1 at Week 16, were included in a post-hoc analysis of ECZTRA 1 and 2. Non-responder imputation (NRI) was used for patients who utilized rescue medication or had missing data, and as observed to address missing data (AO). Clinically meaningful changes were defined as EASI-50, ≥3-point improvement in Worst Daily Pruritus NRS (itch), and ≥4-point improvement in DLQI. At Week 16, 960 patients on tralokinumab and 358 patients on placebo had IGA>1 by NRI (AO: tralokinumab n=898, placebo n=327). 49% (NRI), 82% (AO) of the patients with IGA>1 in the tralokinumab arm achieved clinically meaningful changes in EASI, itch, and/or DLQI. 33% met EASI-50, 23% achieved ≥3-point improvement in Itch NRS, and 41% achieved ≥4-point improvement in DLQI by NRI (AO: 55%, 40%, 71%). At Week 16, tralokinumab patients with IGA>1 achieved significantly (P<0.001) greater responses across all endpoints versus placebo. At 16 weeks of treatment with tralokinumab, partial responders achieved clinically meaningful improvement in AD signs, symptoms, and quality of life." @default.
- W4285992481 created "2022-07-21" @default.
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- W4285992481 date "2022-08-01" @default.
- W4285992481 modified "2023-09-26" @default.
- W4285992481 title "LB946 Clinically meaningful responses achieved with tralokinumab in adults with moderate-to-severe atopic dermatitis who did not meet IGA 0/1 at initial 16-week treatment" @default.
- W4285992481 doi "https://doi.org/10.1016/j.jid.2022.05.965" @default.
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