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LEO Pharma LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021 Monday, April 26, 2021 1:00PM IST (7:30AM GMT)
Ballerup, Denmark & Madison, N.J., United States:
Interim analysis at 56 weeks from ECZTEND, an open-label extension trial, demonstrates sustainable and durable efficacy of tralokinumab in adult patients 1 Patients enrolled in ECZTRA 1 and 2 parent trials who continued into ECZTEND have now been treated with tralokinumab for two years 1 1 LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021. ....
2.0 (2.4) Participants included 1,174 patients from ECZTEND at data cut-off.1 Observed outcomes for all patients enrolled 60 weeks prior to data cut-off (n=513) were analyzed at Week 56.1 At parent-trial baseline, ECZTEND baseline, and Week 56, median EASI score was 26.6, 4.7, and 1.8, respectively.1 At Week 56, IGA and EASI response rates were 49.7% (IGA 0/1), 95.1% (EASI-50), 82.8% (EASI-75), 61.0% (EASI-90), and 79.7% (EASI ≤7). An EASI score of ≤7 corresponds to mild atopic dermatitis.1 At the same 56-week data cut-off, measurements of itch and sleep disruptions due to itch were also reported.1 At Week 56, the mean worst weekly pruritus (i.e. itch) numeric rating scale (NRS) score was 3.3 (parent-trial baseline was 7.7) while the mean eczema-related weekly sleep NRS score was 2.0 (parent-trial baseline was 6.9).1 ....