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
LEO Pharma Receives Positive CHMP Opinion of Adtralza (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis
If authorized, Adtralza (tralokinumab) will be the first approved biologic that specifically targets the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms
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The CHMP opinion is primarily supported by data from ECZTRA 1, 2, and 3 trials included in the Marketing Authorization Application
LEO Pharma A/S, a global leader in medical dermatology, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization of Adtralza
E-Mail Etrasimod 2 mg treatment group achieved statistical significance in the percentage change in weekly peak pruritis (PP-NRS), in the change in Dermatology Life Quality Index (DLQI), and in the change in Patient-Oriented Eczema Measure (POEM) Etrasimod 2 mg was generally well tolerated, consistent with data in previous trials
Park City, Utah, April 23, 2021 - Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced data at a late-breaking session at the American Academy of Dermatology VMX Experience. Etrasimod, a novel investigational drug candidate to treat moderate-to-severe atopic dermatitis (AD), demonstrated statistical significance in both clinician and patient reported outcomes in the ADVISE Phase 2b clinical trial. Etrasimod is a highly selective, once-daily, oral sphingosine 1-phosphate (S1P) receptor modulator. Today s results are presented by Emma Guttman-Yassky, MD, PhD, Waldman Professor and Chairwoman, The Kimberly and Eric J. Waldman Department of Derma
Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla®
Significantly more patients treated with deucravacitinib achieved PASI 75 and sPGA 01 compared to patients treated with placebo and Otezla at Week 16, with an increased benefit versus Otezla at Week 24 and maintained through Week 52 Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 inhibitor with a unique … Significantly more patients treated with deucravacitinib achieved PASI 75 and sPGA 0/1 compared to patients treated with placebo and Otezla at Week 16, with an increased benefit versus Otezla at Week 24 and maintained through Week 52
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Simultaneous inhibition of interleukin(IL)-17A and 17F with bimekizumab led to more rapid clearance of plaque psoriasis in significantly more patients as compared with the IL-17A inhibitor secukinumab (Cosentyx), a large randomized trial showed.
After 16 weeks, 61.7% of patients treated with bimekizumab had a 100% reduction in the Psoriasis Area and Severity Index (PASI 100) compared with 48.9% of the secukinumab arm. The 12.7% absolute difference met statistical criteria for noninferiority and superiority in favor of bimekizumab. Clearance occurred more rapidly with bimekizumab, as 71.0% of patients randomized to the IL-17A/F inhibitor had 75% or greater reduction from baseline in the PASI score at 4 weeks compared with 47.3% of the secukinumab arm.