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MOA www.tsim.org.tw/journal/jour29-6/02.PDF?fbclid=IwAR2B85aLqBUAt5agx6K7u0NkCGTGpr7w6HDCagHhLuu54ZH7FEqHMAdXG3M
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Lebrikizumab ¤T´Á, ¥Dn«ü¼Ð: Primary Outcome Measures ƒÊ : 1.Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate2) Study Type ƒÊ : Interventional (Clinical Trial) Estimated Enrollment ƒÊ : 400 participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, double-blind, parallel group, placebo controlled Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Double-blind Primary Purpose: Treatment Official Title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis. Actual Study Start Date ƒÊ : November 8, 2019 Estimated Primary Completion Date ƒÊ : June 2021 Estimated Study Completion Date ƒÊ : December 2021
clinicaltrials.gov/ct2/show/NCT04178967?term=Lebrikizumab+PHASE+3&draw=2&rank=10
Primary Outcome Measures ƒÊ : 1.Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Secondary Outcome Measures ƒÊ : 1.Percentage of patients achieving EASI-75 (≥75% reduction in EASI score) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
2.Percentage of patients achieving EASI-90 (≥90% reduction in EASI score) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
3.Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
4.Percentage of patients with a Pruritus NRS score of ≥4-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
5.Percentage of patients with a Pruritus NRS score of ≥5-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
6.Percentage change in EASI score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
7.Change from Baseline to Week 16 in percent BSA [ Time Frame: Baseline to Week 16 ]
8.Percentage of patients achieving EASI-90 from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
9.Percentage change in Sleep-loss score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
10.Change from Baseline in Sleep-loss score at Week 16 [ Time Frame: Baseline to Week 16 ]
11.Percentage of patients with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
12.Percentage of patients with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
13.Percentage of patients with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
14.Percentage of patients with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
15.Percentage of patients with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
16.Percentage of patients with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
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Dupilumab treatment in adults with moderate-to-severe atopic dermatitis
Lisa A Beck 1 , Diamant Thaçi, Jennifer D Hamilton, Neil M Graham, Thomas Bieber, Ross Rocklin, Jeffrey E Ming, Haobo Ren, Richard Kao, Eric Simpson, Marius Ardeleanu, Steven P Weinstein, Gianluca Pirozzi, Emma Guttman-Yassky, Mayte Suárez-Fariñas, Melissa D Hager, Neil Stahl, George D Yancopoulos, Allen R Radin
Affiliations Expand
PMID: 25006719 DOI: 10.1056/NEJMoa1314768
Abstract
Background: Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13, has shown efficacy in patients with asthma and elevated eosinophil levels. The blockade by dupilumab of these key drivers of type 2 helper T-cell (Th2)-mediated inflammation could help in the treatment of related diseases, including atopic dermatitis.
Methods: We performed randomized, double-blind, placebo-controlled trials involving adults who had moderate-to-severe atopic dermatitis despite treatment with topical glucocorticoids and calcineurin inhibitors. Dupilumab was evaluated as monotherapy in two 4-week trials and in one 12-week trial and in combination with topical glucocorticoids in another 4-week study. End points included the Eczema Area and Severity Index (EASI) score, the investigator¡¦s global assessment score, pruritus, safety assessments, serum biomarker levels, and disease transcriptome.
Results: In the 4-week monotherapy studies, dupilumab resulted in rapid and dose-dependent improvements in clinical indexes, biomarker levels, and the transcriptome. The results of the 12-week study of dupilumab monotherapy reproduced and extended the 4-week findings: 85% of patients in the dupilumab group, as compared with 35% of those in the placebo group, had a 50% reduction in the EASI score (EASI-50, with higher scores in the EASI indicating greater severity of eczema) (P<0.001); 40% of patients in the dupilumab group, as compared with 7% in the placebo group, had a score of 0 to 1 (indicating clearing or near-clearing of skin lesions) on the investigator¡¦s global assessment (P<0.001); and pruritus scores decreased (indicating a reduction in itch) by 55.7% in the dupilumab group versus 15.1% in the placebo group (P<0.001). In the combination study, 100% of the patients in the dupilumab group, as compared with 50% of those who received topical glucocorticoids with placebo injection, met the criterion for EASI-50 (P=0.002), despite the fact that patients who received dupilumab plus glucocorticoids used less than half the amount of topical glucocorticoids used by those who received placebo plus the topical medication (P=0.16). Adverse events, such as skin infection, occurred more frequently with placebo; nasopharyngitis and headache were the most frequent adverse events with dupilumab.
Conclusions: Patients treated with dupilumab had marked and rapid improvement in all the evaluated measures of atopic dermatitis disease activity. Side-effect profiles were not dose-limiting. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov numbers, NCT01259323, NCT01385657, NCT01639040, and NCT01548404.).
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EASI-50 Dupilumab 71.4%/placebo(¹ï·Ó²Õ)18.8% .¡]1b ,n=21:16 )
Study Type ƒÊ : Interventional (Clinical Trial) Actual Enrollment ƒÊ : 37 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Atopic Dermatitis Actual Study Start Date ƒÊ : July 31, 2011 Actual Primary Completion Date ƒÊ : March 31, 2012 Actual Study Completion Date ƒÊ : March 31, 2012
Experimental: Placebo Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22 Drug: Placebo A total of 4 doses were administered.
Other: Background treatment Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.
Experimental: Dupilumab 150 mg Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22 Drug: Dupilumab A total of 4 doses were administered.
Other Names:•REGN668 •SAR231893 •Dupixent
Other: Background treatment Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.
Experimental: Dupilumab 300 mg Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22 Drug: Dupilumab A total of 4 doses were administered.
Other Names:•REGN668 •SAR231893 •Dupixent
Other: Background treatment Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.
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