Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS)

医学 安慰剂 耐受性 银屑病 银屑病面积及严重程度指数 剂量范围研究 内科学 临床终点 人口 随机对照试验 不利影响 胃肠病学 皮肤病科 双盲 病理 替代医学 环境卫生
作者
Richard B. Warren,Lars E. French,Andrew Blauvelt,Richard Langley,Alexander Egeberg,Ulrich Mrowietz,H.J.A. Hunter,Melinda Gooderham,Per Soelberg Soerensen,Philippe Andrès,Morten Otto Alexander Sommer,Anna Carlsson,Kim D. Kjøller,Bruce Strober
出处
期刊:Journal of The American Academy of Dermatology [Elsevier BV]
卷期号:90 (3): 494-503 被引量:10
标识
DOI:10.1016/j.jaad.2023.11.005
摘要

Background Orismilast is a novel oral phosphodiesterase 4 (PDE4) B/D inhibitor being investigated as a potential treatment for moderate-to-severe psoriasis. Objective To evaluate efficacy and safety of orismilast modified-release formulation in moderate-to-severe psoriasis. Methods This multicenter, randomized (1:1:1:1 to 20, 30, 40 mg orismilast or placebo, twice daily), double-blinded, placebo-controlled, parallel-group, phase 2b, 16-week, dose-ranging study evaluated orismilast in adults with moderate-to-severe plaque psoriasis (NCT05190419). Efficacy endpoints were analyzed using multiple imputation. Results Of 202 randomized patients, baseline characteristics were balanced across arms, except greater severe disease proportions for orismilast versus placebo. Orismilast showed significant improvements in the primary endpoint, percentage change in Psoriasis Area and Severity Index (PASI), from baseline to week 16 (orismilast –52.6% to –63.7%; placebo, –17.3%; all P<0.001). Greater proportions receiving orismilast achieved PASI75 (39.5% to 49.0%; P<0.05) and PASI90 (22.0% to 28.3%; P<0.05 for 20 and 40 mg) versus placebo (PASI75, 16.5%; PASI90, 8.3%) at week 16. Safety findings were as expected with PDE4 inhibition; dose-dependent tolerability effects observed. Limitations Small sample size, disease severity imbalance between groups, limited duration and diversity in study population. Conclusion Orismilast demonstrated greater efficacy versus placebo and a safety profile in line with PDE4 inhibition.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
1秒前
xueyu发布了新的文献求助10
1秒前
1秒前
文献完成签到 ,获得积分10
2秒前
levicho发布了新的文献求助10
3秒前
KK发布了新的文献求助10
4秒前
5秒前
Norl_Corxilea发布了新的文献求助10
6秒前
CodeCraft应助愉快的宛儿采纳,获得10
7秒前
一方通行发布了新的文献求助10
7秒前
levicho完成签到,获得积分10
8秒前
量子星尘发布了新的文献求助10
8秒前
10秒前
11秒前
Norl_Corxilea完成签到,获得积分10
12秒前
15秒前
我是老大应助Culto采纳,获得10
16秒前
18秒前
超帅青烟完成签到,获得积分10
18秒前
18秒前
科目三应助KK采纳,获得10
19秒前
Shuaibin_Pei完成签到,获得积分10
22秒前
张今天也要做科研呀完成签到,获得积分10
22秒前
shinysparrow完成签到,获得积分0
22秒前
传奇3应助LJJ采纳,获得10
23秒前
24秒前
25秒前
科研蚂蚁完成签到,获得积分10
26秒前
桃子完成签到 ,获得积分10
26秒前
魁梧的鲂发布了新的文献求助10
29秒前
健忘白应助su采纳,获得10
29秒前
Culto发布了新的文献求助10
30秒前
31秒前
猫猫完成签到,获得积分10
32秒前
34秒前
momo发布了新的文献求助10
35秒前
小宇子发布了新的文献求助10
35秒前
Mr兔仙森完成签到,获得积分10
36秒前
LJJ发布了新的文献求助10
37秒前
37秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989334
求助须知:如何正确求助?哪些是违规求助? 3531428
关于积分的说明 11253936
捐赠科研通 3270119
什么是DOI,文献DOI怎么找? 1804887
邀请新用户注册赠送积分活动 882087
科研通“疑难数据库(出版商)”最低求助积分说明 809173