沙环素在中国中重度寻常性痤疮患者中的疗效和安全性:开放标签随访的随机3期临床试验

IF 4.2 3区 医学 Q1 DERMATOLOGY
Jianzhong Zhang, Li He, Xue Chen, Ying Tu, Belchin Kostov, Judit Cabedo, Tolga Baykal, Esther García Gil
{"title":"沙环素在中国中重度寻常性痤疮患者中的疗效和安全性:开放标签随访的随机3期临床试验","authors":"Jianzhong Zhang, Li He, Xue Chen, Ying Tu, Belchin Kostov, Judit Cabedo, Tolga Baykal, Esther García Gil","doi":"10.1007/s13555-025-01526-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to evaluate the efficacy and safety of sarecycline in Chinese patients with moderate-to-severe acne vulgaris (AV).</p><p><strong>Methods: </strong>The 12-week (W) randomized, multicenter, double-blind (DB), placebo-controlled phase 3 trial was conducted from 29 October 2021 to 14 October 2022 at 34 centers in China, with a 36W open-label follow-up (OLFU) until 23 June 2023 for patients who responded to treatment during the DB period. Patients aged 9-45 years with AV were randomized (2:1) to sarecycline (approximately 1.5 mg/kg/day) or placebo for 12W. Treatment responders received sarecycline for an additional 12W if acne recurred during the OLFU. Endpoints were absolute change from baseline (CFB) and percent CFB (%CFB) to W3, W6, W9 and W12 in facial inflammatory lesion counts.</p><p><strong>Results: </strong>Three hundred ninety-one patients comprised the intent-to-treat analysis set (mean age: 21.9 years; 58.6% female). Sarecycline-treated patients had a statistically significantly greater reduction in the mean (standard error [SE]) absolute and %CFB to W12 in facial inflammatory lesion counts than placebo-treated patients: - 24.3 (0.7) vs. - 15.4 (1.0) (p < 0.001) and - 73.2% vs. - 46.0% (p < 0.001), respectively, with improvements observed as early as W3. Sarecycline was safe and well tolerated through W12. Incidence of treatment-emergent adverse events (TEAEs) with sarecycline (48.3%) was similar to that of placebo (49.6%). Most TEAEs were mild (87.3%), and few patients reported TEAEs that led to discontinuation of sarecycline (1.9%) or placebo (2.3%). Notably, patients whose acne recurred in the OLFU (23/45 [51.1%]) responded well to a second 12W course of sarecycline with a mean (standard deviation [SD]) reduction of - 23.1 (8.9) in the absolute CFB to the first visit after treatment reinitiation in facial inflammatory lesion counts.</p><p><strong>Conclusions: </strong>Sarecycline was effective and had an acceptable safety profile in treating moderate-to-severe AV in Chinese patients, supporting its value for treating AV in this population.</p><p><strong>Clinical trial registration: </strong>Chinese Clinical Trial Registry (CTR20211314); http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml .</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2000,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up.\",\"authors\":\"Jianzhong Zhang, Li He, Xue Chen, Ying Tu, Belchin Kostov, Judit Cabedo, Tolga Baykal, Esther García Gil\",\"doi\":\"10.1007/s13555-025-01526-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>This study aimed to evaluate the efficacy and safety of sarecycline in Chinese patients with moderate-to-severe acne vulgaris (AV).</p><p><strong>Methods: </strong>The 12-week (W) randomized, multicenter, double-blind (DB), placebo-controlled phase 3 trial was conducted from 29 October 2021 to 14 October 2022 at 34 centers in China, with a 36W open-label follow-up (OLFU) until 23 June 2023 for patients who responded to treatment during the DB period. Patients aged 9-45 years with AV were randomized (2:1) to sarecycline (approximately 1.5 mg/kg/day) or placebo for 12W. Treatment responders received sarecycline for an additional 12W if acne recurred during the OLFU. Endpoints were absolute change from baseline (CFB) and percent CFB (%CFB) to W3, W6, W9 and W12 in facial inflammatory lesion counts.</p><p><strong>Results: </strong>Three hundred ninety-one patients comprised the intent-to-treat analysis set (mean age: 21.9 years; 58.6% female). Sarecycline-treated patients had a statistically significantly greater reduction in the mean (standard error [SE]) absolute and %CFB to W12 in facial inflammatory lesion counts than placebo-treated patients: - 24.3 (0.7) vs. - 15.4 (1.0) (p < 0.001) and - 73.2% vs. - 46.0% (p < 0.001), respectively, with improvements observed as early as W3. Sarecycline was safe and well tolerated through W12. Incidence of treatment-emergent adverse events (TEAEs) with sarecycline (48.3%) was similar to that of placebo (49.6%). Most TEAEs were mild (87.3%), and few patients reported TEAEs that led to discontinuation of sarecycline (1.9%) or placebo (2.3%). Notably, patients whose acne recurred in the OLFU (23/45 [51.1%]) responded well to a second 12W course of sarecycline with a mean (standard deviation [SD]) reduction of - 23.1 (8.9) in the absolute CFB to the first visit after treatment reinitiation in facial inflammatory lesion counts.</p><p><strong>Conclusions: </strong>Sarecycline was effective and had an acceptable safety profile in treating moderate-to-severe AV in Chinese patients, supporting its value for treating AV in this population.</p><p><strong>Clinical trial registration: </strong>Chinese Clinical Trial Registry (CTR20211314); http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml .</p>\",\"PeriodicalId\":11186,\"journal\":{\"name\":\"Dermatology and Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2025-08-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatology and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s13555-025-01526-8\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01526-8","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

本研究旨在评价沙环素在中国中重度寻常性痤疮(AV)患者中的疗效和安全性。方法:从2021年10月29日至2022年10月14日,在中国34个中心进行了为期12周的随机、多中心、双盲(DB)、安慰剂对照的3期试验,对在DB期间对治疗有反应的患者进行了36W的开放标签随访(OLFU),直至2023年6月23日。年龄9-45岁的AV患者随机(2:1)接受沙霉素(约1.5 mg/kg/天)或安慰剂治疗12W。如果在OLFU期间痤疮复发,治疗应答者额外接受12W的赛环素治疗。终点是面部炎症病灶计数从基线(CFB)和CFB百分比(%CFB)到W3、W6、W9和W12的绝对变化。结果:391例患者组成意向治疗分析集(平均年龄:21.9岁,58.6%为女性)。与安慰剂治疗的患者相比,接受赛环素治疗的患者在面部炎症病灶计数的平均(标准误差[SE])绝对值和%CFB / W12的降低具有统计学意义上的显著性:- 24.3(0.7)比- 15.4 (1.0)(p)。结论:赛环素在治疗中国中重度AV患者中是有效的,并且具有可接受的安全性,支持其在该人群中治疗AV的价值。临床试验注册:中国临床试验注册中心(CTR20211314);http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up.

Introduction: This study aimed to evaluate the efficacy and safety of sarecycline in Chinese patients with moderate-to-severe acne vulgaris (AV).

Methods: The 12-week (W) randomized, multicenter, double-blind (DB), placebo-controlled phase 3 trial was conducted from 29 October 2021 to 14 October 2022 at 34 centers in China, with a 36W open-label follow-up (OLFU) until 23 June 2023 for patients who responded to treatment during the DB period. Patients aged 9-45 years with AV were randomized (2:1) to sarecycline (approximately 1.5 mg/kg/day) or placebo for 12W. Treatment responders received sarecycline for an additional 12W if acne recurred during the OLFU. Endpoints were absolute change from baseline (CFB) and percent CFB (%CFB) to W3, W6, W9 and W12 in facial inflammatory lesion counts.

Results: Three hundred ninety-one patients comprised the intent-to-treat analysis set (mean age: 21.9 years; 58.6% female). Sarecycline-treated patients had a statistically significantly greater reduction in the mean (standard error [SE]) absolute and %CFB to W12 in facial inflammatory lesion counts than placebo-treated patients: - 24.3 (0.7) vs. - 15.4 (1.0) (p < 0.001) and - 73.2% vs. - 46.0% (p < 0.001), respectively, with improvements observed as early as W3. Sarecycline was safe and well tolerated through W12. Incidence of treatment-emergent adverse events (TEAEs) with sarecycline (48.3%) was similar to that of placebo (49.6%). Most TEAEs were mild (87.3%), and few patients reported TEAEs that led to discontinuation of sarecycline (1.9%) or placebo (2.3%). Notably, patients whose acne recurred in the OLFU (23/45 [51.1%]) responded well to a second 12W course of sarecycline with a mean (standard deviation [SD]) reduction of - 23.1 (8.9) in the absolute CFB to the first visit after treatment reinitiation in facial inflammatory lesion counts.

Conclusions: Sarecycline was effective and had an acceptable safety profile in treating moderate-to-severe AV in Chinese patients, supporting its value for treating AV in this population.

Clinical trial registration: Chinese Clinical Trial Registry (CTR20211314); http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml .

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信