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Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study

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机构: [a]Department of Dermatology, National Clinical Research Center for Skin and Immune Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [b]Department of Dermatology, Heilongjiang Provincial Hospital, Harbin, China [c]Department of Dermatology, Dermatology Hospital of Jiangxi Province, Nanchang, China [d]Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China [e]Department of Dermatology, Shenyang Military Region General Hospital, Shenyang, China [f]Department of Dermatology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China [g]Department of Dermatology, Beijing Tongren Hospital, Capital Medical University, Beijing, China [h]Department of Dermatology, Chinese Academy of Medical Sciences and Hospital for Skin Diseases, Nanjing, China [i]Department of Dermatology, Guangdong Provincial Dermatology Hospital, Guangzhou, China [j]Department of Dermatology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China [k]Department of Dermatology, Dalian Dermatosis Hospital, Dalian, China [l]Department of Dermatology, Affiliated Hospital of Hebei University of Engineering, Handan, China [m]Department of Dermatology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, China [n]Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China [o]Department of Dermatology, Affiliated Hospital of Chengde Medical College, Chengde, China [p]Department of Dermatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China [q]Department of Dermatology, Second Affiliated Hospital of People’s Liberation Army Military Medical University, Chongqing, China [r]Department of Dermatology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China [s]Department of Dermatology, Wuhan No. 1 Hospital, Wuhan, China [t]Department of Dermatology, Yantai Yuhuangding Hospital, Yantai, China [u]Department of Dermatology, Shengli Oilfield Central Hospital, Dongying, China [v]Department of Dermatology, Zhongnan Hospital of Wuhan University, Wuhan, China [w]Department of Dermatology, The First People’s Hospital of Changzhou, Changzhou, China [x]Department of Dermatology, The First Affiliated Hospital of China Medical University, Shenyang, China [y]Department of Dermatology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China [z]Department of Dermatology, The Second Xiangya Hospital of Central South University, Changsha, China [A]Department of Dermatology, The First Affiliated Hospital of Shantou University Medical College, Shantou, China [B]Department of Dermatology, Shanghai Tenth People’s Hospital, Shanghai, China [C]Department of Dermatology, Shiyan Taihe Hospital, Shiyan, China [D]Department of Dermatology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China [E]Department of Dermatology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China [F]Department of Dermatology, Gansu Provincial People’s Hospital, Lanzhou, China [G]Department of Dermatology, Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China [H]Department of Dermatology, Peking University First Hospital, Beijing, China
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关键词: Betamethasone Psoriasis Relapse Tazarotene

摘要:
Background: Topical agents are still the mainstay for the treatment of mild-to-moderate plaque psoriasis, in which fixed combinations play an important role. Tazarotene/betamethasone dipropionate (Taz/BD) cream is a novel fixed combination approved for treating plaque psoriasis in China, but its efficacy and safety have not been verified in a real-world environment. Objectives: The primary objective was to investigate the efficacy and safety of Taz/BD cream in treating plaque psoriasis. The secondary objectives were to assess its relapse after discontinuation and the efficacy and safety profiles during retreatment. Methods: A prospective, multicenter, large-scale observational study was conducted. Adult patients with chronic plaque psoriasis involving <20% of the body surface area were enrolled. Taz/BD cream was applied once daily for 4 weeks. Patients who achieved ≥90% improvement in the Psoriasis Area and Severity Index (PASI) from baseline to week 4 were followed up to investigate relapse after drug withdrawal. Relapsed patients underwent another 4-week treatment. Results: In total, 2,299 eligible patients were enrolled, and 2,095 patients (91.1%) completed the 4-week study. The mean PASI improvement at week 4 was 53.7%, and the PASI 50/75 response rates were 62.5 and 26.8%, respectively. The mean PASI reduction in plaque induration, desquamation and erythema were 58.3, 61.0 and 40.0%, respectively (p < 0.001). Adverse reactions occurred in 445 patients (20.8%) at week 4. The most frequently reported adverse reactions were local skin irritation, including pruritus (10%), pain (6.7%), erythema (6.1%) and desquamation (1.8%). During the post-treatment period, 47 patients (24.0%) relapsed within 8 weeks after drug discontinuation. Forty-five patients were retreated for another 4 weeks, and the PASI 50/75 response rates were 72.7 and 40.9%, respectively. There were no unexpected safety signals during retreatment. Conclusion: Taz/BD cream is effective and well tolerated in treating mild-to-moderate plaque psoriasis under near real-world conditions and demonstrates efficacy and safety during retreatment. © 2020

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大类 | 3 区 医学
小类 | 3 区 皮肤病学
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 皮肤病学
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出版当年[2019]版:
Q1 DERMATOLOGY
最新[2023]版:
Q2 DERMATOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2019版] 出版当年五年平均 出版前一年[2018版] 出版后一年[2020版]

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第一作者机构: [a]Department of Dermatology, National Clinical Research Center for Skin and Immune Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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通讯机构: [a]Department of Dermatology, National Clinical Research Center for Skin and Immune Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [A]Department of Dermatology, The First Affiliated Hospital of Shantou University Medical College, Shantou, China [*1]Department of Dermatology, National Clinical Research Center for Skin and Immune Diseases, Peking Union Medical College Hospital Chinese Academy of Medical Sciences and Peking Union Medical College No. 1 Shuaifuyuan, Dongcheng District, Beijing 100730 (China)
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