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

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. 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, jinhongzhong@263.net. Department of Dermatology, Heilongjiang Provincial Hospital, Harbin, China. Department of Dermatology, Dermatology Hospital of Jiangxi Province, Nanchang, China. Department of Dermatology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China. Department of Dermatology, Shenyang Military Region General Hospital, Shenyang, China. Department of Dermatology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China. Department of Dermatology, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Department of Dermatology, Chinese Academy of Medical Sciences and Hospital for Skin Diseases, Nanjing, China. Department of Dermatology, Guangdong Provincial Dermatology Hospital, Guangzhou, China. Department of Dermatology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China. Department of Dermatology, Dalian Dermatosis Hospital, Dalian, China. Department of Dermatology, Affiliated Hospital of Hebei University of Engineering, Handan, China. Department of Dermatology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, China. Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. Department of Dermatology, Affiliated Hospital of Chengde Medical College, Chengde, China. Department of Dermatology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China. Department of Dermatology, Second Affiliated Hospital of People's Liberation Army Military Medical University, Chongqing, China. Department of Dermatology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China. Department of Dermatology, Wuhan No. 1 Hospital, Wuhan, China. Department of Dermatology, Yantai Yuhuangding Hospital, Yantai, China. Department of Dermatology, Shengli Oilfield Central Hospital, Dongying, China. Department of Dermatology, Zhongnan Hospital of Wuhan University, Wuhan, China. Department of Dermatology, The First People's Hospital of Changzhou, Changzhou, China. Department of Dermatology, The First Affiliated Hospital of China Medical University, Shenyang, China. Department of Dermatology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. Department of Dermatology, The Second Xiangya Hospital of Central South University, Changsha, China. Department of Dermatology, The First Affiliated Hospital of Shantou University Medical College, Shantou, China. Department of Dermatology, Shanghai Tenth People's Hospital, Shanghai, China. Department of Dermatology, Shiyan Taihe Hospital, Shiyan, China. Department of Dermatology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China. Department of Dermatology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China. Department of Dermatology, Gansu Provincial People's Hospital, Lanzhou, China. Department of Dermatology, Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. Department of Dermatology, Peking University First Hospital, Beijing, China.

Dermatology (Basel, Switzerland). 2021;(4):603-610

Abstract

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.

Methodological quality

Publication Type : Multicenter Study ; Observational Study

Metadata

MeSH terms : Psoriasis