Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study.
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.
['He|Chunxia|C|', 'Jin|Hongzhong|H|', 'Liu|Xiguang|X|', 'Hu|Fengming|F|', 'Zhang|Litao|L|', 'Zhang|Shifa|S|', 'He|Yanling|Y|', 'Yang|Xiumin|X|', 'Chen|Hao|H|', 'Wang|Xiaohua|X|', 'Ji|Chao|C|', 'Lv|Chengzhi|C|', 'Miao|Guoying|G|', 'Li|Xiaojing|X|', 'Diao|Qingchun|Q|', 'Li|Linfeng|L|', 'Li|Xuefei|X|', 'Li|Yuzhen|Y|', 'Wang|Rupeng|R|', 'Zhang|Lijuan|L|', 'Zhou|Xiaoyong|X|', 'Xia|Xiujuan|X|', 'Yan|Min|M|', 'Song|Jiquan|J|', 'Zhang|Ruzhi|R|', 'Geng|Long|L|', 'Zheng|Min|M|', 'Lu|Qianjin|Q|', 'Lu|Tao|T|', 'Shi|Yuling|Y|', 'Jing|Haixia|H|', 'Zhang|Xiaojie|X|', 'Shi|Jianqiang|J|', 'Xia|Jue|J|', 'Gao|Yu|Y|', 'Wang|Yun|Y|']
Tazarotene Betamethasone Psoriasis Relapse