他扎罗汀倍他米松乳膏治疗斑块状银屑病患者的疗效：一项前瞻性、多中心、观察性研究的结果。

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

机构信息

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.

出版信息

Dermatology. 2021;237(4):603-610. doi: 10.1159/000511891. Epub 2020 Dec 22.

DOI:10.1159/000511891

PMID:33352561

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.

摘要

背景

局部治疗药物仍然是治疗轻中度斑块状银屑病的主要手段，其中固定剂量复方制剂发挥着重要作用。他扎罗汀倍他米松乳膏（Taz/BD）是一种新型的固定剂量复方制剂，已在中国获批用于治疗斑块状银屑病，但在真实环境中其疗效和安全性尚未得到验证。

目的

本研究的主要目的是评估他扎罗汀倍他米松乳膏治疗斑块状银屑病的疗效和安全性。次要目的是评估其停药后的复发情况，以及在重新治疗期间的疗效和安全性特征。

方法

这是一项前瞻性、多中心、大规模观察性研究。纳入患有慢性斑块状银屑病且受累体表面积<20%的成年患者。患者接受他扎罗汀倍他米松乳膏每日 1 次治疗，共 4 周。从基线到第 4 周时，若患者的银屑病面积与严重性指数（PASI）改善≥90%，则对其进行随访，以评估停药后的复发情况。复发患者再次接受为期 4 周的治疗。

结果

共纳入 2299 例符合条件的患者，其中 2095 例（91.1%）完成了 4 周的研究。第 4 周时，平均 PASI 改善率为 53.7%，PASI 50/75 应答率分别为 62.5%和 26.8%。斑块状硬化、脱屑和红斑的平均 PASI 改善率分别为 58.3%、61.0%和 40.0%（p<0.001）。第 4 周时，445 例（20.8%）患者出现不良反应。最常见的不良反应为局部皮肤刺激，包括瘙痒（10%）、疼痛（6.7%）、红斑（6.1%）和脱屑（1.8%）。停药后 8 周内，有 47 例（24.0%）患者复发。45 例患者再次接受为期 4 周的治疗，PASI 50/75 应答率分别为 72.7%和 40.9%。重新治疗期间未出现意外的安全性信号。