Pariser David M, Green Lawrence J, Stein Gold Linda, Sugarman Jeffrey L, Lin Tina, Pillai Radhakrishnan
J Drugs Dermatol. 2018 Jul 1;17(7):723-726.
Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use, and posttreatment flare is common. Tazarotene has also been shown to be effective in psoriasis, with efficacy maintained several weeks posttreatment. Fixed combination therapy with TCS and tazarotene may improve psoriasis signs and minimize posttreatment flare or rebound.
To investigate the maintenance of effect posttreatment with a once-daily application of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in comparison with its active ingredients and vehicle in patients with moderate-to-severe plaque psoriasis.
Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Patients randomized (2:2:2:1 ratio) to receive HP/TAZ, individual active ingredients, or vehicle, once-daily for 8 weeks with a 4-week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score, and 'clear' or 'almost clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion.
At the end of the 4-week posttreatment period, 38.2% of patients who had been treated with HP/TAZ were treatment successes; compared with 21.0%, 12.8% and 6.9% of patients who had been treated with HP (P=0.042), TAZ (P=0.004), or vehicle (P=0.002). HP/TAZ lotion was also superior in maintaining reductions in psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At the end of the 4-week posttreatment period, 49.1%, 54.5%, and 54.5% of patients, respectively, were treatment successes: compared with 38.7% (P=0.26), 48.4% (P=0.51), and 48.4% (P=0.51) of patients who had been treated with HP; 29.8% (P=0.049), 31.9% (P=0.022), and 23.4% (P=0.001) who had been treated with TAZ; and 13.8% (P=0.002), 20.7% (P=0.003), and 20.7% (P=0.003) who had been treated with vehicle. Side effects were minimal and tended to resolve during the posttreatment period.
In conclusion, HP 0.01%/TAZ 0.045% lotion provides synergistic efficacy following 8 weeks' therapy that is sustained after a 4-week posttreatment period. J Drugs Dermatol. 2018;17(7):723-726.
银屑病是一种慢性免疫介导性疾病，临床表现差异很大。外用糖皮质激素（TCS）是主要治疗方法。长期安全性仍是一个问题，限制了其使用，且治疗后复发很常见。他扎罗汀在银屑病治疗中也已显示出有效性，治疗后数周仍能维持疗效。TCS与他扎罗汀的固定复方疗法可能改善银屑病症状，并使治疗后复发或反弹最小化。
研究每日一次外用0.01%丙酸氯倍他索/0.045%他扎罗汀（HP/TAZ）洗剂与单一活性成分及赋形剂相比，对中重度斑块状银屑病患者治疗后疗效的维持情况。
在中重度银屑病患者中进行的多中心、随机、双盲、赋形剂对照2期研究（N = 212）。患者按2:2:2:1比例随机分组，接受HP/TAZ、单一活性成分或赋形剂治疗，每日一次，共8周，并在治疗后进行4周随访。疗效评估包括治疗成功（定义为静态医师全面评估[IGA]评分较基线至少改善2级，且“清除”或“几乎清除”），以及对靶皮损处银屑病各体征（红斑、斑块隆起和鳞屑）的影响。
在治疗后4周时，接受HP/TAZ治疗的患者中有38.2%治疗成功；相比之下，接受HP治疗的患者为21.0%，接受TAZ治疗的患者为12.8%，接受赋形剂治疗的患者为6.9%（HP组P = 0.042，TAZ组P = 0.004，赋形剂组P = 0.002）。HP/TAZ洗剂在维持靶皮损处银屑病红斑、斑块隆起和鳞屑体征的减轻方面也更具优势。在治疗后4周时，分别有49.1%、54.5%和54.5%的患者治疗成功：相比之下，接受HP治疗的患者分别为38.7%（P = 0.26）、48.4%（P = 0.51）和48.4%（P = 0.51）；接受TAZ治疗的患者分别为29.8%（P =
