Lebwohl Mark G, Papp Kim A, Mørch Marie Holst, Bernasconi Marie Y Jablonski, Warren Richard B
Department of Dermatology, Icahn School of Medicine at Mount Sinai, 5 East 98th St, New York, NY, USA.
Probity Medical Research, K Papp Clinical Research, 135 Union St E, Waterloo, ON, N2J 1C4, Canada.
Dermatol Ther (Heidelb). 2021 Oct;11(5):1657-1665. doi: 10.1007/s13555-021-00585-x. Epub 2021 Aug 2.
The phase 3 PSO LONG study (NCT02899962) demonstrated superior efficacy of proactive (PM) versus reactive management (RM) using calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis. Here, we evaluated whether certain baseline parameters had an effect on time to first relapse (TTFR), number of relapses, and assessed interactions between treatment effect.
PSO LONG included an initial 4-week open-label phase (once-daily Cal/BD foam) and a 52-week maintenance phase where patients were randomized to twice-weekly Cal/BD (PM) or vehicle foam (RM), with a 4-week once-daily Cal/BD foam rescue treatment for relapse. Baseline parameters analyzed using a stepwise variable selection procedure included body surface area, modified Psoriasis Area Severity Index (mPASI), Physician Global Assessment (PGA), body mass index, age, sex, Dermatology Life Quality Index, and duration of psoriasis. Continuous variables were divided into groups based on standard criteria.
Overall, the effect of treatment on TTFR did not vary across any baseline parameters. Variables with a statistically significant effect on TTFR were: treatment group (PM vs. RM hazard ratio [HR]: 0.56; p < 0.001); PGA (moderate vs. mild HR: 1.42; severe vs. mild HR: 2.32; overall p = 0.009); mPASI (moderate vs. mild HR: 1.19; severe vs. mild HR: 1.77; overall p = 0.009); and sex (women vs. men HR: 1.26; p = 0.030). Variables with a significant effect on the number of relapses were: treatment group (PM vs. RM, rate ratio [RR] 0.52; p < 0.001); PGA at baseline (moderate vs. mild, RR 1.38; severe vs. mild, RR 2.22; overall p < 0.001); and mPASI (moderate vs. mild, RR 1.25; severe vs. mild, HR 1.70; overall p = 0.002).
All patients benefitted from long-term PM versus RM with Cal/BD foam regardless of baseline characteristics, and the benefit of treatment increased with greater disease severity.
ClinicalTrials.gov identifier, NCT02899962.
3期PSO LONG研究（NCT02899962）表明，对于成年银屑病患者，使用0.005%卡泊三醇/0.064%倍他米松二丙酸酯（Cal/BD）泡沫进行主动管理（PM）比被动管理（RM）具有更高的疗效。在此，我们评估了某些基线参数是否对首次复发时间（TTFR）、复发次数有影响，并评估了治疗效果之间的相互作用。
PSO LONG包括初始4周的开放标签期（每日一次Cal/BD泡沫）和52周的维持期，在此期间患者被随机分为每周两次Cal/BD（PM）或赋形剂泡沫（RM），复发时进行为期4周的每日一次Cal/BD泡沫挽救治疗。使用逐步变量选择程序分析的基线参数包括体表面积、改良银屑病面积和严重程度指数（mPASI）、医生整体评估（PGA）、体重指数、年龄、性别、皮肤病生活质量指数和银屑病病程。连续变量根据标准标准进行分组。
总体而言，治疗对TTFR的影响在任何基线参数上均无差异。对TTFR有统计学显著影响的变量为：治疗组（PM与RM，风险比[HR]：0.56；p<0.001）；PGA（中度与轻度，HR：1.42；重度与轻度，HR：2.32；总体p = 0.009）；mPASI（中度与轻度，HR：1.19；重度与轻度，HR：1.77；总体p = 0.009）；以及性别（女性与男性，HR：1.26；p = 0.030）。对复发次数有显著影响的变量为：治疗组（PM与RM，率比[RR] 0.52；p<0.001）；基线时的PGA（中度与轻度，RR 1.38；重度与轻度，RR 2.22；总体p<0.001）；以及mPASI（中度与轻度，RR 1.25；重度与轻度，HR 1.70；总体p = 0.002）。
无论基线特征如何，所有患者使用Cal/BD泡沫进行长期PM与RM均有益，且治疗益处随疾病严重程度增加而增加。
ClinicalTrials.gov标识符，NCT02899962。
