Dermatology, The Rudolfstiftung Hospital, Vienna, Austria.
School of Medicine, Sigmund Freud University, Vienna, Austria.
J Eur Acad Dermatol Venereol. 2018 Feb;32(2):254-259. doi: 10.1111/jdv.14598. Epub 2017 Oct 12.
Apremilast is a novel oral phosphodiesterase-4 inhibitor approved for psoriasis treatment. Randomized trials have documented its efficacy and safety, but data on real-world patients are scarce.
We aim to characterize psoriasis patients treated with apremilast in a real-world setting and calculate drug survival as an important measure of efficacy and compliance.
All patients with psoriasis who received apremilast between 1 April 2015 and 19 January 2017 were evaluated every 4 weeks, and we documented: age, weight, height, smoking status, family history of psoriasis, joint involvement, previous treatments, psoriasis area severity index (PASI) scores, and the onset and duration of adverse events (AE). Efficacy was analysed by PASI50, PASI75 and PASI90, reflecting the improvement of skin lesions compared to the PASI-baseline. Kaplan-Meier statistics were used for drug survival estimates.
Forty-eight patients were included. The median apremilast drug survival was 12.5 weeks (range 1-87). Three patients (6.3%) reached PASI90, nine (18.8%) PASI75 and eight patients (16.7%) PASI50. Patient weight inversely correlated with a PASI50 response (P < 0.05, n = 37), and none of the obese patients (BMI > 30.0, n = 6) reached PASI75, compared to 32% of the non-obese patients (BMI < 30.0, n = 31). Thirty-one patients (64.6%) reported at least one AE, most frequently diarrhoea (n = 21, 43.8%), headache (n = 7, 14.6%) and joint pain (n = 5, 10.4%).
Despite differences between real-world and trial patients, apremilast is safe and effective for the treatment of skin psoriasis in the daily practice. Up to 40% of patients will reach PASI50 or higher, but only few patients will reach PASI90. Bodyweight might affect drug efficacy.
阿普米司特是一种新型的磷酸二酯酶-4 抑制剂，已被批准用于治疗银屑病。随机试验已经证明了其疗效和安全性，但关于真实世界患者的数据却很少。
我们旨在描述在真实环境中接受阿普米司特治疗的银屑病患者，并计算药物的生存率，这是评估疗效和依从性的重要指标。
我们评估了所有在 2015 年 4 月 1 日至 2017 年 1 月 19 日期间接受阿普米司特治疗的银屑病患者，每 4 周记录一次患者的年龄、体重、身高、吸烟状况、银屑病家族史、关节受累情况、既往治疗、银屑病面积严重指数（PASI）评分，以及不良反应（AE）的发生和持续时间。通过 PASI50、PASI75 和 PASI90 评估疗效，反映与 PASI 基线相比皮损的改善情况。采用 Kaplan-Meier 统计法估计药物的生存率。
共纳入 48 例患者。阿普米司特药物的中位生存时间为 12.5 周（范围为 1-87 周）。3 例（6.3%）患者达到 PASI90，9 例（18.8%）患者达到 PASI75，8 例（16.7%）患者达到 PASI50。患者体重与 PASI50 应答呈负相关（P<0.05，n=37），BMI>30.0 的肥胖患者（n=6）无一例达到 PASI75，而非肥胖患者（BMI<30.0，n=31）的这一比例为 32%。31 例（64.6%）患者报告了至少 1 种 AE，最常见的是腹泻（n=21，43.8%）、头痛（n=7，14.6%）和关节痛（n=5，10.4%）。
尽管真实世界和临床试验中的患者存在差异，但阿普米司特在日常实践中安全有效，用于治疗皮肤银屑病。多达 40%的患者将达到 PASI50 或更高水平，但只有少数患者将达到 PASI90。体重可能影响药物的疗效。
