Kapniari Eirini, Dalamaga Maria, Papadavid Evangelia
Second Department of Dermatology and Venereology, Attikon General University Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Department of Biological Chemistry, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Dermatol Ther. 2020 Nov;33(6):e14168. doi: 10.1111/dth.14168. Epub 2020 Sep 13.
Apremilast is the first small molecule approved for the treatment of moderate to severe psoriasis and psoriatic arthritis in adult patients. To evaluate survival, efficacy and safety of apremilast in patients with moderate to severe psoriasis and investigate possible associations between apremilast survival and clinical parameters in a real-world setting. In this retrospective study, a total of 71 patients who started on apremilast treatment between March 2017 and December 2019 were identified and included in the study: 40 (56.3%) males and 31 (43.7%) females, with a mean age of 55.6 ± 13.8 years and a mean Body Mass Index of 28.4 ± 6.9 kg/m . At the end of the study 49.3% of patients remained on apremilast with mean treatment duration 67.2 ± 41.1 weeks (range 4-132). Overall, mean drug survival duration was 78.51 weeks (95% CI: 65.8-91.2 weeks). Mean drug survival was shorter when comorbidities burden was higher (P = .012) and with previous exposure of biological agents (P = .001). Previous exposure to biological agents (HR:3.86, 95% CI: 1.35-11.04, P = .012) and comorbidities burden (HR: 2.27, 95% CI: 1.25-4.12, P = .007) were independent predictors of drug discontinuation adjusting for important clinical parameters. In this real-world setting, apremilast presented better survival rates when introduced early on the onset of moderate psoriasis, especially in biologic naïve patients with less comorbidities. More prospective and larger studies are required to determine clinical parameters affecting drug survival.
阿普米拉斯是首个被批准用于治疗成年中度至重度银屑病和银屑病关节炎的小分子药物。为评估阿普米拉斯在中度至重度银屑病患者中的生存情况、疗效和安全性,并在真实世界环境中研究阿普米拉斯生存情况与临床参数之间可能存在的关联。在这项回顾性研究中,共纳入了2017年3月至2019年12月开始接受阿普米拉斯治疗的71例患者:男性40例(56.3%),女性31例(43.7%),平均年龄55.6±13.8岁,平均体重指数28.4±6.9kg/m²。研究结束时,49.3%的患者仍在使用阿普米拉斯,平均治疗时长为67.2±41.1周(范围4 - 132周)。总体而言,平均药物生存时长为78.51周(95%置信区间:65.8 - 91.2周)。合并症负担较高时平均药物生存时间较短(P = 0.012),且既往使用过生物制剂时也是如此(P = 0.001)。既往使用生物制剂(风险比:3.86,95%置信区间:1.35 - 11.04,P = 0.012)和合并症负担(风险比:2.27,95%置信区间:1.25 - 4.12,P = 0.007)是调整重要临床参数后药物停用的独立预测因素。在这个真实世界环境中,阿普米拉斯在中度银屑病发病早期开始使用时生存率更高,尤其是在合并症较少的未使用过生物制剂的患者中。需要更多前瞻性和大规模研究来确定影响药物生存的临床参数。