Shah Bela J, Mistry Deval, Chaudhary Navin, Shah Shikha
Department of Dermatology Venereology and Leprology, B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India.
Indian Dermatol Online J. 2020 Jan 13;11(1):51-57. doi: 10.4103/idoj.IDOJ_169_19. eCollection 2020 Jan-Feb.
Apremilast is the new oral drug in the management of moderate-to-severe plaque psoriasis with well-established effectiveness and safety in long-term clinical trials and a few real-world studies. However, its effectiveness and safety in Indian setup have not been reported yet.
This was retrospective, single-center, longitudinal, observational cohort study where the total study period was 24 weeks. Effectiveness parameters were the proportion of patients achieving psoriasis area and severity index (PASI) 50, 75, 90, and 100 response at week 16 and 24. Safety was measured as the proportion of patients reporting ≥1 adverse event (AE) during the study period.
Data of a total of 70 patients were included in our study. At week 16, 76.92%, 41.53%, 15.38%, and 6.15% patients achieved PASI 50, 75, 90, and 100, respectively. At week 24, 81.53%, 58.46%, 29.23%, and 10.76% patients achieved PASI 50, 75, 90, and 100, respectively. Mean percentage reduction in PASI was 67% at week 24 and DLQI score was reduced significantly to 3.4 from mean baseline DLQI score of 10.8 ( < 0.001). 40% of patients reported ≥1 AE during the study period. 5 out of 70 patients discontinued apremilast due to AE. Nausea was most common AE reported by 21.4% patients followed by diarrhea (18.57%), headache (17.4%), vomiting (8%), weight loss (7.69%), myalgia (6.15%), and gastritis (6.15%). Most of the AEs were of mild-to-moderate severity.
The results of this study support the long-term use of apremilast monotherapy as an efficacious and safe treatment option for the management of moderate-to-severe plaque psoriasis.
阿普斯特是用于治疗中度至重度斑块状银屑病的新型口服药物，在长期临床试验和一些真实世界研究中已证实其有效性和安全性。然而，其在印度人群中的有效性和安全性尚未见报道。
这是一项回顾性、单中心、纵向观察性队列研究，总研究期为24周。有效性参数为在第16周和第24周达到银屑病面积和严重程度指数（PASI）改善50%、75%、90%和100%的患者比例。安全性通过研究期间报告≥1次不良事件（AE）的患者比例来衡量。
本研究共纳入70例患者的数据。在第16周时，分别有76.92%、41.53%、15.33%和6.15%的患者达到PASI 50、75、90和100改善。在第24周时，分别有81.53%、58.46%、29.23%和10.76%的患者达到PASI 50、75、90和100改善。第24周时PASI平均降低百分比为67%，皮肤病生活质量指数（DLQI）评分从平均基线的10.8显著降至3.4（<0.001）。40%的患者在研究期间报告≥1次AE。70例患者中有5例因AE停用阿普斯特。恶心是最常见的AE，21.4%的患者报告有恶心，其次是腹泻（18.57%）、头痛（17.4%）、呕吐（8%）、体重减轻（7.69%）、肌痛（6.15%）和胃炎（6.15%）。大多数AE为轻度至中度严重程度。
本研究结果支持长期使用阿普斯特单药治疗作为中度至重度斑块状银屑病有效且安全的治疗选择。
