一项开放标签、随机、前瞻性、比较性、三臂临床试验，以评估阿普米拉斯三种不同滴定方法在印度慢性斑块状银屑病患者中的安全性和有效性。
An Open-Label, Randomized, Prospective, Comparative, Three-Arm Clinical Trial to Evaluate the Safety and Effectiveness of Apremilast with Three Different Titration Methods in Patients with Chronic Plaque Psoriasis in India.
作者信息
Viswanath Vishalakshi, Joshi Pradnya, Lawate Prakash, Tare Dakshata, Dhoot Dhiraj, Mahadkar Namrata, Barkate Hanmant
机构信息
Department of Dermatology, Rajiv Gandhi Medical College, Thane, Mumbai, India.
Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India.
出版信息
Psoriasis (Auckl). 2022 Apr 22;12:53-61. doi: 10.2147/PTT.S357184. eCollection 2022.
PURPOSE
To minimize adverse effects (AEs), apremilast is recommended to titrate at the initiation of therapy. But still, many patients experience AEs, resulting in discontinuation of therapy. As a result, many dermatologists have adapted to further titrate apremilast in different ways. The present study was planned to evaluate the safety and effectiveness of apremilast in different dose titration methods as initiation therapy in the treatment of plaque psoriasis.
PATIENTS AND METHODS
In this open-label, randomized, prospective, comparative, three-arm, single center study, 128 plaque psoriasis patients were included. Patients were randomized into three groups. Group I received standard titration for the first 6 days; Group II received all tablets in a starter pack as once a day (OD) total for 13 days; and Group III received two starter packs as 8 tablets each of apremilast 10 mg and 20 mg as OD and 10 tablets of 30 mg as OD, in total for 26 days. All groups received apremilast 30 mg as twice a day after initial titration. The total duration of apremilast therapy in all groups was 16 weeks.
RESULTS
In safety assessment, AEs were reported in 50%, 41.3% and 25% in Groups I, II and III, respectively (p <0.05) with nausea being the most common AE. In Group I, 10.53% of patients discontinued apremilast whereas 6.52% and 2.27% discontinued in Groups II and III respectively. Maximum number of AEs were seen in Group I in first week only (74.19%) compared with other groups. At week 16, on the Psoriasis Area and Severity Index, PASI 75 was achieved in 31.43%, 42.4% and 33.3% of patients in Groups I, II and III, respectively with no statistical difference between any groups.
CONCLUSION
It can be concluded that slower titration is a useful strategy for minimizing AEs while at the same time maintaining effectiveness of apremilast.
目的
为使不良反应（AE）最小化，推荐在治疗开始时对阿普米拉斯进行滴定。但仍有许多患者出现不良反应，导致治疗中断。因此，许多皮肤科医生采用了不同方式对阿普米拉斯进行进一步滴定。本研究旨在评估阿普米拉斯不同剂量滴定方法作为斑块状银屑病初始治疗的安全性和有效性。
患者与方法
在这项开放标签、随机、前瞻性、比较性、三臂、单中心研究中，纳入了128例斑块状银屑病患者。患者被随机分为三组。第一组在前6天接受标准滴定；第二组接受起始包装中的所有片剂，每天一次（OD），共13天；第三组接受两个起始包装，分别为10毫克和20毫克的阿普米拉斯各8片，每天一次（OD），以及30毫克的10片，每天一次（OD），共26天。初始滴定后，所有组均接受阿普米拉斯30毫克，每日两次。所有组阿普米拉斯治疗的总持续时间为16周。
结果
在安全性评估中，第一组、第二组和第三组分别有50%、41.3%和25%的患者报告了不良反应（p<0.05），恶心是最常见的不良反应。在第一组中，10.53%的患者停用了阿普米拉斯，而第二组和第三组分别为6.52%和2.27%。仅在第一周时第一组出现的不良反应数量最多（74.19%），与其他组相比。在第16周时，在银屑病面积和严重程度指数方面，第一组、第二组和第三组分别有31.43%、42.4%和33.3%的患者达到了PASI 75，各组之间无统计学差异。
结论
可以得出结论，缓慢滴定是使不良反应最小化同时维持阿普米拉斯有效性的有效策略。
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