Panda Gautam, Sahoo Jyoti Prakash, Mohanty Prasenjeet, Swain Trupti R
Pharmacology, Sriram Chandra Bhanja Medical College and Hospital, Bhubaneswar, IND.
Pharmacology, Kalinga Institute of Medical Sciences, Bhubaneswar, IND.
Cureus. 2023 May 9;15(5):e38802. doi: 10.7759/cureus.38802. eCollection 2023 May.
In the Indian subcontinent, psoriasis cases have skyrocketed in the last decade. Dry and hot weather aggrandizes the annual incidences. Nowadays, dermatologists harness methotrexate and apremilast to manage chronic plaque psoriasis. There needs to be more comparative studies on these drugs. The primary objective was change in Psoriasis Area and Severity Index (PASI) at six months from the baseline. Change in Dermatology Life Quality Index (DLQI) at six months from the baseline and incidences of adverse events served as the secondary objectives.
This randomized, open-label, 24-week study was executed in Srirama Chandra Bhanja (SCB) Medical College, Cuttack, India, from June 2021 to October 2022. The participants were randomized in a 1:1 ratio to receive tablets of either methotrexate 10-15mg weekly once or apremilast 10-30mg twice daily. Efficacy and safety analyses were performed at baseline, eight, 16, and 24 weeks. We used R software (version 4.1.1; R Foundation for Statistical Computing, Vienna, Austria) for data analysis.
Seventy (82.3%) of 85 enrolled participants completed the study. The mean age of the study population was 41.08±5.17 years. Twenty-two (31.4%) of them were females. The median change in PASI from baseline was -37.25 (-39.00 to -34.25) for apremilast and -34.75 (-37.75 to -31.75) for methotrexate (p=0.006). The median change in DLQI from baseline was -19.50 (-22.00 to -17.00) for apremilast and -21.00 (-25.50 to -17.50) for methotrexate (p=0.079). No serious adverse events were noticed.
Apremilast was more effective than methotrexate in psoriasis treatment. The statistically significant difference was found only in PASI scores.
在印度次大陆,银屑病病例在过去十年中激增。干燥炎热的天气加剧了其年发病率。如今,皮肤科医生使用甲氨蝶呤和阿普米司特来治疗慢性斑块状银屑病。对这些药物的比较研究还不够多。主要目标是从基线起六个月时银屑病面积和严重程度指数(PASI)的变化。次要目标是从基线起六个月时皮肤病生活质量指数(DLQI)的变化以及不良事件的发生率。
这项随机、开放标签、为期24周的研究于2021年6月至2022年10月在印度科塔克的斯里拉马·钱德拉·班贾(SCB)医学院进行。参与者按1:1的比例随机分组,分别接受每周一次10 - 15毫克的甲氨蝶呤片或每日两次10 - 30毫克的阿普米司特片。在基线、第8周、第16周和第24周进行疗效和安全性分析。我们使用R软件(版本4.1.1;奥地利维也纳的R统计计算基金会)进行数据分析。
85名登记参与者中有70名(82.3%)完成了研究。研究人群的平均年龄为41.08±5.17岁。其中22名(31.4%)为女性。阿普米司特组从基线起PASI的中位数变化为 - (37.25( - 39.00至 - 34.25),甲氨蝶呤组为 - 34.75( - 37.75至 - 31.75)(p = 0.006)。阿普米司特组从基线起DLQI的中位数变化为 - 19.50( - 22.00至 - 17.00),甲氨蝶呤组为 - 21.00( - 25.50至 - 17.50)(p = 0.079)。未发现严重不良事件。
在银屑病治疗中,阿普米司特比甲氨蝶呤更有效。仅在PASI评分中发现了统计学上的显著差异。