Department of Dermatology, Venerology and Leprology, B.J. Medical College and Civil Hospital Ahmedabad, Ahmedabad, India.
Australas J Dermatol. 2023 Nov;64(4):e333-e339. doi: 10.1111/ajd.14134. Epub 2023 Jul 24.
Apremilast regulates several pro-inflammatory signals involved in atopic dermatitis (AD).
A randomized, open-labelled study was conducted at a tertiary care centre in India. Fifty patients with AD of >1 year duration were randomly assigned in a 1:1 ratio to receive either apremilast (30 mg twice daily after initial titration) or cyclosporine (5 mg/kg/day) for 24 weeks, followed by a 12-week follow-up period. Primary outcome was mean percentage change in Eczema Area and Severity Index (EASI) from baseline to week 24. Secondary outcome measures were proportion of patients achieving EASI 75, EASI 90, ≥2-point improvement in Investigator's Global Assessment (IGA), SCORing Atopic Dermatitis (SCORAD) 75 at week 24 and percentage of patients experiencing ≥1 adverse effect (AEs).
Mean percentage change in EASI (standard deviation) was -67.79% [22.44] in the apremilast treatment group and -83.06% [21.20] in the cyclosporine treatment group (p < 0.05). At week 24, 52.38% of patients in the apremilast group and 78.26% in the cyclosporine group achieved EASI 75 (p < 0.05); 14.29% in the apremilast group and 52.17% in the cyclosporine group achieved EASI 90 (p < 0.05) and 80.95% in the apremilast group and 82.60% patients achieved ≥2 point reduction in IGA (p > 0.05). 57.14% of patients achieved SCORAD 75 in the apremilast group and 69.56% in the cyclosporine group (p > 0.05). Mean time taken to achieve EASI 75 in the apremilast group was 4.50 ± 4.62 weeks, while it was 3.96 ± 3.43 weeks in the cyclosporine group (p > 0.05). Incidence of AEs was 28.57% in the apremilast group and 21.74%) in the cyclosporine group.
Apremilast demonstrated lesser efficacy in comparison to cyclosporine; it has the advantage of a favourable safety profile and requires no laboratory monitoring.
阿普米司特调节特应性皮炎（AD）中涉及的几种促炎信号。
在印度的一家三级护理中心进行了一项随机、开放标签的研究。50 名 AD 病程>1 年的患者被随机按 1:1 比例分配，分别接受阿普米司特（初始滴定后每天两次 30mg）或环孢素（5mg/kg/天）治疗 24 周，随后进行 12 周的随访期。主要结局是从基线到第 24 周 Eczema Area and Severity Index（EASI）的平均百分比变化。次要结局测量指标包括达到 EASI 75、EASI 90、改善≥2 分的患者比例研究者全球评估（IGA）、SCORing Atopic Dermatitis（SCORAD）75 在第 24 周和经历≥1 种不良反应（AE）的患者百分比。
阿普米司特治疗组 EASI（标准差）的平均百分比变化为-67.79%[22.44]，环孢素治疗组为-83.06%[21.20]（p<0.05）。第 24 周时，阿普米司特组 52.38%和环孢素组 78.26%的患者达到 EASI 75（p<0.05）；阿普米司特组 14.29%和环孢素组 52.17%的患者达到 EASI 90（p<0.05）；阿普米司特组 80.95%和环孢素组 82.60%的患者达到 IGA 改善≥2 分（p>0.05）。阿普米司特组 57.14%和环孢素组 69.56%的患者达到 SCORAD 75（p>0.05）。阿普米司特组达到 EASI 75 的平均时间为 4.50±4.62 周，环孢素组为 3.96±3.43 周（p>0.05）。阿普米司特组不良反应发生率为 28.57%，环孢素组为 21.74%（p>0.05）。
与环孢素相比，阿普米司特的疗效较差；它具有良好的安全性特征优势，且不需要实验室监测。
