Background

Effective anti-inflammatory treatments for hidradenitis suppurativa (HS) are limited.

Objective

To evaluate the efficacy and short-term safety of apremilast in patients with moderate HS.

Methods

A total of 20 patients with moderate HS were randomized in a 3:1 ratio to receive blinded treatment with apremilast, 30 mg twice daily, or placebo for 16 weeks. The primary outcome was the Hidradenitis Suppurativa Clinical Response at week 16. Linear mixed effects modeling (analysis of covariance) was used to assess secondary clinical outcomes between treatment groups.

Results

The HS clinical response was met in 8 of 15 patients in the apremilast group (53.3%) and none of 5 patients in the placebo group (0%) (P = .055) at week 16. Moreover, the apremilast-treated patients showed a significantly lower abscess and nodule count (mean difference, –2.6; 95% confidence interval, –6.0 to –0.9; P = .011), NRS for pain (mean difference, –2.7; 95% –4.5 to –0.9; P = .009), and itch (mean difference, –2.8; 95% confidence interval, –5.0 to –0.6; P = .015) over 16 weeks compared with the placebo-treated patients. There was no significant difference in the Dermatology Life Quality Index over time between the 2 treatment groups (mean difference, –3.4; 95% confidence interval, –9.0 to 2.3; P = .230). The most frequently reported adverse events in the apremilast-treated patients were mild-to-moderate headache and gastrointestinal symptoms, which did not result in dropouts.

Limitations

Small number of patients, relatively short study duration.

Conclusion

Apremilast, at a dose of 30 mg twice daily, demonstrated clinically meaningful efficacy and was generally well tolerated in patients with moderate HS.

中文翻译：

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普雷米司特用于中度化脓性汗腺上皮炎：一项随机对照试验的结果

背景

治疗化脓性汗腺炎（HS）的有效抗炎治疗受到限制。

客观的

评估中度HS患者使用apremilast的疗效和短期安全性。

方法

总共20例中度HS患者以3：1的比例随机分配，接受普瑞司特，每日两次30 mg或安慰剂治疗16周的盲法治疗。主要结局为第16周的化脓性汗腺炎临床反应。线性混合效应模型（协方差分析）用于评估治疗组之间的次要临床结局。

结果

在第16周，prepremilast组的15例患者中有8例（53.3％）达到了HS临床反应，而安慰剂组5例中的5例患者（0％）均未达到（P  = .055）。脓肿和结节数显着降低（平均差异为–2.6； 95％置信区间为–6.0至–0.9；P  = .011），NRS用于疼痛（平均差异为–2.7； 95％–4.5至–0.9；P 与安慰剂治疗的患者相比，在16周内 发痒（平均差异为–009；平均差异为–2.8； 95％置信区间为–5.0至–0.6；P = .015）。两个治疗组之间的皮肤病生活质量指数随时间变化无显着差异（平均差异为–3.4； 95％置信区间为–9.0至2.3；P = .230）。在接受前者治疗的患者中，最常报告的不良事件是轻度至中度的头痛和胃肠道症状，但这并未导致辍学。

局限性

患者数量少，研究持续时间相对较短。

结论

每天两次两次30 mg剂量的Apremilast具有临床意义，对中度HS的患者具有良好的耐受性。