Giamarellos-Bourboulis Evangelos J, Sobell Jeffrey, Ryan Caitriona, Wolkenstein Pierre J, Geng Ziqian, Mulder Gerit D
Wounds. 2017 Nov;29(11):E98-E102.
The objective of this study is to assess the rates of infection-free achievement of hidradenitis suppurativa clinical response (HiSCR) using integrated data from 2 phase 3, placebo-controlled trials, PIONEER I and II.
Analyses from the first 12 weeks of both studies were examined. Patients were randomized to receive adalimumab (ADA) or placebo, and they then were assessed in the clinic at weeks 0, 2, 4, 8, and 12. All reports of an adverse or serious adverse event and infection were classified as treatment-emergent adverse events (TEAEs). The HiSCR was evaluated as the primary endpoint; infection-free HiSCR was also evaluated.
Treatment-emergent adverse events were observed in 55.4% of the ADA group and 64.4% of the placebo (P < .023). The rates of serious TEAEs and infection-related TEAEs were slightly less in the ADA group compared with the placebo group. A significantly higher percentage of ADA-treated patients achieved HiSCR at week 12 compared with placebo (P < .001). At each visit during the study's 12 weeks, a greater proportion of ADA-treated patients achieved infection-free HiSCR compared with patients treated with placebo (P < .001). Mean durations of HiSCR and infection-free HiSCR were significantly longer in ADA-treated patients when compared with placebo-treated patients (P < .001).
Results of this integrated analysis indicate that patients with hidradenitis suppurativa who received a short duration of ADA treatment experienced better combined efficacy and similar safety compared with placebo. Further studies investigating longer ADA treatment may demonstrate further improvements in duration of infection-free clinical response.
本研究的目的是利用3期、安慰剂对照试验PIONEER I和II的综合数据，评估化脓性汗腺炎临床反应（HiSCR）无感染实现率。
检查两项研究前12周的分析结果。患者被随机分配接受阿达木单抗（ADA）或安慰剂治疗，然后在第0、2、4、8和12周在诊所进行评估。所有不良或严重不良事件及感染报告均分类为治疗中出现的不良事件（TEAE）。将HiSCR评估为主要终点；还评估了无感染的HiSCR。
ADA组55.4%的患者和安慰剂组64.4%的患者出现治疗中出现的不良事件（P <.023）。与安慰剂组相比，ADA组严重TEAE和感染相关TEAE的发生率略低。与安慰剂相比，在第12周接受ADA治疗的患者实现HiSCR的比例显著更高（P <.001）。在研究的12周期间的每次访视中，与接受安慰剂治疗的患者相比，接受ADA治疗的患者中实现无感染HiSCR的比例更高（P <.001）。与安慰剂治疗的患者相比，ADA治疗的患者HiSCR和无感染HiSCR的平均持续时间显著更长（P <.001）。
这项综合分析的结果表明，与安慰剂相比，接受短期ADA治疗的化脓性汗腺炎患者联合疗效更好且安全性相似。进一步研究更长时间的ADA治疗可能会显示无感染临床反应持续时间的进一步改善。
