阿达木单抗(Humira)治疗化脓性汗腺炎。

Q1 Medicine
Skin therapy letter Pub Date : 2016-07-01
A K Gupta, C Studholme
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引用次数: 0

摘要

阿达木单抗(Humira®)是一种经美国食品和药物管理局、加拿大卫生部和欧盟委员会批准用于治疗化脓性汗腺炎(HS)的新疗法。阿达木单抗的两项III期试验结果显示,与安慰剂相比,阿达木单抗的疗效显著提高。在PIONEER I和PIONEER II研究中,接受阿达木单抗治疗的参与者中分别有41.8%和58.9%的人观察到脓肿和炎症结节计数减少50%的主要疗效结果,与安慰剂组相比,在这两项试验中均有显著改善(分别为26.0%和27.6%)。尽管阿达木单抗每周治疗(EW)的次要疗效指标的重要性在PIONEER I和PIONEER II研究中并不一致,但在PIONEER II试验中,与安慰剂(32.2%)相比,获得脓肿和炎症结节计数为0,1或2的参与者(EW为51.8%)是显著的。在PIONEER II试验中,参与者还显示,EW患者(45.7%)和安慰剂(20.7%)之间的皮肤疼痛测量值与基线相比显着降低。改良的Sartorius评分在PIONEER I(-24.4)和PIONEER II(-28.9)试验中与安慰剂(分别为-15.7和-9.5)相比从基线下降。包括安慰剂在内的所有治疗组的不良事件均为轻度至中度,具有可比性。综上所述,这些数据得出结论,用阿达木单抗治疗HS是一种安全有效的治疗方法,在治疗的前12周内,脓肿和炎症结节计数显著减少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adalimumab (Humira) for the Treatment of Hidradenitis Suppurativa.

Adalimumab (Humira®) is a novel therapy approved by the US Food and Drug Administration, Health Canada, and the European Commission for the treatment of hidradenitis suppurativa (HS). Results of two Phase III trials of adalimumab demonstrate significantly higher efficacies compared to placebo. Primary efficacy outcome of 50% reduction in abscess and inflammatory nodule count was seen in 41.8% and 58.9% of participants receiving adalimumab in PIONEER I and PIONEER II studies, respectively, showing substantial improvement compared with placebo groups in both trials (26.0% and 27.6%, respectively). Although the significance of secondary efficacy measures of adalimumab every week treatment (EW) was not consistent between PIONEER I and PIONEER II studies, participants achieving abscess and inflammatory nodule counts of 0, 1, or 2 were significant (EW 51.8%) compared to placebo (32.2%) in the PIONEER II trial. Participants also demonstrated a marked decrease in skin pain measurements from baseline between EW patients (45.7%) and placebo (20.7%) in the PIONEER II trial. Modified Sartorius scores were decreased from baseline in both PIONEER I (-24.4) and PIONEER II (-28.9) trials versus placebo (-15.7 and -9.5, respectively). Adverse events were mild to moderate and comparable between all treatment groups including placebo. Taken together, these data conclude that treatment of HS with adalimumab is a safe and effective therapy resulting in a significant decrease in abscess and inflammatory nodule counts within the first 12 weeks of treatment.

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来源期刊
Skin therapy letter
Skin therapy letter Medicine-Medicine (all)
CiteScore
2.80
自引率
0.00%
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0
期刊介绍: The premier international journal on the latest advances, techniques and practice in conservation and restoration from around the world.
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