Gupta A K, Studholme C
Department of Medicine, University of Toronto, Toronto, ON, Canada; Mediprobe Research Inc., London, ON, Canada.
Mediprobe Research Inc., London, ON, Canada.
Skin Therapy Lett. 2016 Jul;21(4):1-4.
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.
阿达木单抗(修美乐®)是一种经美国食品药品监督管理局、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)的新型疗法。两项阿达木单抗III期试验的结果表明,与安慰剂相比,其疗效显著更高。在PIONEER I和PIONEER II研究中,分别有41.8%和58.9%接受阿达木单抗治疗的参与者达到了脓肿和炎性结节数量减少50%的主要疗效指标,与两项试验中的安慰剂组相比均有显著改善(分别为26.0%和27.6%)。尽管PIONEER I和PIONEER II研究中阿达木单抗每周治疗(EW)的次要疗效指标的显著性不一致,但在PIONEER II试验中,达到脓肿和炎性结节数量为0、1或2的参与者与安慰剂组(32.2%)相比具有显著性差异(EW为51.8%)。在PIONEER II试验中,参与者还表现出EW患者(45.7%)与安慰剂组(20.7%)相比,皮肤疼痛测量值较基线有显著下降。在PIONEER I(-24.4)和PIONEER II(-28.9)试验中,改良缝匠肌评分均较基线下降,而安慰剂组分别为-15.7和-9.5。不良事件为轻度至中度,所有治疗组(包括安慰剂组)之间相当。综上所述,这些数据表明,用阿达木单抗治疗HS是一种安全有效的疗法,在治疗的前12周内可使脓肿和炎性结节数量显著减少。