Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
UCL St Luc, Brussels, Belgium.
J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2277-2284. doi: 10.1111/jdv.17551. Epub 2021 Sep 25.
Hidradenitis suppurativa (HS), a chronic, recurrent, debilitating skin disease, is characterized by painful, inflammatory, subcutaneous lesions of the axilla, inguinal and anogenital regions. Overall prevalence of HS is ˜1%, and the impact of disease on patient quality of life (QoL) and healthcare resource utilization (HRU) is high.
To estimate the real-world effectiveness of adalimumab (Humira®) treatment in patients with moderate-to-severe HS on disease severity, pain, QoL, work productivity and HRU.
HARMONY (Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi-cOuNtry studY in Real Life Setting) is a multicentre, postmarketing observational study in adult patients with moderate-to-severe HS. Disease severity and QoL parameters were evaluated using validated measures at 12-week intervals over 52 weeks of treatment. The primary endpoint was the proportion of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR: ≥50% reduction in abscess and inflammatory nodule count, with no increase in abscess and draining fistula counts relative to baseline) at 12 weeks. Secondary endpoints were HiSCR at 24, 36 and 52 weeks and changes in QoL parameters and work productivity assessments. Analyses were conducted using as-observed data.
The proportion of patients reaching the primary HiSCR endpoint was 70.2% (n = 132/188 enrolled) and remained ≥70% until study completion. There were statistically significant (P < 0.0001) reductions in worst and average skin pain. All of the QoL measures evaluated improved significantly (P < 0.0001) by 12 weeks of adalimumab treatment, as did work productivity assessments (P < 0.05), and there was a ˜50% decrease in HRU between baseline and week 52. Adalimumab was well tolerated.
In this real-world setting, adalimumab treatment of moderate-to-severe HS resulted in decreased disease severity and improvements in QoL and productivity. Response to adalimumab was rapid (within 12 weeks) and sustained (52 weeks). No unexpected safety signals were reported.
化脓性汗腺炎（HS）是一种慢性、复发性、使人虚弱的皮肤病，其特征为腋窝、腹股沟和肛门生殖器区域疼痛、炎症、皮下病变。HS 的总体患病率约为 1%，疾病对患者生活质量（QoL）和医疗资源利用（HRU）的影响较大。
评估阿达木单抗（Humira®）治疗中重度 HS 患者的真实世界疗效，评估疾病严重程度、疼痛、QoL、工作生产力和 HRU。
HARMONY（阿达木单抗治疗中重度 HidAdenitis SuppuRativa 患者的有效性-真实世界多中心研究）是一项多中心、上市后观察性研究，纳入成年中重度 HS 患者。在 52 周治疗期间，每隔 12 周使用经过验证的措施评估疾病严重程度和 QoL 参数。主要终点为治疗 12 周时达到 Hidradenitis Suppurativa 临床应答（HiSCR：脓肿和炎性结节计数减少≥50%，与基线相比脓肿和引流瘘管计数无增加）的患者比例。次要终点为治疗 24、36 和 52 周时的 HiSCR 以及 QoL 参数和工作生产力评估的变化。分析采用观察到的数据进行。
达到主要 HiSCR 终点的患者比例为 70.2%（n=132/188 入组患者），直至研究结束时该比例仍保持≥70%。最严重和平均皮肤疼痛均有统计学意义的（P<0.0001）降低。所有评估的 QoL 指标在接受阿达木单抗治疗 12 周时均显著改善（P<0.0001），工作生产力评估也改善（P<0.05），并且基线至 52 周时 HRU 降低约 50%。阿达木单抗的耐受性良好。
在这一真实环境中，中重度 HS 患者接受阿达木单抗治疗后疾病严重程度降低，QoL 和生产力得到改善。对阿达木单抗的应答迅速（12 周内）且持续（52 周）。未报告意外的安全性信号。
