Marzano A V, Genovese G, Casazza G, Moltrasio C, Dapavo P, Micali G, Sirna R, Gisondi P, Patrizi A, Dini V, Bianchini D, Bianchi L, Fania L, Prignano F, Offidani A, Atzori L, Bettoli V, Cannavò S P, Venturini M, Bongiorno M R, Costanzo A, Fabbrocini G, Peris K
Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Department of Physiopathology and Transplantation, Università degli Studi di Milano, Milan, Italy.
Br J Dermatol. 2021 Jan;184(1):133-140. doi: 10.1111/bjd.18983. Epub 2020 Apr 13.
The anti-tumour necrosis factor (TNF)-α adalimumab is the only licenced biologic for moderate-to-severe hidradenitis suppurativa (HS). No predictors of response have been identified so far.
To identify clinical parameters predicting response to adalimumab and confirm its efficacy/safety.
The data of 389 patients with HS treated with adalimumab in 21 Italian centres were reviewed. Sex, age at onset/diagnosis/baseline, body mass index, smoking, phenotype, previous treatments, concomitant antibiotics and 'therapeutic delay', defined as the time from HS onset to adalimumab initiation, were assessed. Response to adalimumab and its impact on quality of life (QoL) were evaluated using the Hidradenitis Suppurativa Clinical Response (HiSCR) and the Dermatology Life Quality Index (DLQI) or the Visual Analogue Scale for pain (VAS pain), respectively. Logistic regression analysis was performed.
The therapeutic delay correlated to lack of response to adalimumab at week 16 [odds ratio (OR) 1·92 for therapeutic delay > 10 years; 95% confidence interval (CI) 1·28-2·89; P = 0·0016). HiSCR was achieved in 43·7% and 53·9% patients at week 16 and 52, respectively. Significant reductions in both DLQI and VAS pain were found between week 16 vs. baseline (P < 0·0001 for both) and week 52 vs. baseline (P < 0·0001 for both). Previous immunosuppressants inversely correlated to HiSCR at week 52 (OR = 1·74, 95% CI 1·04-2·91, P = 0·0342).
Inverse correlation between therapeutic delay and clinical response was found, supporting early adalimumab use and providing evidence for a 'window of opportunity' in HS treatment. Adalimumab efficacy and safety were confirmed, along with patients' QoL improvement. Immunosuppressants could negatively influence the response to adalimumab inducing a switch to non-TNF-α-driven pathways.
抗肿瘤坏死因子（TNF）-α药物阿达木单抗是唯一获批用于治疗中重度化脓性汗腺炎（HS）的生物制剂。目前尚未发现预测其疗效的指标。
确定预测阿达木单抗疗效的临床参数，并证实其有效性和安全性。
回顾了意大利21个中心389例接受阿达木单抗治疗的HS患者的数据。评估了患者的性别、发病/诊断/基线时的年龄、体重指数、吸烟情况、疾病表型、既往治疗史、同时使用的抗生素以及“治疗延迟”（定义为从HS发病到开始使用阿达木单抗的时间）。分别使用化脓性汗腺炎临床反应（HiSCR）和皮肤病生活质量指数（DLQI）或疼痛视觉模拟量表（VAS疼痛）评估对阿达木单抗的反应及其对生活质量（QoL）的影响。进行了逻辑回归分析。
治疗延迟与第16周时对阿达木单抗无反应相关[治疗延迟>10年时的优势比（OR）为1.92；95%置信区间（CI）为1.28-2.89；P = 0.0016]。第16周和第52周时分别有43.7%和53.9%的患者达到HiSCR。在第16周与基线相比（两者P < 0.0001）以及第52周与基线相比（两者P < 0.0001）时，DLQI和VAS疼痛均有显著降低。既往使用免疫抑制剂与第52周时的HiSCR呈负相关（OR = 1.74，95% CI 1.04-2.91，P = 0.0342）。
发现治疗延迟与临床反应呈负相关，支持早期使用阿达木单抗，并为HS治疗中的“机会窗口”提供了证据。证实了阿达木单抗的有效性和安全性，以及患者生活质量的改善。免疫抑制剂可能会对阿达木单抗的反应产生负面影响，导致转向非TNF-α驱动的途径。
