Faculty of Medicine, University of Toronto, Toronto, Canada.
Schulich School of Medicine & Dentistry, Western University, London, Canada.
Am J Clin Dermatol. 2021 Mar;22(2):275-283. doi: 10.1007/s40257-020-00575-3. Epub 2020 Nov 26.
Adalimumab, a tumor necrosis factor-α inhibitor, is a biologic used for the treatment of moderate-to-severe hidradenitis suppurativa (HS). It is well known that patients may experience loss of efficacy from its use in other conditions, and it is suggested that developing a strategy for therapeutic drug monitoring (TDM) may help secure optimal clinical outcomes.
We sought to determine serum adalimumab concentrations and anti-adalimumab antibody (AAA) status in patients with moderate-to-severe HS.
A retrospective case series of 38 patients with suboptimal response to adalimumab 40 mg weekly was conducted at a community dermatology clinic. Adalimumab serum trough levels, AAA status, and inflammatory biomarkers were collected. Blood was drawn on identification of suboptimal response (after a minimum of 12 weeks) and was collected once prior to receiving the next scheduled dose. Kruskal-Wallis and Chi-squared tests were used for data analysis.
A total of 38 patients had a median adalimumab trough concentration of 8.76 (interquartile range [IQR] 1.3-12.5) µg/mL. The median duration of adalimumab therapy of all patients was 21 (IQR 12-24) months. AAAs were detected in nine patients (24%), and all had subtherapeutic serum concentrations (< 6 µg/mL). Patients who were AAA+ had a significantly lower median adalimumab concentration than those who were AAA- (0.02 µg/mL [range 0.02-0.81] vs. 10.14 [range 0.76-48.00]; p = 0.0006).
Patients with AAAs had significantly lower serum adalimumab levels. The current study suggests that TDM may identify underlying reasons for suboptimal response and detect patients who may benefit from dose optimization strategies.
阿达木单抗是一种肿瘤坏死因子-α抑制剂，用于治疗中重度化脓性汗腺炎（HS）。众所周知，患者在其他疾病中使用阿达木单抗可能会失去疗效，因此建议制定治疗药物监测（TDM）策略有助于确保最佳的临床疗效。
我们旨在确定中重度 HS 患者的阿达木单抗血清浓度和抗阿达木单抗抗体（AAA）状态。
对一家社区皮肤科诊所中对阿达木单抗 40mg 每周治疗反应不佳的 38 例患者进行回顾性病例系列研究。收集阿达木单抗血清谷浓度、AAA 状态和炎症生物标志物。在识别治疗反应不佳（至少 12 周后）后采血，并在接受下一次预定剂量前采血一次。数据采用 Kruskal-Wallis 和卡方检验进行分析。
共有 38 例患者的阿达木单抗谷浓度中位数为 8.76（四分位距 [IQR] 1.3-12.5）µg/mL。所有患者阿达木单抗治疗的中位数持续时间为 21（IQR 12-24）个月。9 例（24%）患者检测到 AAA，且所有患者的血清浓度均低于治疗浓度（<6µg/mL）。AAA+患者的阿达木单抗浓度中位数明显低于 AAA-患者（0.02µg/mL[范围 0.02-0.81] vs. 10.14µg/mL[范围 0.76-48.00]；p=0.0006）。
AAA 患者的血清阿达木单抗水平明显较低。本研究表明，TDM 可能确定治疗反应不佳的潜在原因，并发现可能受益于剂量优化策略的患者。
