Soenen Rani, Stove Christophe, Capobianco Alessio, De Schutter Hanne, Dobbelaere Marie, Mahjor Tahmina, Follens Merel, Lambert Jo, Grine Lynda
Department of Dermatology, Ghent University Hospital, 9000 Ghent, Belgium.
Dermatology Research Unit, University Ghent, 9000 Ghent, Belgium.
J Clin Med. 2022 May 26;11(11):3011. doi: 10.3390/jcm11113011.
Therapeutic drug monitoring (TDM) of biologics-encompassing the measurement of (trough) concentrations and anti-drug antibodies-is emerging as a valuable tool for clinical decision making. While this strategy needs further validation, attention on its implementation into the clinic is warranted. Rapid testing and easy sampling are key to its implementation. Here, we aimed to evaluate the feasibility and volunteers' perception of home microsampling for quantification of adalimumab (ADM) concentrations in psoriasis patients. In addition, we compared lateral flow testing (LFT) with enzyme-linked immunosorbent assay (ELISA). Patients participating in the SUPRA-A study (clinicaltrials.gov NCT04028713) were asked to participate in a substudy where volumetric absorptive microsampling (VAMS) was performed at home. At three time points, whole blood and corresponding serum samples were collected for ADM measurement using an in-house ELISA. In addition, the patients' perspective on microsampling was evaluated via a questionnaire. LFT-obtained ADM concentrations agreed very well with ELISA results (Pearson's correlation = 0.95 and R = 0.89). ADM concentrations determined in both capillary (via finger prick) and corresponding venous blood VAMS samples correlated strongly with serum concentrations (Pearson's correlation = 0.87). Our preliminary data (n = 7) on rapid testing and home-based microsampling are considered promising with regard to TDM implementation for adalimumab, warranting further research.
生物制品的治疗药物监测（TDM）——包括（谷）浓度和抗药物抗体的测量——正在成为临床决策的一项有价值的工具。虽然这一策略需要进一步验证，但对其在临床中的应用予以关注是有必要的。快速检测和简便采样是其应用的关键。在此，我们旨在评估在家中进行微量采样以定量银屑病患者体内阿达木单抗（ADM）浓度的可行性以及志愿者的看法。此外，我们还将侧向流动检测（LFT）与酶联免疫吸附测定（ELISA）进行了比较。邀请参与SUPRA - A研究（clinicaltrials.gov NCT04028713）的患者参加一项子研究，在家中进行体积吸收微量采样（VAMS）。在三个时间点，采集全血和相应的血清样本，使用内部ELISA法测量ADM。此外，通过问卷调查评估患者对微量采样的看法。LFT获得的ADM浓度与ELISA结果非常吻合（Pearson相关性 = 0.95，R = 0.89）。在毛细血管血（通过手指针刺采集）和相应静脉血VAMS样本中测定的ADM浓度与血清浓度密切相关（Pearson相关性 = 0.87）。我们关于快速检测和家庭微量采样的初步数据（n = 7）对于阿达木单抗的TDM应用而言很有前景，值得进一步研究。
