Atalay Selma, Berends Sophie E, Groenewoud Hans M M, Mathot Ron A A, Njoo David M, Mommers Johannes M, Ossenkoppele Paul M, Koetsier Marjolein I A, Berends Maartje A, de Vries Annick, van de Kerkhof Peter C M, den Broeder Alfons A, de Jong Elke M G J, van den Reek Juul M P A
Department of Dermatology, Radboudumc, Nijmegen René Descartesdreef 1, Nijmegen, Netherlands.
Department of Hospital Pharmacy, Academic Medical Center, Amsterdam, Netherlands.
J Dermatolog Treat. 2022 Aug;33(5):2680-2684. doi: 10.1080/09546634.2022.2043546. Epub 2022 Feb 23.
Biologics for psoriasis are registered in standard dosages. In patients with low disease activity, reduction of the dose by interval prolongation can prevent overtreatment, and lower risks and costs. However, fear for increased anti-drug antibody (ADA) formation due to interval prolongation of biologics is an important barrier.
To investigate the course of serum drug concentrations, ADA levels, and predictors for successful dose reduction of adalimumab, ustekinumab, and etanercept for psoriasis.
Patients were randomized to dose reduction (DR) or usual care (UC) and followed for one year. The course and extent of detectable ADA levels were expressed as proportions/relative risks for DR UC. Association of baseline characteristics with successful tapering was investigated with log-binomial regression analysis.
In total, 118 patients were included. In adalimumab-treated patients, no significant difference in the proportion of patients with relevant ADA levels in DR UC was seen. For ustekinumab, relevant ADA development was absent in both groups. Baseline trough levels were not predictive for successful DR.
Immunogenicity may not increase by interval prolongation in psoriasis patients with low disease activity. This pilot provides important and reassuring insight into the pharmacological changes after dose tapering of adalimumab, etanercept, and ustekinumab.
用于治疗银屑病的生物制剂以标准剂量注册。在疾病活动度低的患者中，通过延长给药间隔来减少剂量可防止过度治疗，并降低风险和成本。然而，担心生物制剂给药间隔延长会导致抗药抗体（ADA）形成增加是一个重要障碍。
研究阿达木单抗、乌司奴单抗和依那西普治疗银屑病时血清药物浓度变化过程、ADA水平以及成功降低剂量的预测因素。
将患者随机分为剂量减少组（DR）或常规治疗组（UC），随访一年。可检测到的ADA水平的变化过程和程度以DR组与UC组的比例/相对风险表示。采用对数二项回归分析研究基线特征与成功减量的相关性。
共纳入118例患者。在接受阿达木单抗治疗的患者中，DR组和UC组中ADA水平相关的患者比例无显著差异。对于乌司奴单抗，两组均未出现相关的ADA产生。基线谷浓度不能预测DR是否成功。
疾病活动度低的银屑病患者延长给药间隔可能不会增加免疫原性。这项初步研究为阿达木单抗、依那西普和乌司奴单抗减量后的药理学变化提供了重要且令人安心的见解。
