Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.
Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
J Dermatolog Treat. 2022 May;33(3):1591-1597. doi: 10.1080/09546634.2020.1869147. Epub 2021 Jan 7.
BACKGROUND/OBJECTIVES: Tightly-controlled dose reduction was possible during 1 year in psoriasis patients on adalimumab, etanercept or ustekinumab with low disease activity (CONDOR trial). Extended observation is needed to ensure long-term effectiveness and safety of the strategy. With prolonged follow-up, we investigated the clinical effects and safety of the strategy, the proportion of patients with successful dose reduction, and assessed if patients with a disease flare regained remission.
Two-year follow up of a subgroup of patients previously included in a randomized pragmatic study comparing usual care (UC) with stepwise dose reduction (DR). Effectiveness (Psoriasis Area and Severity Index, PASI), Dermatology Life Quality Index (DLQI), adverse events, proportion of patients with successful DR and proportion of persistent disease flares were analyzed.
DR leads temporarily to a slightly increased PASI groupwise, but on the long-term patients regained low PASI. DLQI scores remained stable during follow-up. No serious adverse events due to DR were reported. Forty-one percent of patients remained on a low dose up to 2 years. The number of persistent flares was low in DR and UC.
The proposed dose reduction strategy is effective for a significant part of patients and remains safe up to 2 years of follow-up.
背景/目的：在疾病活动度低的情况下（CONDOR 试验），接受阿达木单抗、依那西普或乌司奴单抗治疗的银屑病患者在一年内可以进行严格控制的剂量减少。需要进行长期观察以确保该策略的长期有效性和安全性。随着随访时间的延长，我们研究了该策略的临床效果和安全性、成功减少剂量的患者比例，并评估了疾病发作的患者是否恢复缓解。
对先前纳入一项比较常规治疗（UC）与逐步剂量减少（DR）的随机实用研究的患者亚组进行为期 2 年的随访。分析有效性（银屑病面积和严重程度指数，PASI）、皮肤病生活质量指数（DLQI）、不良事件、成功减少剂量的患者比例以及持续疾病发作的比例。
DR 暂时导致群体 PASI 略有增加，但长期来看患者恢复了低 PASI。DLQI 评分在随访期间保持稳定。未报告因 DR 导致的严重不良事件。41%的患者在 2 年内仍维持低剂量。DR 和 UC 中持续发作的次数较少。
所提出的剂量减少策略对大部分患者有效，在 2 年的随访期间保持安全。
