Peeters Amy C D, Michielsens Celia A J, Mahler Elien A M, Verhoef Lise M, den Broeder Alfons A, den Broeder Nathan, van Herwaarden Noortje
Department of Rheumatology, Sint Maartenskliniek, Ubbergen, Netherlands.
Department of Rheumatology, Sint Maartenskliniek, Ubbergen, Netherlands.
Lancet Rheumatol. 2025 Sep;7(9):e642-e651. doi: 10.1016/S2665-9913(25)00070-0. Epub 2025 Jul 24.
Results of the DRESS-PS trial showed that a tapering strategy with TNF inhibitors is non-inferior to continuation of the same TNF inhibitor dose for up to 12 months in patients with psoriatic arthritis and axial spondyloarthritis. This study aimed to describe the effectiveness of TNF inhibitor tapering for up to 24 months in patients who participated in the DRESS-PS trial.
This study was a 12-month observational extension of the original 12-month, open-label, non-inferiority DRESS-PS trial conducted at the Sint Maartenskliniek, Nijmegen and Woerden, the Netherlands. Patients aged 16 years and older with psoriatic arthritis or axial spondyloarthritis and stable low disease activity for at least 6 months participated in the original DRESS-PS trial. Patients were randomly assigned to either a treat-to-target tapering strategy (the intervention group), which involved extending the interval between TNF inhibitor doses, resulting in doses of 100%, 66%, 50%, or 0% of the defined daily dose, or to a treat-to-target strategy without tapering (the control group). All patients who participated in the DRESS-PS trial were eligible to participate in this extension study, in which treat-to-target tapering was allowed for all patients, and treatment decisions were made through shared decision making between physicians and patients. The primary outcome was the difference between the original intervention and control groups in the proportion of patients with low disease activity at 24 months; this difference (adjusted for stratification factors at randomisation) was compared, without and with imputation, with the prespecified non-inferiority margin of 20% from the original DRESS-PS trial, and non-inferiority was determined from the adjusted 95% CIs. There was no involvement of people with lived experience of psoriatic arthritis or axial spondyloarthritis in the design, recruitment, conduct, analysis, or reporting of this extension study. The DRESS-PS trial was registered with the Dutch Trial Register, NL6771.
Between Jan 8, 2020, and Oct 10, 2022, 114 of the 122 patients from the DRESS-PS trial participated in this extension study: 79 from the original intervention group (40 with psoriatic arthritis, 39 with axial spondyloarthritis) and 35 from the original control group (18 with psoriatic arthritis, 17 with axial spondyloarthritis). Mean age was 50·0 years (SD 14·5). 70 (61%) patients were men and 44 (39%) were women. The proportion of patients with low disease activity at 24 months was 67% (45 of 67 patients) in the intervention group and 72% (23 of 32 patients) in the control group, with an adjusted difference of 5% (95% CI -15 to 24; p=0·64), which exceeded the prespecified non-inferiority margin. With imputation of missing data, the adjusted difference was 2% (-18 to 16; p=0·85), which fell within the non-inferiority margin. 78 (99%) of 79 patients in the intervention group and 31 (89%) of 35 patients in the control group had at least one adverse event over the full 24-month study period (difference 10% [-1 to 21]; p=0·060). There were no significant differences between groups in adverse events of special interest: infections and injection site reactions.
Treat-to-target tapering of TNF inhibitors remains effective and safe for the maintenance of low disease activity for up to 2 years in patients with psoriatic arthritis and axial spondyloarthritis. Future research should explore the challenges to implementation of tapering strategies in routine care in these patients.
ReumaNederland.
DRESS-PS试验结果表明，对于银屑病关节炎和轴向性脊柱关节炎患者，肿瘤坏死因子（TNF）抑制剂逐渐减量策略并不劣于持续使用相同剂量的TNF抑制剂长达12个月。本研究旨在描述参与DRESS-PS试验的患者中TNF抑制剂长达24个月逐渐减量的有效性。
本研究是在荷兰奈梅亨和沃尔登的圣马丁诊所进行的为期12个月的观察性扩展研究，其前身为为期12个月的开放标签、非劣效性DRESS-PS试验。年龄在16岁及以上、患有银屑病关节炎或轴向性脊柱关节炎且至少6个月疾病活动度稳定较低的患者参与了最初的DRESS-PS试验。患者被随机分配至达标逐渐减量策略组（干预组），该策略包括延长TNF抑制剂剂量间隔，使剂量达到规定日剂量的100%、66%、50%或0%，或分配至无逐渐减量的达标策略组（对照组）。所有参与DRESS-PS试验的患者均有资格参与本扩展研究，其中所有患者均允许达标逐渐减量，且治疗决策通过医生与患者共同决策做出。主要结局是最初干预组和对照组在24个月时疾病活动度较低的患者比例之间的差异；该差异（根据随机分组时的分层因素进行调整）在有无数据插补的情况下，与最初DRESS-PS试验预先设定的20%非劣效界值进行比较，并根据调整后的95%置信区间确定非劣效性。银屑病关节炎或轴向性脊柱关节炎有实际生活经验的人未参与本扩展研究的设计、招募、实施、分析或报告。DRESS-PS试验已在荷兰试验注册中心注册，注册号为NL6771。
在2020年1月8日至2022年10月10日期间，DRESS-PS试验的122名患者中有114名参与了本扩展研究：79名来自最初的干预组（40名患有银屑病关节炎，39名患有轴向性脊柱关节炎），35名来自最初的对照组（18名患有银屑病关节炎，17名患有轴向性脊柱关节炎）。平均年龄为50.0岁（标准差14.5）。70名（61%）患者为男性，44名（39%）为女性。干预组在24个月时疾病活动度较低的患者比例为67%（67名患者中的45名），对照组为72%（32名患者中的23名），调整后的差异为5%（95%置信区间为-15至24；p = 0.64），超过了预先设定的非劣效界值。在进行缺失数据插补后，调整后的差异为2%（-18至16；p = 0.85），落在非劣效界值范围内。干预组79名患者中的78名（99%）和对照组35名患者中的第31名（89%）在整个24个月的研究期间至少发生了一次不良事件（差异为10%[-1至21]；p = 0.060）。在特殊关注的不良事件（感染和注射部位反应）方面，两组之间无显著差异。
对于银屑病关节炎和轴向性脊柱关节炎患者，TNF抑制剂达标逐渐减量在维持长达2年的低疾病活动度方面仍然有效且安全。未来的研究应探索在这些患者的常规护理中实施逐渐减量策略所面临的挑战。
荷兰风湿病协会。
