Nissen Michael, Delcoigne Bénédicte, Di Giuseppe Daniela, Jacobsson Lennart, Hetland Merete Lund, Ciurea Adrian, Nekvindova Lucie, Iannone Florenzo, Akkoc Nurullah, Sokka-Isler Tuulikki, Fagerli Karen Minde, Santos Maria Jose, Codreanu Catalin, Pombo-Suarez Manuel, Rotar Ziga, Gudbjornsson Bjorn, van der Horst-Bruinsma Irene, Loft Anne Gitte, Möller Burkhard, Mann Herman, Conti Fabrizio, Yildirim Cetin Gozde, Relas Heikki, Michelsen Brigitte, Avila Ribeiro Pedro, Ionescu Ruxandra, Sanchez-Piedra Carlos, Tomsic Matija, Geirsson Árni Jón, Askling Johan, Glintborg Bente, Lindström Ulf
Division of Rheumatology, Geneva University Hospital, Geneva, Switzerland.
Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm.
Rheumatology (Oxford). 2022 Nov 28;61(12):4741-4751. doi: 10.1093/rheumatology/keac174.
Many axial spondylarthritis (axSpA) patients receive a conventional synthetic DMARD (csDMARD) in combination with a TNF inhibitor (TNFi). However, the value of this co-therapy remains unclear. The objectives were to describe the characteristics of axSpA patients initiating a first TNFi as monotherapy compared with co-therapy with csDMARD, to compare one-year TNFi retention and remission rates, and to explore the impact of peripheral arthritis.
Data was collected from 13 European registries. One-year outcomes included TNFi retention and hazard ratios (HR) for discontinuation with 95% CIs. Logistic regression was performed with adjusted odds ratios (OR) of achieving remission (Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP < 1.3 and/or BASDAI < 2) and stratified by treatment. Inter-registry heterogeneity was assessed using random-effect meta-analyses, combined results were presented when heterogeneity was not significant. Peripheral arthritis was defined as ≥1 swollen joint at baseline (=TNFi start).
Amongst 24 171 axSpA patients, 32% received csDMARD co-therapy (range across countries: 13.5% to 71.2%). The co-therapy group had more baseline peripheral arthritis and higher CRP than the monotherapy group. One-year TNFi-retention rates (95% CI): 79% (78, 79%) for TNFi monotherapy vs 82% (81, 83%) with co-therapy (P < 0.001). Remission was obtained in 20% on monotherapy and 22% on co-therapy (P < 0.001); adjusted OR of 1.16 (1.07, 1.25). Remission rates at 12 months were similar in patients with/without peripheral arthritis.
This large European study of axial SpA patients showed similar one-year treatment outcomes for TNFi monotherapy and csDMARD co-therapy, although considerable heterogeneity across countries limited the identification of certain subgroups (e.g. peripheral arthritis) that may benefit from co-therapy.
许多轴性脊柱关节炎（axSpA）患者接受传统合成改善病情抗风湿药（csDMARD）与肿瘤坏死因子抑制剂（TNFi）联合治疗。然而，这种联合治疗的价值仍不明确。目的是描述与csDMARD联合治疗相比，初治时使用TNFi单药治疗的axSpA患者的特征，比较TNFi治疗一年的持续率和缓解率，并探讨外周关节炎的影响。
数据来自13个欧洲注册机构。一年的结局包括TNFi持续率和停药风险比（HR）及95%置信区间（CI）。采用逻辑回归分析，计算达到缓解（强直性脊柱炎疾病活动评分（ASDAS）-CRP＜1.3和/或巴斯强直性脊柱炎疾病活动指数（BASDAI）＜2）的校正比值比（OR），并按治疗分层。采用随机效应荟萃分析评估注册机构间的异质性，当异质性不显著时呈现合并结果。外周关节炎定义为基线时（即开始使用TNFi时）≥1个关节肿胀。
在24171例axSpA患者中，32%接受csDMARD联合治疗（各国范围：13.5%至71.2%）。联合治疗组比单药治疗组有更多的基线外周关节炎和更高的CRP。TNFi治疗一年的持续率（95%CI）：TNFi单药治疗组为79%（78，79%），联合治疗组为82%（81，83%）（P＜0.001）。单药治疗缓解率为20%，联合治疗为22%（P＜0.001）；校正OR为1.16（1.07，1.25）。有/无外周关节炎患者12个月时的缓解率相似。
这项针对欧洲轴性脊柱关节炎患者的大型研究表明，TNFi单药治疗和csDMARD联合治疗的一年治疗结局相似，尽管各国存在相当大的异质性，限制了对可能从联合治疗中获益的某些亚组（如外周关节炎）的识别。
