Remote monitoring or patient-initiated care in axial spondyloarthritis: a 3-armed randomised controlled noninferiority trial.

Methods

This is a randomised, controlled, 3-armed, parallel-group, open-label, noninferiority trial. Patients with axSpA in low disease activity on stable treatment with tumour necrosis factor inhibitor were recruited from a Norwegian outpatient clinic.

这是一项随机对照、三臂、平行组、开放标签的非劣效试验。招募自挪威门诊诊所的患者为活动性脊柱关节炎（axSpA）患者，他们在肿瘤坏死因子抑制剂稳定治疗下处于低疾病活动度状态。

Patients were randomly allocated 1:1:1 to remote monitoring, patient-initiated care, or usual care (control group), with 18 months of follow-up.

患者被随机分配为1:1:1，分别接受远程监测、患者主动护理或常规护理（对照组），随访期为18个月。

Primary outcome was mean probability of axSpA Disease Activity Score (ASDAS) of <2.1, compared between groups at 6, 12, and 18 months, with 15% noninferiority margin.

主要结果是平均活动性脊柱关节炎疾病活动评分（ASDAS）<2.1的概率，分别在6个月、12个月和18个月时比较各组之间的差异，非劣效性边界为15%。

Secondary outcomes included other measures of disease activity, physical function, patient satisfaction, change of medication, resource use, and adverse events.

次要结果包括疾病活动性的其他测量指标、身体功能、患者满意度、药物变更、资源使用和不良事件。

Results

Of 243 patients enrolled patients, 235 completed the study (remote monitoring = 75, patient-initiated care = 79, usual care = 81).

在纳入研究的243名患者中，有235名完成了研究（远程监测=75，患者发起的护理=79，常规护理=81）。

At the 6-month, 12-month, and 18-month assessments, 90% or more patients in all 3 groups had ASDAS of <2.1.

在6个月、12个月和18个月的评估中，所有3组中有90%或更多的患者ASDAS小于2.1。

The estimated difference of probability of ASDAS < 2.1 was as follows: usual care vs remote monitoring, -4.1% (97.5% CI, -9.9% to 1.8%); usual care vs patient-initiated care, -1.1% (97.5% CI, -7.2% to 4.9%); and remote monitoring vs patient-initiated care, 2.9% (95% CI, -1.5% to 7.4%).

ASDAS小于2.1的概率估计差异如下：常规护理与远程监测相比，-4.1%（97.5%置信区间，-9.9%至1.8%）；常规护理与患者启动护理相比，-1.1%（97.5%置信区间，-7.2%至4.9%）；远程监测与患者启动护理相比，2.9%（95%置信区间，-1.5%至7.4%）。

Health providers' resource use was lowest in patient-initiated care; other secondary outcomes were comparable.

在患者发起的护理中，卫生提供者的资源使用量最低；其他次要结果相当。

Conclusions

In patients with axSpA in low disease activity and on stable treatment with tumour necrosis factor inhibitor, follow-up with remote monitoring or patient-initiated care was noninferior to usual care in maintaining low disease activity, supporting the implementation of novel follow-up strategies.

对于处于低疾病活动期且接受肿瘤坏死因子抑制剂治疗稳定的轴性脊柱关节炎患者，通过远程监测或患者发起的护理进行随访，在维持低疾病活动方面与常规护理相当，支持实施新型随访策略。