An app-based nonpharmacological intervention improves patient-reported disease activity, functionality, and quality of life in patients with axial spondyloarthritis: a randomised controlled trial.

We evaluated Axia, a CE-marked smartphone application designed for axSpA, that combines personalised exercise therapy, patient education, and disease management, supported by gamification for long-term adherence.

我们评估了Axia，这是一款为axSpA设计的CE认证的智能手机应用程序，它结合了个性化的运动疗法、患者教育和疾病管理，并通过游戏化元素支持长期的依从性。

Methods

To evaluate its clinical efficacy, a 12-week monocentric randomised controlled interventional trial was conducted involving 200 patients with axSpA with stable pharmacotherapy.

为了评估其临床疗效，进行了一项为期12周的单中心随机对照干预试验，涉及200名稳定药物治疗的轴性脊柱关节炎(axSpA)患者。

Patients were randomised (1:1) to either using Axia (intervention group [IG]) or standard of care (control group [CG]).

患者被随机分配（1:1）至使用Axia（干预组[IG]）或常规护理（对照组[CG]）。

Results

A total of 186 participants (mean age 50.61 years, 66% females, 56% with radiographic axSpA, mean Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] 5.17, and 58% received biologicals or Janus kinase inhibitors) completed the study (95 in the IG and 91 in the CG).

共有186名参与者（平均年龄50.61岁，女性占66%，56%的参与者有放射性轴性脊柱关节炎(axSpA)，平均Bath强直性脊柱炎疾病活动指数[BASDAI]为5.17，58%的参与者接受了生物制剂或Janus激酶抑制剂治疗）完成了研究（干预组(IG)95人，对照组(CG)91人）。

Compared to CG, participants in the IG demonstrated significant improvements in BASDAI (analysis of covariance [ANCOVA]-estimated group difference: -1.508, P < .001), Bath Ankylosing Spondylitis Functional Index (-1.139; P < .001), and Ankylosing Spondylitis Quality of Life questionnaire (-2.297; P < .001), all exceeding minimal clinically important difference thresholds.

与对照组(CG)相比，干预组(IG)的参与者在BASDAI（协方差分析[ANCOVA]估计的组间差异：-1.508，P < .001）、Bath强直性脊柱炎功能指数（-1.139；P < .001）和强直性脊柱炎生活质量问卷（-2.297；P < .001）方面显示出显著改善，所有这些改善均超过了最小临床重要差异阈值。

A significantly higher proportion of patients in the IG achieved an Assessment of Spondyloarthritis International Society (ASAS)20 response compared to the CG (51% vs 9%; P < .001), and the ASAS40 response rate was also higher (23% vs 3%; P < .001).

在干预组（IG）中，达到脊柱关节炎国际协会（ASAS）20响应的患者比例显著高于对照组（CG）（51%对比9%；P<.001），并且ASAS40响应率也更高（23%对比3%；P<.001）。

No concerning safety signals were observed.

未观察到令人担忧的安全信号。

Conclusions

These findings support the potential of Axia as a safe and effective nonpharmacological intervention to further improve the state of care of patients with axSpA in addition to conventional anti-inflammatory pharmacotherapy.

这些发现支持Axia作为一种安全有效的非药物干预措施的潜力，可以进一步改善接受传统抗炎药物治疗的轴性脊柱关节炎患者的护理状况。