When Usual Care Is Not So Usual: Protocol Violations and Generalizability in a Treat-to-Target Strategy Trial in Patients With Axial Spondyloarthritis

IF 3.7 2区医学 Q1 RHEUMATOLOGY Arthritis Care & Research Pub Date : 2024-06-24 DOI:10.1002/acr.25387

Clementina López-Medina, Filip van den Bosch, Désirée van der Heijde, Maxime Dougados, Anna Molto

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Abstract

Objective

The objective of this study was to evaluate the impact of protocol violations in the treat-to-target group in the Tight Control in Spondyloarthritis (TICOSPA) trial and to compare the proportion of patients optimally treated according to the Assessment of Spondyloarthritis International Society (ASAS)/EULAR 2016 recommendations for patients with axial spondyloarthritis (axSpA) between the treat-to-target versus usual care (UC) arms.

Methods

This study was a cluster-randomized, controlled 48-week trial including patients with axSpA who fulfilled the ASAS criteria, had an Axial Spondyloarthritis Disease Activity Score >2.1, and were biologic disease-modifying antirheumatic drug naive. Eighteen axSpA expert centers were randomly allocated to one treatment arm: (a) treat-to-target prespecified management strategy (four-week visits), and (b) UC treatment decisions at the rheumatologist's discretion (12-week visits). Protocol violations in the treat-to-target arm and the fulfillment of the 2016 ASAS/EULAR recommendations in both arms were evaluated at every visit. ASAS Health Index (ASAS-HI) and disease activity outcomes at 48 weeks were compared between treat-to-target violators versus nonviolators. Patients treated according to the ASAS/EULAR recommendations were compared between both arms.

Results

A total of 160 patients initiated the trial (80 patients with treat to target; 80 patients with UC). In the treat-to-target arm, 51.2% patients violated the protocol at least once (62.2% of violations resulting in maintenance/reduction of treatment against protocol). After 48 weeks, treat-to-target violators versus nonviolators showed similar ratios of ASAS-HI improvement. The proportion of patients managed according to the ASAS/EULAR recommendations after the first 12 weeks were 63.9% versus 61.8% for the treat-to-target and UC arms, respectively.

Conclusion

Protocol violations in the treat-to-target arm in the TICOSPA trial were frequent, although they did not have an impact on the rate of the primary outcome. The groups with UC was optimally treated, partly explaining the nonachievement of the primary objective in the TICOSPA trial.

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当常规护理不那么常规时：轴性脊柱关节炎靶向治疗策略试验中的方案违规和可推广性。

目的目的是评估TICOSPA试验中靶向治疗（T2T）组违反协议的影响，并比较T2T组与常规护理（UC）组之间根据ASAS/EULAR 2016年轴向脊柱关节炎（axSpA）建议进行最佳治疗的患者比例：分组随机对照 48 周（48W）试验，包括符合 ASAS 标准、ASDAS>2.1 和 bDMARD-naïve 的 axSpA 患者。18个axSpA专家中心被随机分配到一个治疗组：a)T2T：预先指定的管理策略（4W次就诊）；b)UC：由风湿免疫科医生决定治疗方案（12W次就诊）。每次就诊时都会评估 T2T 组违反协议的情况，以及两组是否符合 2016 ASAS/EULAR 建议。在48W时，比较了T2T违规者与非违规者的ASAS-HI和疾病活动性结果。根据ASAS/EULAR建议治疗的患者在两组之间进行比较：160名患者参加了试验（80名T2T患者；80名UC患者）。在 T2T 治疗组中，51.2% 的患者至少违反过一次治疗方案（62.2% 的违反方案导致维持/减少治疗方案）。48 W后，T2T违规者与非违规者的ASAS-HI改善比例相似。头12周后，T2T组和UC组按照ASAS/EULAR建议进行治疗的患者比例分别为63.9%和61.8%：结论：在TICOSPA试验中，T2T组经常违反协议，但对主要结果的发生率没有影响。UC 组得到了最佳治疗，这在一定程度上解释了 TICOSPA 试验未达到主要目标的原因。

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来源期刊

Arthritis Care & Research RHEUMATOLOGY-

CiteScore

9.40

自引率

6.40%

发文量

368

审稿时长

3-6 weeks

期刊介绍： Arthritis Care & Research, an official journal of the American College of Rheumatology and the Association of Rheumatology Health Professionals (a division of the College), is a peer-reviewed publication that publishes original research, review articles, and editorials that promote excellence in the clinical practice of rheumatology. Relevant to the care of individuals with rheumatic diseases, major topics are evidence-based practice studies, clinical problems, practice guidelines, educational, social, and public health issues, health economics, health care policy, and future trends in rheumatology practice.