Objectives

To compare the effect of treat-to-target-based escalations in conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and biologics on clinical disease activity and magnetic resonance imaging (MRI) inflammation in a rheumatoid arthritis (RA) cohort in clinical remission.

Method

One-hundred patients with established RA, Disease Activity Score based on 28-joint count–C-reactive protein (DAS28-CRP) < 3.2, and no swollen joints (hereafter referred to as ‘in clinical remission’) who received csDMARDs underwent clinical evaluation and MRI of the wrist and second to fifth metacarpophalangeal joints every 4 months. They followed a 2 year MRI treatment strategy targeting DAS28-CRP ≤ 3.2, no swollen joints, and absence of MRI osteitis, with predefined algorithmic treatment escalation: first: increase in csDMARDs; second: adding a biologic; third: switch biologic. MRI osteitis and Health Assessment Questionnaire (HAQ) (co-primary outcomes) and MRI combined inflammation and Simplified Disease Activity Index (SDAI) (key secondary outcomes) were assessed 4 months after treatment change and expressed as estimates of group differences. Statistical analyses were based on the intention-to-treat population analysed using repeated-measures mixed models.

Results

Escalation to first biologic compared to csDMARD escalation more effectively reduced MRI osteitis (difference between least squares means 1.8, 95% confidence interval 1.0–2.6), HAQ score (0.08, 0.03–0.1), MRI combined inflammation (2.5, 0.9–4.1), and SDAI scores (2.7, 1.9–3.5).

Conclusions

Treat-to-target-based treatment escalations to biologics compared to escalation in csDMARDs more effectively improved MRI inflammation, physical function, and clinical disease activity in patients with established RA in clinical remission. Treatment escalation in RA patients in clinical remission reduces clinical and MRI-assessed disease activity.

Trial registration

Clinicaltrials.gov identifier: NCT01656278

中文翻译：

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与强化常规 DMARD 相比，启动生物制剂对已确立的类风湿关节炎患者临床缓解期临床和 MRI 结果的影响：IMAGINE-RA 试验的二次分析

目标

比较在临床缓解期的类风湿关节炎 (RA) 队列中，常规合成改善疾病的抗风湿药物 (csDMARDs) 和生物制剂中基于靶向治疗的升级对临床疾病活动和磁共振成像 (MRI) 炎症的影响。

方法

接受 csDMARDs 治疗的 100 名 RA、疾病活动评分基于 28 个关节计数的 C 反应蛋白 (DAS28-CRP) < 3.2 且没有关节肿胀（以下称为“临床缓解”）的患者接受了临床每 4 个月对手腕和第二至第五掌指关节进行评估和 MRI。他们遵循针对 DAS28-CRP ≤ 3.2、无关节肿胀和没有 MRI 骨炎的 2 年 MRI 治疗策略，并采用预定义的算法治疗升级：首先：csDMARDs 增加；第二：添加生物；第三：开关生物。MRI 骨炎和健康评估问卷 (HAQ)（共同主要结果）和 MRI 联合炎症和简化疾病活动指数（SDAI）（关键次要结果）在治疗改变后 4 个月进行评估，并表示为组差异的估计值。统计分析基于使用重复测量混合模型分析的意向治疗人群。

结果

与 csDMARD 升级相比，升级至第一种生物制剂更有效地减少了 MRI 骨炎（最小二乘平均值之差为 1.8，95% 置信区间 1.0-2.6），HAQ 评分（0.08，0.03-0.1），MRI 联合炎症（2.5，0.9-4.1） , 和 SDAI 分数 (2.7, 1.9–3.5)。

结论

与 csDMARD 的升级相比，针对生物制剂的靶向治疗升级更有效地改善了临床缓解期已确诊 RA 患者的 MRI 炎症、身体功能和临床疾病活动。临床缓解期 RA 患者的治疗升级会降低临床和 MRI 评估的疾病活动性。

试用注册

Clinicaltrials.gov 标识符：NCT01656278