Centre for Rheumatology Research, Landspitali University Hospital, Reykjavik, Iceland.
Department of Science and Research, Landspitali University Hospital, Reykjavik, Iceland.
RMD Open. 2019 Jul 16;5(2):e000984. doi: 10.1136/rmdopen-2019-000984. eCollection 2019.
To determine in a retrospective cohort whether patients with psoriatic arthritis (PsA) who would not have fulfilled the inclusion criteria for randomised controlled trials (RCTs) for the TNF inhibitor (TNFi) chosen for their treatment (excl) have similar benefits and drug survival as those patients who would have (incl).
All patients with rheumatic disorders who are treated with biological disease-modifying antirheumatic drugs in Iceland are registered in ICEBIO. On 1 February 2016, 329 individuals with PsA were registered in ICEBIO, of whom 231 had data available for their first start of TNFi and could be evaluated according to the inclusion criteria of the respective RCTs. Disease activity was collected at baseline using Visual Analogue Scale (pain, fatigue and global (patient and physician) assessments), swollen joint count (SJC) and tender joint count (TJC), Disease Activity Score 28-joint count C reactive protein (DAS28-CRP) and Health Assessment Questionnaire (HAQ). Treatment response was measured at 6 and 18 months according to American College of Rheumatology response criteria, DAS28-CRP and Disease Activity Score in Psoriatic Arthritis for 28 joints. Drug survival rate was also analysed.
The demographics of these two groups were similar at baseline, although the incl group had higher SJC (5.5 vs 3.8) and subsequently higher DAS28-CRP (4.6 vs 4.2). While a larger change in disease activity was observed in the incl group with respect to HAQ and SJC, both groups had similar disease activity at follow-up. Drug survival was similar in both groups.
Patients with PsA who would not have fulfilled the inclusion criteria in RCTs reach similar disease activity scores at follow-up of 6 and 18 months and have similar drug survival as those patients who would have been included in RCTs.
在回顾性队列中确定患有银屑病关节炎(PsA)的患者,如果他们不符合所选 TNF 抑制剂(TNFi)随机对照试验(RCT)的纳入标准(排除),那么他们与那些符合纳入标准的患者(纳入)相比,是否具有相似的获益和药物存活率。
冰岛所有接受生物改善疾病抗风湿药物治疗的风湿性疾病患者均在 ICEBIO 登记。2016 年 2 月 1 日,ICEBIO 登记了 329 名患有 PsA 的患者,其中 231 名患者有其首次开始使用 TNFi 的数据,并可根据各自 RCT 的纳入标准进行评估。基线时使用视觉模拟量表(疼痛、疲劳和整体(患者和医生)评估)、肿胀关节计数(SJC)和压痛关节计数(TJC)、28 关节疾病活动度评分 C 反应蛋白(DAS28-CRP)和健康评估问卷(HAQ)收集疾病活动度数据。根据美国风湿病学会反应标准、DAS28-CRP 和 28 关节银屑病关节炎疾病活动度,在 6 和 18 个月时测量治疗反应。还分析了药物存活率。
两组患者的基线人口统计学特征相似,尽管纳入组的 SJC 较高(5.5 对 3.8),随后 DAS28-CRP 较高(4.6 对 4.2)。虽然纳入组的 HAQ 和 SJC 观察到更大的疾病活动度变化,但两组在随访时的疾病活动度相似。两组的药物存活率相似。
不符合 RCT 纳入标准的 PsA 患者在 6 和 18 个月的随访时达到相似的疾病活动评分,并且与那些符合 RCT 纳入标准的患者具有相似的药物存活率。