使用基线风险评分识别在培塞丽珠单抗治疗类风湿关节炎患者中严重感染事件的风险。
Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment.
机构信息
University of Alabama at Birmingham, Birmingham, AL, USA.
Oregon Health and Science University, Portland, OR, USA.
出版信息
Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.
BACKGROUND
The risk of serious infectious events (SIEs) is increased in patients with rheumatoid arthritis (RA). The aim of this study was to develop an age-adjusted comorbidity index (AACI) to predict, using baseline characteristics, the SIE risk in patients with RA treated with certolizumab pegol (CZP).
METHODS
Data of CZP-treated patients with RA were pooled from the RAPID1/RAPID2 randomized controlled trials (RCT CZP) and their open-label extensions (All CZP). Predictors of the first SIE were examined using multivariate Cox models. The AACI was developed by assigning specific weights to patient age and comorbidities on the basis of relative SIE risk. SIE rates were predicted using AACI score and baseline glucocorticoid use, and they were compared with observed rates. The percentage of patients in each SIE risk group achieving low disease activity (LDA)/remission was examined at 1 year of treatment.
RESULTS
Among 1224 RCT CZP patients, 40 reported ≥ 1 SIE (incidence rate [IR] 5.09/100 patient-years [PY]), and 201 of 1506 All CZP patients reported ≥ 1 SIE (IR 3.66/100 PY). Age ≥ 70 years, diabetes mellitus, and chronic obstructive pulmonary disease/asthma made the greatest contributions to AACI score. SIE rates predicted using AACI and glucocorticoid use at baseline showed good agreement with observed SIE rates across low-risk and high-risk groups. At 1 year, more high-risk All CZP patients than low-risk All CZP patients reported SIEs (IR 8.4/100 PY vs. IR 3.4/100 PY). Rates of LDA/remission were similar between groups.
CONCLUSIONS
AACI and glucocorticoid use were strong baseline predictors of SIE risk in CZP-treated patients with RA. Predicted SIE risk was not associated with patients' likelihood of clinical response. This SIE risk score may provide a valuable tool for clinicians when considering the risk of infection in individual patients with RA.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT00152386 (registered 7 September 2005); NCT00160602 (registered 8 September 2005); NCT00175877 (registered 9 September 2005); and NCT00160641 (registered 8 September 2005).
背景
类风湿关节炎（RA）患者发生严重感染性事件（SIE）的风险增加。本研究旨在开发一种年龄调整后的合并症指数（AACI），以便根据基线特征预测接受培塞利珠单抗（CZP）治疗的 RA 患者的 SIE 风险。
方法
来自 CZP 治疗 RA 的 RAPID1/RAPID2 随机对照试验（RCT CZP）及其开放标签扩展（所有 CZP）的数据被汇总。使用多变量 Cox 模型检查 SIE 的预测因子。根据 SIE 风险的相对风险，通过为患者年龄和合并症分配特定权重来开发 AACI。使用 AACI 评分和基线糖皮质激素使用情况预测 SIE 发生率，并将其与观察到的发生率进行比较。在治疗 1 年时，检查每个 SIE 风险组中达到低疾病活动度（LDA）/缓解的患者比例。
结果
在 1224 名 RCT CZP 患者中，40 名患者报告了≥1 次 SIE（发生率 [IR] 为 5.09/100 患者年[PY]），在 1506 名所有 CZP 患者中，201 名患者报告了≥1 次 SIE（IR 为 3.66/100 PY）。年龄≥70 岁、糖尿病和慢性阻塞性肺疾病/哮喘对 AACI 评分的贡献最大。使用 AACI 和基线糖皮质激素使用情况预测的 SIE 发生率与低风险和高风险组的观察到的 SIE 发生率吻合良好。在 1 年时，与低风险的所有 CZP 患者相比，高风险的所有 CZP 患者报告的 SIE 更多（IR 8.4/100 PY vs. IR 3.4/100 PY）。两组之间 LDA/缓解率相似。
结论
AACI 和糖皮质激素使用是 CZP 治疗 RA 患者 SIE 风险的重要基线预测因素。预测的 SIE 风险与患者临床反应的可能性无关。该 SIE 风险评分可能为临床医生在考虑 RA 患者的感染风险时提供一个有价值的工具。
临床试验注册
ClinicalTrials.gov，NCT00152386（2005 年 9 月 7 日注册）；NCT00160602（2005 年 9 月 8 日注册）；NCT00175877（2005 年 9 月 9 日注册）；和 NCT00160641（2005 年 9 月 8 日注册）。
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