Cannon Grant W, Erickson Alan R, Teng Chia-Chen, Huynh Tina, Austin Sharon, Wade Sally W, Stolshek Bradley S, Collier David H, Mutebi Alex, Sauer Brian C
Salt Lake City VA Medical Center, University of Utah, Salt Lake City, UT, USA.
Division of Rheumatology, University of Utah, Salt Lake City, UT, USA.
Rheumatol Adv Pract. 2019 May 28;3(1):rkz015. doi: 10.1093/rap/rkz015. eCollection 2019.
The aim was to estimate the impact of TNF inhibitor (TNFi) exposure on radiographic disease progression in US Veterans with RA during the first year after initiating therapy.
This historical longitudinal cohort design used clinical and claims data to evaluate radiographic progression after initiation of TNFi. US Veterans with RA initiating TNFi treatment (index date), ≥ 6 months pre-index and ≥ 12 months post-index VA enrolment/activity, and initial (6 months pre-index to 30 days post-index) and follow-up (10-18 months post-index) bilateral hand radiographs were eligible. The cumulative TNFi exposure and change in modified Sharp score (MSS) between initial and follow-up radiographs were calculated. The percentage of patients with clinically meaningful change in MSS (≥ 5) for each month of exposure was assessed using a longitudinal marginal structural model with inverse probability of treatment weights. Mean values and CIs were generated using 1000 bootstrapped samples.
For 246 eligible patients, the mean (s.d.) age was 58 (11) years; 81% were male. The mean (s.d.) initial MSS was 19.6 (33.4) (range 0-214). The mean change (s.d.) in MSS was 0.3 (3.6) (median 0, range -19 to 22). Patients with the greatest exposure had the least radiographic progression for both crude and adjusted model analyses. Adjusted rates of MSS change ≥ 5 points (95% CI) were 10.6% (9.8%, 11.4%) for patients with 3 months of exposure compared with 5.4% (5.1%, 5.7%) for patients with 12 months of exposure.
One-year changes in radiographic progression were small. Patients with the greatest cumulative TNFi exposure experienced the least progression.
旨在评估肿瘤坏死因子抑制剂(TNFi)暴露对美国类风湿性关节炎(RA)退伍军人在开始治疗后第一年影像学疾病进展的影响。
本历史性纵向队列设计使用临床和索赔数据来评估TNFi开始治疗后的影像学进展。符合条件的是开始TNFi治疗(索引日期)、索引前≥6个月且索引后≥12个月有退伍军人事务部(VA)登记/活动的美国RA退伍军人,以及初始(索引前6个月至索引后30天)和随访(索引后10 - 18个月)的双侧手部X光片。计算累积TNFi暴露量以及初始和随访X光片之间改良夏普评分(MSS)的变化。使用具有治疗权重逆概率的纵向边际结构模型评估每个暴露月MSS发生临床意义变化(≥5)的患者百分比。使用1000次自抽样样本生成均值和置信区间。
对于246名符合条件的患者,平均(标准差)年龄为58(11)岁;81%为男性。平均(标准差)初始MSS为19.6(33.4)(范围0 - 214)。MSS的平均变化(标准差)为0.3(3.6)(中位数0,范围 - 19至22)。对于粗略和调整模型分析,暴露量最大的患者影像学进展最少。暴露3个月的患者MSS变化≥5分的调整率(95%置信区间)为10.6%(9.8%,11.4%),而暴露12个月的患者为5.4%(5.1%,5.7%)。
影像学进展的一年变化很小。累积TNFi暴露量最大的患者进展最少。