Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Windmill Road, Oxford, OX3 7LD.
Centre for Rheumatology and Spine Diseases, Gentofte University Hospital, Rigshospitalet, Copenhagen, Denmark; The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Semin Arthritis Rheum. 2018 Apr;47(5):605-610. doi: 10.1016/j.semarthrit.2017.09.006. Epub 2017 Sep 23.
To estimate the impact of NICE approval of tumor necrosis factor inhibitor (TNFi) therapies on the incidence of total hip replacement (THR) and total knee replacement (TKR) among rheumatoid arthritis (RA) patients in England and Wales.
Primary care data [Clinical Practice Research Datalink (CPRD)] for the study period (1995-2014) were used to identify incident adult RA patients. The age and sex-standardised 5-year incidence of THR and TKR was calculated separately for RA patients diagnosed in each six-months between 1995-2009. We took a natural experimental approach, using segmented linear regression to estimate changes in level and trend following the publication of NICE TA 36 in March 2002, incorporating a 1-year lag. Regression coefficients were used to calculate average change in rates, adjusted for prior level and trend.
We identified 17,505 incident RA patients of whom 465 and 650 underwent THR and TKR surgery, respectively. The modeled average incidence of THR and TKR over the biologic-era was 6.57/1000 person years (PYs) and 8.51/1000 PYs, respectively, with projected (had pre-NICE TA 36 level and trend continued uninterrupted) figures of 5.63/1000 PYs and 12.92 PYs, respectively. NICE guidance was associated with a significant average decrease in TKR incidence of -4.41/1000 PYs (95% C.I. -6.88 to -1.94), equating to a relative 34% reduction. Overall, no effect was seen on THR rates.
Among incident RA patients in England and Wales, NICE guidance on TNFi therapies for RA management was temporally associated with reduced rates of TKR but not THR.
评估英国国家卫生与临床优化研究所(NICE)批准肿瘤坏死因子抑制剂(TNFi)治疗对英格兰和威尔士类风湿关节炎(RA)患者全髋关节置换术(THR)和全膝关节置换术(TKR)发生率的影响。
本研究使用初级保健数据[临床实践研究数据链(CPRD)],对研究期间(1995-2014 年)的病例进行了分析,以确定新诊断的成年 RA 患者。为每个 6 个月时间段(1995-2009 年)诊断的 RA 患者,分别计算其 THR 和 TKR 的年龄和性别标准化 5 年发生率。我们采用自然实验方法,使用分段线性回归估计在 2002 年 3 月 NICE TA 36 发布后的水平和趋势变化,其中包括 1 年的滞后。回归系数用于计算调整了先前水平和趋势的平均变化率。
我们共确定了 17505 例新诊断的 RA 患者,其中 465 例和 650 例分别接受了 THR 和 TKR 手术。在生物制剂时代,预计 THR 和 TKR 的平均发生率分别为 6.57/1000 人年(PYs)和 8.51/1000 PYs,而如果继续保持 NICE TA 36 之前的水平和趋势,预计这两个数字将分别为 5.63/1000 PYs 和 12.92 PYs。NICE 指南与 TKR 发生率显著下降相关,平均下降了-4.41/1000 PYs(95%置信区间-6.88 至-1.94),相当于相对减少了 34%。总体而言,THR 发生率没有变化。
在英格兰和威尔士的新诊断 RA 患者中,NICE 对 RA 管理中 TNFi 治疗的指南与 TKR 发生率的降低有关,但与 THR 无关。