From the School of Population and Public Health, University of British Columbia; Centre for Health Evaluation and Outcome Sciences, Vancouver, British Columbia, Canada; Sorbonne Universités, UPMC - GRC08, Pierre Louis Institute for Epidemiology and Public Health; University Paris Diderot, Faculty of Medicine; AP-HP, Rheumatology Department, Lariboisiere University Hospital; AP-HP, Rheumatology Department, Pitié Salpétrière University Hospital, Paris; Rheumatology Unit, Hôpital de la Cavale Blanche; EA2216, INSERM ESPRI, ERI29, Université de Brest, LabEx IGO, Brest, France.
S. Harvard, MSc, School of Population and Public Health, University of British Columbia, and Centre for Health Evaluation and Outcome Sciences, and Sorbonne Universités, UPMC - GRC08, Pierre Louis Institute for Epidemiology and Public Health; D. Guh, MSc, Centre for Health Evaluation and Outcome Sciences; N. Bansback, PhD, School of Population and Public Health, University of British Columbia, and Centre for Health Evaluation and Outcome Sciences; P. Richette, MD, PhD, University Paris Diderot, Faculty of Medicine, and AP-HP, Rheumatology Department, Lariboisiere University Hospital; A. Saraux, MD, PhD, Rheumatology Unit, Hôpital de la Cavale Blanche, and EA2216, INSERM ESPRI, ERI29, Université de Brest; B. Fautrel, MD, PhD, Sorbonne Universités, UPMC - GRC08, Pierre Louis Institute for Epidemiology and Public Health, and AP-HP, Rheumatology Department, Pitié Salpétrière University Hospital; A.H. Anis, PhD, School of Population and Public Health, University of British Columbia, and Centre for Health Evaluation and Outcome Sciences.
J Rheumatol. 2017 Oct;44(10):1436-1444. doi: 10.3899/jrheum.161399. Epub 2017 Jul 1.
To evaluate a classification system to define adherence to axial spondyloarthritis (axSpA) anti-tumor necrosis factor (anti-TNF) use recommendations and examine the effect of adherence on outcomes in the DESIR cohort (Devenir des Spondylarthropathies Indifférenciées Récentes).
Using alternate definitions of adherence, patients were classified as adherent "timely" anti-TNF users, nonadherent "late" anti-TNF users, adherent nonusers ("no anti-TNF need"), non-adherent nonusers ("unmet anti-TNF need"). Multivariate models were fitted to examine the effect of adherence on quality-adjusted life-years (QALY), total costs, and nonbiologic costs 1 year following an index date. Generalized linear regression models assuming a γ-distribution with log link were used for costs outcomes and linear regression models for QALY outcomes.
Using the main definition of adherence, there were no significant differences between late anti-TNF users and timely anti-TNF users in total costs (RR 0.86, 95% CI 0.54-1.36, p = 0.516) or nonbiologic costs (RR 0.72, 95% CI 0.44-1.18, p = 0.187). However, in the sensitivity analysis, late anti-TNF users had significantly increased nonbiologic costs compared with timely users (RR 1.58, 95% CI 1.06-2.36, p = 0.026). In the main analysis, there were no significant differences in QALY between timely anti-TNF users and late anti-TNF users, or between timely users and patients with unmet anti-TNF need. In the sensitivity analysis, patients with unmet anti-TNF need had significantly lower QALY than timely anti-TNF users (-0.04, 95% CI -0.07 to -0.01, p = 0.016).
The effect of adherence to anti-TNF recommendations on outcomes was sensitive to the definition of adherence used, highlighting the need to validate methods to measure adherence.
评估一种分类系统,以确定是否符合轴性脊柱关节炎(axSpA)抗肿瘤坏死因子(anti-TNF)使用建议,并在 DESIR 队列(近期未分化脊柱关节病的演变)中研究依从性对结局的影响。
使用不同的依从性定义,将患者分类为依从性“及时”抗 TNF 使用者、不依从性“延迟”抗 TNF 使用者、依从性非使用者(“无抗 TNF 需求”)和不依从性非使用者(“抗 TNF 需求未满足”)。使用多元模型来检验依从性对质量调整生命年(QALY)、总费用和索引日期后 1 年的非生物成本的影响。假设 γ 分布具有对数链接的广义线性回归模型用于成本结果,线性回归模型用于 QALY 结果。
使用主要的依从性定义,延迟抗 TNF 使用者与及时抗 TNF 使用者在总费用(RR 0.86,95%CI 0.54-1.36,p=0.516)或非生物成本(RR 0.72,95%CI 0.44-1.18,p=0.187)方面无显著差异。然而,在敏感性分析中,延迟抗 TNF 使用者的非生物成本明显高于及时使用者(RR 1.58,95%CI 1.06-2.36,p=0.026)。在主要分析中,及时抗 TNF 使用者与延迟抗 TNF 使用者之间,以及及时使用者与抗 TNF 需求未满足的患者之间,QALY 无显著差异。在敏感性分析中,抗 TNF 需求未满足的患者的 QALY 明显低于及时抗 TNF 使用者(-0.04,95%CI-0.07 至-0.01,p=0.016)。
依从性抗 TNF 建议对结局的影响对所使用的依从性定义敏感,这突出表明需要验证衡量依从性的方法。