Huang Yinan, Chatterjee Satabdi, Agarwal Sandeep K, Chen Hua, Johnson Michael L, Aparasu Rajender R
Department of Pharmacy Administration, University of Mississippi, Oxford, MS, United States of America.
Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, TX, United States of America.
Explor Res Clin Soc Pharm. 2023 Jun 15;11:100296. doi: 10.1016/j.rcsop.2023.100296. eCollection 2023 Sep.
Advances in Disease-Modifying Antirheumatic Drugs (DMARDs) have expanded the treatment landscape for Rheumatoid Arthritis (RA). Guidelines recommend adding either conventional synthetic (cs), biologic (b), or targeted synthetic (ts) DMARDs to methotrexate (MTX) for managing RA. Limited evidence exists regarding the factors that contribute to adding a DMARD agent to the MTX regimen. This study examined the factors associated with adding the first DMARD in RA patients initiating MTX.
This retrospective cohort study utilized the MarketScan data (2012-2014) involving adults (aged ≥18) with RA initiating an MTX (index date) between Jul 1, 2012 and Dec 30, 2013, and with continuous enrollment for the 6-month pre-index period. The combination therapy users received the first treatment addition of DMARD starting from day 30 after the index MTX over one year period. The study focused on the addition of csDMARDs, Tumor Necrosis Factor Inhibitors (TNFi) bDMARDs, non-TNFi bDMARDs, or tsDMARDs. Baseline covariates were measured in the 6-month pre-index and grouped into predisposing, enabling, and need factors, as per the Andersen Behavior Model. Multivariable logistic regression examined the factors associated with the addition of TNFi compared to adding a csDMARD. An additional regression model evaluated the factors associated with adding any biologic (combining TNFi and non-TNFi biologics).
Among 8350 RA patients starting MTX, 31.92% ( = 2665) initiated any DMARD within the 1-year post-index period. Among RA patients initiating a DMARD prescription after starting MTX, 945 (11.32%) received combination therapy with treatment addition of a DMARD to MTX regimen; majority added TNFi (550, 58%), followed by csDMARD (352, 37%); non-TNF biologic (40, 4%), or tsDMARD (3, 0.3%). The tsDMARD group was limited and was not included for further analysis. The multivariable model found Preferred Provider Organization insurance coverage (odds ratio [OR], 1.43; 95% confidence interval (CI), 1.06-1.93), chronic pulmonary disease (OR, 1.98; 95% CI, 1.14-3.44), liver disease (OR, 5.24; 95% CI, 1.77-15.49), and Elixhauser score (OR, 0.91; 95% CI, 0.86-0.97) were significantly associated with the addition of TNF-α inhibitors. The separate multivariable model additionally found that patients from metropolitan areas (OR, 1.50; 95% CI, 1.04-2.16) were positively associated with adding any biological agent.
TNFi are often added to MTX for managing RA. Enabling and need factors contribute to the prescribing of a TNFi add-on therapy in RA. Future research should examine the impact of these combination therapies on RA management.
改善病情抗风湿药(DMARDs)的进展拓宽了类风湿关节炎(RA)的治疗前景。指南建议在甲氨蝶呤(MTX)基础上加用传统合成(cs)、生物(b)或靶向合成(ts)DMARDs来治疗RA。关于在MTX治疗方案中加用DMARD药物的相关因素,现有证据有限。本研究调查了开始使用MTX的RA患者加用第一种DMARD的相关因素。
这项回顾性队列研究利用了MarketScan数据(2012 - 2014年),纳入年龄≥18岁、于2012年7月1日至2013年12月30日开始使用MTX(索引日期)且在索引前6个月持续入组的RA成年患者。联合治疗使用者在索引MTX治疗后30天起的一年时间内首次加用DMARD治疗。本研究重点关注加用csDMARDs、肿瘤坏死因子抑制剂(TNFi)bDMARDs、非TNFi bDMARDs或tsDMARDs的情况。根据安德森行为模型,在索引前6个月测量基线协变量,并将其分为易患因素、促成因素和需求因素。多变量逻辑回归分析了与加用TNFi相比加用csDMARD相关的因素。另一个回归模型评估了与加用任何生物制剂(将TNFi和非TNFi生物制剂合并)相关的因素。
在8350例开始使用MTX的RA患者中,31.92%(n = 2665)在索引日期后1年内开始使用任何DMARD。在开始使用MTX后开始使用DMARD处方的RA患者中,945例(11.32%)接受了在MTX治疗方案上加用DMARD的联合治疗;大多数加用TNFi(550例,58%),其次是csDMARD(352例,37%);非TNF生物制剂(40例,4%)或tsDMARD(3例,0.3%)。tsDMARD组样本量有限,未纳入进一步分析。多变量模型发现,首选医疗机构保险覆盖(比值比[OR],1.43;95%置信区间[CI],1.06 - 1.93)、慢性肺病(OR,1.98;95% CI,1.14 - 3.44)、肝病(OR,5.24;95% CI,1.77 - 15.49)和埃利克斯豪泽评分(OR,0.91;95% CI,0.86 - 0.97)与加用TNF-α抑制剂显著相关。单独的多变量模型还发现,来自大都市地区的患者(OR,1.50;95% CI,1.04 - 2.16)与加用任何生物制剂呈正相关。
TNFi常被加用于MTX治疗RA。促成因素和需求因素影响了RA患者TNFi联合治疗的处方。未来研究应考察这些联合治疗对RA管理的影响。