Reyes Juan M, Gutierrez-Ardila Magda V, Madariaga Hugo, Otero William, Guzman Renato, Izquierdo Jorge, Del Castillo David J, Abello Mauricio, Velez Patricia, Ponce de Leon Dario, Lukic Tatjana, Amador Luisa F, Castaño Natalia
Pfizer Bogota Colombia.
Pfizer Santiago Chile.
Health Sci Rep. 2023 Mar 3;6(3):e1034. doi: 10.1002/hsr2.1034. eCollection 2023 Mar.
A noninterventional prospective study was performed in Colombia and Peru. The aim was to describe the impact of access to treatment on Patient-reported outcomes (PRO) in patients with Rheumatoid arthritis (RA) after failure to conventional disease-modifying antirheumatic drugs (DMARDs) in real-life conditions.
The impact of access to treatment was measured by access barriers, time to supply (TtS) and interruption evaluating their effect in changes of PROs between baseline and 6-month follow-up between February 2017 and November 2019. The association of access to care with disease activity, functional status, health-related quality of life was assessed using bivariate and multivariable analysis. Results are expressed in least mean difference; TtS in mean number of days for delivery of treatment at baseline. Variability measures were standard deviation and standard error.
One hundred seventy patients were recruited, 70 treated with tofacitinib and 100 with biological DMARDs. Thirty-nine patients reported access barriers. The mean of TtS was 23 ± 38.83 days. The difference from baseline to 6-month visit in PROs were affected by access barriers and interruptions. There was not statistically significant difference in the of PRO's score among visits in patients that reported delay of supply of more than 23 days compared to patients with less days of delay.
This study suggested the access to treatment can affect the response to the treatment at 6 months of follow-up. There seems to be no effect in the PROs for delay of TtS during the studied period.
在哥伦比亚和秘鲁开展了一项非干预性前瞻性研究。目的是描述在现实生活中,类风湿关节炎(RA)患者在传统抗风湿药物(DMARDs)治疗失败后,获得治疗对患者报告结局(PRO)的影响。
通过获取障碍、供应时间(TtS)和中断情况来衡量获得治疗的影响,并评估其在2017年2月至2019年11月基线与6个月随访期间对PRO变化的作用。使用双变量和多变量分析评估获得治疗与疾病活动、功能状态、健康相关生活质量之间的关联。结果以最小均值差异表示;TtS以基线时治疗交付的平均天数表示。变异度量为标准差和标准误差。
招募了170名患者,70名接受托法替布治疗,100名接受生物DMARDs治疗。39名患者报告了获取障碍。TtS的均值为23±38.83天。从基线到6个月随访时PRO的差异受获取障碍和中断情况的影响。与延迟天数较少的患者相比,报告供应延迟超过23天的患者在各次随访中PRO评分无统计学显著差异。
本研究表明,获得治疗可能会影响随访6个月时的治疗反应。在研究期间,TtS延迟似乎对PROs没有影响。