Strand Vibeke, Miller Paul, Williams Setareh A, Saunders Katherine, Grant Shannon, Kremer Joel
Division of Immunology/Rheumatology, Stanford University School of Medicine, Portola Valley, CA, USA.
Payer & Real World Evidence, AstraZeneca, Macclesfield, UK.
Rheumatol Ther. 2017 Dec;4(2):489-502. doi: 10.1007/s40744-017-0078-y. Epub 2017 Aug 22.
Despite the availability of multiple effective therapies, discontinuation/switching of treatment is common for many patients with rheumatoid arthritis (RA). This study was designed to examine initiation of biologic disease-modifying anti-rheumatic drugs (bDMARDs) within the Consortium of Rheumatology Researchers of North America (Corrona) RA Registry, and characterize reasons for discontinuation.
Inclusion criteria were: Corrona-registered adults (≥18 years) with RA (2002-2011); age of RA onset: ≥16 years; ≥6 months' follow-up after initiation of first/subsequent bDMARD. Patients receiving both tumor necrosis factor antagonists and non-TNF antagonists were included. Treatment discontinuation was defined as first report of stopping initial therapy or initiation of new bDMARD at/between visits, using a follow-up physician questionnaire.
Overall, 6209 patients met inclusion criteria and 80.7% received TNF antagonists. Median time to discontinuation/change of therapy was 25.1 months (26.5 months with TNF antagonists vs. 20.5 months with non-TNF antagonists; log-rank p < 0.0001); 82.2, 67.3, and 51.1% of patients remained on therapy at 6, 12, and 24 months, respectively. Reasons for discontinuation were captured for 49.2% of patients, including: loss of efficacy (35.8%); physician preference (27.8%); safety (20.1%); patient preference (17.9%); and no access to treatment (9.0%). Baseline factors with greatest correlation to discontinuation were modified Health Assessment Questionnaire scores, patient-reported anxiety/depression, initiation of bDMARD treatment in 2007-2010 versus 2002-2003, and Clinical Disease Activity Index scores.
Almost one-third of patients in the US discontinue currently available bDMARD therapies for RA by 12 months and almost half by 24 months, most commonly due to loss of efficacy.
Corrona LLC and MedImmune.
尽管有多种有效疗法可供选择，但许多类风湿关节炎（RA）患者仍常出现治疗中断/换药的情况。本研究旨在调查北美风湿病研究人员联盟（Corrona）类风湿关节炎注册中心内生物性改善病情抗风湿药物（bDMARDs）的起始使用情况，并对停药原因进行特征分析。
纳入标准为：Corrona注册的成年RA患者（≥18岁，2002 - 2011年）；RA发病年龄≥16岁；首次/后续使用bDMARD开始后随访≥6个月。同时接受肿瘤坏死因子拮抗剂和非肿瘤坏死因子拮抗剂治疗的患者也纳入研究。使用随访医生问卷，将治疗中断定义为在随访期间首次报告停止初始治疗或开始新的bDMARD治疗。
总体而言，6209例患者符合纳入标准，80.7%接受肿瘤坏死因子拮抗剂治疗。停药/换药的中位时间为25.1个月（肿瘤坏死因子拮抗剂治疗组为26.5个月，非肿瘤坏死因子拮抗剂治疗组为20.5个月；对数秩检验p < 0.0001）；6个月、12个月和24个月时分别有82.2%、67.3%和51.1%的患者仍在接受治疗。49.2%的患者记录了停药原因，包括：疗效丧失（35.8%）；医生偏好（27.8%）；安全性（20.1%）；患者偏好（17.9%）；以及无法获得治疗（9.0%）。与停药相关性最大的基线因素为改良健康评估问卷评分、患者报告的焦虑/抑郁、2007 - 2010年与2002 - 2003年开始使用bDMARD治疗以及临床疾病活动指数评分。
在美国，近三分之一的RA患者在12个月内停用目前可用的bDMARD疗法，近一半患者在24个月内停用，最常见的原因是疗效丧失。
Corrona LLC和MedImmune。
