Nicholls Dave, Barrett Rina, Button Peter, Truman Matt, Bird Paul, Roberts Lynden, Tymms Kathleen, Littlejohn Geoffrey, Griffiths Hedley
University of the Sunshine Coast and Coast Joint Care, Rheumatology Research Unit, Maroochydore, Queensland, Australia.
Roche Products Pty Limited, Medical Affairs, Sydney, New South Wales, Australia.
Intern Med J. 2018 Oct;48(10):1185-1192. doi: 10.1111/imj.14028.
The comparative effectiveness of biologic treatment regimens in a real world Australian population is unknown.
To assess the effectiveness of biological disease-modifying anti-rheumatic drugs (bDMARD) as monotherapy or in combination with methotrexate and/or other conventional DMARD (cDMARD) for the treatment of rheumatoid arthritis (RA).
A retrospective, non-interventional study was conducted that investigated the use of bDMARD in adult patients with RA in routine clinical practice. Data were extracted from the Optimising Patient Outcomes in Australian Rheumatology - Quality Use of Medicines Initiative database. Real-world effectiveness was measured using the 28-joint disease activity score (DAS28) and clinical disease activity index (CDAI) by treatment group at baseline, weeks 12 and 24.
A total of 2970 patients was included with a median (min-max) age of 60.0 (19.0-94.0) years and median (min-max) duration of RA before first bDMARD treatment of 6.0 (0.2-58.3) years. A total of 1177 patients received more than one bDMARD during the analysis period of 1 January 1997 to 15 August 2015. Patients had 4922 treatment 'episodes' (defined as a cycle of continuous individual bDMARD prescribing in a single patient). Patients received a mean (SD) of 1.7 (1.0) episodes of treatment with median (min-max) treatment duration of 0.7 (0-11.8) years; median treatment duration was higher with the first treatment episode. bDMARD were most commonly initiated in combination with methotrexate (73.9% of episodes) and least commonly as monotherapy (9.9% of episodes). Median (min-max) baseline DAS28 decreased from 5.3 (0-8.7) with the first bDMARD to 3.7 (0-8.8) with the second. Median baseline CDAI similarly decreased.
Patients tended to persist longer on their first bDMARD treatment. bDMARD as monotherapy or in combination appear to be accepted treatment strategies in the real world.
生物治疗方案在澳大利亚真实人群中的相对疗效尚不清楚。
评估生物性改善病情抗风湿药物（bDMARD）单药治疗或与甲氨蝶呤和/或其他传统改善病情抗风湿药物（cDMARD）联合使用治疗类风湿关节炎（RA）的有效性。
进行了一项回顾性、非干预性研究，调查bDMARD在成年RA患者常规临床实践中的使用情况。数据从澳大利亚风湿病优化患者结局-合理用药倡议数据库中提取。通过治疗组在基线、第12周和第24周时使用28关节疾病活动评分（DAS28）和临床疾病活动指数（CDAI）来衡量真实世界中的有效性。
共纳入2970例患者，年龄中位数（最小值-最大值）为60.0（19.0-94.0）岁，首次使用bDMARD治疗前RA病程中位数（最小值-最大值）为6.0（0.2-58.3）年。在1997年1月1日至2015年8月15日的分析期间，共有1177例患者接受了不止一种bDMARD治疗。患者有4922个治疗“疗程”（定义为单个患者连续使用单个bDMARD的一个周期）。患者接受治疗的平均（标准差）疗程为1.7（1.0）个，治疗持续时间中位数（最小值-最大值）为0.7（0-11.8）年；首次治疗疗程的治疗持续时间中位数更高。bDMARD最常与甲氨蝶呤联合起始使用（73.9%的疗程），最不常作为单药使用（9.9%的疗程）。首次使用bDMARD时DAS28基线中位数（最小值-最大值）从5.3（0-8.7）降至第二次使用时的3.7（0-8.8）。基线CDAI中位数也有类似下降。
患者首次使用bDMARD治疗的持续时间往往更长。bDMARD单药治疗或联合治疗在现实世界中似乎是被接受的治疗策略。
