Navarro-Millán Iris, Herrinton Lisa J, Chen Lang, Harrold Leslie, Liu Liyan, Curtis Jeffrey R
University of Alabama at Birmingham, Birmingham, Alabama, United States of America.
Kaiser Permanente, Northern California, San Francisco, California, United States of America.
PLoS One. 2016 Mar 23;11(3):e0149781. doi: 10.1371/journal.pone.0149781. eCollection 2016.
To describe patient preferences in selecting specific biologics and compare clinical response using patient reported outcomes (PROs) among patients with rheumatoid arthritis (RA) started on different anti-tumor necrosis factor (TNF) therapies.
Participants were enrollees in Kaiser Permanente Northern California. Patients with RA who had at least two provider visits and started a new anti-TNF therapy from 10/2010-8/2011, were eligible for participation in this longitudinal study. Using a telephone survey, patient preferences in biologic selection and RAPID3, MDHAQ, and SF-12 scores were collected at baseline and at 6 months. Patient scores rating injection/infusion-site burning and stinging (ISBS) were collected at 6 months.
In all, 267 patients with RA responded to the baseline survey, of whom 57% preferred an injectable biologic, 22% preferred an infused biologic, and 21% had no preference. Motivation for injectable biologics was convenience (92%) and for infusion therapy was dislike or lack of self-efficacy for self-injection (16%). After 6 months of treatment with anti-TNF, 70% of the 177 patients who answered the ISBS question reported ISBS with the last dose; on a scale of 1 (none) to 10 (worst), 41% of these reported a score of 2-5; and 29% reported a score of 6-10. Adalimumab users experienced 3.2 times (95% confidence interval 1.2-8.6) the level of ISBS that etanercept users experienced. There were no significant differences in RAPID3, MDHAQ, or SF-12 scores between etanercept or adalimumab initiators.
Convenience and fear of self-injection were important considerations to patients selecting a biologic drug. Although more convenient, adalimumab associated with more ISBS than did etanercept, and this rate was higher than reported in clinical trials. At 6 months, PROs did not differ between etanercept and adalimumab users.
描述类风湿关节炎(RA)患者在选择特定生物制剂时的偏好,并比较开始使用不同抗肿瘤坏死因子(TNF)疗法的患者使用患者报告结局(PROs)的临床反应。
参与者为北加利福尼亚凯撒医疗集团的注册患者。2010年10月至2011年8月期间至少有两次就诊且开始新的抗TNF治疗的RA患者符合参与这项纵向研究的条件。通过电话调查,在基线和6个月时收集患者在生物制剂选择方面的偏好以及RAPID3、MDHAQ和SF-12评分。在6个月时收集患者对注射/输液部位灼痛和刺痛(ISBS)的评分。
共有267例RA患者回复了基线调查,其中57%更喜欢注射用生物制剂,22%更喜欢静脉输注用生物制剂,21%没有偏好。选择注射用生物制剂的动机是方便(92%),而选择输液治疗的动机是不喜欢自我注射或缺乏自我注射的能力(16%)。在接受抗TNF治疗6个月后,回答ISBS问题的177例患者中有70%报告在最后一剂治疗时出现了ISBS;在1(无)至10(最严重)的评分量表上,其中41%报告的评分为2至5分;29%报告的评分为6至10分。接受阿达木单抗治疗的患者经历的ISBS水平是接受依那西普治疗患者的3.2倍(95%置信区间1.2至8.6)。依那西普或阿达木单抗初始治疗者在RAPID3、MDHAQ或SF-12评分方面没有显著差异。
方便性和对自我注射的恐惧是患者选择生物药物时的重要考虑因素。尽管阿达木单抗更方便,但与依那西普相比,其与更多的ISBS相关,且该发生率高于临床试验报告。在6个月时,依那西普和阿达木单抗使用者的PROs没有差异。