生物类似物益赛普治疗晚期强直性脊柱炎患者报告结局分析—一项基于倾向性评分匹配的分析研究

田君梅; 陈锦云; 徐婷; 姚瑶; 吴敏

doi:10.7619/jcmp.20212943

生物类似物益赛普治疗晚期强直性脊柱炎患者报告结局分析—一项基于倾向性评分匹配的分析研究

Patient-reported outcomes in patients with advanced ankylosing spondylitis treated by etanercept biosimilar: a retrospective study based on propensity score matching

摘要

摘要:
目的应用患者报告结局量表(PROs)分析生物类似物益赛普治疗晚期强直性脊柱炎(AS)的临床疗效。
方法回顾性分析145例确诊为晚期AS患者的临床资料，根据是否使用益赛普分为益赛普治疗组(Bg组, n=43)、非生物制剂治疗组(nBg组, n=102)。对2组患者资料进行1∶1倾向性评分匹配(PSM)后, Bg组和nBg组分别纳入37例患者，分析其随访治疗第4周、第12周时的PROs。采用强直性脊柱炎生活质量问卷(ASQoL)、健康状况问卷-残疾指数(HAQ-DI)、慢性病治疗功能评估-疲劳量表(FACIT-F)、欧洲五维健康量表(EQ-5D)的视觉标尺评分(EQ-VAS)、工作效率和活动障碍调查问卷(WPAI)以及强直性脊柱炎疾病活动指数(BASDAI)、强直性脊柱炎功能指数(BASFI)评价患者各项评分。
结果治疗第4周和12周时, Bg组BASDAI评分改善程度优于nBg组，差异有统计学意义(P < 0.05或P < 0.01)。治疗第12周时, Bg组的ASQoL评分改善程度优于nBg组，差异有统计学意义(P < 0.05)。第4周和12周时, Bg组中HAQ-DI评分、FACIT-F评分和WPAI-GH评分中的总工作生产力损失评分改善程度优于nBg组，差异有统计学意义(P < 0.05)。治疗第12周时, Bg组HAQ-DI、ASQoL评分改善≥MCID患者占比为91.89%、97.30%, 高于nBg组的59.46%、67.57%, 差异有统计学意义(P < 0.05)。治疗第4周和第12周时, Bg组FACIT-F评分改善≥MCID的患者占比为75.68%、91.89%, 高于nBg组的43.24%, 51.35%, 差异有统计学意义(P < 0.001)。基线时处于高疾病活动状态(BASDAI≥4)的患者，治疗12周时Bg组达到低疾病活动状态(BASDAI < 4)患者的占比高于nBg组，差异有统计学意义(P=0.002)。
结论生物类似物益赛普可改善晚期AS患者与健康相关的生活质量、疾病活动和工作效率，晚期AS患者仍可从益赛普治疗中获益。

Abstract:
Objective To analyze clinical effect of etanercept on patient-reported outcomes (PROs) in patients with advanced ankylosing spondylitis(AS).
Methods Clinical data of 145 patients with advanced AS were retrospective analyzed, and the patients were divided into etanercept biosimilar group (Bg group, n=43) and abiotic agent group (nBg group, n=102). After a ratio of 1 to 1 propensity score matching (PSM), 37 patients were enrolled in the Bg group and nBg group, respectively, and their PROs at 4 and 12 weeks were analyzed. Ankylosing spondylitis quality of life (ASQoL), Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Euro-QoL-Visual Analogue Scale (EQ-VAS) of Euro-QoL-5-dimension health status questionnaire (EQ-5D), and Work Productivity and Activity Impairment-General Health questionnaire (WPAI-GH), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index(BASFI) were used to evaluate the score of each item.
Results At 4 and 12 weeks, the improvement of BASDAI score in the Bg group was better than that in the nBg group (P < 0.05 or P < 0.01). At 12 weeks, Bg group had more significant improvement in the Bg group in ASQoL score (P < 0.05). At 4 and 12 weeks, the improvement degree of HAQ-DI, FACIT-F and over all work impairment score of WPAI-GH in the Bg group was better than that in the nBg group (P < 0.05). At the 12th week of treatment, the proportions of patients with improvement ≥MCID of HAQ-DI and ASQoL scores in the Bg group were 91.89% and 97.30%, respectively, which were higher than 59.46% and 67.57% in the nBg group (P < 0.05). At the 4th and 12th week of treatment, the proportions of patients with improvement score ≥MCID of FACIT-F score in the Bg group were 75.68% and 91.89%, which were higher than 43.24% and 51.35% in the nBg group (P < 0.001). In patients with high disease activity (BASDAI scored ≥4) at baseline, the proportion of patients with low disease activity (BASDAI scored < 4) in the Bg group was significantly higher than that in the nBg group at week 12 (P=0.002).
Conclusion Etanercept biosimilar improves health-related quality of life, disease activity and work efficiency in patients with advanced AS. Therefore, patients with advanced AS can still benefit from treatment of etanercept biosimilar.

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