接受肿瘤坏死因子抑制剂治疗的强直性脊柱炎患者未满足的需求；一项大型跨国真实世界研究的结果
Unmet needs in ankylosing spondylitis patients receiving tumour necrosis factor inhibitor therapy; results from a large multinational real-world study.
作者信息
Deodhar A, Strand V, Conaghan P G, Sullivan E, Blackburn S, Tian H, Gandhi K, Jugl S M, Alten R
机构信息
1Oregon Health and Science University, Portland, OR USA.
Biopharmaceutical Consultant, Portola Valley, CA USA.
出版信息
BMC Rheumatol. 2020 Mar 2;4:19. doi: 10.1186/s41927-020-0118-z. eCollection 2020.
BACKGROUND
Symptoms and comorbidities of ankylosing spondylitis (AS) considerably reduce health-related quality of life (HRQoL) and ability to work. This real-world study assessed rates of tumour necrosis factor inhibitor (TNFi) use and switching, treatment failure, and associations between failing TNFi and HRQoL, work productivity and activity impairment (WPAI).
METHODS
AS patients and their treating physicians completed questionnaires capturing patient demographics, clinical status, TNFi treatment history, reasons for switching TNFi, HRQoL and WPAI. Current TNFi was determined as "failing" if, after ≥3 months, physician-rated disease severity had worsened, remained severe, was "unstable/deteriorating", physicians were dissatisfied with disease control and/or did not consider treatment a "success".
RESULTS
The analysis included 2866 AS patients from 18 countries. Of 2795 patients with complete treatment data, 916 (32.8%) patients had never received TNFi therapy, 1623 (58.1%) patients were receiving their 1st TNFi and 200 (7.2%) patients had ever received ≥2 TNFi (treatment switch). Primary or secondary lack of efficacy were the commonest reasons for switching, and the mean delay in switching after primary lack of efficacy was 11.1 months. 232 (15.4%) patients on TNFi were currently "failing" who, compared to those with treatment success, reported poorer HRQoL: 5-dimension EuroQoL (EQ-5D-3 L): 0.63 vs. 0.78; Medical Outcomes Study Short-Form Health Survey version 2 (SF-36v2) mental component summary (MCS): 41.8 vs. 46.3; physical component summary (PCS): 40.2 vs. 45.1; impaired work productivity: 46.4% vs. 25.0%; and activity: 44.5% vs. 29.6%; all < 0.001.
CONCLUSIONS
Among AS patients, switching TNFi is uncommon and delayed by nearly 1 year despite primary lack of efficacy. Patients currently failing TNFi experience worse physical function, HRQoL and work productivity.
背景
强直性脊柱炎（AS）的症状和合并症会显著降低健康相关生活质量（HRQoL）和工作能力。这项真实世界研究评估了肿瘤坏死因子抑制剂（TNFi）的使用和换药率、治疗失败情况，以及TNFi治疗失败与HRQoL、工作生产力和活动障碍（WPAI）之间的关联。
方法
AS患者及其治疗医生完成了调查问卷，内容涵盖患者人口统计学信息、临床状况、TNFi治疗史、TNFi换药原因、HRQoL和WPAI。如果在≥3个月后，医生评定的疾病严重程度恶化、仍为重度、“不稳定/恶化”，医生对疾病控制不满意和/或不认为治疗“成功”，则当前使用的TNFi被判定为“治疗失败”。
结果
分析纳入了来自18个国家的2866例AS患者。在2795例有完整治疗数据的患者中，916例（32.8%）患者从未接受过TNFi治疗，1623例（58.1%）患者正在接受首次TNFi治疗，200例（7.2%）患者曾接受过≥2种TNFi治疗（换药）。原发性或继发性疗效不佳是换药的最常见原因，原发性疗效不佳后换药的平均延迟时间为11.1个月。232例（15.4%）正在使用TNFi的患者目前“治疗失败”，与治疗成功的患者相比，这些患者报告的HRQoL较差：5维度欧洲生活质量量表（EQ-5D-3L）：0.63对0.78；医学结局研究简明健康调查第2版（SF-36v2）心理成分总结（MCS）：41.8对46.3；身体成分总结（PCS）：40.2对45.1；工作生产力受损：46.4%对25.0%；活动：44.5%对29.6%；所有均P<0.001。
结论
在AS患者中，TNFi换药情况不常见，尽管原发性疗效不佳，但换药延迟近1年。目前TNFi治疗失败的患者身体功能、HRQoL和工作生产力较差。
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