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阿巴西普作为一线和后续生物制剂的持久性,以及来自大型多地点真实世界研究的 HAQ 改善。

The durability of abatacept as a first and subsequent biologic and improvement in HAQ from a large multi-site real-world study.

机构信息

Division of Rheumatology, Department of Medicine, St Joseph׳s Health Care, University of Western Ontario, 268 Grosvenor St, London, Ontario, Canada N6A 4V2.

Department of Surgical Epidemiology, JSS Research, St Laurent, Quebec, Canada.

出版信息

Semin Arthritis Rheum. 2015 Apr;44(5):499-505. doi: 10.1016/j.semarthrit.2014.09.009. Epub 2014 Sep 28.

DOI:10.1016/j.semarthrit.2014.09.009
PMID:25440158
Abstract

OBJECTIVES

Assessment of the effectiveness of newer biologics such as abatacept is essential in real-world practice.

METHODS

RA patients administered infusions of abatacept via the Orencia Response Program network with at least one follow-up evaluation were included. The number needed to treat (NNT) to improve HAQ by at least the minimal clinically important difference (MID ≥ 0.22) and abatacept survival and differences between biologic-naïve and TNFi-experienced patients were assessed.

RESULTS

Among 2929 patients enrolled, 1771 (60.5%) were eligible for analysis (mean age was 57.6 years, disease duration was 16.5 ± 11.0 (SD) years, 77.2% were female, and 79.2% had past TNFi), with mean follow-up of 13.8 ± 12.3 (SD) months. Half had comorbidities including hypertension (17%), diabetes (8.4%), asthma (6.0%), hypothyroidism (5.7%), and hyperlipidemia (4.0%). Mean (SE) durability of treatment was 26.8 (0.53) months, where 66% were receiving abatacept at 12 months and 53% at 24 months. Patient survival was longer where abatacept was the first biologic vs. post-TNFi (P = 0.0001). In the use of abatacept as a first biologic, 70% achieved MID in HAQ vs. 71% if post-TNFi (P = 0.65) with NNT to improve one patient with at least MID of HAQ was 1.4.

CONCLUSIONS

Abatacept is effective in improving HAQ in RA both pre and post first biologic in real-world patients with comorbidities. For those still on abatacept, HAQ continued to improve over the first 2 years. The durability of abatacept is better as a first biologic, but NNT to improve HAQ patients on treatment is the same post-DMARDs and post-TNFi. For treatment durability and HAQ MID achievement, abatacept use as a first biologic is better.

摘要

目的

评估新型生物制剂(如阿巴西普)的疗效在真实世界实践中至关重要。

方法

纳入接受奥伦萨响应计划网络中阿巴西普输注治疗且至少有一次随访评估的 RA 患者。评估改善 HAQ(至少改善临床重要差异(MID≥0.22))的治疗需要人数(NNT)、阿巴西普的生存率以及生物制剂初治患者和 TNF 抑制剂经验患者之间的差异。

结果

在纳入的 2929 名患者中,1771 名(60.5%)符合分析条件(平均年龄为 57.6 岁,病程为 16.5±11.0(SD)年,77.2%为女性,79.2%有既往 TNF 抑制剂治疗史),平均随访时间为 13.8±12.3(SD)个月。半数患者合并有高血压(17%)、糖尿病(8.4%)、哮喘(6.0%)、甲状腺功能减退(5.7%)和高脂血症(4.0%)等共病。治疗的平均(SE)持续时间为 26.8(0.53)个月,其中 66%的患者在 12 个月时接受阿巴西普治疗,53%的患者在 24 个月时接受阿巴西普治疗。阿巴西普作为首种生物制剂与 TNF 抑制剂后使用相比,患者的存活率更长(P=0.0001)。在阿巴西普作为首种生物制剂的使用中,70%的患者在 HAQ 中达到 MID,而 TNF 抑制剂后使用的患者达到 71%(P=0.65),改善一名 HAQ 至少有 MID 的患者的 NNT 为 1.4。

结论

在伴有合并症的真实世界患者中,阿巴西普作为首种生物制剂治疗 RA 可有效改善 HAQ。对于仍在接受阿巴西普治疗的患者,在最初的 2 年内 HAQ 持续改善。作为首种生物制剂,阿巴西普的耐用性更好,但 DMARDs 和 TNF 抑制剂后使用的 NNT 以改善 HAQ 患者相同。对于治疗的耐久性和 HAQ MID 的实现,阿巴西普作为首种生物制剂的使用效果更好。

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