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稳定低疾病活动度和稳定治疗的类风湿关节炎患者中 infliximab 的下调和停药:一项观察性队列研究。

Down-titration and discontinuation of infliximab in rheumatoid arthritis patients with stable low disease activity and stable treatment: an observational cohort study.

机构信息

Department of Rheumatology, Sint Maartenskliniek, Hengstdal 3, Postbus 9011, Nijmegen 6500 GM, The Netherlands.

出版信息

Ann Rheum Dis. 2012 Nov;71(11):1849-54. doi: 10.1136/annrheumdis-2011-200945. Epub 2012 Apr 13.

DOI:10.1136/annrheumdis-2011-200945
PMID:22504561
Abstract

UNLABELLED

Down-titration, or discontinuing infliximab, has proven to be feasible in RA patients. Therefore, our local treatment protocol includes tapering infliximab dose. This observational study describes the prevalence of successful down-titration in daily clinical practice and its effect on costs and quality of life (QoL).

METHODS

Infliximab was down-titrated with 25% of the original dose (3 mg/kg) every 8-12 weeks without interval change until discontinuation or flare in all RA patients with stable low 28-joint disease activity score (DAS28) and stable treatment for >6 months. During 1 year DAS28, RA medication, outpatient clinic visits, RA related absenteeism and EuroQoL5D (European QoL questionnaire, EQ5D) were documented. Prevalence of successful down-titration and changes in DAS28, QoL and costs were described.

RESULTS

In 16% (95% CI 6 to 26) and 45% (95% CI 31 to 59), respectively, infliximab could be discontinued or down-titrated. Mean infliximab dose decreased significantly from 224 mg (95% CI 212 to 236 mg) at start, to 130 mg (95% CI 105 to 154 mg) after 1 year. Median DAS28 increased from 2.5 (p25-75=2.0-2.9) to 2.8 (2.2-3.6) (p=0.002). Extra corticosteroids were given in 8% of the visits. Disease modifying antirheumatic drugs were seldom changed. There was no statistical difference in QoL after down-titration. Mean reduction in the costs was €3474 (95% CI 2457 to 4492) per patient.

CONCLUSION

In the majority of patients with stable low DAS28 and stable treatment, infliximab can be down-titrated or discontinued, which results in a considerable reduction in costs without influencing QoL.

摘要

目的

在 RA 患者中,下调或停止使用英夫利昔单抗已被证明是可行的。因此,我们的当地治疗方案包括逐渐减少英夫利昔单抗的剂量。本观察性研究描述了在日常临床实践中成功下调剂量的流行情况及其对成本和生活质量(QoL)的影响。

方法

在所有 RA 患者中,在稳定的低 28 关节疾病活动评分(DAS28)和稳定治疗>6 个月的情况下,每 8-12 周将英夫利昔单抗的剂量下调 25%(3mg/kg),不改变间隔,直到停药或出现疾病发作。在 1 年的 DAS28 期间,记录 RA 药物、门诊就诊、RA 相关缺勤和欧洲生活质量 5 维问卷(欧洲 QoL 问卷,EQ5D)。描述成功下调剂量的流行情况以及 DAS28、QoL 和成本的变化。

结果

分别有 16%(95%CI6 至 26)和 45%(95%CI31 至 59)的患者可以停止或下调英夫利昔单抗的剂量。英夫利昔单抗的平均剂量从开始时的 224mg(95%CI212 至 236mg)显著下降至 1 年后的 130mg(95%CI105 至 154mg)。中位 DAS28 从 2.5(p25-75=2.0-2.9)增加到 2.8(2.2-3.6)(p=0.002)。在 8%的就诊中给予了额外的皮质类固醇。改变疾病修饰抗风湿药物的情况很少见。下调剂量后 QoL 无统计学差异。每位患者的成本平均减少 3474 欧元(95%CI2457 至 4492)。

结论

在大多数稳定低 DAS28 和稳定治疗的患者中,可以下调或停止使用英夫利昔单抗,这可以显著降低成本,而不会影响 QoL。

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