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专家共识:一组评估生物制剂治疗银屑病关节炎疗效的结局指标:MERECES 研究。

Expert Consensus on a Set of Outcomes to Assess the Effectiveness of Biologic Treatment in Psoriatic Arthritis: The MERECES Study.

机构信息

J.D. Cañete, MD, PhD, Arthritis Unit, Rheumatology Department, Hospital Clínic and IDIBAPS, Barcelona;

J.M. Nolla, MD, PhD, Department of Rheumatology, Hospital Universitario de Bellvitge IDIBELL, L'Hospitalet de Llobregat, Barcelona.

出版信息

J Rheumatol. 2020 Nov 1;47(11):1637-1643. doi: 10.3899/jrheum.191056. Epub 2020 Feb 1.

Abstract

OBJECTIVE

To reach a consensus on the instruments to be used in clinical practice to evaluate the effectiveness of biological disease-modifying antirheumatic drug (bDMARD) treatment in patients with psoriatic arthritis (PsA) in the short to medium term (3-6 mos), and to establish the minimum health outcomes for treatment continuation.

METHODS

A 2-round Delphi questionnaire was developed based on both the information gathered in the literature review and 4 discussion groups. The suitability and feasibility of the proposed sets of instruments were assessed on a 7-point Likert scale. Consensus was established when at least 75% of healthcare professionals (HCP) reached agreement. To define a minimum health outcome to continue treatment, a combination of 4 disease activity states and 3 health-related quality of life states were defined for 3 hypothetical patient profiles. HCP were given a dichotomous choice (yes/no) to respond to whether they would continue treatment in each case.

RESULTS

The second round was completed by 106 HCP. Consensus was reached on the use of (1) Disease Activity in Psoriatic Arthritis + Psoriatic Arthritis Impact of Disease (PsAID12) or minimal disease activity + PsAID12 + C-reactive protein, in peripheral PsA; and (2) Ankylosing Spondylitis Disease Activity Score + PsAID12, in axial PsA. Health outcomes considered sufficient to continue treatment were stricter for bDMARD-naive patients than for patients who failed several bDMARD.

CONCLUSION

To the best of our knowledge, this is the first multidisciplinary consensus on a set of outcomes for the evaluation of bDMARD effectiveness in PsA, in routine clinical practice.

摘要

目的

就用于评估中短期(3-6 个月)内生物改善病情抗风湿药物(bDMARD)治疗银屑病关节炎(PsA)患者疗效的临床实践工具达成共识,并确定治疗继续的最低健康结果。

方法

基于文献综述中收集的信息和 4 个讨论组,制定了 2 轮 Delphi 问卷。使用 7 分李克特量表评估提出的仪器套件的适用性和可行性。当至少 75%的医疗保健专业人员(HCP)达成一致时,即可达成共识。为了确定继续治疗的最低健康结果,为 3 个假设患者的个人资料定义了 4 种疾病活动状态和 3 种与健康相关的生活质量状态的组合。HCP 被要求对每种情况是否会继续治疗做出二选一(是/否)的回答。

结果

第二轮有 106 名 HCP 完成。达成共识的是在(1)外周型 PsA 中使用疾病活动度在银屑病关节炎 + 银屑病关节炎对疾病的影响(PsAID12)或最低疾病活动度 + PsAID12 + C 反应蛋白;和(2)中轴型 PsA 中使用强直性脊柱炎疾病活动评分 + PsAID12。与治疗失败的患者相比,bDMARD 初治患者继续治疗的健康结果要求更为严格。

结论

据我们所知,这是首次针对常规临床实践中评估 bDMARD 在 PsA 中的疗效的一套结果达成的多学科共识。

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