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阿达木单抗治疗肠病性脊柱关节炎的疗效:一项为期 12 个月的多学科观察性研究。

Adalimumab efficacy in enteropathic spondyloarthritis: A 12-mo observational multidisciplinary study.

机构信息

Dipartimento Scienze Cliniche e Molecolari, Clinica Medica, Università Politecnica delle Marche, Ancona 60126, Italy.

Dipartimento Biomedico di Medicina Interna e Specialistica, Sezione di Reumatologia, Università degli Studi di Palermo, Palermo 90021, Italy.

出版信息

World J Gastroenterol. 2017 Oct 21;23(39):7139-7149. doi: 10.3748/wjg.v23.i39.7139.

Abstract

AIM

To report adalimumab (Ada) efficacy on articular-gastrointestinal disease and health-related quality of life (HRQoL) in patients with enteropathic spondyloarthritis (ES).

METHODS

A cohort of 52 patients with ES was evaluated in the departments of gastroenterology and internal medicine. At baseline, all patients underwent assessment by an integrated gastro-rheumatologic evaluation of articular and gastrointestinal activity, as well patient reported outcomes (PROs) of the HRQoL questionnaires. After this integrated evaluation and following a specific working flowchart, the Ada anti-tumor necrosis factor (TNF)-inhibitor was assigned to a cohort of 30 patients and its clinical efficacy was evaluated at baseline and after 6-mo and 12-mo treatment by the following tests: (1) Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP); Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) for articular activity; (2) Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Activity Index (CDAI) and partial Mayo (pMayo) score for gastrointestinal symptoms and activity; and (3) Health Assessment Questionnaire (HAQ), Patient Global Assessment (PGA) and Short Form-36 health survey (SF-36) questionnaires for PROs of the HRQoL.

RESULTS

Integrated evaluation and management of the patients affected by ES, carried out simultaneously by a gastroenterologist and a rheumatologist, allowed clinicians to choose the optimal therapeutic strategy. In a cohort of 30 ES patients affected by active articular and gastrointestinal disease, or axial active articular inflammation, Ada led to fast and sustained improvement of both articular and gastrointestinal disease activities. In fact, all the clinimetric evaluation tests exploring articular or gastrointestinal activity, as well as all the HRQoL scores, showed a significant improvement having been achieved at the earliest (6-mo) assessment. This important clinical improvement was maintained at the 12-mo follow-up. Importantly, global and gastrointestinal quality of life significantly correlated with articular disease activity, providing evidence to support that the integrated evaluation is the best option to manage patients with ES.

CONCLUSION

Ada treatment, upon multidisciplinary (gastro-rheumatologic) evaluation, significantly improves both articular and gastrointestinal inflammation, thereby improving the HRQoL in patients affected by ES.

摘要

目的

报告阿达木单抗(Ada)在肠病性脊柱关节炎(ES)患者中的关节-胃肠道疾病和健康相关生活质量(HRQoL)疗效。

方法

在胃肠病学和内科部门评估了 52 例 ES 患者。在基线时,所有患者均接受了关节和胃肠道活动的综合胃肠风湿病学评估以及 HRQoL 问卷的患者报告结果(PROs)评估。在进行了这种综合评估并遵循特定的工作流程图之后,将阿达抗肿瘤坏死因子(TNF)抑制剂分配给 30 例患者队列,并通过以下测试在基线和治疗 6 个月和 12 个月后评估其临床疗效:(1)强直性脊柱炎疾病活动评分-C 反应蛋白(ASDAS-CRP);巴斯强直性脊柱炎疾病活动指数(BASDAI),巴斯强直性脊柱炎功能指数(BASFI)和巴斯强直性脊柱炎计量指数(BASMI)用于评估关节活动度;(2)炎症性肠病问卷(IBDQ),克罗恩病活动指数(CDAI)和部分梅奥(pMayo)评分用于评估胃肠道症状和活动度;以及(3)健康评估问卷(HAQ),患者总体评估(PGA)和简短表格-36 健康调查(SF-36)问卷用于评估 HRQoL 的 PROs。

结果

对同时由胃肠病学家和风湿病学家进行的 ES 患者的综合评估和管理,使临床医生能够选择最佳的治疗策略。在 30 例患有活动性关节和胃肠道疾病或轴向活动性关节炎症的 ES 患者队列中,阿达木单抗迅速并持续改善了关节和胃肠道疾病的活动度。实际上,所有探索关节或胃肠道活动的临床计量学评估测试以及所有 HRQoL 评分均在最早的(6 个月)评估时显示出显著改善。这种重要的临床改善在 12 个月的随访中得以维持。重要的是,整体和胃肠道生活质量与关节疾病活动度显著相关,这为支持综合评估是管理 ES 患者的最佳选择提供了证据。

结论

经过多学科(胃肠风湿病学)评估后,阿达木单抗治疗可显著改善关节和胃肠道炎症,从而改善 ES 患者的 HRQoL。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b98b/5656461/fea3d46741ae/WJG-23-7139-g001.jpg

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