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戈利木单抗治疗强直性脊柱炎的急性前葡萄膜炎发生率降低 - GO-EASY 研究。

Reduced Occurrence Rate of Acute Anterior Uveitis in Ankylosing Spondylitis Treated with Golimumab - The GO-EASY Study.

机构信息

From the Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, locations Reade and VU University Medical Center, Amsterdam; Department of Rheumatology, Franciscus Vlietland Hospital, Schiedam; Department of Rheumatology, Antonius Hospital, Sneek; Department of Rheumatology, Gelre Hospital, Apeldoorn; Department of Rheumatology, Maasstad Hospital, Rotterdam; Department of Rheumatology, Medical Centre Leeuwarden, Leeuwarden; Department of Immunology, Merck Sharp & Dohme (MSD), Haarlem, the Netherlands.

R.E. van Bentum, MD, Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, locations Reade and VU University Medical Center; S.C. Heslinga, MD, Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, locations Reade and VU University Medical Center; M.T. Nurmohamed, MD, PhD, Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, locations Reade and VU University Medical Center; A.H. Gerards, MD, Department of Rheumatology, Franciscus Vlietland Hospital; E.N. Griep, MD, PhD, Department of Rheumatology, Antonius Hospital; C.B. Koehorst, MD, Department of Rheumatology, Gelre Hospital; M.R. Kok, MD, PhD, Department of Rheumatology, Maasstad Hospital; A.M. Schilder, MD, Department of Rheumatology, Medical Centre Leeuwarden; M. Verhoef, MSc, Department of Immunology, MSD, the Netherlands; I.E. van der Horst-Bruinsma, MD, PhD, Department of Rheumatology, Amsterdam Rheumatology and immunology Center, locations Reade and VU University Medical Center.

出版信息

J Rheumatol. 2019 Feb;46(2):153-159. doi: 10.3899/jrheum.180312. Epub 2018 Nov 1.

Abstract

OBJECTIVE

Acute anterior uveitis (AAU) is common in ankylosing spondylitis (AS). Golimumab (GOL), a tumor necrosis factor-α inhibitor (TNFi), has proven to be effective in the treatment of AS. To date, the effect of GOL on the incidence of AAU in AS is unknown. The objective was to study the AAU occurrence rate in patients with AS during GOL treatment and secondarily, the efficacy of GOL in daily clinical practice.

METHODS

The study was a multicenter prospective study in a real-world setting in patients with AS who were treated with GOL for 12 months. The occurrence of AAU was assessed in the year before the initial TNFi treatment and during GOL treatment and calculated for the period at risk for a new AAU. Measures for disease activity [Ankylosing Spondylitis Disease Activity Score (ASDAS)] and treatment response [Assessment of Spondyloarthritis international Society (ASAS20 score)] were collected.

RESULTS

In total, 93 patients (65% male, 55% TNFi-naive, 27% history of AAU) were included, with a median disease duration of 7 years and ASDAS score of 3.1. During GOL treatment, the AAU occurrence rate was reduced from 11.1 to 2.2 per 100 patient-years (rate-ratio 0.20, 95% CI 0.04-0.91). After 3 months of treatment, 41% of the patients experienced a clinically important improvement of the ASDAS score (p < 0.001) and 36% an ASDAS20 response (p < 0.001). At month 12, 49% had achieved an ASAS20 response (p < 0.001).

CONCLUSION

In AS, the AAU occurrence rate and disease activity decreased significantly during GOL treatment. Therefore, GOL can be considered a good choice in patients with AS who need a TNFi, especially in cases of recurrent AAU. (EudraCT number: 2012-002458-21).

摘要

目的

急性前葡萄膜炎(AAU)在强直性脊柱炎(AS)中较为常见。肿瘤坏死因子-α抑制剂(TNFi)戈利木单抗(GOL)已被证明在 AS 的治疗中有效。迄今为止,GOL 对 AS 患者 AAU 发生率的影响尚不清楚。本研究旨在探讨 GOL 治疗期间 AS 患者 AAU 的发生率,并进一步研究 GOL 在日常临床实践中的疗效。

方法

这是一项多中心前瞻性研究,在真实环境中,对接受 GOL 治疗 12 个月的 AS 患者进行研究。在开始接受 TNFi 治疗前的 1 年和 GOL 治疗期间评估 AAU 的发生情况,并计算新发生 AAU 的风险期。收集疾病活动度(强直性脊柱炎疾病活动评分(ASDAS))和治疗反应(评估强直性脊柱炎国际协会(ASAS20 评分))的指标。

结果

共纳入 93 例患者(65%为男性,55%为 TNFi 初治患者,27%有 AAU 病史),中位病程为 7 年,ASDAS 评分为 3.1。在 GOL 治疗期间,AAU 的发生率从 11.1 降至 2.2/100 患者年(发生率比 0.20,95%CI 0.04-0.91)。治疗 3 个月后,41%的患者 ASDAS 评分有临床显著改善(p<0.001),36%的患者 ASDAS20 反应(p<0.001)。治疗 12 个月时,49%的患者达到 ASAS20 反应(p<0.001)。

结论

在 AS 中,GOL 治疗期间 AAU 的发生率和疾病活动度显著下降。因此,对于需要 TNFi 的 AS 患者,尤其是复发性 AAU 患者,GOL 可作为一种较好的选择。(EudraCT 编号:2012-002458-21)。

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