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治疗药物监测指导阿达木单抗治疗慢性非感染性葡萄膜炎患者的管理:一项回顾性研究。

Therapeutic drug monitoring guides the management of patients with chronic non-infectious uveitis treated with adalimumab: a retrospective study.

机构信息

Hopital de La Croix-Rousse Ophtalmologie, Lyon, France.

Hospital Lariboisière Anaesthesiology and Resuscitation Unit, Paris, France.

出版信息

Br J Ophthalmol. 2022 Oct;106(10):1380-1386. doi: 10.1136/bjophthalmol-2021-319072. Epub 2021 Apr 19.

DOI:10.1136/bjophthalmol-2021-319072
PMID:33875451
Abstract

AIM

To assess the relevance of therapeutic drug monitoring (TDM) of adalimumab (ADA) treatment for the control of intraocular inflammation and treatment adjustment in chronic non-infectious uveitis (CNIU).

METHODS

Retrospective study of CNIU patients treated with ADA and for whom at least one dosage of serum ADA level and an antibodies against ADA (AAA) serology were performed, between June 2003 and July 2019.

RESULTS

A total of 44 ADA-treated patients benefited from a TDM. A total of 48/79 (61%) TDM were performed in responders, 11/79 (14%) in primary non-responders, and 20/79 (25%) in secondary non-responders. Responders had significantly higher ADA levels than non-responders (p=0.0004). AAA were detectable in six patients, they were primary non-responders (n=2), secondary non-responders (n=3) or responders (n=1). In the five non-responders and immunised patients, ADA was switched (to golimumab or methotrexate). Among non-responders, TDM led to an increased frequency of injections 12/31 (38%), increased dose 1/31 (3%) and switch of treatment 10/31 (32%) (one missing data). No modification of biotherapy was performed 7/31 (22%) and only local or oral corticotherapy was adjusted. In 24/31 cases of therapeutic adjustment in non-responders, an improvement was observed in 87% of cases. Among responders for whom the ADA level was above the efficacy threshold, the frequency of injections was decreased for 15/31 (48.4%) cases and no relapse was observed in 12/15 (80%) cases.

CONCLUSION

TDM of ADA treatment proved relevant to provide CNIU patients with a personalised and optimised treatment course (in terms of frequency and type of drug).

摘要

目的

评估阿达木单抗(ADA)治疗的治疗药物监测(TDM)对于控制慢性非传染性葡萄膜炎(CNIU)的眼内炎症和治疗调整的相关性。

方法

这是一项回顾性研究,纳入了 2003 年 6 月至 2019 年 7 月期间接受 ADA 治疗且至少进行过一次血清 ADA 水平和抗 ADA 抗体(AAA)检测的 CNIU 患者。

结果

共有 44 名接受 ADA 治疗的患者进行了 TDM。48/79(61%)的 TDM 用于应答者,11/79(14%)用于原发性无应答者,20/79(25%)用于继发性无应答者。应答者的 ADA 水平显著高于无应答者(p=0.0004)。6 名患者可检测到 AAA,他们分别是原发性无应答者(n=2)、继发性无应答者(n=3)或应答者(n=1)。在 5 名无应答者和免疫患者中,ADA 被替换(换成戈利木单抗或甲氨蝶呤)。在无应答者中,TDM 导致注射次数增加 12/31(38%),剂量增加 1/31(3%),治疗方案改变 10/31(32%)(1 例数据缺失)。7/31(22%)未调整生物治疗,仅调整局部或口服皮质激素治疗。在 24/31 例无应答者的治疗调整中,87%的病例观察到改善。在 ADA 水平高于疗效阈值的应答者中,15/31(48.4%)的病例减少了注射次数,12/15(80%)的病例无复发。

结论

ADA 治疗的 TDM 证明与为 CNIU 患者提供个性化和优化的治疗方案(从药物的频率和类型方面)相关。

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