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生物制剂一线治疗银屑病关节炎:一项前瞻性观察研究。

First-line biologic therapy with tumor necrosis factor inhibitors for psoriatic arthritis: a prospective observational study.

机构信息

PhD. Pharmacist and Adjunct Professor, Department of Pharmacy and Nutrition, Universidade Federal do Espírito Santo (UFES), Alegre (ES), Brazil.

PhD. Physician and Associate Professor, Department of Locomotor System, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte (MG), Brazil.

出版信息

Sao Paulo Med J. 2022 Nov-Dec;140(6):787-797. doi: 10.1590/1516-3180.2021.0434.R1.22022022.

Abstract

BACKGROUND

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects multiple joints. It is associated with psoriasis and treated with synthetic and biologic drugs.

OBJECTIVE

The objective of this study was to assess the outcomes of patients who received biologic therapy with tumor necrosis factor (TNF) inhibitors in terms of effectiveness, safety, functionality, and quality of life.

DESIGN AND SETTING

A prospective observational study was performed at a single center in Belo Horizonte, Brazil.

METHODS

Patients with PsA who received their first TNF inhibitor treatment were followed up for 12 months. Disease activity was measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI). Functionality was measured using the Health Questionnaire Assessment (HAQ), and quality of life was evaluated using the European Quality of Life Five Dimensions (EQ-5D). Multiple linear regression was used to identify predictors of the clinical response at 12 months.

RESULTS

A total of 143 patients treated with adalimumab or etanercept were evaluated. Most of the clinical measures were significantly improved at 12 months. However, 31%-51% of the patients did not achieve good clinical control. No differences were observed between adalimumab and etanercept, except for poor functionality at 12 months among patients treated with etanercept. The main predictors of a worse clinical response were female sex, etanercept use, poor functionality, or lower quality of life at baseline. The main adverse reactions were alopecia, headache, injection site reaction, sinusitis, flu, dyslipidemia, and infections.

CONCLUSION

TNF inhibitor therapy was effective and safe. However, despite improvements in clinical measures, most patients did not achieve satisfactory control of the disease.

摘要

背景

银屑病关节炎(PsA)是一种影响多个关节的慢性炎症性疾病。它与银屑病有关,并用合成和生物药物治疗。

目的

本研究旨在评估接受肿瘤坏死因子(TNF)抑制剂生物治疗的患者在疗效、安全性、功能和生活质量方面的结果。

设计和设置

在巴西贝洛奥里藏特的一家单中心进行了一项前瞻性观察性研究。

方法

接受首次 TNF 抑制剂治疗的 PsA 患者接受了 12 个月的随访。使用 Bath 强直性脊柱炎疾病活动指数(BASDAI)和临床疾病活动指数(CDAI)测量疾病活动。使用健康问卷评估(HAQ)测量功能,使用欧洲生活质量五维(EQ-5D)评估生活质量。使用多元线性回归分析确定 12 个月时临床反应的预测因素。

结果

共评估了 143 例接受阿达木单抗或依那西普治疗的患者。大多数临床指标在 12 个月时显著改善。然而,31%-51%的患者未达到良好的临床控制。阿达木单抗和依那西普之间除了依那西普治疗的患者在 12 个月时功能较差外,没有观察到差异。临床反应较差的主要预测因素是女性、依那西普的使用、功能较差或基线时生活质量较低。主要不良反应为脱发、头痛、注射部位反应、鼻窦炎、流感、血脂异常和感染。

结论

TNF 抑制剂治疗有效且安全。然而,尽管临床指标有所改善,但大多数患者仍未达到满意的疾病控制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38b4/9671557/0b5bc0893eac/1806-9460-spmj-1516-3180-2021-0434-R1-22022022-gf01.jpg

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