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生物药物治疗强直性脊柱炎的疗效评估:队列研究,米纳斯吉拉斯州,2018 - 2023年

Evaluation of the performance of biological drugs in the treatment of ankylosing spondylitis: cohort study, Minas Gerais, 2018-2023.

作者信息

Santos Bárbara Rodrigues Alvernaz Dos, Oliveira Gerusa Araújo de, Silva Grazielle Dias, Santos Jessica Barreto Ribeiro Dos, Garcia Marina Morgado, Junior Augusto Afonso Guerra, Acurcio Francisco de Assis, Alvares-Teodoro Juliana

机构信息

Universidade Federal de Minas Gerais, Departamento de Farmácia Social, Belo Horizonte, MG, Brazil.

Secretaria de Estado de Saúde de Minas Gerais, Belo Horizonte, MG, Brazil.

出版信息

Epidemiol Serv Saude. 2025 Sep 8;34:e20240116. doi: 10.1590/S2237-96222025v34e20240116.en. eCollection 2025.

Abstract

OBJECTIVES

To assess the persistence and time until discontinuation of biological drugs used by people with ankylosing spondylitis treated in the Brazilian Unified Health System and to investigate the factors associated with them.

METHODS

Data were collected from an open historical cohort between 2018 and 2023 on the administrative processes required for requesting medicines from the specialized component of pharmaceutical assistance in Minas Gerais, Brazil. Sociodemographic and clinical data and treatment history were collected. A descriptive analysis of the variables was performed. The Cox proportional hazards model was used to identify factors associated with time to discontinuation of the first biological drug. The logistic regression model was used to evaluate the factors associated with persistence at 12 and 24 months of treatment.

RESULTS

A total of 530 participants were included, with an average age of 46 years, of which 50.0% were male. Adalimumab and golimumab were the most prescribed drugs. The mean follow-up time was 26.4 months, and the median time to discontinuation was 34 months. Persistence at 12 and 24 months was 82.0% and 63.0%. No significant differences were observed between biological drugs.

CONCLUSION

The analysis of persistence and time to discontinuation showed no differences between the drugs, which justified their maintenance in the first line of treatment of the protocol. Factors associated with the clinical profile of users may be related to differences in effectiveness, but more in-depth studies are needed to confirm these results, given the limitations of using administrative data in epidemiological research.

摘要

目的

评估巴西统一卫生系统中接受治疗的强直性脊柱炎患者使用生物药物的持续时间及停药时间,并调查与之相关的因素。

方法

收集了2018年至2023年期间一个开放历史队列的数据,这些数据来自巴西米纳斯吉拉斯州药物援助专门部门申请药物所需的行政程序。收集了社会人口统计学和临床数据以及治疗史。对变量进行了描述性分析。采用Cox比例风险模型确定与首次生物药物停药时间相关的因素。采用逻辑回归模型评估治疗12个月和24个月时与持续用药相关的因素。

结果

共纳入530名参与者,平均年龄46岁,其中50.0%为男性。阿达木单抗和戈利木单抗是处方最多的药物。平均随访时间为26.4个月,停药中位时间为34个月。治疗12个月和24个月时的持续用药率分别为82.0%和63.0%。生物药物之间未观察到显著差异。

结论

对持续用药时间和停药时间的分析表明,各药物之间没有差异,这证明它们可维持在方案的一线治疗中。与使用者临床特征相关的因素可能与疗效差异有关,但鉴于在流行病学研究中使用行政数据存在局限性,需要更深入的研究来证实这些结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65b7/12435891/c16c3383773b/2237-9622-ress-34-e20240116-f1-en.jpg

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