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生物制剂单药治疗在日常临床实践中类风湿关节炎患者队列中的患病率。

Prevalence of biologics monotherapy in a cohort of patients with Rheumatoid Arthritis in daily clinical practice.

作者信息

Catay Erika, Bravo Maximiliano, Rosa Javier, Soriano Enrique R

机构信息

Sección Reumatologia, Servicio de Clinica Médica, Hospital Italiano de Buenos Aires, and Instituto Universitario del Hospital Italiano de Buenos Aires, Peron 4190, CABA, (1181), Buenos Aires, Argentina.

Fundacion P.M. Catoggio para el Progreso de la Reumatologia, Buenos Aires, Argentina.

出版信息

BMC Musculoskelet Disord. 2016 Mar 1;17:110. doi: 10.1186/s12891-016-0959-1.

Abstract

BACKGROUND

Real-life registry data reveal approximately one-third of patients taking biologic agents use them as monotherapy, in spite that combination therapy with Disease Modifying Drugs is more efficacious than monotherapy. The aim of our study was to assess the prevalence of biologics monotherapy in a cohort of patients with RA followed at a single center, and to analyze the reasons for monotherapy, including patients with prescriptions that do not take the medication.

METHODS

All patients with Rheumatoid Arthritis, with biologic therapy followed at our Rheumatology Unit were included. Prevalence and reasons for biologics monotherapy was calculated in general, for each biologic course and for each biologic. Prescription data was obtained from the Electronic Medical Record, and drugs acquisition was obtained from the Hospital Administrative database. Drug survival was also calculated and compared between monotherapy and combination therapy.

RESULTS

Seventy nine patients with 115 courses of biologic treatments were included. In 40 (35 %, 95 % CI: 26-44 %) of all biologics courses, biologics were initiated as monotherapy. In 27 courses (23 %, 95 % CI: 16-32 %) biologic monotherapy was prescribed by the treating rheumatologists, and in the other 13 (11 %, 95 % CI: 6-18 %) it was initiated as such by decision of the patient regardless of the physician indication. Reasons for prescription of biologic monotherapy by the treating rheumatologists were adverse events with previous DMARDs in 55.5 %, and was not specified in the remaining courses. Only 25 % of biologics' courses were monotherapy from the beginning to the end of the biologic therapy. The overall survival on biologics was 45 % (95 % CI: 35-55 %) at 3 years. There were no statistically differences in biologics survival by modality (monotherapy vs combination) (p = 0.543), course (p = 0.4454), or by biologic drug (p = 0.9612).

CONCLUSIONS

Almost 1/3 of patients on biologics use them as monotherapy. This is due to physician's preferences in 60 % of the cases, and to patients not compliance with the indication in around 40 % of the cases. Better communications is needed to assure that physicians and patients agree on the prescribed and used medication.

摘要

背景

真实世界的注册数据显示,尽管使用改善病情抗风湿药的联合治疗比单一疗法更有效,但约三分之一使用生物制剂的患者将其作为单一疗法使用。我们研究的目的是评估在单一中心随访的类风湿关节炎患者队列中生物制剂单一疗法的患病率,并分析单一疗法的原因,包括有处方但未用药的患者。

方法

纳入在我们风湿病科接受生物治疗的所有类风湿关节炎患者。计算生物制剂单一疗法的总体患病率、每个生物疗程以及每种生物制剂的患病率及原因。处方数据从电子病历中获取,药物获取情况从医院管理数据库中获取。还计算并比较了单一疗法和联合疗法的药物留存率。

结果

纳入了79例患者,共进行了115个疗程的生物治疗。在所有生物制剂疗程中,有40个(35%,95%可信区间:26 - 44%)开始时采用单一疗法。在27个疗程(23%,95%可信区间:16 - 32%)中,生物制剂单一疗法由主治风湿病医生开出,在另外13个疗程(11%,95%可信区间:6 - 18%)中,患者自行决定开始单一疗法,而不管医生的指示。主治风湿病医生开出生物制剂单一疗法的原因中,55.5%是既往使用改善病情抗风湿药出现不良事件,其余疗程未明确说明原因。在生物治疗从开始到结束的整个过程中,只有25%的生物制剂疗程采用单一疗法。生物制剂3年的总体留存率为45%(95%可信区间:35 - 55%)。在单一疗法与联合疗法(p = 0.543)、疗程(p = 0.4454)或生物制剂药物(p = 0.9612)方面,生物制剂留存率无统计学差异。

结论

近三分之一使用生物制剂的患者将其作为单一疗法使用。这在60%的情况下是由于医生的偏好,在约40%的情况下是由于患者未遵循医嘱。需要更好的沟通以确保医生和患者就所开和所用药物达成一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7341/4774002/d7220892fd13/12891_2016_959_Fig1_HTML.jpg

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