Abstract：
OBJECTIVE: Information on the persistence of tofacitinib (TOF) in psoriatic arthritis (PsA) is scarce in real-world conditions. Our objective was to analyze the persistence and safety of TOF under these conditions.
METHODS: This was a single-center retrospective longitudinal observational study of all patients with PsA who received at least 1 dose of TOF. The main focus was on adverse events (AEs) and drug survival. Drug survival was analyzed by Kaplan-Meier curves and persistence explanatory factors by multivariate Cox regression models. The hazard ratio (HR) was used to measure association.
RESULTS: Seventy-two patients were included, 54 women and 18 men, mean age 51.9 (SD 11.1) years, mean disease duration of 10.4 (SD 6.99) years. TOF was ≥ third line of therapy in > 70% of cases. The median survival was 13.0 (IQR 5.3-29.0) months. One-year retention rate was 52.7% (95% CI 42.4-65.6). TOF survival was not influenced by sex, disease duration, comorbidities, or line of treatment. Younger patients (HR 0.96, P = 0.01) and those with enthesitis (HR 0.37, P = 0.03) showed lower odds of drug discontinuation. The overall rate of AEs was 52.9 (95% CI 38.5-70.6)/100 person-years. Most AEs occurred during the first 6 months of exposure.
CONCLUSIONS: In this real-world study, TOF showed a reasonably good retention rate in a PsA population that was mostly refractory to biologic and oral targeted synthetic disease-modifying antirheumatic drugs. There were no new causes for concern regarding safety. Patients with refractory PsA and enthesitis might be a specific target population for this drug.
METHODS: This was a single-center retrospective longitudinal observational study of all patients with PsA who received at least 1 dose of TOF. The main focus was on adverse events (AEs) and drug survival. Drug survival was analyzed by Kaplan-Meier curves and persistence explanatory factors by multivariate Cox regression models. The hazard ratio (HR) was used to measure association.
RESULTS: Seventy-two patients were included, 54 women and 18 men, mean age 51.9 (SD 11.1) years, mean disease duration of 10.4 (SD 6.99) years. TOF was ≥ third line of therapy in > 70% of cases. The median survival was 13.0 (IQR 5.3-29.0) months. One-year retention rate was 52.7% (95% CI 42.4-65.6). TOF survival was not influenced by sex, disease duration, comorbidities, or line of treatment. Younger patients (HR 0.96, P = 0.01) and those with enthesitis (HR 0.37, P = 0.03) showed lower odds of drug discontinuation. The overall rate of AEs was 52.9 (95% CI 38.5-70.6)/100 person-years. Most AEs occurred during the first 6 months of exposure.
CONCLUSIONS: In this real-world study, TOF showed a reasonably good retention rate in a PsA population that was mostly refractory to biologic and oral targeted synthetic disease-modifying antirheumatic drugs. There were no new causes for concern regarding safety. Patients with refractory PsA and enthesitis might be a specific target population for this drug.
摘要：
目的：关于托法替尼在PsA中持续存在的信息在现实生活中很少。我们的目的是分析托法替尼在这些条件下的持久性和安全性。
方法：对所有接受至少一剂托法替尼的PsA患者进行单中心回顾性纵向观察研究。主要关注不良事件和药物生存。通过Kaplan-Meier曲线分析药物生存期，并通过多变量Cox回归模型分析持久性解释因素。使用危险比(HR)作为关联的量度。
结果：纳入72例患者，54名女性和18名男性,平均年龄51.9±11.1岁，平均病程10.4±6.99年。在超过70%的病例中，托法替尼是≥3行治疗。中位生存期为13个月(IQR:5.3-29)。一年保留率为52.7%(95CI:42.4-65.6)。托法替尼生存率不受性别影响，疾病持续时间,合并症,或治疗线。年轻患者（HR0.96，p<0.05）和附着点炎患者（HR0.37，p<0.05）停药的几率较低。总不良事件（AE）率为52.9（95CI：38.5-70.6）100人年。大多数AE发生在暴露的前6个月。
结论：在这项现实生活中的研究中，托法替尼在生物和口服靶向合成DMARDs大多难以治疗的PsA人群中表现出相当好的保留率.难治性PsA和附着点炎患者可能是该药物的特定目标人群。没有新的警报信号出现。
方法：对所有接受至少一剂托法替尼的PsA患者进行单中心回顾性纵向观察研究。主要关注不良事件和药物生存。通过Kaplan-Meier曲线分析药物生存期，并通过多变量Cox回归模型分析持久性解释因素。使用危险比(HR)作为关联的量度。
结果：纳入72例患者，54名女性和18名男性,平均年龄51.9±11.1岁，平均病程10.4±6.99年。在超过70%的病例中，托法替尼是≥3行治疗。中位生存期为13个月(IQR:5.3-29)。一年保留率为52.7%(95CI:42.4-65.6)。托法替尼生存率不受性别影响，疾病持续时间,合并症,或治疗线。年轻患者（HR0.96，p<0.05）和附着点炎患者（HR0.37，p<0.05）停药的几率较低。总不良事件（AE）率为52.9（95CI：38.5-70.6）100人年。大多数AE发生在暴露的前6个月。
结论：在这项现实生活中的研究中，托法替尼在生物和口服靶向合成DMARDs大多难以治疗的PsA人群中表现出相当好的保留率.难治性PsA和附着点炎患者可能是该药物的特定目标人群。没有新的警报信号出现。
