在实际临床实践中管理轴向银屑病关节炎患者的非干预性多中心观察研究(NiSaXPA)结果

T. Korotaeva, E. Gubar, E. Loginova, Y. L. Korsakova, E. A. Vasilenko, I.-D. Yu. Ilyevsky, L. V. Ivanova, E. Akulinushkina, P. Shesternya, O. V. Matveychuk, Y. Y. Grabovetskaya, A. A. Barakat, M. A. Korolev, E. Zonova, O. Georginova, I. V. Kolotilina, I. M. Marusenko, I. B. Vinogradova, O. Nesmeyanova, N. E. Grigoriadi, A. V. Petrov, D. Krechikova, T. Kropotina, S. Yakupova, V. I. Mazurov
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This article presents the results of an interim analysis of data from a non-interventional multicenter observational study on the treatment of patients with axPsA in real-life clinical practice (NiSaXPA) in Russian centers.Objective: to identify patients with axPsA, their characteristics and describe treatment tactics in real-life clinical practice.Material and methods. Patients with PsA who met the inclusion criteria were prospectively followed up during routine visits to a rheumatologist. Participants' axial radiographs were uploaded to a database in order for it to be confirmed the presence or absence of axPsA by two independent experts, a rheumatologist and a radiologist. Patients with a confirmed axPsA diagnosis participated in a further data collection phase (Visit 2, week 24).Results and discussion. Six hundred patients were enrolled into the study. At the time of analysis, 386 (64.3%) of them (209 men and 177 women) were screened for axPsA. The diagnosis of axPsA was confirmed in 241 (62.4%) cases; these patients formed the Per Protocol (PP) population. The mean age of patients with axPsA in the PP population was 46.30±12.6 years and the body mass index (BMI) was 27.4±5.2 kg/m2 . In 14.9% of patients, the duration of psoriasis was less than 1–5 years, in 21.5% – 5–10 years and in 63.6% – more than 10 years. The duration of PsA symptoms was less than 1–5 years in 31.2 % of patients, 5–10 years in 31.6 % and more than 10 years in 37.2 %. Low disease activity (BASDAI ˂ 4) was achieved in 33.3 % of patients with axPsA at visit 1 and in 64.3 % at visit 2; the BASDAI index declined on average from 4.67±1.95 to 3.31±1.89 points.In real-life clinical practice, patients were most frequently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) – 88.7% and 71.7% (visits 1 and 2, respectively), and synthetic disease-modifying antirheumatic drugs (sDMARDs) –79.1% and 70.7%, respectively; therapy with biologic disease-modifying antirheumatic drugs (bDMARDs) was initiated in 40.2% and 60.6% of patients, respectively.Conclusion. The results of the interim analysis of this observational study showed that in 87.2% of patients who met the CASPAR criteria for PsA there was a suspicion of axial manifestations of PsA on the primary care level. However, only 62.4% of them had a confirmed diagnosis of axPsA on centralized expert assessment, which may indicate a possible overdiagnosis of axial lesions in real-life practice and emphasizes the importance of collaboration between a rheumatologist and a radiologist when analyzing the results of imaging studies. 33.3% of patients with axPsA had low disease activity according to BASDAI at baseline and 64.3% after 24 weeks, meaning that the disease was only adequately controlled in one third of cases despite therapy; the number of these patients doubled after a change in therapy. 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引用次数: 0

摘要

银屑病关节炎(PsA)是一种关节、脊柱和软骨的慢性免疫炎症性疾病,属于脊柱关节炎的范畴,通常见于银屑病患者。近年来,对轴向型 PsA(axPsA)的研究十分活跃。然而,在现实的临床实践中,有关 axPsA 患者诊断和治疗方法的数据并不充分。本文介绍了一项非干预性多中心观察性研究(NiSaXPA)的数据中期分析结果,该研究涉及俄罗斯各中心在实际临床实践中对axPsA患者的治疗。符合纳入标准的PsA患者在风湿免疫科医生的常规就诊期间接受了前瞻性随访。参与者的轴向X光片被上传到数据库中,以便由两名独立专家(一名风湿免疫科医生和一名放射科医生)确认是否存在axPsA。确诊为axPsA的患者参加了进一步的数据收集阶段(第2次就诊,第24周)。研究共招募了 600 名患者。分析时,其中 386 人(64.3%)(男性 209 人,女性 177 人)接受了 axPsA 筛查。241例(62.4%)患者确诊为axPsA,这些患者构成了按方案(PP)人群。PP 组 axPsA 患者的平均年龄为(46.30±12.6)岁,体重指数(BMI)为(27.4±5.2)kg/m2。14.9%的患者银屑病病程少于1-5年,21.5%的患者病程为5-10年,63.6%的患者病程超过10年。31.2%的患者 PsA 症状持续时间少于 1-5 年,31.6%的患者持续时间为 5-10 年,37.2%的患者持续时间超过 10 年。33.3%的axPsA患者在第1次就诊时达到了低疾病活动度(BASDAI ˂4),64.3%的患者在第2次就诊时达到了低疾病活动度(BASDAI ˂4);BASDAI指数平均从4.67±1.95点降至3.31±1.89点。在实际临床实践中,患者最常接受的处方是非类固醇抗炎药(NSAIDs)--88.7%和71.7%(分别为第1次和第2次就诊),以及合成改善病情抗风湿药(sDMARDs)--79.1%和70.7%;分别有40.2%和60.6%的患者开始接受生物改善病情抗风湿药(bDMARDs)治疗。这项观察性研究的中期分析结果显示,在符合CASPAR PsA标准的患者中,87.2%的患者在初级保健阶段怀疑有PsA的轴向表现。这可能表明在现实生活中轴向病变可能被过度诊断,并强调了风湿免疫科医生和放射科医生在分析影像学检查结果时合作的重要性。根据BASDAI,33.3%的axPsA患者在基线时疾病活动度较低,而在24周后有64.3%的患者疾病活动度较低,这意味着尽管接受了治疗,但只有三分之一的患者病情得到了充分控制;在改变疗法后,这些患者的人数增加了一倍。在现实世界的临床实践中,axPsA患者最常服用的药物是非甾体抗炎药(NSAID)和sDMARD类药物;在观察期结束时,生物制剂药物的使用频率介于40.2%和60.6%之间。
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Results of a non-interventional observational multicenter study of the management of patients with axial psoriatic arthritis in real-life clinical practice (NiSaXPA)
Psoriatic arthritis (PsA) is a chronic immunoinflammatory disease of the joints, spine and entheses from the group of spondyloarthritis, which is usually observed in patients with psoriasis. In recent years, the axial form of PsA (axPsA) has been actively researched. However, there is insufficient data on approaches to the diagnosis and treatment of patients with axPsA in real-life clinical practice. This article presents the results of an interim analysis of data from a non-interventional multicenter observational study on the treatment of patients with axPsA in real-life clinical practice (NiSaXPA) in Russian centers.Objective: to identify patients with axPsA, their characteristics and describe treatment tactics in real-life clinical practice.Material and methods. Patients with PsA who met the inclusion criteria were prospectively followed up during routine visits to a rheumatologist. Participants' axial radiographs were uploaded to a database in order for it to be confirmed the presence or absence of axPsA by two independent experts, a rheumatologist and a radiologist. Patients with a confirmed axPsA diagnosis participated in a further data collection phase (Visit 2, week 24).Results and discussion. Six hundred patients were enrolled into the study. At the time of analysis, 386 (64.3%) of them (209 men and 177 women) were screened for axPsA. The diagnosis of axPsA was confirmed in 241 (62.4%) cases; these patients formed the Per Protocol (PP) population. The mean age of patients with axPsA in the PP population was 46.30±12.6 years and the body mass index (BMI) was 27.4±5.2 kg/m2 . In 14.9% of patients, the duration of psoriasis was less than 1–5 years, in 21.5% – 5–10 years and in 63.6% – more than 10 years. The duration of PsA symptoms was less than 1–5 years in 31.2 % of patients, 5–10 years in 31.6 % and more than 10 years in 37.2 %. Low disease activity (BASDAI ˂ 4) was achieved in 33.3 % of patients with axPsA at visit 1 and in 64.3 % at visit 2; the BASDAI index declined on average from 4.67±1.95 to 3.31±1.89 points.In real-life clinical practice, patients were most frequently prescribed non-steroidal anti-inflammatory drugs (NSAIDs) – 88.7% and 71.7% (visits 1 and 2, respectively), and synthetic disease-modifying antirheumatic drugs (sDMARDs) –79.1% and 70.7%, respectively; therapy with biologic disease-modifying antirheumatic drugs (bDMARDs) was initiated in 40.2% and 60.6% of patients, respectively.Conclusion. The results of the interim analysis of this observational study showed that in 87.2% of patients who met the CASPAR criteria for PsA there was a suspicion of axial manifestations of PsA on the primary care level. However, only 62.4% of them had a confirmed diagnosis of axPsA on centralized expert assessment, which may indicate a possible overdiagnosis of axial lesions in real-life practice and emphasizes the importance of collaboration between a rheumatologist and a radiologist when analyzing the results of imaging studies. 33.3% of patients with axPsA had low disease activity according to BASDAI at baseline and 64.3% after 24 weeks, meaning that the disease was only adequately controlled in one third of cases despite therapy; the number of these patients doubled after a change in therapy. In real-world clinical practice, patients with axPsA are most commonly prescribed drugs from the NSAID and sDMARD groups; the frequency of use of biologic drugs varied between 40.2 and 60.6% by the end of the observation period.
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