Athanassiou Panagiotis, Kotrotsios Anastasios, Kallitsakis Ioannis, Bounas Andreas, Dimitroulas Theodoros, Garyfallos Alexandros, Tektonidou Maria G, Vosvotekas Giorgos, Livieratos Achilleas, Petrikkou Evangelia, Katsifis Gkikas
"Agios Pavlos" General Hospital of Thessaloniki, Thessaloniki, Greece.
Private Practice, Karditsa, Greece.
Qual Life Res. 2022 May;31(5):1385-1399. doi: 10.1007/s11136-021-03044-4. Epub 2021 Nov 28.
To examine the impact of golimumab, on work productivity, activity limitation, and quality of life (QoL) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).
This real-world, multicenter, prospective study consecutively enrolled adult consented work-active patients with axSpA or PsA, newly initiated on golimumab as per the approved label. Prior receipt of > 1 prior biologic, or switching from another tumor-necrosis factor inhibitor due to primary non-response or safety reasons was not allowed. The Work Productivity and Activity Impairment-Specific Health Problem and the EuroQol 5-Dimensions (EQ-5D)-5-Level instruments were completed by the patients to assess the impact of golimumab on work productivity and activity impairment, and generic QoL, respectively.
Overall, 121 eligible patients (mean age: 45.4 years; median disease duration: 11.3 months), 51 diagnosed with PsA and 70 with axSpA, were enrolled by 19 rheumatologists. Over a 11.9-month median observation period, < 1% of injections were missed (as collected by patient diaries), and the 12-month golimumab retention rate was 91.7%. At 3, 6, and 12 months post baseline, in the overall population, work productivity loss improved by a median of 31.4%, 44.2%, and 50.0%; activity impairment improved by 40.0%, 40.0%, and 50.0%; and the EQ-5D UK-weighted utility index improved by 0.24, 0.32, and 0.36 points, respectively (p < 0.001 for all). Statistically significant improvements in these measures were also noted in the PsA and axSpA subpopulations.
In the routine care in Greece, golimumab displays beneficial effects on work productivity, daily activities, and QoL in work-active patients with axSpA and PsA.
Trial registration number and date of registration: As per the local regulations the study has been registered at the national registry for non-interventional studies https://www.dilon.sfee.gr/studiesp_d.php?meleti_id=MK8259-6083 .
研究戈利木单抗对中轴型脊柱关节炎(axSpA)和银屑病关节炎(PsA)患者工作效率、活动受限及生活质量(QoL)的影响。
本项真实世界、多中心、前瞻性研究连续纳入了成年且同意参与的正在工作的axSpA或PsA患者,这些患者按照批准的标签首次开始使用戈利木单抗。不允许事先接受过>1种生物制剂治疗,或因原发性无反应或安全原因从另一种肿瘤坏死因子抑制剂转换而来的患者入组。患者完成工作效率和活动障碍-特定健康问题问卷以及欧洲五维健康量表(EQ-5D)-5级量表,分别评估戈利木单抗对工作效率和活动障碍以及一般生活质量的影响。
总体而言,19位风湿病专家共纳入了121例符合条件的患者(平均年龄:45.4岁;疾病持续时间中位数:11.3个月),其中51例诊断为PsA,70例诊断为axSpA。在11.9个月的中位观察期内,错过注射的比例<1%(通过患者日记收集),戈利木单抗12个月的保留率为91.7%。在基线后3、6和12个月时,在总体人群中,工作效率损失中位数分别改善了31.4%、44.2%和50.0%;活动受限改善了40.0%、40.0%和50.0%;EQ-5D英国加权效用指数分别提高了0.24、0.32和0.36分(所有p<0.001)。在PsA和axSpA亚组中,这些指标也有统计学上的显著改善。
在希腊的常规治疗中,戈利木单抗对正在工作的axSpA和PsA患者的工作效率、日常活动及生活质量显示出有益影响。
试验注册号和注册日期:根据当地法规,本研究已在国家非干预性研究注册中心注册,网址为https://www.dilon.sfee.gr/studiesp_d.php?meleti_id=MK8259-6083 。