Westhovens Rene, Ravelingien Isabelle, Vandevyvere Klaas, Pansar Ingrid, Purcaru Oana, Kumke Thomas, Gyselbrecht Lieve
Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, KU Leuven , Leuven , Belgium.
Rheumatology, University Hospitals Leuven , Leuven , Belgium.
Acta Clin Belg. 2019 Oct;74(5):342-350. doi: 10.1080/17843286.2018.1509923. Epub 2018 Aug 30.
: To report changes in productivity and social participation - alongside clinical and patient-reported outcomes (PROs) - in patients with rheumatoid arthritis (RA) receiving certolizumab pegol (CZP) during routine clinical practice in Belgium. : This was a prospective, non-interventional study, in which patients were prescribed CZP at their physicians' discretion and followed during routine clinical visits. The primary outcomes were household productivity and social participation at the last visit (~52 weeks), measured through responses to the Work Productivity Survey. Secondary outcomes included workplace productivity and achievement of DAS28(ESR) clinical response, low disease activity and remission at the last visit. Baseline demographics and adverse events (AEs) were recorded for all patients who received ≥1 dose CZP. : A total of 141 patients were enrolled in the study, of whom 119 (84.4%) formed the full analysis set (received ≥1 dose CZP and had ≥1 post-baseline measurement for ≥1 primary outcome). At Visit 1 (baseline), patients reported an average of 11.0 paid work days, 16.8 household work days and 5.5 days of social participation affected by their disease over the previous month. Rapid improvements in household productivity and social participation were evident from Visit 2 (2-8 weeks). By the final visit, mean improvements were observed for all aspects of productivity, participation and clinical/PROs. A total of 24 AEs were reported. : CZP has a positive impact on productivity and social participation in patients with RA in the Belgian daily practice setting, with safety and efficacy profiles that mirror those observed in the trial setting.
报告在比利时常规临床实践中接受赛妥珠单抗(CZP)治疗的类风湿关节炎(RA)患者的生产力和社会参与度变化,以及临床和患者报告结局(PROs)。
这是一项前瞻性、非干预性研究,患者由医生酌情开具 CZP 并在常规临床就诊期间接受随访。主要结局是最后一次就诊(约52周)时的家庭生产力和社会参与度,通过对工作生产力调查的回答来衡量。次要结局包括工作场所生产力以及最后一次就诊时达到 DAS28(ESR)临床缓解、低疾病活动度和缓解状态。记录所有接受≥1剂 CZP 的患者的基线人口统计学和不良事件(AE)。
共有141名患者纳入研究,其中119名(84.4%)构成完整分析集(接受≥1剂 CZP 且对≥1项主要结局有≥1次基线后测量)。在第1次就诊(基线)时,患者报告在前一个月中平均有11.0个工作日、16.8个家务工作日和5.5天的社会参与度受疾病影响。从第2次就诊(2 - 8周)开始,家庭生产力和社会参与度有明显快速改善。到最后一次就诊时,生产力、参与度和临床/PROs 的各个方面均观察到平均改善。共报告了24例不良事件。
在比利时日常实践环境中,CZP 对 RA 患者的生产力和社会参与度有积极影响,其安全性和有效性概况与试验环境中观察到的情况相符。