Szántó Sándor, Poór Gyula, Opris Daniela, Iaremenko Oleg, Procházková Leona, Kuuse Reet, Nagy Orsolya, Chernyshov Valentyn, Géher Pál
Department of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.
National Institute of Rheumatology & Physiotherapy, Budapest, Hungary.
J Comp Eff Res. 2016 Aug;5(5):475-85. doi: 10.2217/cer-2016-0020. Epub 2016 Jul 15.
Adalimumab effectiveness on clinical, functional and work-related outcomes was evaluated in patients with active ankylosing spondylitis or psoriatic arthritis treated in routine clinical practice in central-eastern Europe.
Patients (n = 555) were followed for 12 months. Primary end point was percentage of patients with a treatment response (≥50% decrease from baseline in Bath Ankylosing Spondylitis Disease Activity Index or ≥1.2 point decrease from baseline in Disease Activity Index-28 joint for axial or peripheral symptoms, respectively). Functional status was evaluated by the Bath Ankylosing Spondylitis Functional Index and Health Assessment Questionnaire Disability Index. Working ability was evaluated by the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem.
76.1% of patients with axial symptoms and 83.5% with peripheral symptoms achieved a treatment response. Frequency of extra-articular manifestations decreased. Improvements were observed in functional status and workability. No new safety signals were observed.
Adalimumab was effective and well tolerated during real-world use in central-eastern Europe.
在中东欧地区接受常规临床治疗的活动性强直性脊柱炎或银屑病关节炎患者中，评估阿达木单抗对临床、功能及与工作相关结局的疗效。
对555例患者进行了为期12个月的随访。主要终点为出现治疗反应的患者百分比（分别为巴斯强直性脊柱炎疾病活动指数较基线下降≥50%，或针对轴向或外周症状的疾病活动指数28关节较基线下降≥1.2分）。通过巴斯强直性脊柱炎功能指数和健康评估问卷残疾指数评估功能状态。通过工作效率和活动障碍问卷 - 特定健康问题评估工作能力。
76.１% 的轴向症状患者和83.5% 的外周症状患者出现了治疗反应。关节外表现的频率降低。功能状态和工作能力均有改善。未观察到新的安全信号。
在中东欧地区实际应用中，阿达木单抗疗效显著且耐受性良好。
