Rheumatologisches Praxiszentrum, Munich, Germany.
Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin, Berlin, Germany.
Rheumatol Int. 2019 Jan;39(1):131-140. doi: 10.1007/s00296-018-4180-4. Epub 2018 Nov 10.
The TNF inhibitor golimumab (GLM) is a treatment option in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). The GO-NICE study assessed patient-reported outcomes (PRO) in patients newly treated with monthly GLM 50 mg subcutaneously (SC) under real-life conditions in Germany. A prospective non-interventional study with 24-month observation per patient was conducted at 158 sites. Available for analysis were 1,458 patients, 474 with rheumatoid arthritis (RA: 54.9 ± 13.4 years, 72.8% females, 60.4% biologic-naïve), 501 with psoriatic arthritis (PsA: 50.5 ± 12.1 years, 54.1% females; 47.5% biologic-naïve), and 483 with ankylosing spondylitis (AS: 43.6 ± 12.3 years, 66.5% males; 58.4% biologic-naïve). A total of 664 patients completed follow-up to month 24. An improvement of QoL by EuroQoL EQ-5D-3L was seen after 6 months and was maintained over 24 months. The patients' health state today (EQ visual analog scale) improved statistically significantly (p < 0.0001 vs. BL) from 51.0 at baseline (BL) to 63.4 (RA), from 48.4 to 64.3 (PsA) and from 46.8 to 66.5 (AS). Functional ability (FFbH) improved significantly (p < 0.003 vs. BL) from BL 68.2 to 76.1 points (RA), from 69.0 to 76.8 points (PsA), and from 69.0 to 78.5 points (AS). The mean FACIT-Fatigue score increased significantly (p < 0.0001 vs. BL) from BL 32.4 to 38.3 points (RA), from 30.0 to 35.9 points (PsA), and from 29.9 to 37.9 points after 24 months (AS); p < 0.0001 vs. BL each. On treatment with GLM SC once monthly, significant improvements in patient-reported QoL parameters were noted in a very similar manner in all three diseases.Trial registration ClinTrials.gov Identifier: NCT01313858. Registered March 14, 2011; https://clinicaltrials.gov/ct2/show/record/NCT01313858 .
肿瘤坏死因子抑制剂戈利木单抗（GLM）是类风湿关节炎（RA）、银屑病关节炎（PsA）和强直性脊柱炎（AS）患者的治疗选择之一。GO-NICE 研究在德国的真实环境下，评估了新接受每月皮下注射 GLM 50mg 的患者的患者报告结局（PRO）。该研究是一项前瞻性、非干预性的 24 个月观察期的研究，每位患者观察 24 个月。可分析的患者有 1458 例，其中 474 例为类风湿关节炎（RA：54.9±13.4 岁，72.8%为女性，60.4%为生物制剂初治），501 例为银屑病关节炎（PsA：50.5±12.1 岁，54.1%为女性；47.5%为生物制剂初治），483 例为强直性脊柱炎（AS：43.6±12.3 岁，66.5%为男性，58.4%为生物制剂初治）。共有 664 例患者完成了 24 个月的随访。在 6 个月时观察到 QoL 通过欧洲五维健康量表（EQ-5D-3L）得到改善，并且在 24 个月内得到维持。患者今天的健康状况（EQ 视觉模拟量表）从基线时的 51.0 显著改善（p<0.0001 与 BL 相比）至 63.4（RA）、48.4 至 64.3（PsA）和 46.8 至 66.5（AS）。功能能力（FFbH）显著改善（p<0.003 与 BL 相比），从 BL 的 68.2 点改善至 76.1 点（RA）、69.0 点改善至 76.8 点（PsA）和 69.0 点改善至 78.5 点（AS）。FACIT-Fatigue 评分的平均值显著提高（p<0.0001 与 BL 相比），从 BL 的 32.4 点提高至 38.3 点（RA）、30.0 点提高至 35.9 点（PsA）和 29.9 点提高至 37.9 点（AS）；与 BL 相比，p<0.0001。接受 GLM 皮下注射治疗后，在所有三种疾病中，患者报告的 QoL 参数均以非常相似的方式得到显著改善。
NCT01313858。注册于 2011 年 3 月 14 日；https://clinicaltrials.gov/ct2/show/record/NCT01313858。
