Zabludowitz Center for Autoimmune Diseases, Sheba Medical Center, Ramat Gan, Israel; Department of Internal Medicine 'B', Sheba Medical Center, Ramat Gan, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Zabludowitz Center for Autoimmune Diseases, Sheba Medical Center, Ramat Gan, Israel; Department of Internal Medicine 'B', Sheba Medical Center, Ramat Gan, Israel; Rheumatology Unit, Sheba Medical Center, Ramat Gan, Israel.
Best Pract Res Clin Rheumatol. 2018 Oct;32(5):692-700. doi: 10.1016/j.berh.2019.02.012. Epub 2019 Feb 27.
Golimumab is a recombinant human monoclonal antibody targeted against tumour necrosis factor-alpha (TNF-α). Golimumab is effective in the management of patients with active psoriatic arthritis (PsA). The aim of this study is to evaluate the clinical efficacy and survival of golimumab monotherapy versus co-administration with methotrexate (MTX) in patients with PsA in the clinical practice. This retrospective observational trial included patients with PsA. Efficacy was assessed by disease activity scores - DAS28, BASDAI, physician global assessment of disease (PGA) and CRP. Golimumab survival rate was estimated using the Kaplan-Meier analysis and univariate and multivariate Cox regression models. Forty-one patients with PsA were recruited; 26 patients were treated with golimumab, whereas 15 patients received combination therapy with MTX. The treatment resulted in significantly improved clinical measures of disease activity in comparison with baseline, including DAS28 CRP (4.1 vs 2.6, p ≤ 0.0001) and BASDAI (5.6 vs 3.8, p ≤ 0.001). Overall, 29 (71%) patients continued golimumab treatment (18 patients on monotherapy and 11 on combination therapy). The difference in the duration of golimumab survival between the combination therapy and monotherapy groups was not statistically significant (12.5 vs 12 months, p = 0.2). Similar efficacy profiles and survival rates were documented in patients with PsA regardless of the co-administration of methotrexate.
固立苏是一种靶向肿瘤坏死因子-α(TNF-α)的重组人源单克隆抗体。固立苏在治疗活动期银屑病关节炎(PsA)患者方面具有疗效。本研究旨在评估固立苏单药治疗与联合甲氨蝶呤(MTX)治疗在临床实践中治疗 PsA 患者的临床疗效和生存率。这项回顾性观察性试验纳入了患有 PsA 的患者。采用疾病活动评分(DAS28、BASDAI、医生总体疾病评估(PGA)和 CRP)评估疗效。采用 Kaplan-Meier 分析和单因素及多因素 Cox 回归模型估计固立苏的生存率。共纳入 41 例 PsA 患者;26 例患者接受固立苏治疗,15 例患者接受 MTX 联合治疗。与基线相比,治疗导致疾病活动的临床指标明显改善,包括 DAS28 CRP(4.1 比 2.6,p≤0.0001)和 BASDAI(5.6 比 3.8,p≤0.001)。总体而言,29 例(71%)患者继续接受固立苏治疗(18 例单药治疗,11 例联合治疗)。联合治疗和单药治疗组的固立苏生存时间差异无统计学意义(12.5 比 12 个月,p=0.2)。无论是否联合使用甲氨蝶呤,患有 PsA 的患者均具有相似的疗效和生存率。