Santos-Moreno Pedro, Martinez Susan, Ibatá Linda, Villarreal Laura, Rivero Manuel, Rojas-Villarraga Adriana
Rheumatology, Biomab IPS, Bogotá, DC, Colombia.
Epidemiology, Biomab IPS, Bogotá, DC, Colombia.
Biologics. 2021 Oct 22;15:433-440. doi: 10.2147/BTT.S322860. eCollection 2021.
Although it is known that methotrexate (MTX) increases the effectiveness of biological drugs (mainly anti-TNFs) in patients with rheumatoid arthritis (RA), in real life, it is known that many patients using anti-TNFs are on monotherapy due to many causes. This article compares the effectiveness of certolizumab as monotherapy as combined with MTX or leflunomide (LFN) in RA patients with failure to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in a real-world setting.
A retrospective observational cohort study was conducted at a specialized centre for RA management in Colombia. Patients treated with certolizumab as monotherapy or in combination with MTX, LFN, or MTX+LFN, between 2011 and 2020 with a minimum 3-month follow-up were included. Demographics and RA clinical characteristics were recorded; effectiveness was assessed as the improvement in Disease Activity Score (DAS28) getting remission or low disease activity at 3, 6, and 12 months of treatment.
A total of 181 patients were included, 24 received certolizumab as monotherapy, 62 certolizumab plus MTX, 47 certolizumab plus LFN and 48 certolizumab plus MTX+LFN. At 3 months of follow-up, 80% of the patients showed decreased disease activity, with no significant differences between groups; at 12 months of treatment, response in certolizumab monotherapy group was 94.4% compared to 81.8% in combination with MTX, 80.5% in combination with LFN and 51.4% in combination with MTX+LFN. Response at 3 months (OR 4.04; 95% CI 1.28-12.69) and positive anti-CCP (OR 3.83; 95% CI 1.11-13.21) were associated with 12-month response.
Certolizumab seems to be effective as monotherapy in the treatment of RA patients with failure to csDMARDs.
虽然已知甲氨蝶呤（MTX）可提高生物药物（主要是抗TNF药物）对类风湿关节炎（RA）患者的疗效，但在现实生活中，由于多种原因，许多使用抗TNF药物的患者采用单药治疗。本文比较了在现实环境中，赛妥珠单抗单药治疗以及与MTX或来氟米特（LFN）联合治疗对传统合成改善病情抗风湿药物（csDMARDs）治疗失败的RA患者的疗效。
在哥伦比亚一家RA管理专科中心进行了一项回顾性观察队列研究。纳入2011年至2020年间接受赛妥珠单抗单药治疗或与MTX、LFN或MTX + LFN联合治疗且随访至少3个月的患者。记录人口统计学和RA临床特征；疗效评估为治疗3、6和12个月时疾病活动评分（DAS28）改善至缓解或低疾病活动度。
共纳入181例患者，24例接受赛妥珠单抗单药治疗，62例接受赛妥珠单抗加MTX，47例接受赛妥珠单抗加LFN，48例接受赛妥珠单抗加MTX + LFN。随访3个月时，80%的患者疾病活动度降低，各治疗组间无显著差异；治疗12个月时，赛妥珠单抗单药治疗组的缓解率为94.4%，与MTX联合治疗组为81.8%，与LFN联合治疗组为80.5%，与MTX + LFN联合治疗组为51.4%。3个月时的缓解情况（OR 4.04；95% CI 1.28 - 12.69）和抗环瓜氨酸肽抗体阳性（OR 3.83；95% CI 1.11 - 13.21）与12个月时的缓解情况相关。
赛妥珠单抗单药治疗对csDMARDs治疗失败的RA患者似乎有效。
