Colina Matteo, Khodeir Micheline, Rimondini Roberto, Valentini Marco, Campomori Federica, Corvaglia Stefania, Campana Gabriele
UOC (Operative Complex Unit) of Internal Medicine, Rheumatology Service, Section of Internal Medicine, Department of Medicine and Oncology, "Santa Maria della Scaletta" Hospital, via Montericco 4, 40026, Imola, Italy.
Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.
Clin Drug Investig. 2024 Mar;44(3):141-148. doi: 10.1007/s40261-024-01341-7. Epub 2024 Jan 31.
Long-term treatment of patients with rheumatoid arthritis with tumor necrosis factor-α inhibitors leads to initial changes in disease activity that can predict a late treatment response. This observational and retrospective study aimed to determine when it is possible to foresee the response to therapy in the case of long-standing rheumatoid arthritis comparing also the efficacy of the original biologics with their biosimilars.
A total of 1598 patients were recruited and treated with the original biologics, adalimumab and etanercept, or with biosimilars. Patients were monitored over a period of 48 months and disease activity scores (28-Joint Disease Activity Score, Simplified Disease Activity Index, and Clinical Disease Activity Index) were measured every 6 months.
No differences in disease activity levels were observed in etanercept versus biosimilars (GP2015/SB4) and adalimumab versus biosimilar (GP2017) patient groups. All scores significantly decreased in all treatments during the first 18 months of therapy, and after 24 months reached a minimum that lasted up to 48 months.
We conclude that biosimilars of adalimumab and etanercept have equivalent effectiveness over a long period of time compared to their originator drugs, and also that the levels of disease activity after 6 months of tumor necrosis factor-α inhibitors (originator drugs and biosimilars) might predict the response to therapy at 4 years in patients with long-standing rheumatoid arthritis.
使用肿瘤坏死因子-α抑制剂对类风湿关节炎患者进行长期治疗会导致疾病活动度出现初始变化，这些变化可预测后期治疗反应。这项观察性回顾性研究旨在确定在长期类风湿关节炎病例中何时能够预见治疗反应，同时比较原研生物制剂与其生物类似药的疗效。
共招募了1598例患者，用原研生物制剂阿达木单抗和依那西普或其生物类似药进行治疗。对患者进行为期48个月的监测，每6个月测量疾病活动度评分（28关节疾病活动度评分、简化疾病活动指数和临床疾病活动指数）。
依那西普与其生物类似药（GP2015/SB4）以及阿达木单抗与其生物类似药（GP2017）患者组之间在疾病活动度水平上未观察到差异。在治疗的前18个月内，所有治疗组的所有评分均显著下降，24个月后降至最低并持续至48个月。
我们得出结论，阿达木单抗和依那西普的生物类似药与原研药相比在较长时间内具有等效疗效，并且肿瘤坏死因子-α抑制剂（原研药和生物类似药）治疗6个月后的疾病活动度水平可能预测长期类风湿关节炎患者4年时的治疗反应。
