Shimizu Hirohito, Kobayashi Hisanori, Kanbori Masayoshi, Ishii Yutaka
Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K, Tokyo, Japan.
External Collaboration and Portfolio Management Department, Clinical Science Division, R&D, Janssen Pharmaceutical K.K, Tokyo, Japan.
Mod Rheumatol. 2021 May;31(3):556-565. doi: 10.1080/14397595.2020.1797266. Epub 2020 Aug 11.
To assess the real-world effectiveness of golimumab in Japanese patients with rheumatoid arthritis who had previously received first-line biologic therapy.
A analysis of post-marketing surveillance was performed. The effectiveness of golimumab was assessed in 731 patients with an inadequate response to first-line biologic therapy stratified by their prior biologic agents. Outcome variables included DAS28-CRP, DAS28-ESR, SDAI and CDAI, and medication persistence. Logistic regression analyses were conducted to identify factors associated with the likelihood of achieving a DAS28-CRP response (good/moderate) after 24 weeks of golimumab treatment.
Patients demonstrated significant improvement in the clinical signs and symptoms of rheumatoid arthritis at 24 weeks, as indicated by the reduction of DAS28-CRP (Δ0.87), DAS28-ESR (Δ0.85), SDAI (Δ7.32), and CDAI (Δ6.98) scores. This result was consistent across the subgroups stratified by previous biologic therapy. Multivariate analysis failed to identify any factors associated with response to golimumab.
In the real-world clinical setting, switching to golimumab was effective for Japanese patients with an inadequate response to first-line biologic therapy regardless of the biologic agent, including both TNF and non-TNF inhibitors.
评估戈利木单抗在既往接受过一线生物治疗的日本类风湿关节炎患者中的真实世界疗效。
进行了一项上市后监测分析。对731例对一线生物治疗反应不佳的患者,根据其先前使用的生物制剂进行分层,评估戈利木单抗的疗效。结局变量包括28关节疾病活动评分(基于C反应蛋白)(DAS28-CRP)、28关节疾病活动评分(基于血沉)(DAS28-ESR)、简化疾病活动指数(SDAI)和临床疾病活动指数(CDAI),以及药物持续性。进行逻辑回归分析以确定与戈利木单抗治疗24周后达到DAS28-CRP反应(良好/中等)可能性相关的因素。
患者在24周时类风湿关节炎的临床体征和症状有显著改善,表现为DAS28-CRP(Δ0.87)、DAS28-ESR(Δ0.85)、SDAI(Δ7.32)和CDAI(Δ6.98)评分降低。这一结果在根据先前生物治疗分层的亚组中是一致的。多变量分析未能确定任何与对戈利木单抗反应相关的因素。
在真实世界临床环境中,无论先前使用的生物制剂是肿瘤坏死因子(TNF)抑制剂还是非TNF抑制剂,转换为戈利木单抗对一线生物治疗反应不佳的日本患者均有效。