Okazaki Masateru, Kobayashi Hisanori, Ishii Yutaka, Kanbori Masayoshi, Yajima Tsutomu
Immunology Department, Medical Affairs Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
Japan Safety and Surveillance Division, Research and Development Division, Janssen Pharmaceutical K.K., Tokyo, Japan.
Rheumatol Ther. 2018 Jun;5(1):185-201. doi: 10.1007/s40744-018-0095-5. Epub 2018 Feb 22.
The aim of this study was to investigate real-world treatment patterns for use of golimumab and concomitant medications in Japanese patients with rheumatoid arthritis.
This study was a post hoc retrospective analysis from post-marketing surveillance data on 2350 Japanese patients with moderate/severe rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided based on initiation treatment or dose adjustment patterns with golimumab, methotrexate, or oral glucocorticoids.
Logistic regression analysis revealed that the baseline factors associated with administration of golimumab (100 mg) were higher body weight, failure of prior biological therapy (bio-failure), no previous methotrexate use, and respiratory disease, while previous methotrexate use and absence of renal impairment or respiratory disease were associated with concomitant methotrexate therapy, and previous glucocorticoid use was associated with concomitant glucocorticoid therapy. The following associations were identified with regard to dose adjustment during treatment: bio-failure, no previous methotrexate use, previous csDMARDs use, presence of respiratory disease, allergy history, and higher CRP for golimumab dose escalation; shorter disease duration, previous GC, and no previous methotrexate use for methotrexate dose escalation; no prior biological therapy and renal impairment for methotrexate dose reduction; no previous GC use for glucocorticoid dose escalation; and absence of Steinbrocker's stage II/III/IV, absence of Steinbrocker's class II, no bio-failure, and no previous csDMARDs use for glucocorticoid dose reduction.
This study revealed that various baseline factors were associated with initiation of treatment and dose adjustment of golimumab, methotrexate, or oral glucocorticoids, reflecting both the treatment strategies of physicians for improving RA symptoms and/or reducing adverse events.
Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation.
本研究旨在调查日本类风湿性关节炎患者使用戈利木单抗及联合用药的真实治疗模式。
本研究是一项事后回顾性分析,数据来自对2350例接受戈利木单抗治疗24周的中度/重度类风湿性关节炎日本患者的上市后监测。研究人群根据使用戈利木单抗、甲氨蝶呤或口服糖皮质激素的起始治疗或剂量调整模式进行划分。
逻辑回归分析显示,与使用戈利木单抗(100mg)相关的基线因素包括体重较高、既往生物治疗失败(生物治疗失败)、既往未使用甲氨蝶呤以及呼吸系统疾病;而既往使用甲氨蝶呤以及无肾功能损害或呼吸系统疾病与联合使用甲氨蝶呤治疗相关,既往使用糖皮质激素与联合使用糖皮质激素治疗相关。在治疗期间的剂量调整方面发现了以下关联:生物治疗失败、既往未使用甲氨蝶呤、既往使用传统合成改善病情抗风湿药(csDMARDs)、存在呼吸系统疾病、过敏史以及较高的C反应蛋白(CRP)与戈利木单抗剂量增加相关;病程较短、既往使用糖皮质激素以及既往未使用甲氨蝶呤与甲氨蝶呤剂量增加相关;既往未进行生物治疗以及肾功能损害与甲氨蝶呤剂量减少相关;既往未使用糖皮质激素与糖皮质激素剂量增加相关;不存在斯坦布鲁克(Steinbrocker)II/III/IV期、不存在斯坦布鲁克II级、无生物治疗失败以及既往未使用csDMARDs与糖皮质激素剂量减少相关。
本研究表明,多种基线因素与戈利木单抗、甲氨蝶呤或口服糖皮质激素的起始治疗和剂量调整相关,这既反映了医生改善类风湿性关节炎症状和/或减少不良事件的治疗策略。
杨森制药株式会社和三菱田边制药株式会社。