Sato Eri, Tanaka Eiichi, Nakajima Ayako, Inoue Eisuke, Shimizu Yoko, Yamaguchi Rei, Ochiai Moeko, Shidara Kumi, Hoshi Daisuke, Sugimoto Naoki, Seto Yohei, Taniguchi Atsuo, Momohara Shigeki, Yamanaka Hisashi
Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
Mod Rheumatol. 2015 Jul;25(4):528-33. doi: 10.3109/14397595.2014.995892. Epub 2015 Feb 9.
To assess the effectiveness of the golimumab (GLM) 50-mg and 100-mg regimens in patients with rheumatoid arthritis (RA) in daily practice.
We retrospectively analyzed RA patients who started GLM between September 2011 and July 2012. Patients were divided into three groups: a 50-mg group; a 50/100-mg group (had a dose increase to 100 mg); and a 100-mg group (started GLM at 100 mg). We assessed Disease Activity Score 28 (DAS28) and treatment continuation rate. Risk factors associated with time to discontinuation of the 50-mg regimen were determined with proportional hazards analysis.
We analyzed 74 patients: 43 in the 50-mg group, 23 in the 50/100-mg group, and 8 in the 100-mg group. DAS28 improved from 4.0 ± 1.0, 4.8 ± 1.0, and 4.7 ± 1.9, respectively, at baseline to 2.4 ± 1.2, 3.3 ± 1.5, and 2.5 ± 0.7, respectively, at week 52. Treatment continuation rates at week 52 were 73.7%, 60.9%, and 87.5%, respectively. In the 50/100-mg group, the mean DAS28 improved significantly from 4.4 ± 1.2 before to 3.6 ± 1.3 12 weeks after the dose increase. Oral corticosteroid therapy ≥ 5 mg/day, previous use of two biologic agents, and DAS28 > 5.1 at initiation of GLM were significantly associated with discontinuation of the 50-mg regimen.
Both GLM 50-mg and 100-mg regimens are effective in patients with RA in daily practice.
评估在日常临床实践中，戈利木单抗（GLM）50毫克和100毫克方案对类风湿关节炎（RA）患者的有效性。
我们回顾性分析了2011年9月至2012年7月开始使用GLM的RA患者。患者被分为三组：50毫克组；50/100毫克组（剂量增加至100毫克）；以及100毫克组（起始剂量为100毫克）。我们评估了疾病活动评分28（DAS28）和治疗持续率。通过比例风险分析确定与50毫克方案停药时间相关的危险因素。
我们分析了74例患者：50毫克组43例，50/100毫克组23例，100毫克组8例。DAS28分别从基线时的4.0±1.0、4.8±1.0和4.7±1.9，改善至第52周时的2.4±1.2、3.3±1.5和2.5±0.7。第52周时的治疗持续率分别为73.7%、60.9%和87.5%。在50/100毫克组中，剂量增加前DAS28平均为4.4±1.2，增加后12周显著改善至3.6±1.3。口服糖皮质激素治疗≥5毫克/天、既往使用过两种生物制剂以及GLM起始时DAS28>5.1与50毫克方案停药显著相关。
在日常临床实践中，GLM 50毫克和100毫克方案对RA患者均有效。
