V. Boyadzhieva, N. Stoilov, M. Ivanova, R. Stoilov
{"title":"类风湿性关节炎的治疗:csDMARDS与bDMARDS。评估疾病活动性的前瞻性研究","authors":"V. Boyadzhieva, N. Stoilov, M. Ivanova, R. Stoilov","doi":"10.35465/27.1.2019.PP3-15","DOIUrl":null,"url":null,"abstract":"The assessment of disease activity is an essential component in the selection of therapeutic approach for the prevention of disability of patients with RA. The current study was conducted to evaluate the disease activity in patients on csDMARDs and bDMARDs after 6 months to 1-year of treatment and to determine whether the benefits of different therapies were sustained over time. For the purpose of the study were selected 220 patients with a mean age 55.05 ± 10.63 SD years, meeting the 1987 ACR classification criteria for RA. Patients were stratified according to treatment regimens into 2 age-matched treatment groups: 96 on csDMARDs and 124 on bDMARD therapy. Patient‘s assessment of disease related pain, global health and physician assessment of global health was made by visual analogue scale (VAS) – 100 mm. Disease activity was the primary outcome domain. Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month of the follow-up period. C-reactive protein (CRP) was used to measure the infl ammation process. DAS28-CRP, CDAI and SDAI were calculated according to the standard formulas. Comparison was performed by analysis variance ANOVA. On baseline, patients on bDMARDs had a significantly higher mean time-averaged 28-joint disease activity score (5.03 ± 0.84 SD vs. 4.35 ± 1.20 SD, p < 0,001), CDAI (25.06 ± 7.32 SD vs. 20.83 ± 10.53 SD, p < 0.001) and SDAI (28.27 ± 8.74 SD vs. 23.19 ± 11.89 SD, p < 0.001) compared to those on csDMARDs. On the 6th month in both groups (bDMARDS and csDMARDs) we found significant decrease in mean DAS28 (p < 0.001, p < 0.001), although no significant difference in disease activity between the groups was measured by this indicator (3.75 ± 2.49 SD vs 3.90 ± 1.10 SD, p = 0.566). Patients on bDMARDs had significantly lower disease activity compared to those on csDMARDs after 6th and 12th month of treatment assessed by CDAI (13.43 ± 4.98 SD vs 16.81 ± 9.94 SD, p = 0.001; 8.65 ± 4.53 SD vs 15.86 ± 10.02 SD, p < 0.001), and SDAI (14.63 ± 5.42 SD vs 18.38 ± 10.49 SD, p < 0.001; 9.39 ± 4.92 SD vs 16.79 ± 10.5 SD, p < 0.001). Unlike results reported by DAS28-CRP which showed no change between the 6th and 12th month in patients receiving csDMARDs (3.90 ± 1.10 SD, 3.82 ± 1.12 SD, p = 0.156), we observed a statistically significant difference in all three time intervals (0, the 6th, 10th month) of the follow up period regarding to CDAI and SDAI. After a year prospective follow-up, therapy with biologic DMARDs results in sustained suppression – minimal disease activity assessed by DAS28-CRP, CDAI and SDAI, compared to patients receiving DMARDs who had moderate disease activity according to these tools. The therapy with bDMARDs was superior to csDMARDs therapy for suppressing disease activity (assessed by DAS28-CRP, CDAI and SDAI) of rheumatoid arthritis (RA) on the 6th and 12th month of the follow-up period.","PeriodicalId":38954,"journal":{"name":"Revmatologiia (Bulgaria)","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2019-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"Treatment of rheumatoid arthritis: csDMARDS versus bDMARDS. Prospective study to evaluate disease activity\",\"authors\":\"V. Boyadzhieva, N. Stoilov, M. Ivanova, R. 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Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month of the follow-up period. C-reactive protein (CRP) was used to measure the infl ammation process. DAS28-CRP, CDAI and SDAI were calculated according to the standard formulas. Comparison was performed by analysis variance ANOVA. On baseline, patients on bDMARDs had a significantly higher mean time-averaged 28-joint disease activity score (5.03 ± 0.84 SD vs. 4.35 ± 1.20 SD, p < 0,001), CDAI (25.06 ± 7.32 SD vs. 20.83 ± 10.53 SD, p < 0.001) and SDAI (28.27 ± 8.74 SD vs. 23.19 ± 11.89 SD, p < 0.001) compared to those on csDMARDs. On the 6th month in both groups (bDMARDS and csDMARDs) we found significant decrease in mean DAS28 (p < 0.001, p < 0.001), although no significant difference in disease activity between the groups was measured by this indicator (3.75 ± 2.49 SD vs 3.90 ± 1.10 SD, p = 0.566). Patients on bDMARDs had significantly lower disease activity compared to those on csDMARDs after 6th and 12th month of treatment assessed by CDAI (13.43 ± 4.98 SD vs 16.81 ± 9.94 SD, p = 0.001; 8.65 ± 4.53 SD vs 15.86 ± 10.02 SD, p < 0.001), and SDAI (14.63 ± 5.42 SD vs 18.38 ± 10.49 SD, p < 0.001; 9.39 ± 4.92 SD vs 16.79 ± 10.5 SD, p < 0.001). Unlike results reported by DAS28-CRP which showed no change between the 6th and 12th month in patients receiving csDMARDs (3.90 ± 1.10 SD, 3.82 ± 1.12 SD, p = 0.156), we observed a statistically significant difference in all three time intervals (0, the 6th, 10th month) of the follow up period regarding to CDAI and SDAI. After a year prospective follow-up, therapy with biologic DMARDs results in sustained suppression – minimal disease activity assessed by DAS28-CRP, CDAI and SDAI, compared to patients receiving DMARDs who had moderate disease activity according to these tools. 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引用次数: 2
摘要
疾病活动性的评估是选择预防RA患者残疾的治疗方法的重要组成部分。目前的研究旨在评估服用csDMARDs和bDMARDs的患者在治疗6个月至1年后的疾病活动性,并确定不同疗法的益处是否能持续一段时间。本研究选择220例患者,平均年龄55.05±10.63 SD年,符合1987年ACR对RA的分类标准。根据治疗方案将患者分为2个年龄匹配的治疗组:96例接受csdmard治疗,124例接受bDMARD治疗。采用视觉模拟量表(VAS) - 100 mm对患者疾病相关疼痛、整体健康状况和医生整体健康状况进行评估。疾病活动性是主要结果域。独立关节评估者在基线、第6个月和第12个月对28个关节进行了评估。用c反应蛋白(CRP)测定炎症过程。按标准公式计算DAS28-CRP、CDAI、SDAI。比较采用方差分析(ANOVA)。基线时,bDMARDs患者的平均28关节疾病活动度评分(5.03±0.84 SD比4.35±1.20 SD, p < 0.001)、CDAI(25.06±7.32 SD比20.83±10.53 SD, p < 0.001)和SDAI(28.27±8.74 SD比23.19±11.89 SD, p < 0.001)均显著高于csDMARDs患者。在两组(bDMARDS和csDMARDs)的第6个月,我们发现平均DAS28显著降低(p < 0.001, p < 0.001),尽管该指标在两组之间的疾病活动性没有显著差异(3.75±2.49 SD vs 3.90±1.10 SD, p = 0.566)。在CDAI评估的第6个月和第12个月后,bDMARDs患者的疾病活动性明显低于csDMARDs患者(13.43±4.98 SD vs 16.81±9.94 SD, p = 0.001;8.65±4.53 SD vs 15.86±10.02 SD, p < 0.001), SDAI(14.63±5.42 SD vs 18.38±10.49 SD, p < 0.001;9.39±4.92 SD vs 16.79±10.5 SD, p < 0.001)。与DAS28-CRP报告的结果不同,接受csDMARDs的患者在第6个月和第12个月之间没有变化(3.90±1.10 SD, 3.82±1.12 SD, p = 0.156),我们观察到CDAI和SDAI在随访期间的三个时间间隔(0、6、10个月)均有统计学差异。经过一年的前瞻性随访,与接受DMARDs治疗的患者相比,生物DMARDs治疗的结果是持续的抑制——DAS28-CRP、CDAI和SDAI评估的疾病活动性最小,根据这些工具,接受DMARDs治疗的患者疾病活动性中等。在第6个月和第12个月,bDMARDs治疗在抑制类风湿性关节炎(RA)的疾病活动性(通过DAS28-CRP、CDAI和SDAI评估)方面优于csDMARDs治疗。
Treatment of rheumatoid arthritis: csDMARDS versus bDMARDS. Prospective study to evaluate disease activity
The assessment of disease activity is an essential component in the selection of therapeutic approach for the prevention of disability of patients with RA. The current study was conducted to evaluate the disease activity in patients on csDMARDs and bDMARDs after 6 months to 1-year of treatment and to determine whether the benefits of different therapies were sustained over time. For the purpose of the study were selected 220 patients with a mean age 55.05 ± 10.63 SD years, meeting the 1987 ACR classification criteria for RA. Patients were stratified according to treatment regimens into 2 age-matched treatment groups: 96 on csDMARDs and 124 on bDMARD therapy. Patient‘s assessment of disease related pain, global health and physician assessment of global health was made by visual analogue scale (VAS) – 100 mm. Disease activity was the primary outcome domain. Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month of the follow-up period. C-reactive protein (CRP) was used to measure the infl ammation process. DAS28-CRP, CDAI and SDAI were calculated according to the standard formulas. Comparison was performed by analysis variance ANOVA. On baseline, patients on bDMARDs had a significantly higher mean time-averaged 28-joint disease activity score (5.03 ± 0.84 SD vs. 4.35 ± 1.20 SD, p < 0,001), CDAI (25.06 ± 7.32 SD vs. 20.83 ± 10.53 SD, p < 0.001) and SDAI (28.27 ± 8.74 SD vs. 23.19 ± 11.89 SD, p < 0.001) compared to those on csDMARDs. On the 6th month in both groups (bDMARDS and csDMARDs) we found significant decrease in mean DAS28 (p < 0.001, p < 0.001), although no significant difference in disease activity between the groups was measured by this indicator (3.75 ± 2.49 SD vs 3.90 ± 1.10 SD, p = 0.566). Patients on bDMARDs had significantly lower disease activity compared to those on csDMARDs after 6th and 12th month of treatment assessed by CDAI (13.43 ± 4.98 SD vs 16.81 ± 9.94 SD, p = 0.001; 8.65 ± 4.53 SD vs 15.86 ± 10.02 SD, p < 0.001), and SDAI (14.63 ± 5.42 SD vs 18.38 ± 10.49 SD, p < 0.001; 9.39 ± 4.92 SD vs 16.79 ± 10.5 SD, p < 0.001). Unlike results reported by DAS28-CRP which showed no change between the 6th and 12th month in patients receiving csDMARDs (3.90 ± 1.10 SD, 3.82 ± 1.12 SD, p = 0.156), we observed a statistically significant difference in all three time intervals (0, the 6th, 10th month) of the follow up period regarding to CDAI and SDAI. After a year prospective follow-up, therapy with biologic DMARDs results in sustained suppression – minimal disease activity assessed by DAS28-CRP, CDAI and SDAI, compared to patients receiving DMARDs who had moderate disease activity according to these tools. The therapy with bDMARDs was superior to csDMARDs therapy for suppressing disease activity (assessed by DAS28-CRP, CDAI and SDAI) of rheumatoid arthritis (RA) on the 6th and 12th month of the follow-up period.