Combination treatment with methotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis - An investigator-initiated, multicenter, randomized, double-blind, parallel-group, placebo-controlled study
Combination treatment with methotrexate, cyclosporine, and intraarticular betamethasone compared with methotrexate and intraarticular betamethasone in early active rheumatoid arthritis - An investigator-initiated, multicenter, randomized, double-blind, parallel-group, placebo-controlled study
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DOI：
10.1002/art.21796
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发表时间：
2006-05-01
影响因子：
--
通讯作者：
Horslev-Petersen, Kim
中科院分区：
文献类型：
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作者：
Hetland, Merete Lund;Stengaard-Pedersen, Kristian;Horslev-Petersen, Kim
客观的。探讨通过甲氨蝶呤和关节内注射倍他米松治疗是否可以对早期活动性类风湿性关节炎（RA）实现疾病控制，以及在治疗方案中添加环孢素是否有任何额外效果。方法。患者 (n = 160) 随机接受甲氨蝶呤 7.5 毫克/周加环孢素 2.5 毫克/公斤体重/天（联合治疗）或甲氨蝶呤加安慰剂环孢素（单一治疗）。在第 0、2、4、6 和 8 周以及此后每 4 周，将倍他米松注射到肿胀的关节中（每次就诊最多 4 个关节或 4 个关节）。从第8周开始，如果存在滑膜炎，则将甲氨蝶呤剂量逐步增加至20毫克/周，随后逐步增加环孢素或安慰剂环孢素剂量至4毫克/公斤。结果。 52 周时，根据美国风湿病学会标准 (ACR20)，联合治疗组的改善率为 85%，而单一治疗组的改善率为 68%（P = 0.02）。两组的个体总体 ACR 反应 (ACR-N) 中位数分别为 80.0%（四分位距 40.1-91.8%）和 54.5%（四分位距 2.4-87.8%）（P = 0.025）。在 48 周和 52 周时，联合治疗组中有 35% 的人达到了 ACR 缓解标准，而单一治疗组中有 28% 的人达到了 ACR 缓解标准。联合治疗组和单一治疗组第 52 周时 Larsen 评分的进展分别为 -0.2 +/- 6.5 和 0.4 +/- 6.9（平均 SD）。 Serum creatinine levels increased by 7%, and hypertrichosis was more prevalent, in the combination therapy group.Conclusion.甲氨蝶呤和关节内糖皮质激素联合治疗对预后不良的早期活动性 RA 患者显示出良好的疾病控制效果并阻止了糜烂的进展。添加环孢菌素改善了 ACR20 和 ACR-N 反应，而 ACR50 和 ACR70 反应、缓解率和放射学变化在两个研究组之间没有差异。
Objective. To investigate whether disease control can be achieved in early active rheumatoid arthritis (RA) by treatment with methotrexate and intraarticular betamethasone, and whether the addition of cyclosporine to the regimen has any additional effect.Methods. Patients (n = 160) were randomized to receive methotrexate 7.5 mg/week plus cyclosporine 2.5 mg/kg of body weight/day (combination therapy) or methotrexate plus placebo-cyclosporine (monotherapy). At weeks 0, 2, 4, 6, and 8 and every 4 weeks thereafter, betamethasone was injected into swollen joints (maximum 4 joints or 4 nil per visit). Beginning at week 8, if synovitis was present, the methotrexate dosage was increased stepwise up to 20 mg/week, with a subsequent stepwise increase in the cyclosporine or placebo-cyclosporine dosage up to 4 mg/kg.Results. At 52 weeks, 20% improvement according to the American College of Rheumatology criteria (ACR20) was achieved in 85% of the combination therapy group versus 68% of the monotherapy group (P = 0.02). The median individual overall ACR response (ACR-N) in the 2 groups was 80.0% (interquartile range 40.1-91.8%) and 54.5% (interquartile range 2.4-87.8%), respectively (P = 0.025). At 48 and 52 weeks, ACR remission criteria were met in 35% of the combination therapy group and 28% of the monotherapy group. Progression in the Larsen score at 52 weeks was -0.2 +/- 6.5 and 0.4 +/- 6.9 (mean SD) in the combination therapy and monotherapy groups, respectively. Serum creatinine levels increased by 7%, and hypertrichosis was more prevalent, in the combination therapy group.Conclusion. Combined treatment with methotrexate and intraarticular glucocorticoid showed excellent disease control and stopped the progression of erosions in patients with early active RA, who had a poor prognosis. Addition of cyclosporine improved the ACR20 and ACR-N responses, whereas the ACR50 and ACR70 responses, remission rates, and radiographic changes did not differ between the 2 study groups.