Mid-term clinico-radiologic findings of an open label observation study of add on tacrolimus with biologies or non-biologic DMARDs
Mid-term clinico-radiologic findings of an open label observation study of add on tacrolimus with biologies or non-biologic DMARDs
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添加他克莫司与生物制剂或非生物 DMARD 的开放标签观察研究的中期临床放射学结果
DOI：
10.1007/s00296-011-2200-8
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发表时间：
2011
影响因子：
4
通讯作者：
et al.
中科院分区：
文献类型：
--
作者：
Takakubo Y;Tamaki Y;Takagi M;et al.
他克莫司（TAC）通过介导抑制钙调神经磷酸酶激活来抑制免疫炎症，治疗类风湿关节炎（RA）。据报道，RA的各种联合治疗上级单药治疗。因此，目的是在治疗抵抗患者中研究附加TAC与生物制剂（BIO）和/或非BIO疾病缓解抗风湿药物（DMARD）的组合。在8例RA患者中，将TAC添加到BIO（TAC/BIO组），41例添加到非BIO DMARD（TAC/非BIO组）。TAC/BIO组的平均C反应蛋白（CRP）从基线时的33 mg/l降至第一年时的16 mg/l（P< 0.05），TAC/非BIO组从41 mg/l至14 mg/l（P< 0.05）;平均DAS 28-CRP（28个关节计数）疾病活动性评分在TAC/BIO组中从5.3降低至4.4（P< 0.05），在TAC/非BIO组中从5.0降低至3.9（P< 0.05）。TAC/BIO组Δ改良Sharp总分的中位数从基线前一年的43分降至随访第一年的3分（P< 0.05），TAC/非BIO组从22分降至第二年的0分（P< 0.05）。在这项研究中，26名患者发生了26起不良事件（共53%）;然而，唯一的严重不良事件是一例非典型分枝杆菌疾病（2%）。TAC与BIO或非BIO DMARD的联合治疗代表了治疗难治性RA的有效且相对安全的治疗模式。
Tacrolimus (TAC) suppresses immune-inflammation by an intermediary inhibition of calcineurin activation in the treatment of rheumatoid arthritis (RA). Various combination therapies for RA have been reported to be superior to monotherapies. The aim was therefore to study add-on TAC in a combination with biologics (BIO) and/or non-BIO disease-modifying anti-rheumatic drugs (DMARDs) in treatment-resistant patients. In eight RA patients, TAC was added on to BIO (TAC/BIO group) and in forty-one to non-BIO DMARDs (TAC/non-BIO group). The mean C-reactive protein (CRP) decreased from 33 mg/l at the baseline to 16 mg/l at first year in the TAC/BIO group (P< 0.05), from 41 to 14 mg/l in the TAC/non-BIO group (P< 0.05); the mean DAS28-CRP (28 joint count) disease activity score decreased from 5.3 to 4.4 in the TAC/BIO group (P< 0.05) and from 5.0 to 3.9 in the TAC/non-BIO group (P< 0.05). The median of Δ modified total Sharp score decreased from 43 during the year preceding the baseline to 3 during the first year of the follow-up in the TAC/BIO group (P< 0.05) and from 22 to 0 during the second year in the TAC/non-BIO group (P< 0.05). Twenty-six adverse events occurred in this study in 26 patients (53% in all); however, the only severe adverse event was one case of an atypical mycobacterial disease (2%). The combination therapy of TAC with BIO or non-BIO DMARDs represents an effective and relatively safe mode of therapy in treatment-resistant RA.