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Maintenance of efficacy and safety with subcutaneous golimumab in rheumatoid arthritis patients with low disease activity who previously received TNF inhibitors

机译:在预先接受TNF抑制剂的低疾病活动患者中患有皮下戈洛单抗的疗效和安全性维持疗效和安全性

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The study was conducted to evaluate continued maintenance of the efficacy and safety of therapy by switching to subcutaneous golimumab (GLM-SC) in rheumatoid arthritis patients with low disease activity or remission who previously received a tumor necrosis factor (TNF) inhibitor. Thirty patients who had been treated with etanercept or infliximab were switched to GLM-SC in maintaining disease activity at a low level. The patients were divided into two groups through discussion with each patient, considering general condition and convenience: the low disease activity (LDA) group and the LDAq8w group, which included patients with low disease activity or remission who switched to 50 mg GLM therapy at 4- and 8-week intervals, respectively. The effects of the TNF inhibitors to GLM-SC switch were evaluated at 12, 24, and 52 weeks after switching. The mean DAS28-ESR and DAS-CRP values in the LDA groups (16 patients) and LDAq8w groups (14 patients) were maintained from baseline throughout the 52-week treatment period. DAS28-ESR remission (93.8 and 92.3%) rates were also maintained through week 52 from the baseline remission rate (75.0 and 78.6%) in the LDA and LDAq8w groups, respectively. Thus, both GLM-SC treatment regimens were effective in maintaining the clinical response achieved with LDA secondary to TNF inhibitors. No serious adverse events occurred, and the continuation rate at 52 weeks was 100% in both groups. Therapeutic efficacy is adequately maintained in most patients switching from TNF inhibitor to GLM-SC (50 mg/4-8 weeks). Patients receiving TNF inhibitor can seamlessly switch to GLM-SC without serious safety concerns.
机译:进行该研究以评估持续维持治疗的疗效和安全性,通过切换到皮下疾病性关节炎患者的皮下科毒性(GLM-SC),所述类风湿性关节炎患者患者,所述疾病性关节炎患者,所述疾病活性或前述肿瘤坏死因子(TNF)抑制剂的缓解。已经用依那西普或英夫利昔单抗治疗的30名患者切换到GLM-SC,以保持低水平的疾病活性。考虑到一般条件和便利性,患者通过讨论将患者分为两组:低疾病活动(LDA)组和LDAQ8W组,其中包括低疾病活动或缓解的患者,他们在4次切换到50 mg GLM治疗 - 和8周的间隔分别。 TNF抑制剂对GLM-SC开关的影响在切换后的12,24和52周评估。在整个52周治疗期间,LDA组(16例)和LDAQ8W组(14名患者)中的平均DAS28-ESR和DAS-CRP值在基线中维持。 DAS28-ESR缓解(93.8和92.3%)率也通过LDA和LDAQ8W组中的基线缓解率(75.0和78.6%)来维持。因此,GLM-SC治疗方案都有效地维持与TNF抑制剂的LDA实现的临床反应。没有发生严重的不良事件,两组持续52周的延续率为100%。在大多数从TNF抑制剂转化为GLM-SC(50mg / 4-8周)的大多数患者中,治疗疗效被充分维持。接受TNF抑制剂的患者可以无缝地切换到GLM-SC,而无需严重的安全问题。

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