Background

Golimumab (GLM) has been reported to have lower immunogenicity than do other TNF inhibitors used for treating rheumatoid arthritis (RA). We previously found a prolonged effect of and improvement similar to that associated with infliximab (IFX) after switching to subcutaneous GLM (GLM-SC) for control of RA activity or adverse events. Thus, this study aimed to evaluate the continued maintenance of treatment efficacy and safety for > 2 years by switching to GLM-SC in RA patients with low disease activity or in remission after previous treatment with another tumor necrosis factor (TNF) inhibitor.

Methods

Thirty-two patients treated with etanercept or infliximab were switched to GLM-SC and maintained low disease activity. The patients were divided into two groups (GLMq4w and GLMq8w) through discussion with each patient, considering their general condition and convenience. The groups included patients with low disease activity or in remission who switched to 50-mg GLM therapy at 4-week and 8-week intervals, respectively.

Results

The mean DAS28-ESR and DAS-CRP values in the GLMq4w group (17 patients) and GLMq8w group (15 patients) were maintained from baseline throughout the 104-week treatment period. Two patients from the GLMq4w group showed disease flaring to moderate disease activity. No serious adverse events occurred, and the treatment continuation rate at 104 weeks was 100% in both groups. After > 2 years of treatment, three patients in the GLMq8w group and one patient in the GLMq4w group discontinued GLM treatment due to relapse or complications. The 5-year survival rates were 88.2% and 75.5% in the GLMq4w and GLMq8w groups, respectively. The average treatment duration was 5.0 (2.0–7.5) years.

Conclusion

Administration of GLM-SC at 4-week and 8-week intervals after switching from TNF inhibitors showed sustained long-term efficacy and acceptable safety in RA patients with low disease activity.

中文翻译：

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长期维持戈利木单抗对既往接受其他 TNF 抑制剂治疗的低疾病类风湿性关节炎患者注射间隔的有效性：一项观察性研究的至少 2 年数据

背景

据报道，戈利木单抗 (GLM) 的免疫原性低于用于治疗类风湿性关节炎 (RA) 的其他 TNF 抑制剂。我们之前发现，在改用皮下 GLM (GLM-SC) 以控制 RA 活动或不良事件后，与英夫利昔单抗 (IFX) 相关的延长效果和改善类似。因此，本研究旨在评估在疾病活动性低或先前用另一种肿瘤坏死因子 (TNF) 抑制剂治疗后缓解的 RA 患者中，通过改用 GLM-SC 来评估持续维持治疗效果和安全性 > 2 年。

方法

32 名接受依那西普或英夫利昔单抗治疗的患者转为 GLM-SC 并保持低疾病活动度。通过与每位患者讨论，将患者分为两组（GLMq4w和GLMq8w），考虑到他们的一般情况和方便。这些组包括疾病活动度低或处于缓解期的患者，他们分别以 4 周和 8 周的时间间隔改用 50 毫克 GLM 治疗。

结果

GLMq4w 组（17 名患者）和 GLMq8w 组（15 名患者）的平均 DAS28-ESR 和 DAS-CRP 值在整个 104 周治疗期间均保持在基线水平。来自 GLMq4w 组的两名患者表现出疾病爆发至中度疾病活动。两组均未发生严重不良事件，104周时继续治疗率为100%。治疗 > 2 年后，GLMq8w 组 3 名患者和 GLMq4w 组 1 名患者因复发或并发症而停止 GLM 治疗。GLMq4w 和 GLMq8w 组的 5 年生存率分别为 88.2% 和 75.5%。平均治疗持续时间为 5.0 (2.0-7.5) 年。

结论

在从 TNF 抑制剂转换后，每隔 4 周和 8 周给予 GLM-SC，在低疾病活动性 RA 患者中显示出持续的长期疗效和可接受的安全性。