Introduction

While dose escalation of golimumab has been used for patients with rheumatoid arthritis who demonstrate an inadequate response to the standard dose, its effectiveness has not been fully evaluated. The aim of this study was to assess the clinical outcome observed by dose escalation of golimumab for patients with rheumatoid arthritis in the daily clinical setting.

Methods

A post hoc analysis was performed of data from the 24-week post-marketing surveillance conducted in Japan (n = 5154). A total of 301 patients with moderate or high disease activity at baseline who underwent dose escalation of golimumab were assessed for effectiveness at 24 weeks based on several variables, such as DAS28-CRP, SDAI, and CDAI, as well as for medication persistence through 24 weeks. In addition, the study population was stratified by the time to dose escalation, and effectiveness was likewise evaluated. Logistic regression analysis was performed to identify factors associated with a moderate/good EULAR response to golimumab at 24 weeks.

Results

Patients with golimumab dose escalation showed significant improvement of the clinical signs and symptoms of rheumatoid arthritis at 24 weeks, as indicated by reduction of the DAS28-CRP (∆0.89), SDAI (∆8.64), and CDAI (∆8.28) scores. This result was relatively consistent across the subgroups stratified by the timing of dose escalation. According to Kaplan-Meier analysis, 78.1% of the patients continued to receive golimumab at 24 weeks, and this was also similar among the subgroups stratified by the time to dose escalation. Multivariate analysis identified male sex and previous biologic therapy as factors that were significantly associated with the clinical response at 24 weeks.

Conclusion

In real-world clinical practice, improvement of disease activity was observed after uptitration of golimumab from 50 to 100 mg regardless of the timing. Male patients and biologic-naive patients were more likely to respond to dose escalation of golimumab.

Trial Registration

UMIN-CTR, Identifier: UMIN000015895.

中文翻译：

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Golimumab剂量递增对日本类风湿性关节炎患者的影响：上市后监测数据的事后分析。

介绍

虽然戈利木单抗的剂量递增已用于风湿性关节炎患者，但对标准剂量反应不足，但尚未完全评估其有效性。这项研究的目的是评估在日常临床环境中通过戈利木单抗剂量递增对类风湿关节炎患者观察到的临床结果。

方法

对在日本进行的24周 售后监测的数据进行了事后分析（n = 5154）。根据几个变量（例如DAS28-CRP，SDAI和CDAI）以及在24天内的药物持续性，评估了总共301名基线时中度或高疾病活动度，接受golimumab剂量升高的患者在24周时的有效性周。此外，按剂量递增时间对研究人群进行分层，并同样评估有效性。进行逻辑回归分析以鉴定与24周时对戈利木单抗的中度/良好EULAR反应相关的因素。

结果

戈利木单抗剂量升高的患者在24周时显示出类风湿关节炎的临床体征和症状有明显改善，如DAS28-CRP（∆0.89），SDAI（∆8.64）和CDAI（∆8.28）得分降低所表明。在按剂量递增时间分层的各个亚组中，该结果相对一致。根据Kaplan-Meier分析，在24周时有78.1％的患者继续接受戈利木单抗，这在按剂量递增时间分层的亚组中也相似。多变量分析确定了男性和先前的生物疗法是与24周临床反应显着相关的因素。

结论

在现实世界的临床实践中，戈利木单抗从50毫克调升至100毫克后，无论何时，均可观察到疾病活动性的改善。男性患者和未接受过生物学治疗的患者对戈利木单抗剂量递增的反应更大。

试用注册

UMIN-CTR，标识符：UMIN000015895。