Pappas Dimitrios A, Etzel Carol J, Zlotnick Steve, Best Jennie, Blachley Taylor, Kremer Joel M
Columbia University, New York, NY, USA.
Corrona, LLC, Waltham, MA, USA.
Rheumatol Ther. 2019 Sep;6(3):421-433. doi: 10.1007/s40744-019-0162-6. Epub 2019 Jun 25.
Prednisone is frequently administered in combination with other therapies for the treatment of rheumatoid arthritis (RA); however, its chronic use is associated with an increased risk of comorbidities and mortality. The objective of this analysis was to evaluate changes in prednisone use among patients with RA treated with tocilizumab (TCZ) in routine US clinical practice.
TCZ-naïve patients in the Corrona RA registry who initiated TCZ were included. The primary outcome was the proportion of patients with changes in prednisone use over 12 months (primary analysis) and 6 months (secondary analysis). Changes in disease activity over 6 and 12 months (± 3 months) were assessed using the Clinical Disease Activity Index (CDAI). Outcomes were assessed in the overall population and separately for patients receiving TCZ monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs.
Of patients receiving prednisone at baseline (mean [SD] dose: 7.7 [5.2] mg/day), 30.6% discontinued prednisone over 12 months; among patients receiving > 7.5 mg of prednisone at the time of TCZ initiation, 63.0% discontinued prednisone or decreased their dose by ≥ 5 mg over 12 months. In secondary analyses, 29.7% of patients receiving prednisone at baseline had discontinued prednisone over 6 months; among those receiving > 7.5 mg of prednisone at baseline, 51.3% discontinued or decreased their dose by ≥ 5 mg over 6 months. Changes in prednisone use and improvement from baseline in CDAI score over 6 and 12 months were comparable between patients who initiated TCZ monotherapy vs. TCZ combination therapy.
In this real-world analysis, many patients initiating TCZ monotherapy or combination therapy were able to discontinue or decrease their prednisone dose over 12 months. Similar changes in prednisone dose were observed over 6 months.
ClinicalTrials.gov identifier, NCT01402661.
Corrona, LLC and Genentech, Inc. Plain language summary available for this article.
泼尼松常与其他疗法联合用于治疗类风湿关节炎(RA);然而,长期使用会增加合并症和死亡风险。本分析的目的是评估在美国常规临床实践中接受托珠单抗(TCZ)治疗的RA患者中泼尼松使用情况的变化。
纳入Corrona RA注册中心中开始使用TCZ的初治患者。主要结局是泼尼松使用在12个月(主要分析)和6个月(次要分析)内发生变化的患者比例。使用临床疾病活动指数(CDAI)评估6个月和12个月(±3个月)内的疾病活动变化。在总体人群中评估结局,并分别对接受TCZ单药治疗或与传统合成改善病情抗风湿药联合治疗的患者进行评估。
在基线时接受泼尼松治疗的患者(平均[标准差]剂量:7.7[5.2]mg/天)中,30.6%在12个月内停用了泼尼松;在开始使用TCZ时接受>7.5mg泼尼松治疗的患者中,63.0%在12个月内停用了泼尼松或剂量降低≥5mg。在次要分析中,基线时接受泼尼松治疗的患者中有29.7%在6个月内停用了泼尼松;在基线时接受>7.5mg泼尼松治疗的患者中,51.3%在6个月内停用或剂量降低≥5mg。开始使用TCZ单药治疗与TCZ联合治疗的患者在6个月和12个月内泼尼松使用的变化以及CDAI评分相对于基线的改善情况相当。
在这项真实世界分析中,许多开始使用TCZ单药治疗或联合治疗的患者在12个月内能够停用或降低泼尼松剂量。在6个月内观察到泼尼松剂量有类似变化。
ClinicalTrials.gov标识符,NCT01402661。
Corrona有限责任公司和基因泰克公司。本文有通俗易懂的摘要。