Department of Internal Medicine II, Rheumatology, Clinical Immunology and Osteology, Schlosspark-Klinik University Medicine Berlin, Heubnerweg 2, 14059, Berlin, Germany.
Charité Universitaetsmedizin Berlin, Berlin, Germany.
Clin Rheumatol. 2019 Nov;38(11):3049-3059. doi: 10.1007/s10067-019-04648-5. Epub 2019 Jul 12.
AbataCepT In rOutiNe clinical practice (ACTION; NCT02109666) was an observational study of patients with rheumatoid arthritis who initiated intravenous abatacept in clinical practice. We aimed to compare abatacept retention rates and clinical outcomes in patients from Germany versus other countries.
Baseline characteristics, crude retention rates, and clinical outcomes were compared by treatment line in the German cohort at 2 years. In addition, biologic-naïve patients were compared with biologic-naïve patients pooled from other participating countries.
In the German cohort, 677/680 (99.6%) patients enrolled were evaluable and 171/677 (25.3%) were biologic naïve. At baseline, abatacept monotherapy was received by a similar proportion of biologic-naïve and biologic-failure patients in the German cohort, but by a greater proportion of biologic-naïve patients in German versus other countries cohort (27.5 vs. 12.9%). The overall crude abatacept retention rate at 2 years in the German cohort was 39.9%; retention rate did not differ significantly by treatment line, but among biologic-naïve patients it was lower in Germany than in the other countries cohort (42.1 vs. 58.7%; log-rank test p < 0.001). At 2 years, good/moderate European League Against Rheumatism (EULAR) response rates in biologic-naïve patients were 85.5% in the German and 92.1% in other countries cohort (p = 0.163).
In the German cohort of ACTION, abatacept retention at 2 years was similar in biologic-naïve and biologic-failure patients. Biologic-naïve patients in German cohort had a significantly lower abatacept retention rate and a trend of lower good/moderate EULAR response rate than those in the other countries cohort.
• Analyses of data from national patient cohorts provide insight on local treatment patterns. • In the German cohort of the ACTION study, abatacept retention at 2 years was similar in biologic-naïve and biologic-failure patients. • Biologic-naïve patients from the German cohort had a significantly lower abatacept retention rate and a trend of lower good/moderate EULAR response rate than patients from other countries. • Data from large international studies may not be directly applicable to individual countries.
AbataCepT 在常规临床实践中的研究(ACTION;NCT02109666)是一项观察性研究,纳入了在临床实践中开始接受静脉用阿巴西普治疗的类风湿关节炎患者。我们旨在比较德国与其他国家患者的阿巴西普保留率和临床结局。
在德国队列中,比较了第 2 年时各治疗线的基线特征、未调整的保留率和临床结局。此外,还比较了德国队列中的生物制剂初治患者和来自其他参与国家的生物制剂初治患者。
在德国队列中,677/680(99.6%)名入组患者可评估,171/677(25.3%)名患者为生物制剂初治。在基线时,德国队列中生物制剂初治和生物制剂失败患者接受阿巴西普单药治疗的比例相似,但德国队列中生物制剂初治患者接受阿巴西普单药治疗的比例高于其他国家队列(27.5% vs. 12.9%)。德国队列中阿巴西普的总未调整保留率在第 2 年时为 39.9%;各治疗线的保留率无显著差异,但在生物制剂初治患者中,德国队列的保留率低于其他国家队列(42.1% vs. 58.7%;log-rank 检验,p<0.001)。在第 2 年时,德国和其他国家队列中生物制剂初治患者的良好/中度欧洲抗风湿病联盟(EULAR)缓解率分别为 85.5%和 92.1%(p=0.163)。
在 ACTION 的德国队列中,生物制剂初治和生物制剂失败患者在第 2 年的阿巴西普保留率相似。德国队列中的生物制剂初治患者的阿巴西普保留率显著较低,且良好/中度 EULAR 缓解率有较低的趋势,但差异无统计学意义。
• 分析国家患者队列的数据可深入了解当地的治疗模式。• 在 ACTION 研究的德国队列中,生物制剂初治和生物制剂失败患者在第 2 年的阿巴西普保留率相似。• 来自德国队列的生物制剂初治患者的阿巴西普保留率显著较低,且良好/中度 EULAR 缓解率有较低的趋势,而来自其他国家队列的患者则无此趋势。• 来自大型国际研究的数据可能不适用于个别国家。