Department of Hematology and Oncology, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY, USA.
Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, PA, USA.
Ann Hematol. 2024 Apr;103(4):1139-1147. doi: 10.1007/s00277-023-05613-8. Epub 2024 Feb 1.
This retrospective cohort study described real-world treatment patterns and healthcare resource utilization (HCRU) of patients with warm autoimmune hemolytic anemia (wAIHA) initiating treatment with first-line (1L) oral corticosteroids (OCS) + rituximab (R) compared to 1L OCS. Patients with a wAIHA diagnosis code (D59.11) between 8/2020-3/2022 were identified using US pharmacy and medical claims databases. Patients initiating 1L OCS ± R were identified (date of initiation = 'index date') with a 1-year pre-index period and a variable (minimum 1-year) follow-up period. The final sample comprised 77 1L OCS + R patients and 400 1L OCS patients (~ 60% female, mean age > 64 years). Over the 1-year follow-up, HCRU was higher in the OCS + R cohort with higher mean number of physician office visits (22.9 and 14.4; p < 0.01), including hematology/oncology office visits, and higher utilization of rescue therapy (59.7% and 33.3%; p < 0.01), driven by higher use of injectable corticosteroids. Patients in OCS + R and OCS groups completed 1L therapy after a similar mean duration of 103.5 and 134.6 days, respectively (p = 0.24). In the majority of patients, second-line (2L) therapy was initiated at a similar timepoint: 66.2% OCS + R and 72.0% OCS cohorts (p = 0.31) initiated 2L in a mean of 218.3 and 203.2 days (p = 0.76) after the end of 1L treatment, respectively. The addition of rituximab in 1L did not extend the remission period, with most patients in both cohorts initiating 2L therapy within less than 1 year of completing 1L treatment. 1L OCS + R patients also had substantial HCRU burden. More effective novel therapies are needed to address the high unmet need in wAIHA.
这项回顾性队列研究描述了接受一线(1L)口服皮质类固醇(OCS)+利妥昔单抗(R)治疗的温抗体自身免疫性溶血性贫血(wAIHA)患者与接受 1L OCS 治疗相比的真实世界治疗模式和医疗资源利用(HCRU)。使用美国药房和医疗索赔数据库,于 2020 年 8 月至 2022 年 3 月之间,确定了 wAIHA 诊断代码(D59.11)的患者。确定了起始 1L OCS±R 的患者(起始日期=“索引日期”),其预索引期为 1 年,随访期为可变(至少 1 年)。最终样本包括 77 例 1L OCS+R 患者和 400 例 1L OCS 患者(~60%为女性,平均年龄>64 岁)。在 1 年的随访期间,OCS+R 组的 HCRU 更高,平均就诊次数(22.9 次和 14.4 次;p<0.01),包括血液科/肿瘤科就诊次数更高,并且抢救治疗的利用率(59.7%和 33.3%;p<0.01)更高,这是由于更多地使用了注射用皮质类固醇。OCS+R 和 OCS 组的患者分别在平均 103.5 和 134.6 天后完成 1L 治疗(p=0.24)。在大多数患者中,二线(2L)治疗在相似的时间点开始:66.2%的 OCS+R 和 72.0%的 OCS 队列(p=0.31)分别在 1L 治疗结束后平均 218.3 和 203.2 天(p=0.76)开始 2L。在 1L 中添加利妥昔单抗并未延长缓解期,两个队列中的大多数患者在完成 1L 治疗不到 1 年内均开始接受 2L 治疗。1L OCS+R 患者的 HCRU 负担也很大。需要更有效的新型疗法来满足 wAIHA 的高未满足需求。