University of Alabama at Birmingham, Birmingham, AL, USA.
Foundation for Advancing Science, Technology, Education and Research, Birmingham, AL, USA.
Bone. 2024 Jan;178:116954. doi: 10.1016/j.bone.2023.116954. Epub 2023 Nov 5.
To evaluate the impact of the COVID lock-down on treatment interruptions of romosozumab, a first in class biologic therapy, administered by healthcare providers once monthly.
We used Medicare data from 1/1/2017 to 9/30/2021 to identify women age ≥65 initiating romosozumab between 4/1/2019 and 6/30/2021. Patient demographics, provider specialty, and baseline comorbidities were identified. Romosozumab dispensations were grouped into five 6-month periods based on the dispensing date from FDA licensure to the end of the data (Period 1 to 5). "Treatment interruption" was defined as any interval gap between 2 dispensations >60 days. The numbers of treatment interruption event were aggregated per period per patient. Mixed effect Poisson regression with patient-level random effects was performed, including an interaction term between Period and number of prior doses.
There were 12,216 romosozumab new users identified. A total of 2724 treatment interruption events were identified among 2229 romosozumab users. After adjustment, comparing with the period immediately before the lockdown (Period 2: 2019-10-1-2020-3-30), the IRRs (95 % CI) for treatment interruption were 0.49 (0.29, 0.81), 1.65 (1.48, 1.85), 1.79 (1.60, 2.01), and 1.67 (1.49, 1.87) for periods 1, 3, 4, and 5, respectively, per 1 prior dose change (p < 0.01 for all IRRs), where Periods 3, 4, and 5 were post-lockdown.
Compared to the pre-COVID period, the lockdown negatively impacted the continuity of romosozumab treatment among Medicare beneficiaries. Prioritizing in-time assistance for patients receiving a provider-administered parenteral therapy is critical when patients' in-person access to their provider is compromised.
评估 COVID 封锁对每月由医疗保健提供者给药一次的首创生物疗法罗莫佐单抗治疗中断的影响。
我们使用 2017 年 1 月 1 日至 2021 年 9 月 30 日的医疗保险数据，确定了 2019 年 4 月 1 日至 2021 年 6 月 30 日期间开始接受罗莫佐单抗治疗的年龄≥65 岁的女性患者。患者人口统计学、提供者专业和基线合并症被确定。根据从 FDA 许可到数据结束的配药日期（第 1 期至第 5 期），将罗莫佐单抗的配药分为五个 6 个月期。“治疗中断”定义为两次配药之间间隔超过 60 天的任何时间间隔。每个患者每个时期的治疗中断事件次数进行汇总。采用具有患者水平随机效应的混合效应泊松回归，包括时期和之前剂量数之间的交互项。
确定了 12216 名罗莫佐单抗新使用者。在 2229 名罗莫佐umab 用户中，共发现 2724 例治疗中断事件。调整后，与封锁前的时期（第 2 期：2019 年 10 月 1 日至 2020 年 3 月 30 日）相比，治疗中断的 IRR（95%CI）分别为 0.49（0.29，0.81）、1.65（1.48，1.85）、1.79（1.60，2.01）和 1.67（1.49，1.87），每增加一次先前剂量变化（所有 IRR 均<0.01），其中第 3、4 和 5 期为封锁后。
与 COVID 前时期相比，封锁对医疗保险受益人的罗莫佐单抗治疗连续性产生了负面影响。当患者亲自接触提供者的机会受到损害时，优先为接受提供者管理的肠外治疗的患者提供及时帮助至关重要。
