Chang Chunlan, Ristuccia Robert, Zheng Zhishui, Takahashi Takeshi, Nomura Takanobu, Dennis Eslie
Kyowa Kirin, Inc., Princeton, New Jersey.
Kyowa Kirin, Inc., Princeton, New Jersey.
Clin Ther. 2024 Dec;46(12):1024-1033. doi: 10.1016/j.clinthera.2024.09.011. Epub 2024 Oct 8.
During the coronavirus disease 2019 (COVID-19) pandemic, professional organizations suggested extending dosing intervals for systemic cancer therapies to limit in-person visits. Mogamulizumab, indicated for adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after ≥1 prior systemic therapy, should be administered every 7 days of the first 28-day cycle (loading) and every 14 days of each subsequent cycle (maintenance) according to the approved prescribing information in the United States (US). This study examined the real-world use of mogamulizumab before and during the COVID-19 pandemic in the US.
Using Symphony Health's Integrated Dataverse (IDV) database, adults with ≥1 diagnosis of MF or SS and ≥1 mogamulizumab claim between October 1, 2018 and December 22-, 2022 were identified. Patients in MF and SS cohorts were divided into 3 subgroups based on the date they initiated mogamulizumab treatment: pre-COVID-19 (October 1, 2018-March 31, 2020), COVID-19 Phase 1 (April 1, 2020-July 31, 2021), and COVID- 19 Phase 2 (August 1, 2021-December 22, 2022).
During the study, 270 patients with MF and 337 patients with SS initiated mogamulizumab. The pre-COVID-19, COVID-19 Phase 1, and COVID-19 Phase 2 subgroups included 95, 81, and 94 patients with MF and 124, 119, and 94 patients with SS, respectively. In the MF cohort, mean loading dosing intervals were 13, 12, and 9 days for the pre-COVID-19, COVID-19 Phase 1, and COVID-19 Phase 2 subgroups, respectively, and mean maintenance dosing intervals were 16, 16, and 16 days, respectively. In the SS cohort, mean loading dosing intervals were 16, 11, and 11 days, and mean maintenance dosing intervals were 19, 18, and 16 days, respectively. For both cohorts, more patients in the COVID-19 Phase 1 and Phase 2 subgroups than in the pre-COVID-19 subgroup had gaps of ≤10 days between loading doses and ≤21 days between maintenance doses.
In patients with MF and SS, loading dosing intervals in the pre-COVID-19 period were longer than the loading schedule per the approved prescribing information, but there was a trend towards closer concordance in the COVID-19 periods. Maintenance dosing intervals in patients with MF were consistently similar to the approved schedule across treatment periods, and in patients with SS became more closely aligned over time. Thus, dosing intervals for mogamulizumab in both loading and maintenance cycles do not appear to have been extended during the COVID-19 Phase 1 and Phase 2 periods compared with the pre-COVID-19 period, despite recommendations to extend dosing intervals for systemic cancer therapies during COVID-19.
在2019年冠状病毒病（COVID-19）大流行期间，专业组织建议延长全身性癌症治疗的给药间隔，以减少面对面就诊。莫加莫拉单抗适用于≥1次既往全身治疗后复发或难治性蕈样肉芽肿（MF）或塞扎里综合征（SS）的成人患者，根据美国批准的处方信息，在第1个28天周期（负荷期）应每7天给药1次，随后每个周期（维持期）应每14天给药1次。本研究调查了美国COVID-19大流行之前和期间莫加莫拉单抗的实际使用情况。
利用Symphony Health的综合数据集（IDV）数据库，确定在2018年10月1日至2022年12月22日期间有≥1次MF或SS诊断且有≥1次莫加莫拉单抗用药记录的成人患者。MF和SS队列中的患者根据开始莫加莫拉单抗治疗的日期分为3个亚组：COVID-19大流行前（2018年10月1日至2020年3月31日）、COVID-19第1阶段（2020年4月1日至2021年7月31日）和COVID-19第2阶段（2021年8月1日至2022年12月22日）。
在研究期间，270例MF患者和337例SS患者开始使用莫加莫拉单抗。COVID-19大流行前、COVID-19第1阶段和COVID-19第2阶段亚组分别包括95例、81例和94例MF患者以及124例、119例和94例SS患者。在MF队列中，COVID-19大流行前、COVID-19第1阶段和COVID-19第2阶段亚组的平均负荷给药间隔分别为13天、12天和9天，平均维持给药间隔分别为16天、16天和16天。在SS队列中，平均负荷给药间隔分别为16天、11天和11天，平均维持给药间隔分别为19天、18天和16天。对于两个队列，COVID-19第1阶段和第2阶段亚组中负荷剂量间隔≤10天且维持剂量间隔≤21天的患者比COVID-19大流行前亚组更多。
在MF和SS患者中，COVID-19大流行前时期的负荷给药间隔长于批准处方信息中的负荷给药方案，但在COVID-19期间有更接近一致的趋势。MF患者的维持给药间隔在整个治疗期间始终与批准方案相似，而SS患者的维持给药间隔随着时间推移变得更加一致。因此，与COVID-19大流行前时期相比，在COVID-19第1阶段和第2阶段期间，莫加莫拉单抗在负荷期和维持期的给药间隔似乎均未延长，尽管有建议在COVID-19期间延长全身性癌症治疗的给药间隔。
