Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Neurorehabilitation Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Eur J Neurol. 2023 Sep;30(9):2859-2864. doi: 10.1111/ene.15891. Epub 2023 Jun 5.
During the COVID-19 pandemic, ocrelizumab administration was frequently postponed because of a lack of safety information and to favour vaccination. The clinical implications of ocrelizumab administration delay in multiple sclerosis (MS) patients were assessed.
Relapsing (RMS) and primary progressive (PPMS) MS patients receiving ocrelizumab for at least 6 months at our centre were retrospectively classified, according to the possible occurrence of a delay (≥4 weeks) in treatment administration. Patients were categorized in the extended-interval dosing (EID) group in the presence of at least one delayed infusion; otherwise they were considered as part of the standard interval dosing (SID) cohort. MS history, magnetic resonance imaging examinations and B-cell counts were also retrospectively collected and analysed.
A total of 213 RMS and 61 PPMS patients were enrolled; 115 RMS and 29 PPMS patients had been treated according to the SID regimen, whilst 98 RMS and 32 PPMS patients were included in the EID cohort. Average follow-up after delay was 1.28 ± 0.7 years in the EID cohort. In RMS, comparing SID and EID patients, no differences were found considering the occurrence of clinical relapses (9.6% vs. 16.3%, p = 0.338), magnetic resonance imaging activity (9.8% vs. 14.1%, p = 0.374) or disability progression (11.3% vs. 18.4%, p = 0.103). Similar findings were observed in PPMS patients. In the pooled EID group, treatment delay correlated with CD19-positive relative (r = 0.530, p < 0.001) and absolute (r = 0.491, p < 0.001) cell counts, without implications on disease activity.
Sporadic ocrelizumab administration delay granted sustained treatment efficacy in our cohort. Prospective data should be obtained to confirm these observations and set up systematic extended-interval regimens.
在 COVID-19 大流行期间,由于缺乏安全性信息以及优先接种疫苗,奥瑞珠单抗的给药经常被推迟。评估多发性硬化症(MS)患者奥瑞珠单抗给药延迟的临床意义。
根据治疗给药可能延迟(≥4 周),对在本中心接受奥瑞珠单抗治疗至少 6 个月的复发型(RMS)和原发性进展型(PPMS)MS 患者进行回顾性分类。如果至少有一次输注延迟,则将患者归入延长间隔给药(EID)组;否则,他们被视为标准间隔给药(SID)队列的一部分。还回顾性收集和分析了 MS 病史、磁共振成像检查和 B 细胞计数。
共纳入 213 例 RMS 和 61 例 PPMS 患者;115 例 RMS 和 29 例 PPMS 患者接受 SID 方案治疗,98 例 RMS 和 32 例 PPMS 患者纳入 EID 队列。EID 队列中延迟后的平均随访时间为 1.28±0.7 年。在 RMS 中,SID 和 EID 患者相比,临床复发(9.6% vs. 16.3%,p=0.338)、磁共振成像活动(9.8% vs. 14.1%,p=0.374)或残疾进展(11.3% vs. 18.4%,p=0.103)方面无差异。PPMS 患者也观察到类似的结果。在合并的 EID 组中,治疗延迟与 CD19 阳性相对(r=0.530,p<0.001)和绝对(r=0.491,p<0.001)细胞计数相关,但对疾病活动无影响。
在本队列中,奥瑞珠单抗的偶发性给药延迟可维持治疗效果。应获得前瞻性数据以证实这些观察结果,并制定系统的延长间隔方案。