抗 CD20 疗法与神经免疫性疾病中的妊娠：来自德国的队列研究。
Anti-CD20 therapies and pregnancy in neuroimmunologic disorders: A cohort study from Germany.
机构信息
From the Institute of Clinical Neuroimmunology (T.K., I.M.), Biomedical Center and University Hospital, Ludwig-Maximilians Universitaet München, Munich; Department of Neurology (S.T., A.I.C., I.A., K.H.), Katholisches Klinikum, St. Josef Hospital, Ruhr University Bochum; Institute of Clinical Pharmacy and Pharmacotherapy (A.I.C.), Heinrich Heine University Düsseldorf; Department of Neurology (A.B.), University Hospital of Augsburg; Klinik für Neurologie (F.H.), Krankenhaus Martha-Maria Halle-Dölau gGmbH, Halle (Saale); Klinik für Neurologie (U.H.-v.O.), Knappschaftskrankenhaus Dortmund Klinikum Westfalen, Dortmund; Marianne-Strauß-Klinik (M.-M.H.), Berg; Department of Neurology (J.K.), Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen; Department of Neurology (M.R., O.A.), Medical Faculty, Heinrich Heine University Düsseldorf; Department of Neurology (M.R.), Center for Neurology and Neuropsychiatry, LVR-Klinikum Düsseldorf; Department of Neurology (M.S.), University of Leipzig; Sektion Neuroimmunologie (A.W.), Klinik für Neurologie, Klinikum Herford; Institute of Neuropathology and Department of Neurology (M.S.W.), University Medical Center, Georg August University Göttingen, Germany.
出版信息
Neurol Neuroimmunol Neuroinflamm. 2020 Dec 17;8(1). doi: 10.1212/NXI.0000000000000913. Print 2021 Jan.
OBJECTIVE
To report pregnancy outcomes and disease activity (DA) in women with MS, neuromyelitis optica spectrum disorders (NMOSDs), and other neuroimmunologic diseases (ONID) after treatment with rituximab (RTX)/ocrelizumab (OCR) 12 months before or during pregnancy.
METHODS
Data were collected in the German MS and pregnancy registry and centers from the Neuromyelitis Optica Study Group. Sixty-eight known outcomes of 88 pregnancies from 81 women (64 MS, 10 NMOSD, and 7 ONID) were included and stratified in 3 exposure groups: >6M-group = RTX/OCR >6 but ≤12 months before the last menstrual period (LMP) (n = 8); <6M group = RTX/OCR <6 months before the LMP (n = 47); preg group = RTX/OCR after the LMP (n = 13).
RESULTS
Pregnancy outcomes were similar between groups, but significantly more preterm births (9.8% vs 45%) occurred after exposure during pregnancy. Overall, 2 major congenital abnormalities (3.3%), both in the preg group, were observed. Three women had severe infections during pregnancy. All women with MS (35) and 12/13 women with NMOSD, RTX/OCR exposure before the LMP and known pregnancy outcomes after gestational week 22 were relapse free during pregnancy. Five of 29 (17.2%) women with relapsing-remitting MS (RRMS) and 1 of 12 (8.3%) with NMOSD and at least 6 months postpartum follow-up experienced a relapse postpartum. Duration of RTX/OCR and early retreatment but not detection of B-cells were possible predictors for postpartum relapses in patients with RRMS/NMOSD.
CONCLUSIONS
Although RTX/OCR might be an interesting option for women with RRMS/NMOSD who plan to become pregnant to control DA, more data on pregnancy outcomes and rare risks are needed.
目的
报告在怀孕前 12 个月或怀孕期间接受利妥昔单抗（RTX）/奥瑞珠单抗（OCR）治疗的多发性硬化症（MS）、视神经脊髓炎谱系障碍（NMOSD）和其他神经免疫疾病（ONID）女性的妊娠结局和疾病活动（DA）。
方法
数据来自德国 MS 和妊娠登记处和视神经脊髓炎研究组的中心。纳入了 81 名女性 88 例妊娠的 68 例已知结局，并分为 3 个暴露组：>6M 组=RTX/OCR 在末次月经（LMP）前 6 至 12 个月（n=8）；<6M 组=RTX/OCR 在 LMP 前 6 个月内（n=47）；妊娠组=RTX/OCR 在 LMP 后（n=13）。
结果
各组间妊娠结局相似，但妊娠期间暴露后早产发生率明显更高（9.8% vs 45%）。总体上，观察到 2 例主要先天畸形（3.3%），均发生在妊娠组。3 名女性在怀孕期间发生严重感染。所有 MS 女性（35 例）和已知妊娠结局后达到妊娠 22 周的 13 例 NMOSD 女性中，有 12 例在妊娠期间未复发。5 例复发缓解型多发性硬化症（RRMS）女性（5/29，17.2%）和 1 例 NMOSD 女性（1/12，8.3%）在产后至少 6 个月随访时发生产后复发。RRMS/NMOSD 患者产后复发的可能预测因素为 RTX/OCR 的持续时间、早期再治疗，但与 B 细胞检测无关。
结论
虽然 RTX/OCR 可能是计划怀孕以控制 DA 的 RRMS/NMOSD 女性的一个有趣选择，但仍需要更多关于妊娠结局和罕见风险的数据。
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