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首页> 外文期刊>Reproductive toxicology >Developmental and peri-postnatal study in cynomolgus monkeys with belimumab, a monoclonal antibody directed against B-lymphocyte stimulator.
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Developmental and peri-postnatal study in cynomolgus monkeys with belimumab, a monoclonal antibody directed against B-lymphocyte stimulator.

机译：含贝利木单抗的食蟹猴的发育和产后研究，贝利单抗是针对B淋巴细胞刺激剂的单克隆抗体。

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摘要

Belimumab is a fully human monoclonal antibody antagonist for soluble B-lymphocyte stimulator, and is a potential therapeutic for various autoimmune disorders. To support clinical use, belimumab was administered intravenously to pregnant cynomolgus monkeys every 2 weeks throughout gestation at dosages of 5 and 150 mg/kg. Fetuses were delivered by C-section on Gestation Day 150 from one-half of the mothers, and evaluated for teratologic effects (external, visceral, skeletal, and heart), pharmacodynamics (PD) and toxicokinetics (TK). Remaining mothers delivered their infants naturally, enabling extensive assessment of PD and TK during a 1-year postnatal period. Effects attributed to belimumab were limited to the expected pharmacology, primarily decreased numbers of B-lymphocytes in peripheral blood of mothers and infants, and in fetal lymphoid tissues. Infants demonstrated full recovery upon cessation of exposure. In conclusion, belimumab was well tolerated at pharmacologically active dose levels in pregnant cynomolgus monkeys and their infants after exposure throughout pregnancy.
机译：Belimumab是可溶性B淋巴细胞刺激剂的完全人类单克隆抗体拮抗剂，并且是多种自身免疫性疾病的潜在治疗剂。为支持临床使用，在妊娠期间每2周向怀孕的食蟹猕猴静脉注射贝利木单抗，剂量为5和150 mg / kg。胎儿在​​妊娠第150天通过剖腹产从一半母亲那里分娩，并评估其致畸作用（外部，内脏，骨骼和心脏），药效学（PD）和毒物动力学（TK）。其余的母亲自然分娩，因此可以在产后1年内对PD和TK进行广泛评估。归因于贝利木单抗的作用仅限于预期的药理作用，主要是母亲和婴儿外周血以及胎儿淋巴组织中B淋巴细胞数量减少。婴儿停止接触后可完全康复。总之，在整个怀孕期间，怀孕食蟹猕猴及其婴儿在药理活性剂量水平上对贝利木单抗的耐受性良好。

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