Bellomi Francesca, Muto Antonella, Palmieri Graziana, Focaccetti Chiara, Dianzani Caterina, Mattei Maurizio, Jaber Amer, Antonelli Guido
Department of Experimental Medicine, Virology Section, La Sapienza University, Rome, Italy.
New Microbiol. 2007 Jul;30(3):241-6.
The in vivo immunogenicity of a new interferon (IFN) beta-1a product (Rebif New Formulation; RNF) was compared with that of two approved recombinant human IFN beta-1a products (Rebif and Avonex). Immunogenic potential was assessed based on time to development of neutralizing antibodies (NAbs) and NAb titer. Female BALB/c mice (six in each group) received RNF, Rebif or Avonex (1.0 microg/mL subcutaneously three times weekly), and serum samples collected on Days 7, 21, and 35 (Study 1), or 28, 42, 49, and 60 (Study 2) were assayed for NAbs. In Study 1, no mice had NAbs at Day 7, but by Day 21 one mouse in the RNF group had NAbs, compared with three and four mice in the Rebif and Avonex groups, respectively. Results were similar in Study 2. All control mice were NAb negative; all actively treated mice had NAbs by day 35 or 42. Throughout Study 1, NAb titers were lowest in the RNF group and highest in the Avonex group, and at day 35, NAb titers were significantly lower in the RNF group than the Rebif group (p = 0.037). Results indicate that, on a gram-for-gram basis, RNF appears less immunogenic than Rebif or Avonex.
将一种新型干扰素β-1a产品（Rebif新配方；RNF）的体内免疫原性与两种已获批的重组人干扰素β-1a产品（Rebif和Avonex）进行了比较。基于中和抗体（NAbs）产生的时间和NAb滴度评估免疫原性潜力。雌性BALB/c小鼠（每组6只）接受RNF、Rebif或Avonex（每周皮下注射3次，每次1.0μg/mL），并在第7、21和35天（研究1）或第28、42、49和60天（研究2）采集血清样本检测NAbs。在研究1中，第7天时没有小鼠产生NAbs，但到第21天时，RNF组有1只小鼠产生了NAbs，相比之下，Rebif组和Avonex组分别有3只和4只小鼠产生了NAbs。研究2的结果相似。所有对照小鼠NAb均为阴性；所有积极治疗的小鼠在第35天或第42天时均产生了NAbs。在整个研究1中，RNF组的NAb滴度最低，Avonex组最高，且在第35天时，RNF组的NAb滴度显著低于Rebif组（p = 0.037）。结果表明，以每克计算，RNF的免疫原性似乎低于Rebif或Avonex。
