Pungor E, Files J G, Gabe J D, Do L T, Foley W P, Gray J L, Nelson J W, Nestaas E, Taylor J L, Grossberg S E
Berlex Laboratories, Inc., Richmond, CA 94804-0099, USA.
J Interferon Cytokine Res. 1998 Dec;18(12):1025-30. doi: 10.1089/jir.1998.18.1025.
We have adapted the new MxA gene-induction bioassay to measure neutralizing antibodies to interferon-beta1b (IFN-beta1b, the active ingredient in Betaseron) in sera from patients treated with Betaseron. This antibody assay has been validated to quantify neutralizing titers of 1:20 and above, with a precision of +/- 0.20 in log10. We have used this MxA gene-induction antibody assay to reinvestigate serum samples from multiple sclerosis (MS) patients treated with Betaseron. The titers measured were closely comparable to those obtained in antiviral assays. Data obtained by both methods show that neutralizing antibodies may appear and subsequently disappear over time in the sera of some patients treated with Betaseron. Sera from some patients contain binding antibodies to IFN-beta1b. It was shown that binding antibody titers do not correlate quantitatively or qualitatively with neutralizing antibody titers, and indeed, a number of patients develop high levels of binding antibodies but never form measurable levels of neutralizing antibodies.
我们已对新的Mx A基因诱导生物测定法进行了调整，以检测接受倍泰龙治疗的患者血清中针对干扰素β-1b（IFN-β1b，倍泰龙的活性成分）的中和抗体。该抗体测定法已得到验证，可定量检测效价为1:20及以上的中和抗体，其精度在log10中为±0.20。我们使用这种Mx A基因诱导抗体测定法对接受倍泰龙治疗的多发性硬化症（MS）患者的血清样本进行了重新检测。所测得的效价与抗病毒测定中获得的效价密切可比。两种方法获得的数据均表明，在一些接受倍泰龙治疗的患者血清中，中和抗体可能会出现，随后随时间消失。一些患者的血清中含有针对IFN-β1b的结合抗体。结果表明，结合抗体效价与中和抗体效价在数量或质量上均无相关性，实际上，许多患者产生了高水平的结合抗体，但从未形成可测量水平的中和抗体。
