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From the Mellen Center for Multiple Sclerosis Treatment and Research (Drs. Rudick and Weinstock-Guttman), Cleveland Clinic Foundation, Cleveland, OH; Biogen (Drs. Simonian, Alam, and Jones, and M. Campion and J.O. Scaramucci), Cambridge, MA; Department of Neurology (Drs. Coats and Salazar), Walter Reed Army Medical Center, Washington, DC; University of California at San Francisco/Mount Zion Multiple Sclerosis Center (Dr. Goodkin), San Francisco, CA; Department of Neurology (Dr. Herndon), Jackson VA Medical Center, Jackson, MS; Department of Neurology (Dr. Mass), Good Samaritan Hospital and Medical Center, Portland, OR; Department of Neurology (Dr. Richert), Georgetown University Medical Center, Washington, DC; MSCRG Data Management and Statistical Center (Dr. Cookfair), Department of Neurology, The Buffalo General Hospital, Buffalo, NY; Department of Radiology-MRI (Dr. Simon), University of Colorado Health Sciences Center, Denver, CO; and William C. Baird Multiple Sclerosis Research Center (Drs. Munschauer and Jacobs), Millard Fillmore Health System, and the Department of Neurology, The Buffalo General Hospital, Buffalo, NY.
Address correspondence and reprint requests to Dr. Richard A. Rudick, Mellen Center, Area U100, Cleveland Clinic Foundation, Cleveland, OH 44106.
Background: Interferon beta is an effective treatment for relapsing multiple sclerosis(MS). As with other protein drugs, neutralizing antibodies (NAB) can develop that reduce the effectiveness of treatment.
Objectives: To determine the incidence and biological significance of NAB to interferon beta-1a (IFN-ß-1a; Avonex; Biogen, Cambridge, MA) in MS patients.
Methods: A two-step assay for NAB to IFN-ß-1a was developed and used to assay serum samples from participants in the phase III clinical trial of IFN-ß-1a, and from patients in an ongoing open-label study of IFN-ß1a. The biological significance of NAB to IFN-ß-1a was determined by relating the NAB assay result to in vivo induction of the IFN-inducible molecules neopterin and ß-2 microglobulin, and the clinical significance was determined by comparing clinical and MRI measures of disease activity after 2 years of IFN-ß-1a therapy in patients who were NAB+ and NAB-. The incidence of NAB was compared in MS patients who had used only IFN-ß-1a with the incidence in MS patients who had used only IFN-ß-1b.
Results: In patients in the open-label study, development of NAB to IFN-ß-1a resulted in a titer-dependent reduction in neopterin induction after interferon injections. In patients in the phase III study, development of NAB was associated with a reduction in ß-2 microglobulin induction. In the phase III study, a trend toward reduced benefit of IFN-ß-1a on MRI activity in NAB+ versus NAB- patients was observed. The incidence of NAB to IFN-ß-1a in the open-label study was approximately 5% over 24 months of treatment of IFN-ß-1a therapy, but was four- to sixfold higher using the same assay for patients exposed only to IFN-ß-1b for a similar duration. There were no clinical, MRI, or CSF characteristics that were predictive of which patients would develop NAB.
Conclusions: NAB directed against IFN-ß have in vivo biological consequences in patients with MS. The frequency with which MS patients develop NAB against IFN-ß is significantly greater with IFN-ß-1b therapy compared with IFN-ß-1a therapy. Treatment decisions in MS patients treated withIFN-ß should take into account development of NAB.
*See the Appendix on page 1271 for a list of MSCRG members and their affiliations.
Received September 16, 1997. Accepted in final form February 16, 1998.
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