Abstract
BackgroundMany patients with relapsing-remitting multiple sclerosis (MS) treated with high-dose interferon-β (IFNβ) develop serum binding antibodies (BAb) and neutralizing antibodies (NAb). NAb reduces the biological activity of IFNβ, which contributes to clinical failure in these patients. We investigated whether access to antibody (Ab) test results would alter usual care of (IFNβ)-treated patients and whether BAb could predict NAb.MethodsThis was a randomized, controlled, open-label, parallel-group, multicenter study in patients with multiple sclerosis. Subjects (n = 1358) were randomly assigned to Ab testing or usual care. BAb and NAb titres were measured using standard assays. Primary and secondary outcomes were the proportion of patients whose IFNβ therapy changed and the type of and reasons for therapy changes.ResultsTherapy changes differed between the Ab testing and usual care arms (19.6% and 14.0%, respectively; p = 0 · 004). Results from Ab testing were more frequently reported as the reason for therapy change in the Ab testing arm than in the usual care arm (p < 0.0001). NAb and BAb positivity significantly increased the likelihood of therapy change and reduced IFNβ-associated adverse events. BAb titres were a significant predictor of NAb positivity (p = 0.0012). Initial BAb-positive and NAb-positive status in both study arms had a significant impact on the overall number of patients with a therapy change (p < 0.05).ConclusionAccess to Ab test results impacted therapy management. BAb titres can predict NAb positivity in patients on high-dose IFNβ.
Highlights
Many patients with relapsing-remitting multiple sclerosis (MS) treated with high-dose interferon-β (IFNβ) develop serum binding antibodies (BAb) and neutralizing antibodies (NAb)
BAb bind to IFNβ but do not necessarily inhibit its biological activity, and they can be detected within the first month of therapy [2]
Logistic regression analysis demonstrated BAb titres were a significant predictor of NAb positivity (p = 0.0012), with an odds ratio of 1.03
Summary
Many patients with relapsing-remitting multiple sclerosis (MS) treated with high-dose interferon-β (IFNβ) develop serum binding antibodies (BAb) and neutralizing antibodies (NAb). NAb reduces the biological activity of IFNβ, which contributes to clinical failure in these patients. We investigated whether access to antibody (Ab) test results would alter usual care of (IFNβ)-treated patients and whether BAb could predict NAb. Many patients with relapsing-remitting multiple sclerosis (MS) treated with high-dose interferon-β (IFNβ) develop serum binding antibodies (BAb) and neutralizing antibodies (NAb). BAb bind to IFNβ but do not necessarily inhibit its biological activity, and they can be detected within the first month of therapy [2]. The methodology to detect NAb is cumbersome and non-standardized; simpler BAb assays are preferred for screening before analyzing for NAb. BAb screening has low false-negative rates and high sensitivity/specificity. There have been opposing assessments of the importance of BAb and NAb testing relative to clinical management of IFN-treated patients, in Europe (European Federation of Neurologic Societies [EFNS]), America (American Academy of Neurology), and Canada [3,8,12]
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