Durelli L, Barbero P, Bergui M, Versino E, Bassano MA, Verdun E, Rivoiro C, Ferrero C, Picco E, Ripellino P, Giuliani G, Montanari E, Clerico M
MRI activity and neutralizing antibody as predictors of response to IFN-{beta} treatment in MS. [JOURNAL ARTICLE]
J Neurol Neurosurg Psychiatry 2007 Nov 6.
BACKGROUND: Not all patients with multiple sclerosis (MS) experience a satisfactory treatment response and may require treatment adjustment. Indicators for assessing treatment effectiveness need to be sought and validated.
OBJECTIVE: To prospectively validate MRI activity and neutralizing anti-interferon antibody (NAb) status during the first 6 months of interferon-beta (IFN-beta) treatment as response indicators in MS.
METHODS: Patients with relapsing-remitting MS were prospectively followed during the first 2 years of treatment. Neurological assessments were performed every 3 months or when a relapse was suspected. MRI scans performed at baseline and Months 3, 4, 5, and 6 after start of treatment were centrally assessed for disease activity: new T2 or gadolinium-enhancing T1 lesions. NAb were assessed using the MxA protein assay; positivity was defined as two consecutive titers >/=20 NU/mL. We evaluated the sensitivity and specificity of an active scan, NAb positivity, or both during the first 6 months of treatment to predict clinical disease activity (relapses or confirmed disability progression) in the following 18 months.
RESULTS: 147 patients were assessed at 16 centers. Predictivity parameters (with confidence intervals) were: active scan, sensitivity 52% (34% to 69%), specificity 80% (65% to 91%), p = 0.002; NAb positivity, sensitivity 71% (45% to 88%), specificity 66% (55% to 76%), p = 0.01; active scan and NAb positivity, sensitivity 71% (38% to 91%), specificity 86% (73% to 94%), p = 0.0003.
CONCLUSIONS: MRI activity and NAb occurrence during the first 6 months of IFN-beta treatment are reliable predictors of long-term clinical response, particularly when combined.
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