MRI assessments
Near-complete suppression of MRI activity was maintained through 4 years in the continuous ofatumumab group. The adjusted mean number of Gd+ T1 lesions per scan in the core and extension periods was: 0.02 (95% CI: 0.02–0.03) and 0.01 (95% CI: 0.00–0.02), respectively; a reduction of 65.0% (Lesion activity on MRI in the core and extension periods: (a) within-group comparison, mean number of Gd+ T1 lesions/scan; (b) between-group comparison, mean number of Gd+ T1 lesions; (c) within-group comparison, mean annualized rate of neT2 lesions; and (d) between-group comparison, mean number of neT2 lesions (efficacy analysis set).Data from the efficacy analysis set. Panels A and C: data are presented as mean (95% CI). Data were estimated from fitting a piecewise negative binomial model for the core and open-label extension time periods with log-link, adjusted for treatment and region as factors for panels A and B, and treatment for panels C and D. For panels A and B, baseline number of T1 Gd+ lesions and patient’s age at baseline were covariates; the natural log of the number of scans with evaluable Gd+ lesion counts by period is used as offset to obtain the lesion rate per scan in each period. For panels C and D, baseline volume of T2 lesions and patient’s age at baseline were covariates; the natural log of the time-in-study (in years) by period is used as offset to annualize the lesion rate in each period. Baseline variables are from the core period baseline. CI: confidence interval; Gd+: gadolinium-enhancing; neT2: new/enlarging T2; RR, rate ratio.Continuous ofatumumab treatment led to an 87.9% reduction (