Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis

Figures

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  Figure 1. Study design Screening was performed up to 6 weeks before randomization. After completion (or premature discontinuation) of the 24-week treatment phase, patients entered the 24-week follow-up, which assessed patient safety and B-cell repletion. Thereafter (week 48 onwards), individual patients whose CD19+ B-lymphocyte counts remained below the LLN and who did not start a DMT, entered the IFU period. CD = conditioning dose; PBO = placebo; q4w = every 4 weeks; q12w = every 12 weeks.

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  Figure 2. Efficacy and pharmacodynamics (A) Primary efficacy outcome measure: mean (95% confidence interval) cumulative number of GdE T1 lesions over time (all evaluable scans dataset). (B) New lesion evolution (post hoc): mean number of new GdE T1 lesions at different MRI time points. From week 8 through 24, the appearance of new GdE T1 lesions was very low at doses of ≥30 mg every 12 weeks. (C) Pharmacodynamic response showing dose-response depletion of CD19 B cells and repletion kinetics (safety population). The median time to repletion based on Kaplan-Meier estimates was ≈11 months for the ofatumumab 3 and 30 mg every 12 weeks groups and ≈14 months for the ofatumumab 60 mg every 12 and 4 weeks groups. (A) Faster repletion time (of ≈6 months) was noted for the placebo group, who received a single ofatumumab 3 mg dose at week 12 (and in whom 32% did not deplete). Of those patients whose B cells had repleted by the end of the study, the time to repletion appeared to generally be longer in the 60-mg ofatumumab dose groups compared with the other ofatumumab dose groups. There were no signs of B-cell repletion during the 4-week interdosing interval with the every 4 weeks regimen. Some B-cell…