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B-Cell Depletion and Efficacy Outcomes With Ofatumumab: Subgroup Analysis From the Pooled Phase 3 ASCLEPIOS I and II Trials. Hauser SL et al. AAN 2020.P7.1-013 |
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Ofatumumab rapidly lowered B cells during the loading regimen (20 mg SC on Days 1, 7 and 14) in all patients regardless of body weight, and maintained low levels with ongoing monthly 20 mg SC injections |
SC, subcutaneous
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Effect of Subcutaneous Ofatumumab on Lymphocyte Subsets in Patients With RMS: Analysis from the APLIOS Study. Wiendl H, et al. EAN 2020. LB129.
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Ofatumumab 20 mg SC led to rapid and sustained depletion of both total CD20+ B cells and CD20+ T cells in RMS patients in the APLIOS study |
↑ Dose administration; RMS, relapsing multiple sclerosis; SC, subcutaneous
Additional information
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Onset of B-Cell Depletion and Suppression of MRI Activity With Ofatumumab Treatment in Relapsing Multiple Sclerosis: The APLIOS Study. Bar-Or A, et al. AAN 2020. P8.1-001.
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Ofatumumab showed a rapid, close to complete, and sustained B-cell depletion, with no B-cell reconstitution. This corresponded to significant reduction of Gd+ lesions in RMS patients over 12 weeks |
↑ Dose administration; Gd+, gadolinium-enhancing; RMS, relapsing multiple sclerosis
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Population Pharmacokinetic-B Cell Modeling for Ofatumumab in Patients with Relapsing Multiple Sclerosis Yu H, et al. CNS Drugs . 2022 Mar;36(3):283-300
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Data from RMS Phase 3 clinical studies indicate a median time to B-cell recovery to LLN or baseline value of 24.6 weeks post treatment discontinuation (Ref. EUPI) Pharmacokinetic (PK) B cell modelling and simulation for B-cell repletion corroborate this data, predicting median time to B cell recovery to LLN of 23 weeks post treatment discontinuation |
LLN, lower limit of normal;
*majority of B-cell repletion data are from ASCLEPIOS safety follow-up period