Prescribing information

   

A targeted and precisely delivered B-cell therapy1

Sustained B-cell depletion over the dosing period with
KESIMPTA from ASCLEPIOS I and II (pooled analysis)1,2

Reduction of B cells was seen as early as 1 week after treatment initiation2,3

Monthly dosing maintained consistent levels of B-cell depletion with a 20 mg dose1

 

Steady B-cell repletion upon discontinuation of KESIMPTA*1,4

Relapsing forms of MS Phase 3 clinical studies indicate a median time to B-cell recovery to LLN or baseline value of 24.6 weeks post-treatment discontinuation†1

 

LLN=lower limit of normal.

*Based on pharmacokinetic B-cell modelling (B cell model: an indirect response model to describe the stimulation of B-cell lysis by free ofatumumab concentrations) of B-cell counts from 1,461 patients with subcutaneous KESIMPTA administration and 25 patients with intravenous KESIMPTA administration across five pooled studies MIRROR, OMS115102, ASCLEPIOS I & II and APLIOS). Simulation is for subcutaneous route with pre-filled syringe and using Phase 3 dosing regimen.

References

  1. KESIMPTA [Summary of Product Characteristics]. Basel, Switzerland: Novartis AG; April 2021.
  2. Hauser SL, Bar-Or A, Cohen J, et al. B-cell depletion and efficacy outcomes with ofatumumab: subgroup analysis from the pooled phase 3 ASCLEPIOS I and II trials [Poster P7.1-013]. Presented at: AAN; 25 April–1 May 2020; Toronto, Canada [cancelled].
  3. Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab versus teriflunomide in multiple sclerosis. New Engl J Med. 2020;383(6):546–557.
  4. Graham G, Yu H, David OJ, et al. Rapid and sustained B-cell depletion with ofatumumab: Population pharmacokinetic B-cell modeling in relapsing multiple sclerosis patients [PO396]. Presented at: 8th Joint ACTRIMS-ECTRIMS Meeting, MS Virtual 2020; 11–13 September 2020.
UK | March 2021 | 109627
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