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B-cell depletion1‡ 

 


In a study of bioequivalence using the same dosing regimen as in ASCLEPIOS I and ASCLEPIOS II, before initiation of the maintenance phase, total CD19+ B-cell levels below the defined threshold of 10 cells/μL were achieved in 94% of patients starting at Week 4 and 98% of patients at Week 12.
 

 

B-cell repletion1‡

 

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Calendar

Data from the two RMS Phase 3 studies indicate a median time to B-cell recovery to either LLN or baseline value of 24.6 weeks post-treatment discontinuation.

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Calendar

PK and PD (B-cell) modelling and simulation for B-cell repletion corroborate these data, predicting median time to B-cell recovery to LLN of 23 weeks post-treatment discontinuation.

Mechanism of Action
 

KESIMPTA® binds specifically to the small and large extracellular loops of the CD20+ molecule1✝︎ 
 

KESIMPTA® is a selective immunomodulator1✝︎ 

Ofatumumab is the first and only recombinant fully human monoclonal immunoglobulin G1 (IgG1) antibody against human CD20 expressed on B-cells.1,2* 


After subcutaneous administration, ofatumumab is believed to be predominantly absorbed via the lymphatic system similarly to other therapeutic monoclonal antibodies. 

 

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Lymph node
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Ofatumumab

KESIMPTA® binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule.1 

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Complement Component

Binding induces lysis of CD20+ B-cells, primarily through complement-dependent cytotoxicity (CDC) and to a lesser extent through antibody-dependent cell-mediated toxicity (ADCC).1 

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B-cell lysis

KESIMPTA® has also been shown to induce cell lysis in both high and low CD20-expressing cells. CD20-expressing T cells are also depleted by KESIMPTA®.1 

 

Images adapted from the KESIMPTA® Product Monograph.

 

 

* Comparative clinical significance has not been established.
† Clinical significance has not been established.
‡ Pooled data from treatment epochs of ASCLEPIOS I and II (safety set).

References

  1. KESIMPTA® Product Monograph. Novartis.

  2. Data on file. Novartis Pharmaceuticals Canada Inc. 

KESIMPTA, SensoReady and the Go Program are registered trademarks.  
© Novartis Pharmaceuticals Canada Inc. September 2025

FA-11447944E

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