Prescribing information

 

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KESIMPTA® (ofatumumab) is indicated for adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. KESIMPTA® is the first and only self-administered once-monthly (20 mg), subcutaneous (SC), B-cell therapy for RMS.1,2 

It is a recombinant human immunoglobulin (IgG1) which selectively binds to sites on CD20 molecules expressed on B-cells. KESIMPTA® mechanism of action results in lysis of CD20 expressing cells leading to a depletion of B cells.1,2

KESIMPTA® is a subcutaneous targeted and precisely delivered therapy that provides a sustained B-cell depletion over the dosing period as seen in clinical trials.1–3 As early as Week 1 of KESIMPTA treatment, B-cell reduction was observed, with close to complete depletion by Week 4.5 Upon discontinuation, KESIMPTA® allows steady B-cell repletion. Clinical studies indicate the median time for B-cell recovery to the lower limit of normal or baseline value of 24.6 weeks post treatment discontinuation.1,2

To learn more, review either the KESIMPTA®:

  • Efficacy: KESIMPTA®’s efficacy and safety profile was assessed in two identically designed Phase III studies (ASCLEPIOS I and II). Both studies compared ofatumumab (ASCLEPIOS I n=465, ASCLEPIOS II n=481) against teriflunomide (ASCLEPIOS I n=462, ASCLEPIOS II n=474) and demonstrated a significant reduction in the annual relapse rate primary endpoint by 51% (0.11 vs 0.22, p<0.001) and 59% (0.10 vs 0.25, p<0.001) respectively.1,2 ALITHIOS is a long-term study designed to assess the benefit-risk profile of KESIMPTA. Patients on the continuous KESIMPTA arm experienced 0.05 ARR* at 4 years, equivalent to 1 relapse every 20 patient years.6 
  • Safety profile: Across the pooled analysis of ASCLEPIOS clinical trials, ofatumumab exhibited a comparable safety profile to teriflunomide.1,2 In the ALITHIOS open-label extension, no new safety risks were identified in cumulative safety data for up to 4 years.7 Please refer to the KESIMPTA® safety profile for more information. 
  • Self-administration:  KESIMPTA® is intended for self-administration: patients can administer their treatment at home using the KESIMPTA® pen1,2, meaning that your patients with relapsing MS have access to a treatment that integrates into their daily lives, leaving them with more time to spend on the things that matter most. The first injection should be performed under the guidance of an appropriately trained healthcare professional.1,2

Patients must not be prescribed KESIMPTA® (ofatumumab) if they have: 

  • Hypersensitivity to the active substance or to any of the excipients listed in the SmPC for GB and the SmPC for NI
  • Patients in a severely immunocompromised state 
  • Severe active infection until resolution
  • Known active malignancy 

Please refer to KESIMPTA® prescribing informationSmPC for GB and SmPC for NI.

NICE recommendation8

In England, Wales and Northern Ireland, KESIMPTA is now reimbursed following NICE Technology Appraisal Guidance recommending KESIMPTA as a treatment option for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

KESIMPTA is reimbursed only if the confidential patient access scheme discount applies.

 

Scottish Medicine Consortium recommendation9

Advice: following a full submission

Ofatumumab (KESIMPTA®) is accepted for restricted use within NHSScotland.

Indication under review: treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

SMC restriction: treatment of relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

Two Phase III studies demonstrated superiority of ofatumumab in reducing annualised relapse rate when compared with another disease-modifying treatment (DMT) in adult patients with RMS.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower.

 

*Data on the ARR were analysed using a negative binomial-regression model, with an offset for time spent in the trial in years to adjust for varying treatment durations among patients. Confirmed relapses are those accompanied by a clinically relevant change in the EDSS.3,6

ARR, annualised relapse rate; CD20, cluster of differentiation 20; EDSS, expanded disability status scale; MS, multiple sclerosis; NICE, National Institute for Health and Care Excellence; PAS, patient access scheme; RMS, relapsing forms of multiple sclerosis; SMC, Scottish Medicines Consortium; SmPC, Summary of Product Characteristics.

References:

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UK | April 2023 | 250990-1

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]