Prescribing information

 

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Indicated for adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.1,2

The Summary of Product Characteristics (SmPC) of KESIMPTA can be viewed by clicking here for GB and here for NI. 

The first and only self-administered once-monthly (20 mg), subcutaneous (SC), B-cell therapy for RMS
• KESIMPTA is intended for patient self-administration with initial guidance from an HCP

 

 

 

 

ARR=annualized relapse rate; CDW=confirmed disability worsening; DMT=disease-modifying treatment; Gd+=gadolinium enhancing; HCP=healthcare professional; NEDA=no evidence of disease activity; PAS=patient access scheme; RMS=relapsing forms of multiple sclerosis; SC=subcutaneous.

*Primary endpoint: relative reduction in adjusted ARR vs teriflunomide of 51% (0.11 vs 0.22) in ASCLEPIOS I and 59% (0.10 vs 0.25) in ASCLEPIOS II.1,2
Post hoc analysis of KESIMPTA patients who achieved NEDA-3. No conclusions of clinical outcomes can be drawn. Post hoc analysis of ASCLEPIOS I and ASCLEPIOS II studies included all patients from the pivotal trial full analysis set population in the intent-to-treat principle, but patients who discontinued from the study drug prematurely for reasons other than “lack of efficacy” or “death” and had NEDA-3 before early discontinuations were excluded. The analysis occurred within the prespecified time period (i.e. 0–12 months and 12–24 months), and included patients who achieved NEDA-3, defined as no 6-month CDW, confirmed relapse, ≥1 Gd+ T1 lesions, ≥1 T2 lesions, or discontinuation from the study drug due to either lack of efficacy or death.1,2,10 88% (8.8/10 patients) of patients taking KESIMPTA achieved NEDA-3 in months 12–24. 7,8
The first injection of KESIMPTA should be performed under the guidance of an appropriately trained healthcare professional. The initial dosing period consists of 20 mg SC doses at Weeks 0, 1 and 2.1,2
§Based on a survey of 80 MS patients and 50 MS nurses. The survey was conducted in two phases – central location pilots (Germany) followed by face-to-face semi-structured in-field interviews across the USA, Germany, France, and Italy. Comparison autoinjector pens included Rebismart®, Rebidose®, Avonex Pen®, Autoject® 2, YpsoMate® and Plegridy Pen®. 84% of participants preferred the Sensoready® autoinjector over other MS disease-modifying therapy autoinjectors.

References

  1. KESIMPTA [Summary of Product Characteristics]. Great Britain: Novartis Pharmaceuticals UK Ltd; April 2021.
  2. KESIMPTA [Summary of Product Characteristics]. Novartis Ireland Limited; March 2021.
  3. Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab versus Teriflunomide in Multiple Sclerosis. New Engl J Med. 2020;383:547–547.
  4. Perrin Ross, A, Besser C, Naval S, et al. Patient and Nurse Preferences for the Sensoready® Autoinjector Pen Versus Other Autoinjectors in Multiple Sclerosis: Results From a Multicenter Survey [Poster P210]. Poster presented at: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2021; 25–27 February 2021.
  5. National Institute for Health and Care Excellence (2021). Ofatumumab for treating relapsing multiple sclerosis (NICE guideline 699). Available at: https://www.nice.org.uk/guidance/ta699/resources/ofatumumab-for-treating.... [Accessed June 2021].
  6. Scottish Medicines Consortium (2021). Advice following a full submission: ofatumumab (Kesimpta®) is accepted for restricted use within NHSScotland. Available at: https://www.scottishmedicines.org.uk/medicines-advice/ofatumumab-kesimpt... [Accessed July 2021].
  7. Data on file. OMB157 (ofatumumab). Summary of clinical efficacy in relapsing multiple sclerosis. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019.
  8. Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab vs Teriflunomide in Relapsing Multiple Sclerosis: Analysis of No Evidence of Disease Activity (NEDA-3) from ASCLEPIOS I and II Trials [Poster LB62]. Presented at: 6th European Academy of Neurology (EAN) Congress as Virtual Congress;  23–26 May 2020.
  9. 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: American Academy of Neurology (AAN); 25 April–1 May 2020; Toronto, Canada [cancelled].    
  10. Data on file. OMB157 (ofatumumab). OMB 157G 5.3.5.3. Statistical overview. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019.
Rate this content: 
Average: 4.6 (5 votes)
UK | August 2021 | 143599
×

Ask Speakers

×

Medical Information Request

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 uk.patientsafety@novartis.com or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at medinfo.uk@novartis.com