Novartis Kesimpta six-year efficacy data show substantial benefits in recently diagnosed treatment- naïve people with relapsing multiple sclerosis - Seite 3

The study also found that treatment with Kesimpta for up to six years was well-tolerated with no unexpected safety signals identified.² The rates of adverse events (AEs), serious AEs, serious infections, and malignancies remained stable with no increased risks over six years.²

The overall rates of AEs and serious AEs up to six years of Kesimpta treatment were consistent between the core Phase III trials and the ALITHIOS extension study.² The most common AEs were infections (COVID-19 [34.3%], nasopharyngitis [20.6%], upper respiratory tract infection [14.9%], and urinary tract infection [14.4%]).² The incidence of serious infections remained stable over time and did not increase with Kesimpta treatment up to six years.²

Mean serum immunoglobulin G (IgG) levels remained stable up to six years of treatment and the majority of patients (97.2%) had lgG levels above the lower limit of normal (LLN).² Mean serum immunoglobulin M (IgM) levels decreased over time but remained above the LLN for the majority of patients (65.9%).² No clinically meaningful association was observed between IgG/IgM levels below the LLN and risk of serious infections.²

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord.³ MS, which affects around 2 million people worldwide, can be characterized into four main types: clinically isolated syndrome (CIS), relapsing-remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS).^4,5 The various forms of MS can be distinguished based on whether a patient experiences relapses (clearly defined acute inflammatory attacks of worsening neurological function), and/or whether they experience progression of neurologic damage and disability from the onset of the disease.³

About Kesimpta (ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). Kesimpta is the first fully human anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously (SC) in RMS.^{6, 7, 8}

The treatment regimen was designed and tested to enhance safety and tolerability and minimize the risk of systemic injection-related reactions.⁶ Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. Monthly Kesimpta 20 mg doses are associated with rapid reduction and near-complete peripheral B-cell depletion, with no significant effect on pharmacokinetics due to body weight.⁶ As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion.⁹ The selective mechanism of action and SC administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen.¹⁰