Novartis’ Kesimpta: First At-Home, Once-Monthly Subcutaneous B-Cell Therapy for Multiple Sclerosis, Favored by Patients and Nurses

February 17, 2021 /Bio ValleyBIOON/ --Novartis(Novartis) recently announced new results from a multicenter survey showing that, in the treatment of multiple sclerosis (MS), patients and caregivers prefer self-administering Kesimpta (ofatumumab) using the Sensoready autoinjector pen over autoinjectors used for other disease-modifying therapies (84% vs. 16%).

Survey results indicate that, compared with autoinjectors for other disease-modifying therapies on the market, the Sensoready autoinjector pen ranks highest in “ease of self-injection using the pen,” “patients’ ability to use it independently,” and “ease of preparation and setup for both patients and nurses.”

These data will be presented at the 6th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS), held on February 25–27, 2021. The findings continue to demonstrate that Kesimpta has the potential to become a preferred treatment option, as the ease of administration plays a significant role in patient satisfaction and treatment adherence.

Amy Perrin Ross, a multiple sclerosis (MS) nurse, stated, “As an MS nurse, I need to know that the patients with multiple sclerosis under my care will be able to successfully administer their treatment independently. The Sensoready autoinjector is easy to assemble and use, enabling MS patients to self-administer their therapy confidently, independently, and comfortably.”

Estelle Vester Blokland, Global Head of Medical Affairs in Neuroscience at Novartis, stated, “For patients with chronic conditions such as multiple sclerosis (MS), access to highly effective treatments and maintaining flexibility in daily life are essential. InNovartis, we are committed to redesigning medications and solutions so that patients can use them independently at home through safe and efficient treatments, thereby maintaining such flexibility in their daily lives.”

Kesimpta isNovartisA newly developed drug for multiple sclerosis (MS) was approved in the United States in August 2020FDAApproved as a subcutaneous injection for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Currently, the drug is under review by the European Union, with results expected in the first half of 2021.

Kesimpta is a novel B-cell-targeted therapy that demonstrates superior efficacy and a comparable safety profile to Aubagio (teriflunomide), a first-line multiple sclerosis (MS) medication, positioning it as the preferred treatment option for a broad population of patients with relapsing MS (RMS). Aubagio, an oral MS drug from Sanofi, is a leading oral disease-modifying therapy (DMT) in the industry.

Results from two pivotal Phase III ASCLEPIOS studies demonstrated that, compared with Aubagio, Kesimpta reduced the annualized relapse rate (ARR) by more than 50% and lowered the relative risk of 3-month confirmed disability progression (CDP) by over 30%. Furthermore, compared with Aubagio, Kesimpta significantly reduced gadolinium-enhancing T1 brain lesions and new or enlarging T2 lesions. An independent post hoc analysis indicated that Kesimpta may halt new disease activity in patients with relapsing multiple sclerosis (RMS), with nearly 90% of patients treated with Kesimpta showing no evidence of disease activity (NEDA-3) during the second year of treatment.

Notably, Kesimpta is the first and only B-cell therapy that can be easily administered and managed at home, delivered via a Sensoready autoinjector pen as a once-monthly subcutaneous injection.

Traditionally, B-cell–binding/depleting agents for the treatment of multiple sclerosis (MS) have been administered primarily in hospitals or infusion centers, which increases healthcare system costs and imposes lifestyle burdens on some patients. Kesimpta is a highly effective B-cell therapy administered via once-monthly subcutaneous injection, enabling patients to self-administer treatment at home and avoid visits to hospitals or infusion centers, thereby addressing a significant unmet need among patients with relapsing forms of MS (RMS).

One of the goals of managing RMS is to preserve neurological function and slow the progression of disability. Although several disease-modifying therapies (DMTs) are available for the treatment of RMS, most patients with RMS still experience disease activity. Evidence suggests that initiating high-efficacy therapy early can improve long-term outcomes in patients with RMS.

Ofatumumab is a fully human anti-CD20 monoclonal antibody that functions by binding to CD20 molecules on the surface of B cells, thereby inducing effective B-cell lysis and depletion. Ofatumumab was first approved in the United States in 2009FDAApproved, marketed under the brand name Arzerra, for the treatment of chronic lymphocytic leukemiaLeukemia(CLL), this drug requires high-dose intravenous infusion in a healthcare facility.

NovartisSubsequently, ofatumumab for the treatment of RMS was investigated in a new development program, as B cells are well known to play a role inAutoimmunityplays a key role in the development of relapsing forms of multiple sclerosis (RMS), such as MS. The clinical development program for ofatumumab in RMS spanned 10 years and, as part of rigorous research, involved more than 2,300 patients worldwide, reflecting a broad patient population. Kesimpta works through a unique mechanism of action, and its treatment regimen (dosing) is specifically designed for RMS, playing a critical role in outcomes. This represents a different dosing schedule and route of administration compared with the previously approved indication for chronic lymphocytic leukemia (CLL).

NovartisMS Portfolio

As a next-generation B-cell depleting agent, Kesimpta offers the favorable safety profile of rapid B-cell depletion with preserved immunity, along with the convenience of self-administration via once-monthly subcutaneous injection. Since its market launch, the drug is poised to challenge Roche’s rapidly growing CD20-targeted therapy, Ocrevus (ocrelizumab), whose global sales surged by 57% in 2019 to reach an impressive CHF 3.708 billion.

Multiple Sclerosis (MS) disrupts the normal functioning of the brain, optic nerves, and spinal cord through inflammation and tissue damage, affecting approximately 2.3 million people worldwide. The disease is typically classified into three types: Relapsing-Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS, generally defined by cognitive and physical changes along with the overall accumulation of disability), and Primary Progressive Multiple Sclerosis (PPMS). Approximately 85% of patients initially present with relapsing forms of multiple sclerosis.

In this field,NovartisThe product portfolio includes: Gilenya (fingolimod, an S1P modulator), Mayzent (siponimod, a next-generation S1P modulator), and Extavia (interferon beta-1b for subcutaneous injection). In addition, its Sandoz division markets Glatopa (glatiramer acetate, 20 mg/mL and 40 mg/mL) in the United States, which is a generic version of Teva’s blockbuster multiple sclerosis drug Copaxone. (Bioon.com)

Original Source: Novartis data show multiple sclerosis patients and nurses prefer Kesimpta® (ofatumumab) Sensoready® autoinjector pen