Note: This story was updated April 21, 2021, to clarify that Kesimpta will be available in the next three months on the NHS, after further clarification from the company.
Kesimpta (ofatumumab) will be available in the next three months through the National Health Service (NHS) of England and Wales as an at-home, self-administered treatment for people with relapsing-remitting multiple sclerosis (RRMS) who are either having relapses or have other evidence of MS activity.
A poster presentation at the AAN meeting, based on Phase 3 data in newly diagnosed patients, also showed it effective at preventing disability progression in the absence of a relapse in this group.
The National Institute for Health Care and Excellence (NICE) made the recommendation to include Kesimpta in the NHS, allowing RRMS patients to access it at low and fixed prices, following Kesimpta’s recent approval in the U.K. for relapsing forms of multiple sclerosis (MS).
The Scottish Medicines Consortium, analogous to NICE, is also considering adding Kesimpta to that country’s NHS list of medications. A decision is expected later this year.
“This is great news!,” David Martin, CEO of the MS Trust, said in an organization press release. “People need access to a range of treatments so that they can work with their consultant to find the one that suits them the best. Ofatumumab offers access to an effective treatment which doesn’t require regular hospital visits.”
Kesimpta, developed by Novartis, is an antibody therapy that lessens the inflammation associated with nerve death by latching onto the CD20 receptor on the surface of immune B-cells. This interferes with the B-cells’ ability to trigger an abnormal immune response.
The company set a U.K. list price for Kesimpta of £1,492.50 (about $2,073) per unit pack (prefilled autoinjector pen), excluding taxes, NICE reported in favoring approval, and agreed to discount pricing for NHS inclusion. The discount was not disclosed.
NICE based its recommendation on data from two Phase 3 trials — ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) — comparing Kesimpta’s safety and efficacy to that of Aubagio (teriflunomide) in people with relapsing forms of MS.
These trials showed that, compared with Aubagio, Kesimpta significantly reduced participants’ annual relapse rates by over 50%, lowered the relative risk of disability progression after three months by over 30%, and was associated with fewer brain lesions on magnetic resonance imaging (MRI) scans.
Recent results presented at the 2021 virtual American Academy of Neurology (AAN) Annual Meeting also showed that Kesimpta outperformed Aubagio at reducing relapse-independent disability progression in newly diagnosed patients, and that it remained effective regardless of patient body weight.
These poster with the findings, “Ofatumumab Reduces Disability Progression Independent of Relapse Activity in Patients with Relapsing Multiple Sclerosis,” was presented at AAN by Ludwig Kappos, MD, a professor of neurology at the University Hospital and University of Basel, in Switzerland.
Despite the availability of highly effective disease modifying therapies that suppress relapse activity in relapsing forms of MS, some patients still experience a gradual disability worsening that is independent of relapses, even early in the disease course.
In this analysis, Kappos and colleagues examined data from the ASCLEPIOS trials to investigate if Kesimpta could prevent progression independent of relapse activity, or PIRA, in a subgroup of newly diagnosed patients not on any treatment before entering the trials.
PIRA is defined as a sustained increase in Expanded Disability Status Scale (EDSS) scores from study initiation without the presence of relapses. Over half of recorded instances of confirmed disability worsening among these newly diagnosed patients were PIRA.
Researchers separated participants into two subsets for analysis. Subset A consisted of those without confirmed relapses throughout the study period (about 2.5 years) while those in subset B had no confirmed relapses prior to a PIRA event.
Results showed that Kesimpta significantly delayed a confirmed three-month and six-month PIRA in the overall population and in both subsets, compared with Aubagio. Patients in subset A experienced a 45% reduction in the risk of a three-month confirmed PIRA and a 56% reduction in the risk of a six-month confirmed PIRA. That risk reduced by 49% and 59%, respectively, among patients in subset B.
These reductions in both groups were irrespective of a patient’s body weight, researchers also found.
“Our results show that PIRA occurs typically in relapsing patients and ofatumumab reduces PIRA as compared to teriflunomide by approximately 50% and the chosen and now approved dose … has a robust … impact on disease activity [and] on progression independent of relapse activity,” Kappos concluded.
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