Kesimpta is the first B-cell therapy that can be self-administered by patients at home using the Sensoready autoinjector pen, once monthly after starting therapy. It is being developed and marketed worldwide by Novartis under a license agreement between
The approval was based on data from the Phase III ASCLEPIOS I and II trials, which investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once daily oral teriflunomide 14mg in adults with RMS as well as the Phase II APLIOS study, which determined the bioequivalence of the subcutaneous delivery of ofatumumab via a pre-filled syringe and a Sensoready pen in patients with RMS. The results from the ASCLEPIOS studies were presented at the 35th
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About ASCLEPIOS
The ASCLEPIOS I and II studies (NCT02792218 and NCT02792231) are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase III studies evaluating the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus teriflunomide 14mg oral tablets taken once daily in adults with a confirmed diagnosis of RMS1,2. The studies enrolled 1,882 patients with relapsing MS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.51,2. The studies were conducted in over 350 sites in 37 countries.
The primary endpoint of both studies was to demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the ARR in patients treated up to 30 months1,2. Secondary endpoints included time to disability progression confirmed at three and six months respectively, confirmed disability improvement at six months, gadolinium enhancing T1 lesions, number of new or enlarging T2 lesions, serum levels of neurofilament light chain (NfL), and rate of brain volume loss1,2. Safety and the pharmacokinetic properties of ofatumumab were also all measured throughout the treatment period1,2.
About APLIOS
The APLIOS study (NCT03560739) was a 12-week, open-label, Phase II bioequivalence study to determine the onset of B-cell depletion with ofatumumab subcutaneous monthly injections and the bioequivalence of subcutaneous administration of ofatumumab via a pre-filled syringe - as used in ASCLEPIOS I and II - and a Sensoready pen in patients with RMS. 284 patients were randomized according to injection device and site including the abdomen and the thigh. B-cell depletion was measured nine times over 12 weeks and Gd+ lesion counts were assessed at baseline and at Weeks 4, 8 and 12.3
About Kesimpta (ofatumumab)
Ofatumumab is a fully human CD20 monoclonal antibody (mAb) self-administered by a once-monthly subcutaneous injection in development for relapsing forms of multiple sclerosis (RMS). Kesimpta (ofatumumab) is approved in the
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage of the brain, optic nerves and spinal cord4. MS disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss5. MS, which affects approximately 2.5 million people worldwide6, is often characterized into the following forms: primary progressive MS (PPMS) and relapsing forms of MS (RMS), which includes relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS)7. Approximately 85% of patients initially present with RMS8.
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