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Anti-CD20 Monoclonal Antibody Shows Favorable Benefit for Relapsing Multiple Sclerosis
The use of ofatumumab in patients with relapsing multiple sclerosis (RMS) carried no risk of increased or more severe infections, including COVID-19. Furthermore, no progressive multifocal leukoencephalopathy events were observed in the phase 3b ALITHIOS study, according to an article in the Multiple Sclerosis Journal.
Results from the open-label extension study showed that it was well tolerated in nearly 2000 patients with up to 3.5-years exposure.
“The cumulative safety data suggest that treatment with ofatumumab over an extended period of time is well tolerated in adults with RMS and support the long-term use of ofatumumab in all RMS patients, including early MS patients. These data give confidence to people living with MS and their prescribing physicians,” said Lykke Hinsch Gylvin, MD, Novartis Pharmaceuticals, Basel, Switzerland.
Ofatumumab, the first fully human anti-CD20 monoclonal antibody, is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in MS.
Related: Ocrelizumab Effective at Controlling Relapse in Patients with Multiple Sclerosis
Lower serum immunoglobulin (Ig) levels, which have been observed in anti-CD20 therapies, have been linked to an apparent increased risk of infection. But in the ALITHIOS trial, immunoglobulin G (IgG) levels remained stable and immunoglobulin M (IgM) levels remained above the lower limit of normal in most patients.
The safety population had 1969 patients: 1292 continuously treated with ofatumumab (median time-at-risk 35.5 months, 3253 patient-years) and 677 newly switched (median time-at-risk 18.3 months, 986 patient-years). A total of 1650 patients (83.8%) experienced an adverse event and 191 (9.7%) had a serious adverse event.
Two deaths were reported but were unrelated to the drug.
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