Positive data for subcutaneous monoclonal in multiple sclerosis

2023-07-13 17:37:07

Subcutaneous injection of ocrelizumab was noninferior to its intravenous administration in patients with relapsing forms of multiple sclerosis (MSR) or primary progressive disease (MPS). These are the results – released today by Roche – relating to the phase 3 study (Ocarina 2), aimed at evaluating the monoclonal antibody administered twice a year by subcutaneous injection over 10 minutes, compared to intravenous infusion based on the pharmacokinetics (blood levels) at 12 weeks. Multiple sclerosis is a chronic disease affecting more than 2.8 million people worldwide. It develops when the immune system abnormally attacks the insulating and supportive layer surrounding nerve cells causing inflammation and the resulting damage. The first symptom of the disease occurs between the ages of 20 and 40, making it the leading cause of nontraumatic disability in young adults.

The Ocarina 2 study, which met the primary and secondary endpoints and has a safety profile consistent with the intravenous one, also reports that subcutaneous injection of ocrelizumab is comparable to intravenous administration in terms of efficacy on parameters detected with magnetic resonance such as the reduction of lesions at 12 weeks. The 10-minute injection was designed to be delivered without the need for intravenous administration infrastructure and therefore could also be administered in multiple sclerosis centers with no infrastructure or limited capacity for intravenous administration. The subcutaneous administration – recalls the company – maintains the same intravenous regimen, twice a year, to which patients with multiple sclerosis treated with the drug have shown to be largely adherent. The subcutaneous formulation could therefore further improve the treatment experience in multiple sclerosis centers with limited capacity or no infrastructure for intravenous administration.

“These results offer people with multiple sclerosis the ability to obtain the breakthrough benefits of ocrelizumab in the way that best fits their situation, saving time and This new subcutaneous injection will allow ocrelizumab to be delivered in 10 minutes twice a year, reducing the time people with multiple sclerosis spend treating their disease.” Ocrelizumab remains the first and only approved therapy for both RMS and for SMPP, with over 300,000 people treated worldwide.The detailed results of the trial – concludes the note – will be presented shortly at a medical conference and subjected to evaluation by health authorities around the world.