The multiple sclerosis drug also works under the skin
[ad_1]
Ocrelizumab, the monoclonal antibody that targets runaway B lymphocytes in multiple sclerosis, also works when given subcutaneously. And with the same safety as the more traditional formulation, administered intravenously. A change in the form of delivery, but which could improve the quality of life of people with MS, lightening the load for healthcare facilities and making therapy easier and more accessible: in fact, 10 minutes twice a year is enough for subcutaneous administration, and less complex healthcare infrastructure is required.
Multiple sclerosis, 80% of ocrelizumab-treated patients without signs of disease after two years
by Anna Lisa Bonfranceschi
A formulation that “creates space” for the drug
The news on the drug – as anticipated a monoclonal antibody, which targets the CD20 protein on B lymphocytes, thus carrying out an immunosuppressive activity – concern precisely the method of administration. To be correctly conveyed in the circulation, in the subcutaneous formulation the antibody is combined with an enzyme (a hyaluronidase) which degrades the hyaluronic acid found in the subcutaneous tissue. This creates the necessary space to house ocrelizumab, a large molecule which is then absorbed into the blood from the subcutaneous tissue.
Subcutaneous ocrelizumab was tested in the Ocarina II study, a phase 3 trial that compared the new method of administration with the intravenous one, testing pharmacokinetics, safety and efficacy in 236 patients, some with relapsing forms of the disease – among the most common – others with primarily progressive forms (about 15% of cases). At twelve weeks, from the point of view of pharmacokinetics, the subcutaneous formulation was shown to be non-inferior to the intravenous one, and comparable also in terms of efficacy (assessed by magnetic resonance analysis) and safety.
Multiple sclerosis, discovery of the indicator of the severity of the disease
by Letizia Gabaglio
Ten minutes versus two hours
The data confirm for the moment that the subcutaneous formulation could therefore improve the delivery of the therapy. In fact, the intravenous method of administering the drug takes about a couple of hours, although an improvement on the 3 and a half hours required in the past. The data coming from Ocarina II will now be submitted to the health authorities for further evaluation.
[ad_2]
Source link
