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Trial of 5-Minute Subcutaneous Rituximab Injection: Positive Results

  [ 7 votes ]   [ Post a Comment ]
www.ProHealth.com • December 10, 2012


Dec 8: Basil, Switzerland-based Roche pharmaceuticals company reports positive results from two international phase III trials of its MabThera – a form of rituximab that can be injected under the skin rather than delivered intravenously.

Rituximab is used to treat illnesses involving overactive or dysfunctional immune B cells, such as lymphomas, and some autoimmune disorders such as RA; and, according to pilot trials may benefit at least a subset of ME/CFS patients. (For background click here.)

The MabThera studies suggest this subcutaneously delivered rituximab, submitted for approval to the European Medicines Agency on Dec 4:

• Requires much less patient time in an infusion center (5 minutes vs. 2-1/2 hours for administration)

• Delivers comparable (“noninferior”) concentrations in the blood vs the IV mode of administration, with similar, mostly mild to moderate adverse event and administration related reactions.

• Based on an exploratory switch from IV to subcutaneous administration, does not appear to compromise proven response rates (in this case anti-lymphoma efficacy).

• And as a ready-to-use formulation should reduce pharmacy and staff preparation and administration time.

Source: Based on Roche press release, Dec 8, 2012. For full details, go to http://www.roche.com/med-cor-2012-12-08b.htm





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