Monday, August 26, 2013

Rituximab a look at off-label use

I only just now chanced to look at a study from the German registry RABBIT on rituximab (RTX). A. Richter and colleagues looked at [FRI0212]: “Is there a downside in off-label use of rituximab? - 2-year data from the German biologics register RABBIT.” We look at 709 patients in all groups, but we don’t know anything on the distribution on groups like RTX + MTX, RTX + LEF , and RTX mono; the authors also calculated for RF pos. and RF neg. The authors concluded: “Off-label uses of RTX in combination with LEF or of RTX in monotherapy are not inferior to RTX+MTX therapy regarding safety, effectiveness and therapy adherence. RTX+LEF or RTX monotherapy are useful alternatives for patients being intolerant to MTX, with the particular feature that RTX monotherapy should be restricted to rheumatoid factor positive patients to ensure therapy adherence.“ The last conclusion is due to “rheumatoid factor negative patients had a two-fold increased hazard to drop-out if treated in RTX monotherapy (2.15, p≤0.01).”

Somehow I think this is good news as we have to work under conditions, where RTX + LEF is considered off-label and RTX won’t be reimbursed. Some rheumatologists here in Germany prescribe a very, very low dose MTX co medication not to risk being off-label. So any study proving that monotherapy is effective, is welcome. We would also like to reduce the prednisolone and maybe twice 500 mg RTX are as effective as twice 1000 mg. Lots of questions and I hope, we’ll see the answers soon.

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