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.
28.08.2013
I’ve just looked at an article, which is
of interest. M. Bredemeier
and colleagues looked at: “Low- versus high-dose rituximab for rheumatoid
arthritis: A systematic review and meta-analysis.” The authors concluded: “Low-dose RTX has similar effectiveness and
met non-inferiority criteria for most primary outcomes. Considering the lower
cost, it should be the standard RTX regimen for rheumatoid arthritis.”
The study looked at 2x500 mg against
2x1000 mg rituximab. It didn’t look at intervals. Spacing the interval might
not look like a straight forward infringement of an off-label prohibition. But
I’m already happy about this study as it points in the right direction, leading
to cost reduction without loosing effectiveness. Link:
No comments:
Post a Comment