There’s news on mavrilimumab!
G.R. Burmester and colleagues published the following study in Annals of
the Rheumatic diseases: “Efficacy and safety of mavrilimumab in subjects with rheumatoid
arthritis.” They concluded: “Mavrilimumab induced rapid clinically significant
responses in RA subjects, suggesting that inhibiting the mononuclear phagocyte
pathway may provide a novel therapeutic approach for RA.”
No so quickly, you might say.
Mavrilimumab is a human monoclonal antibody (MAB) targeting granulocyte-macrophage
colony-stimulating factor (GM-CSF) receptor. The authors evaluated mavrilimumab
in a randomised, double-blind, placebo-controlled phase 2 study. In results we
find: “55.7% of mavrilimumab-treated subjects met the primary endpoint versus
34.7% placebo (p=0.003) at week 12; for the 10 mg, 30 mg, 50 mg, and 100 mg
groups, responses were 41.0% (p=0.543), 61.0% (p=0.011), 53.8% (p=0.071), and
66.7% (p=0.001) respectively.” And there’s where we have to talk. 10 and 50 mg
do not show significant effects, while 30 and 100 mg do. It is unclear, why 30
mg should be better than 50 mg; most probably the effect is due to the still
small size of the different groups. So this has to be checked in a larger group
of active RA patients.
Link to the Abstract: http://www.ncbi.nlm.nih.gov/pubmed/23234647
and you can open a Free Full Text there.
The article ends: “This hypothesis will be evaluated in future larger,
appropriately powered clinical studies.” And these studies must show a
reduction of radiographic progress. The approval of xeljanz in Europe for
instance has been postponed because EMEA wants more date on radiographic
progression.
Let’s sum it up: mavrilimumab is doing better than I expected from the
data being published during the past year. I hope we’ll get a new targeted
therapy, but I still think it’s to early to celebrate.
Links: http://rheumatologe.blogspot.de/2013/06/mavrilimumab-at-eular-2013-meeting.html
und http://rheumatologe.blogspot.de/2013/03/mavrilimumab.html
und http://rheumatologe.blogspot.de/2012/07/mavrilimumab-at-eular-2012.html
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