Adisinsight
updated its information on Mavrilimumab on Dec. 12th 2018. I’ve just
checked this source as I wanted to know more about the fate of Mavrilimumab
after having listened to a talk by Prof. G.R. Burmester, one of the chief
investigators on Mavrilimumab, last weekend.
Mavrilimumab
is a human MAB for the treatment of rheumatoid arthritis. It targets the GMCSF [Granulocyte
macrophage colony stimulating factor] receptor and alpha-chain. I’ve written
about Mavrilimumab for the first time after the 2012 EULAR Meeting in Berlin.
I
already harbored concerns about the drug: “Mavrilimumab did better than
placebo, but the effect didn't last as long as the follow-up period after
stopping the drug. The most common adverse events had been a decrease in CO
diffusing capacity. Did any reader, who worked on studies, ever have to monitor
CO diffusing capacity? As I haven't, this point leaves me a little bit uneasy.”
Or: “My opinion: this doesn't seem to be the start of a success story. But
still, as we need new drugs: All the best, Mavrilimumab!”
In January
2018 ME Weinblatt and colleagues published study details on: “A Randomized
Phase IIb Study of Mavrilimumab and Golimumab in Rheumatoid Arthritis.” The
authors concluded: “The findings of this study demonstrate the clinical
efficacy of both treatments, mavrilimumab at a dosage of 100 mg every other
week and golimumab at a dosage of 50 mg every 4 weeks, in patients with RA.
Both regimens were well-tolerated in patients who had shown an inadequate
response to DMARDs and/or other anti-TNF agents.”
In June
2017 GR Burmester and colleagues published study details on: “A randomised
phase IIb study of mavrilimumab, a novel GM-CSF receptor alpha monoclonal
antibody, in the treatment of rheumatoid arthritis.” The authors concluded: “Mavrilimumab
significantly decreased RA disease activity, with clinically meaningful
responses observed 1 week after treatment initiation, representing a novel
mechanism of action with persuasive therapeutic potential.” Oh, with persuasive
therapeutic potential! We’ll look into the persuasion quickly!
What is
the news on this persuasive therapeutic potential? What does Adis Insight tell
us? The indication of rheumatoid arthritis is discontinued. Adis Insight: “The
US FDA places a clinical hold on a submitted IND application for a phase II trial
in Giant cell arteritis, as additional information has been requested regarding
the delivery device to be used in the trial”.
I’m
still not convinced that Mavrilimumab could be a drug to treat inflammatory
rheumatic diseases, though I am in favor for new ways of action as we already
have enough TNF-alpha-inhibitors or IL-6-inhibitors. Maybe GMCSF [Granulocyte
macrophage colony stimulating factor] simply isn’t a good target. Let’s hope
that other targets work better.
Links:
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