Thursday, January 17, 2019

Mavrilimumab discontinued

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.



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