Wednesday, June 19, 2013

Fostamatinib at the EULAR 2013

Concerning fostamatinib I had grown suspicious if it will come to market at all.

EULAR 2012: “It looks a bit too good not to cause suspicion, not in the results but in the relevance. I think we should look careful at the results of the studies that are to come in the next two years. Larger numbers of patients in phase 2 studies would make me more confident that fostamatinib may become a useful drug in the treatment of rheumatoid arthritis.”
ACR 2012, after I had to look at a rodent study: “And there has been nothing more at the ACR 2012 meeting! Perhaps asking for a date, when fostamatinib is to be launched, was a bit premature. I ask myself if there really is any drug in sight!”

Any new developments at the EULAR 2013 to get less suspicious?

There has been a study, one study. P. C. Taylor and colleagues presented [OP0048]: “OSKIRA-4: a phase IIb randomised, placebocontrolled study of the efficacy and safety of fostamatinib monotherapy”. Objectives were the efficacy of fostamatinib monotherapy compared with placebo and the assessment of non-inferiority of fostamatinib to Adalimumab. Two study arms of fostamatinib were superior to placebo, but one wasn’t. All three fostamatinib arms were inferior to adalimumab. The authors argue: “However, the performance of ADA monotherapy in this trial was at the upper end of that observed in previous studies. Fosta is being evaluated in combination with DMARDs in the ongoing Phase III programme.” If I choose to run a 100 m sprint against Donovan Bailey and loose, I can’t argue that he was exceptional quick this day.

The suspicion reaches maximum proportions. We must ask the people in charge if it’s still ethical to continue the phase III study as up to 27% diarrhoea as well as other adverse events may harm the patients, who take part in the trial. I don’t think that FDA or EMEA will approve a drug with such a weak effect and side effects nowadays.

PS. OT: I wouldn’t have approved anakinra for the indication rheumatoid arthritis!


PPS. Just got a post on Twitter by Philip Gardiner @PhilipGardiner : AstraZeneca has already dropped the fostacitinib!

No comments:

Post a Comment