Tuesday, October 14, 2014

Fostamatinib in Rheumatoid Arthritis

I was quite surprised reading the title of the following study by M.C. Genovese and colleagues: „ A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of 2 Dosing Regimens of Fostamatinib in Patients with Rheumatoid Arthritis with an Inadequate Response to a Tumor Necrosis Factor-α Antagonist.” I thought that fostamatinib had been abandoned as a drug against rheumatoid arthritis. Reading the whole abstract it turned out that I was right: “Because of efficacy and safety results from the phase III clinical program, the companies developing fostamatinib have decided not to study it further in RA at this time.” But let’s look at the first half of the conclusion, too: “Fostamatinib 100 mg bid, but not fostamatinib 100 mg bid for 4 weeks then 150 mg qd, achieved statistical improvements in ACR20 at 24 weeks versus placebo.” In results we find: “Significantly more patients in fostamatinib Group A (36.2%; p = 0.004), but not B (27.8%; p = 0.168), achieved ACR20 at Week 24 versus placebo (21.1%).” Even if the difference between groups is statistically significant, achieving an ACR20 of only 36.2% is too low to continue studies as there are safety concerns as well. Nevertheless, publishing the negative results is most wanted!


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