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!
Links:
Abstract of the study: http://www.ncbi.nlm.nih.gov/pubmed/25225285
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