Integrated analysis supports safety profile of abatacept in RA
medwireNews: A pooled analysis of data from nine randomized placebo-controlled trials suggests that abatacept has a favorable safety profile among patients with rheumatoid arthritis (RA).
“This analysis represents the largest safety study of abatacept treatment to date,” say Teresa Simon (Bristol-Myers Squibb, Princeton, New Jersey, USA) and fellow researchers.
The study included a total of 2653 patients treated with abatacept and 1485 given placebo, with 2357 and 1254 patient–years of exposure, respectively. Seven trials used intravenous abatacept and two used the subcutaneous form.
The investigators report in ACR Open Rheumatology that overall adverse event (AE) profiles “were comparable” among patients given abatacept and those given placebo, with 88% and 85%, respectively, experiencing AEs.
The majority of AEs were mild or moderate in severity, and the most commonly occurring events in both groups were headache, upper respiratory tract infection, nasopharyngitis, and nausea. In all, 54% of abatacept-treated patients and 52% of those given placebo experienced infections and infestations.
Rates of serious AEs were also similar in the abatacept and placebo groups, at 13% versus 12%, and 12 deaths occurred in each group, equating to 0.4% and 0.8% of abatacept- and placebo-treated patients, respectively.
“The findings from this integrated pooled analysis of [intravenous] and [subcutaneous] abatacept add robust confirmation of the safety profile of abatacept,” conclude Simon and team.
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