In gout patients, compared to triamcinolone 40 mg, canakinumab 150 mg was associated with a higher proportion of serious adverse events, at least one adverse event, infection and serious infections.
"The types of adverse events and serious adverse events observed were generally consistent with the underlying patient population, with the exception of infections," Dr. Yim noted. "However, the increase in these (adverse events) is particularly notable in light of the fact that they were observed after a single injection of canakinumab."
FDA reviewers also raised concerns about laboratory abnormalities associated with canakinumab use that could negatively affect gout patients over the long term. These include declines in renal function values, increased triglyceride levels, and elevations in serum uric acid levels.
Although small increases in serum uric acid should be manageable with adequate doses of urate-lowering therapy, "one could also imagine that for certain patients whose serum uric acid is not adequately controlled that a further increase might enhance tophi formation," Dr. Yim commented. "In any case, this finding, as with hypertriglyceridemia and creatinine elevation, raises questions regarding the net impact that canakinumab treatment could have on gout patients and their comorbidities."
This coverage is provided courtesy of "The Pink Sheet." This news organization and "The Pink Sheet" are owned by Elsevier.