The approval of Ilaris for acute gouty arthritis
attacks in patients without appropriate treatment options provides new hope for those debilitated by this excruciating condition," said David Epstein, Division Head of Novartis Pharmaceuticals.
Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis
by suppressing inflammation: results of a randomized, dose-ranging study.
Members of the FDA's Arthritis Advisory Committee considered canakinumab, a monoclonal antibody that neutralizes interleukin-1 beta, a promising treatment, and all but one panelist agreed that the 150-mg subcutaneous dose that was studied in two phase III trials was shown to be effective in treating an attack of gouty arthritis
in this population.
, is mainly referred to as gout is a medical condition usually characterized by recurrent attacks of acute inflammatory arthritis.
This study is the first to show that in men with no previous history of coronary artery disease, gouty arthritis
is a significant independent correlate of subsequent acute myocardial infarction," they said.
Ilaris is the only available fully human monoclonal antibody that specifically targets IL-1 beta and, when approved, will offer patients suffering gouty arthritis
attacks rapid pain relief via a single subcutaneous injection of 150 mg.
One can so define gouty arthritis
, in which joint fluid crystals serve as a "gold standard" against which to measure the usefulness of other observations.
No pain, sensitivity, joint movement limitation or gouty arthritis
was detected in the other peripheral joints.
These findings cannot be extrapolated to the treatment of intercurrent gout or chronic gouty arthritis
, since long-term steroid use has severe adverse effects.
PARIS -- Serum urate levels are often normal during acute gouty arthritis
attacks, according to Dr.