6/23/11 The U.S. Food and Drug Administration’s Arthritis Advisory Committee voted 11 to 1 against approving a biologic drug called Ilaris, or canakinumab, to treat gout. It cited safety concerns – adverse events, including increased rates of infection – despite a strong consensus that it is effective for treating gout attacks.
The positive results and an unmet need among a subset of patients may mean the drug’s potential as a gout treatment is not over. "I hope the company continues to work with the FDA to address the concerns raised, given the promising efficacy of the drug," says Tuhina Neogi, MD, PhD, a consultant to the Arthritis Advisory Committee and an associate professor of medicine at Boston University Medical Center.
Ilaris was approved two years ago to treat a group of rare inflammatory conditions called cryopyrin-associated periodic syndromes, or CAPS. Drug maker Novartis later submitted a supplemental application to the FDA for treatment of gouty arthritis.
Gout is a type of inflammatory arthritis that affects nearly 6 million Americans, according to the Centers for Disease Control and Prevention. It occurs when high levels of uric acid in the blood form uric acid crystals that settle into joints and the soft tissues surrounding them. The accumulation of crystals in the joint does not cause symptoms, so people are rarely aware of their condition until the first attack: a sudden and rapid escalation of inflammation – at first, typically in a single joint and often, but not always, in the big toe – causing extreme pain.
Gout, sometimes referred to as gouty arthritis, occurs in some people who have a metabolic disorder causing chronic overproduction or under-elimination of uric acid. Long-term management focuses on medication and lifestyle changes to lower uric acid levels, potentially eliminating or reducing the crystal deposits and subsequent attacks.
The gout attack, however, is driven by inflammation. Each attack resolves within a couple of weeks, even without treatment. But the inflammation and immediate pain is so excruciating and debilitating that medication is used to relieve the attack more quickly and often is continued to minimize risk of further attacks while uric acid lowering medication is initiated and levels stabilized.
During an acute gout attack, doctors use a nonsteroidal anti-inflammatory drug, or NSAID, such as indomethacin or naproxen. Colchicine and corticosteroids, including prednisone and triamcinolone, are other common options to provide relief, especially in patients who cannot tolerate NSAIDs.
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