BioCentury
ARTICLE | Clinical News

Novartis presents Phase II canakinumab data

November 13, 2012 2:09 AM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) presented at the American College of Rheumatology meeting on Monday data from two open-label Phase II trials evaluating canakinumab to treat Familial Mediterranean Fever (FMF) and tumor necrosis factor (TNF)-receptor associated periodic syndrome (TRAPS), respectively. In a Phase II trial in nine patients with colchicine-resistant FMF who experienced one FMF attack or more per month in the three months prior, monthly 150 mg canakinumab met the primary endpoint of the proportion of patients with a 50% or greater reduction in attack frequency during the three-month treatment period. Specifically, 100% of patients achieved the endpoint.

Additional data from a Phase II trial in 20 patients with active TRAPS showed that median time to relapse after discontinuing monthly 150 or 300 mg canakinumab was three months. In June, Novartis reported that canakinumab met the primary endpoint of complete or almost complete response at day 15 in the TRAPS trial. TRAPS is a genetically inherited disease characterized by long and intermittent attacks that can involve fever, rash, abdominal pain, conjunctivitis, severe skin infection, eye inflammation and severe joint pain. FMF is a genetically inherited disease characterized by short attacks that can involve fever, rash and painful inflammation that affects the joints and abdomen (see BioCentury Extra, June 6). ...