Canakinumab meets TRAPS endpoint

Novartis AG (NYSE:NVS; SIX:NOVN) said monthly canakinumab met the primary endpoint of complete or almost complete response at day 15 in a Phase II trial to treat tumor necrosis factor (TNF)-receptor associated periodic syndromes (TRAPS). Complete responses were defined as clinical remission and normal C-reactive protein (CRP) and/or serum amyloid A (SAA) levels, while almost complete responses were defined as clinical remission and elevated CRP and/or serum amyloid A (SAA) levels but with a 70% or greater reduction from baseline. Specifically, 95% of patients achieved a complete or almost complete response at day 15 that was maintained through the end of the four-month treatment period. The threshold for meeting the primary endpoint was not disclosed.

The open-label, international trial enrolled 20 patients with active TRAPS, 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. Data were presented at the European League Against Rheumatism meeting in Berlin. ...