Swiss drugmaker Novartis (NVS: Quote) Wednesday said data from a phase III study showed that 62 percent of patients with systemic juvenile idiopathic arthritis or SJIA were symptom-free with ACZ885 or canakinumab treatment.
Further, a Phase II study in patients with tumor necrosis factor receptor-associated periodic syndrome or TRAPS showed substantial symptom relief. Both studies met their primary end points. Both SJIA and TRAPS are autoinflammatory diseases that usually start in childhood.
ACZ885 is a fully human monoclonal antibody that inhibits IL-1 beta. Data also showed that one third of patients became steroid-free within five months of treatment with ACZ885.
SJIA therapy aims to suppress systemic inflammation and induce disease inactivity. Disease inactivity comprises absence of symptoms including no active arthritis, no fever, no rheumatoid rash, as well as normalized blood markers normally associated with inflammation.
The pivotal Phase III study comprised of an open-label, single-arm active treatment period followed by a randomized, double-blind, placebo-controlled, event-driven withdrawal design period. A total of 177 patients between the ages of 2 and 20 years with active SJIA were enrolled.
The primary endpoints were to assess if ACZ885 allows tapering of steroids in at least 25 percent of SJIA patients and demonstrate that time to flare is extended with ACZ885 compared to placebo.
In the late-stage study, data showed that 62 percent of SJIA patients treated with ACZ885 had inactive disease status at the end of the placebo-controlled period. On the contrary, patients who had received ACZ885 treatment and were then randomized to receive placebo had a 32 percent rate of inactive disease at this time point.
Both primary endpoints were met, with 45 percent of patients successfully reducing their use of steroids within 28 weeks of commencing treatment with ACZ885.
Data also supported the safety and efficacy profile of ACZ885 in the study population. Side effects were similar to those already seen for ACZ885's approved indication in CAPS (Cryopyrin-Associated Periodic Syndromes), including infections and neutropenia. Infections were the most common category of adverse event in both parts of the study.
Cases of macrophage activation syndrome or MAS, a severe, potentially life-threatening, complication of several chronic rheumatic diseases of childhood, were also reported.
The Phase II, open-label, multicenter study investigating the efficacy and safety of ACZ885 in patients with active TRAPS involves 20 patients with a median age of 39 years, who receive ACZ885 150 mg or 300 mg every four weeks. The primary endpoint of the study, is complete or almost complete response at Day 15.
The results of the trials will be presented on June 7 at the annual congress of the European League Against Rheumatism in Berlin, Germany.
The stock edged up 0.08 percent in Zurich on Tuesday at 49.53 Swiss francs on 2.51 million shares.
by RTT Staff Writer
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