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Novartis Phase III Study Shows ACZ885 Helped Substantially Reduce Steroid Use in 45% of Patients With Serious Form of Childhood Arthritis
Date:11/6/2011

a maximum of 20 weeks passed without reaching this goal (unsuccessful tapering of steroids)[1]. In Part II of the study, patients were randomized to either continue receiving ACZ885, or to receive placebo every 4 weeks, until a pre-specified number (37) of flare-events ("flares") had occurred[1].

The primary endpoints were to: a) assess if ACZ885 allows tapering of steroids in at least 25% of SJIA patients (Part I); and b) demonstrate that time to next flare is extended with ACZ885 vs. placebo (Part II)[1].

In Part I of the study (representing 58 patient years), 138 of 177 patients (78%) reported an adverse event (AE), with the most common being nasopharyngitis, headache and cough. Serious adverse events (SAEs) were reported in 15 patients, with the most common being infections, MAS (four cases) or flare-associated events[1]. Five SAEs led to discontinuation, and one patient died of MAS[1]. During Part II, AEs (the most common being arthralgia, cough, nasopharyngitis and pyrexia) were reported by 40 of 50 (80%) ACZ885-treated patients (vs. 35 of 50 [70%] placebo patients previously treated with ACZ885)[1]; and six patients in each arm experienced one or more SAE, which mainly included infections, MAS and flare-associated events[1]. Six patients, all in the placebo arm, discontinued the study due to AEs or SAEs during Part II[1]. One patient died from MAS after study discontinuation in the placebo group.

MAS is a potentially fatal condition known to be associated with SJIA and is characterized by liver abnormalities, bleeding disorders, central nervous system dysfunction and multiple organ failure[4]. Approximately 10% of SJIA patients are diagnosed with MAS, some of whom suffer repeated episodes[4].

About ACZ885ACZ885 is a fully human monoclonal antibody that inhibits IL-1 beta, which is an important part of the body's immune system defenses. Excessive production of IL-1 beta plays a major role in certain inflammatory d
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