OBJECTIVE: In pivotal trials, canakinumab has been shown to be effective in the treatment of @entity4932 (JIA), but reported adverse events have included @entity15835 ( @entity15835 ). This study was undertaken to assess the impact of canakinumab on @entity15835 incidence. METHODS: An independent @entity15835 Adjudication Committee (MASAC), consisting of 3 of the authors, was convened, and a search of databases from clinical studies of canakinumab treatment in systemic JIA was performed using MASAC-specified adverse event terms to identify potential @entity15835 events. These were then adjudicated as "probable @entity15835 ," "possible @entity15835 ," or " @entity15835 unlikely," using criteria developed by the MASAC. @entity15835 rates were expressed as numbers of cases per 100 @entity1 -years. RESULTS: Of 72 potential @entity15835 cases identified, 21 events (19 with canakinumab treatment; 2 with placebo treatment) in 19 @entity1 were adjudicated as being probable @entity15835 and 10 events in 9 @entity1 as being possible @entity15835 . Systemic JIA was well controlled in the majority of canakinumab-treated @entity1 at the time of @entity15835 . The time period between initiation of canakinumab treatment and onset of @entity15835 ranged from 3 to 1,358 days (median 292 days). When the rates of probable @entity15835 events were compared between canakinumab-treated @entity1 (2.8 per 100 @entity1 -years) and placebo-treated @entity1 (7.7 per 100 @entity1 -years), the difference was not significant (-4.9 [95% confidence interval -15.6, 5.9]). There were 3 deaths due to @entity15835 -related complications (2 in @entity1 receiving canakinumab; 1 in a @entity1 receiving placebo); full recovery was reported in all other @entity1 . Infections were the most common trigger of @entity15835 , and the clinical features of @entity15835 were not modified by canakinumab. CONCLUSION: Canakinumab does not have a significant effect on @entity15835 risk or its clinical features in @entity1 with systemic JIA. Infections are the most common trigger, and @entity15835 occurs even in @entity1 whose systemic JIA is well controlled with this treatment.

Rate and Clinical Presentation of Macrophage Activation Syndrome in @entity1 With XXXX Treated With Canakinumab.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity15835 :: ('MESH:D055501', 'Disease') :: ['macrophage activation syndrome', 'MAS'] @entity4932 :: ('MESH:D001171', 'Disease') :: ['systemic juvenile idiopathic arthritis']
@entity4932 :: (MESH:D001171,Disease) :: ['Systemic Juvenile Idiopathic Arthritis']
