No abstract

BACKGROUNDAdalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of juvenile idiopathic arthritis (JIA). We tested the efficacy of adalimumab in the treatment of JIA-associated uveitis. METHODSIn this multicenter, double-blind, randomized, placebo-controlled trial, we assessed the efficacy and safety of adalimumab in children and adolescents 2 years of age or older who had active JIA-associated uveitis. Patients who were taking a stable dose of methotrexate were randomly assigned in a 2:1 ratio to receive either adalimumab (at a dose of 20 mg or 40 mg, according to body weight) or placebo, administered subcutaneously every 2 weeks. Patients continued the trial regimen until treatment failure or until 18 months had elapsed. They were followed for up to 2 years after randomization. The primary end point was the time to treatment failure, defined according to a multicomponent intraocular inflammation score that was based on the Standardization of Uveitis Nomenclature criteria. RESULTSThe prespecified stopping criteria were met after the enrollment of 90 of 114 patients. We observed 16 treatment failures in 60 patients (27%) in the adalimumab group versus 18 treatment failures in 30 patients (60%) in the placebo group (hazard ratio, 0.25; 95% confidence interval [CI], 0.12 to 0.49; P<0.0001 [the prespecified stopping boundary]). Adverse events were reported more frequently in patients receiving adalimumab than in those receiving placebo ( CONCLUSIONSAdalimumab therapy controlled inflammation and was associated with a lower rate of treatment failure than placebo among children and adolescents with active JIA-associated uveitis who were taking a stable dose of methotrexate. Patients who received adalimumab had a much higher incidence of adverse events and serious adverse events than those who received placebo.

One hundred and sixty-one consecutive patients with primary acute pancreatitis were admitted to a doubleblind trial of intravenous Trasylol therapy as a supplement to a standard regimen of conservative management. The patients were subdivided into younger (less than 60 years) and older patients (aged 60 years and over), and subjects in each group were randomly allocated on a double-blind basis either to Trasylol therapy (starter 500 000 KIU and thereafter 200 000 q.i.d. for 5 days) or to placebo. There were 14 deaths (8.7per cent), 7 in the Trasylol and 7 in the placebo group, and no significant difference was found in either the mortality or the major complications rate, eifher overall or within either age group.All I4 patients who died met the objective criteria for severe acute pancreatitis determined by the presence of at least three of a possible nine factors during the first 48 h of admission. Severe acute pancreatitis was present in 37 per cent of patients, who were evenly distributed between the Trasylol and placebo groups. Neither in those patients with severe nor those with less severe acute pancreatitis was there any sign%cant difference between the two therapeutic regimens. Supplementary intravenous Trasylol therapy at this dosage confers no advantage over standard conservative treatment in the management of patients with primary acute pancreatitis.

No abstract

No abstract