New Data from Clinical Trials

Three Phase in pivotal trials of a novel anti-IgE therapeutic agent enrolled adolescents and adults 12-75 years of age with moderate to severe persistent asthma and children 6-12 years of age with mild to moderate persistent asthma. The trials included patients who had a documented history of asthma for greater than 

In the pediatric trial, children 6-12 years of age had a geometric mean IgE level of 241 lU/mL (95% Cl 219-265 n = 334). In the adolescent and adult trial of moderate to severe asthma conducted in the United States, the overall geometric mean for patients aged 12-75 years was 131 lU/mL (95% Cl 122-140 n = 525). The overall geometric mean in adolescents and adults (n = 546) from a third clinical trial conducted both in North America and Europe was 157 lU/mL (95% Cl 146-168 n = 546). 

To examine the effects of age and sex, we pooled the data from the two pivotal trials in adolescents and adults (Table 4). We observed the typical association of age and IgE with higher geometric mean IgE levels in adolescents compared with adults. Adolescents 12-17 years of age had a geometric mean IgE level of 208 lU/mL (95% Cl 177-245). Adults aged 18 4 years had a geometric mean IgE level of 149 lU/mL (95% Cl 139-159), and adults aged 45 years had a geometric mean IgE level of 125 lU/mL (95% Cl 115-136). These data are consistent with observations from the literature that IgE levels wane with age (1,9,10,12,20,23). 

Our data are consistent with the literature that IgE levels are higher among asthmatics than in a normal, healthy population (10,12,19,51). In the anti-IgE clinical trials, the geometric mean levels of IgE were higher in children and adolescents than in adults and higher in adult males than adult females. 

We were also able to observe the stability of IgE concentrations over time by tracking the IgE levels in placebo patients. Mean total IgE concentrations were generally stable in placebo patients in the pivotal AA smdies. Geometric means of total IgE in adolescents and adults were within 5% of baseline values after 6 months of follow-up. Total IgE within-patient variability in patients with AA 

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The unexpected conclusion The results of CAST challenged the assumption that treating postmyocardial arrhythmia—and perhaps arrhythmias in general—was in fact beneficial. CAST accentuated the fact that the efficacy of many antiarrhythmic agents remains unproven in placebo-controlled, random trials (Figure 17.4). This has caused many clinicians to review current drug recommendations, particularly as new data from clinical trials become available. 

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