Our specific is designed were to (1) examine patient characteristics of those eligible and ineligible for omalizumab, (2) further describe the apparent onset of effect after initiation of omalizumab and offset of treatment effect after stopping therapy, and (3) determine whether the efficacy of omalizumab differs by age, asthma severity, dosing regimen, and prespecified biomarkers. METHODS The design of this KRN 633 study is summarized in the primary outcome manuscript.12 Briefly, ICATA was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial that compared omalizumab with placebo added to guidelines-based therapy in 419 inner-city children, adolescents, and young adults (ages of 6C20 years) with persistent allergic asthma. and skin test results) differed. The time of onset of omalizumab effect was 30 days and time of offset was between 30 and 120 days. No difference in efficacy was noted by age or asthma severity, but high exhaled nitric oxide, blood eosinophils, and body mass index predicted efficacy. CONCLUSIONS A significant portion of children and adolescents particularly suited for omalizumab because of asthma KRN 633 severity status may be ineligible due to IgE 1300 IU/mL. Omalizumab reduced asthma symptoms and exacerbations rapidly; features associated with efficacy can be identified to guide patient selection. .001) and reduced the proportion of participants who had one or more exacerbations from 48.8% to 30.3% ( .001). These improvements occurred with omalizumab despite reductions in the use of ICS and long-acting analysis to learn more about the efficacy of omalizumab and its pharmacodynamics in children and adolescents. Our specific is designed were to (1) examine patient characteristics of those eligible and ineligible for omalizumab, (2) further describe the apparent onset of effect after initiation of omalizumab and offset of treatment effect after stopping therapy, and (3) determine whether the efficacy of omalizumab differs by age, asthma severity, dosing regimen, and prespecified biomarkers. METHODS The design of this study is usually summarized in the primary end result manuscript.12 Briefly, ICATA was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial that compared omalizumab with placebo added to guidelines-based therapy in 419 inner-city children, adolescents, and young adults (ages of 6C20 years) with persistent allergic asthma. Participants experienced a physicians diagnosis of asthma or symptoms for 1 year. Persons receiving long-term control therapy were also required to have symptoms of prolonged asthma or evidence of uncontrolled disease as indicated by hospitalization or unscheduled urgent care in the 6 to 12 months preceding study KRN 633 access. Those not receiving long-term control therapy were eligible for ICATA only if they met both of the above criteria. Finally, all were required to have at least one positive perennial allergen skin test and a excess weight and IgE suitable for dosing by an expanded dosing table explained below (Table I). Allergen skin testing consisted of a panel of 14 extracts of indoor and outdoor allergens most relevant to inner-city environments. Written informed consent was obtained from each participant or their parent or legal guardian. Participants more youthful than 18 years of age provided assent. This trial is usually registered with www.clinicaltrials.gov, number “type”:”clinical-trial”,”attrs”:”text”:”NCT00377572″,”term_id”:”NCT00377572″NCT00377572. TABLE I Omalizumab Dosing Table in ICATA analysis, the primary end result measure was used along with 2 secondary outcomes, exacerbation rate and ICS usage, to evaluate the onset and offset of effect of omalizumab after starting and discontinuing this treatment, respectively. In addition, these outcome steps were used to determine whether the effect of omalizumab was comparative in participants with moderate and severe asthma, and in participants 12 years and 12 to 20 years of age. Statistical analysis All reported analyses are comparisons. Recruitment eligibility group comparisons were made with analysis of variance and chi-square assessments. KRN 633 On the basis of previous research,16 ICATA was designed KRN 633 with a 12-week wash-in period at the beginning of the double-blind period that was not included in main intent-to-treat analysis that was previously reported12; the same convention was used here unless normally noted. Like previous analyses, longitudinal analyses were performed with linear mixed-effects models with random intercept and slope (to account for the within-subject correlation) and with visit and group as fixed effects; the models were adjusted for baseline symptom level, site, dosing routine, and season. Subgroup analyses were performed with a baseline-adjusted statistical test for conversation and were considered significant at a value .10.17 Statistical analyses were performed with SAS software, version 9.2 (SAS Institute), and R, version 2.14. RESULTS Eligibility Dosing eligibility status and reasons for ineligibility (IgE too high, Rabbit Polyclonal to OR6P1 IgE too low, IgE/excess weight combination.
Our specific is designed were to (1) examine patient characteristics of those eligible and ineligible for omalizumab, (2) further describe the apparent onset of effect after initiation of omalizumab and offset of treatment effect after stopping therapy, and (3) determine whether the efficacy of omalizumab differs by age, asthma severity, dosing regimen, and prespecified biomarkers
