Prescription patterns for asthma medications in children and adolescents with health care insurance in the United States.

Asthma is the most common chronic condition of childhood, and its prevalence has increased over recent decades. However, many children and adolescents with asthma are not being managed in accordance with guideline recommendations. The objective of this study was to analyze prescribing patterns for asthma medications in 6- to 18-yr-olds, with a focus on those aged 6-11 yr. Data from patients enrolled for ≥6 months in PharMetrics were analyzed between June 1, 1995, and September 30, 2008. PharMetrics contains data from 45 million US patients from 85 health care plans, including standard and mail order prescription records. Prescriptions for asthma medication for each patient were recorded. The overall asthma cohort included 659,169 patients; 34,950 (5%) were classified as having severe asthma. The 6- to 11-yr-old subgroup consisted of 374,068 patients (56.7% of the overall asthma cohort). Almost 40% of the population received no medication (severe asthma 1.0%; non-severe asthma 37.6%), with almost identical findings in the 6- to 11-yr-old subgroup. In patients with non-severe and severe asthma, frequency of medication use was as follows: short-acting ß(2) -agonists (53% and 92%), oral steroids (23% and 64%), leukotriene receptor antagonists (17% and 49%); inhaled corticosteroids alone (15% and 80%) and in combination with long-acting ß(2) -agonists (10% and 22%), respectively. Results for patients in the 6- to 11-yr subgroup were similar to those of the overall cohort. In conclusion, a considerable proportion of children and adolescents with asthma do not receive any asthma medication. Among those who do receive medication, adherence to current guidelines is questionable.

Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma.

OBJECTIVE: This pooled analysis assessed the safety of omalizumab in children with allergic (immunoglobulin E-mediated) asthma. STUDY DESIGN: Two double-blind, placebo-controlled studies in children (6 to < 12 years) with moderate-to-severe allergic asthma investigated the efficacy/safety of omalizumab. Children on optimized asthma care (inhaled corticosteroids ± other controller medications) were randomized (2:1) to omalizumab (75-375 mg sc, q2 or q4 wk) or placebo. Pooled safety findings from these trials are presented in this publication. RESULTS: The safety population included 926 children (omalizumab, n = 624; placebo, n = 302). Adverse events (AEs) were more frequently reported in the placebo (91.7%) than omalizumab (89.7%) group. The most common AEs were nasopharyngitis, upper respiratory tract infection and headache. Suspected treatment-related AEs included headache, erythema and urticaria; none of which were reported by ≥ 2% of patients receiving omalizumab. Serious AEs (SAEs) were reported by 3.4% and 6.6% of patients receiving omalizumab and placebo, respectively; the most common were appendicitis, pneumonia and bronchitis; no deaths were reported. CONCLUSIONS: Omalizumab has an acceptable safety profile, with a risk of AEs similar to placebo. This, combined with its efficacy profile, suggests that omalizumab may provide an additional asthma management option for children (6 to < 12 years) uncontrolled with current therapy that follows established guidelines.

Anaphylaxis epidemiology in patients with and patients without asthma: a United Kingdom database review.

BACKGROUND: There are currently limited data regarding the epidemiology of anaphylaxis. OBJECTIVE: To estimate the incidence of anaphylaxis from all causes, to explore the variety of diagnoses that may predispose to an anaphylactic episode, and to estimate the rate of recurrence of anaphylaxis in patients with no asthma, nonsevere asthma, and severe asthma. METHODS: The Health Improvement Network database provided data on individuals 10 to 79 years old who had been enrolled for at least 1 year with a general practitioner in the United Kingdom and had at least 1 health contact in the year before entering the study. RESULTS: Anaphylaxis incidence rates (per 100,000 person-years) were 21.28 (95% CI, 17.64-25.44) and 50.45 (95% CI, 44.67-56.76) in the no asthma and overall asthma cohorts, respectively. Risk of anaphylaxis was greater in the nonsevere asthma (relative risk, 2.07; 95% CI, 1.65-2.60) and severe asthma (relative risk, 3.29; 95% CI, 2.47-3.47) subgroups compared with the no asthma cohort. The incidence rate of anaphylaxis was higher in women than men (22.65 vs 19.56 per 100,000 person-years). Within the overall asthma population, patients at significantly increased risk of anaphylaxis included those with allergic rhinitis or atopic dermatitis, and current users of antihistamines, oral steroids, or antibiotics (compared with nonusers). Drug and food allergies were the most common known causes of anaphylaxis. CONCLUSION: Patients with asthma have a greater risk of anaphylaxis than those without asthma, and the risk is greater in severe than nonsevere asthma. Women are at higher risk of anaphylaxis than men, especially those with severe asthma.

Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma.

BACKGROUND: Many children with asthma continue to experience symptoms despite available therapies. OBJECTIVE: This study evaluated the efficacy and safety of omalizumab, a humanized anti-IgE mAb, in children with moderate-to-severe persistent allergic (IgE-mediated) asthma that was inadequately controlled despite treatment with medium-dose or high-dose inhaled corticosteroids (ICSs) with or without other controller medications. METHODS: A randomized, double-blind, placebo-controlled trial enrolled children age 6 to <12 years with perennial allergen sensitivity and history of exacerbations and asthma symptoms despite at least medium-dose ICSs. Patients were randomized 2:1 to receive omalizumab (75-375 mg sc, q2 or q4 wk) or placebo over a period of 52 weeks (24-week fixed-steroid phase followed by a 28-week adjustable-steroid phase). RESULTS: A total of 627 patients (omalizumab, n = 421; placebo, n = 206) were randomized, with efficacy analyzed in 576 (omalizumab, n = 384; placebo, n = 192). Over the 24-week fixed-steroid phase, omalizumab reduced the rate of clinically significant asthma exacerbations (worsening symptoms requiring doubling of baseline ICS dose and/or systemic steroids) by 31% versus placebo (0.45 vs 0.64; rate ratio, 0.69; P = .007). Over a period of 52 weeks, the exacerbation rate was reduced by 43% versus placebo (P < .001). Omalizumab significantly reduced severe exacerbations. Over a period of 52 weeks, omalizumab had an acceptable safety profile, with no difference in overall incidence of adverse events compared with placebo. CONCLUSION: Add-on omalizumab is effective and well tolerated as maintenance therapy in children (6 to <12 years) with moderate-to-severe persistent allergic (IgE-mediated) asthma whose symptoms are inadequately controlled despite medium to high doses of ICSs.

The cumulative burden of oral corticosteroid side effects and the economic implications of steroid use.

Oral corticosteroids (OCS) are a key part of therapy regimens for a diverse variety of conditions. Despite their efficacy, they are associated with a wide variety of adverse events. The purpose of this review was to identify the range of adverse events that have been reported to be related to oral corticosteroids, examine the factors that influence their incidence and estimate the economic burden caused by these adverse events. In 61 identified studies, 21 different categories of OCS related adverse events were reported with increased fracture risk being the category most frequently described. Most studies that examined factors linked to the incidence of OCS related adverse events found that dose, age, gender, duration of use, treatment history, smoking habits or cholesterol level were influential in determining risk. Additionally, a cumulative economic analysis of selected adverse events found the annual cost of treating these events in the UK to be at least 165 pounds per patient taking OCS. The clinical and economic burden of OCS related adverse events highlights the need for OCS sparing therapies to be developed.