Association between consistent omalizumab treatment and asthma control.

BACKGROUND: Omalizumab is indicated for patients with moderate-to-severe allergic asthma with inadequately controlled symptoms. OBJECTIVE: We evaluated the association between consistent omalizumab treatment and asthma control. METHODS: Health insurance claims from the MarketScan database (2002Q1-2011Q2) were analyzed. Asthmatic patients with ≥12 months of continuous insurance coverage after the first omalizumab claim (index date) after 6 months of continuous omalizumab use were included. A 12-month landmark period was used to assess treatment consistency, defined as uninterrupted treatment without a gap of ≥28 days in omalizumab use. The effect of consistent omalizumab treatment on asthma control between months 13 and 24 was evaluated. Multivariate time-varying Cox regressions were also conducted to assess the adjusted effect of treatment interruption on asthma control from month 1 to month 24. RESULTS: A total of 3044 patients (mean age, 48.5 years; female, 62%) formed the study population. Patients consistent with omalizumab treatment at 12 months (39% of patients) were less likely to have an uncontrolled asthma event during months 13 to 24 with only 49% of patients experiencing one event compared with 54% in the non consistent subgroup (P = .02). In addition, consistent omalizumab treatment at 12 months was associated with a 51% reduction in the mean number of asthma-related emergency department (ED) visits per patient and a 28% reduction in asthma-related hospitalizations. Multivariate analyses corroborated these findings (hazard ratio for consistent vs non-consistent: risk of short-acting ß2-agonists prescription, oral corticosteroids prescription, ED visit, or hospitalization, 0.76; 95% CI, 0.69-0.83]). CONCLUSION: This analysis showed that consistent omalizumab treatment was associated with significant reductions in ED visits and hospitalizations.

Burden of illness of patients with allergic asthma versus non-allergic asthma.

OBJECTIVE: Allergic and non-allergic asthma share similar symptoms, but differ in that allergic asthma is triggered by inhaled allergens. This study compared healthcare resource utilization (HCRU) and costs between these groups using US employer-based claims data. METHODS: Health insurance claims from Truven Marketscan database (2002Q1-2010Q2) were analyzed. Included patients had ≥2 asthma diagnoses and ≥1 year of eligibility prior to and following the date of first asthma diagnosis. Patients with ≥1 diagnosis for allergic asthma and ≥1 diagnosis for other allergic conditions formed the allergic asthma cohort whereas patients without any of these diagnoses formed the non-allergic asthma cohort. Allergic and non-allergic asthma patients were matched 1:1. HCRU and costs during the study period were compared between cohorts using incidence rate ratios (IRR) and bootstrap methods. RESULTS: Sixty four thousand four hundred and seventy three allergic and non-allergic asthma patients were matched (mean age = 30; 57.1% female; mean CCI = 0.2), with 7.1% and 0.36% having received an allergy test during the baseline period, respectively. During the study period, allergic asthma patients had significantly more asthma-related pharmacy dispensings (IRR[95% CI] = 2.25[2.22-2.28], p < 0.001) and asthma-related outpatient visits (IRR[95% CI] = 2.29[2.27-2.32], p < 0.001). Allergic asthma patients incurred 39% greater per-patient-per-year all-cause costs (allergic: $4008; non-allergic: $2889, p < 0.001) and 79% greater asthma-related costs (allergic: $1063; non-allergic: $592, p < 0.001) than non-allergic asthma patients. CONCLUSIONS: These results indicate, even in a relatively healthy population, allergic asthma is associated with greater HCRU and costs. Guideline-recommended IgE allergy tests should be employed in distinguishing the two forms of asthma, to optimize patient management and reduce costs.

Omalizumab: an update on efficacy and safety in moderate-to-severe allergic asthma.

Omalizumab is an anti-immunoglobulin E (anti-IgE) monoclonal antibody approved in the United States since 2003 for treatment of moderate-to-severe allergic asthma in adults and adolescents (aged ≥12 years) inadequately controlled with inhaled corticosteroids (ICSs). Current treatment guidelines recommend considering the addition of omalizumab if allergic asthma symptoms are not adequately controlled with high-dose ICS + long-acting beta-agonist (LABA) therapy. This study was designed to review the clinical efficacy and safety of omalizumab as established in previously published pivotal clinical trials used to support registration in the United States, i.e., primarily including patients receiving only concomitant ICS therapy, as well as results from the recently completed additional study, which specifically enrolled patients who were poorly controlled despite high-dose ICS + LABA therapy ± additional controllers (including oral corticosteroids [OCSs]). Summary of published omalizumab pivotal trials and associated extension trials, plus key results from the additional study, were used. Pediatric data (i.e., <12 years) were outside the scope of this article. Treatment with omalizumab significantly reduced asthma exacerbations versus placebo when added to ICS therapy during both steroid-stable and steroid-reduction phases of two pivotal trials. In the additional study, omalizumab significantly reduced asthma exacerbation rates versus placebo when added to high-dose ICS + LABA therapy with or without other controller medications. Results from the additional clinical study further support current asthma guideline recommendations to consider omalizumab in steps 5 or 6 for persistent allergic asthma patients whose symptoms are not adequately controlled despite high-dose ICS + LABA therapy ± additional controllers (including OCS).

A 26-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma.

OBJECTIVE: The 2007 National Heart, Lung, and Blood Institute (NHLBI) asthma guidelines shifted the focus of care from asthma severity to ongoing assessment of asthma control using the components of impairment and risk. We evaluated the effect of omalizumab on asthma control in patients with persistent allergic asthma inadequately controlled with NHLBI Step 4 or above asthma therapy. METHODS: In this double-blind, placebo-controlled study, patients ≥12 years (n = 271) received omalizumab (n = 136) or placebo (n = 135) every 2 or 4 weeks for 24 weeks. The primary efficacy variable, change from baseline in Asthma Control Test (ACT) total score, and Investigator's Global Evaluation of Treatment Effectiveness (IGETE, secondary efficacy variable) were evaluated at week 24. RESULTS: ACT score improved more with omalizumab compared with placebo (least squares means [LSMs]: 5.01, 4.36); however, the difference was not significant (p = .1779). Similarly, IGETE was not significantly different (p = .1177), but more patients treated with omalizumab (26/127, 20%) compared with placebo (19/131, 15%) had IGETE rated as "Excellent." Significant benefits were observed for omalizumab compared with placebo for change in ACT score (LSMs: 6.66, 5.27; p = .0334) and IGETE (p = .0321) at week 24 in a subgroup of patients with very poorly controlled asthma (ACT ≤ 15) at baseline. There were no significant differences for the subgroup of patients with forced expiratory volume in 1 second ≤ 80% predicted at baseline. Adverse events (AEs) were similar between groups with no drug-related serious AEs or deaths. CONCLUSIONS: For allergic asthma patients with NHLBI Step 4 or above asthma therapy, omalizumab consistently improved asthma control; however, compared with placebo, differences were not significant. Placebo-treated patients had substantial improvement in their ACT score, which may have limited the ability to detect differences between treatment groups. Subgroup analyses showed significant improvements with omalizumab versus placebo in patients with very poorly controlled asthma.