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Introduction: Chronic idiopathic/spontaneous urticaria (CIU/CSU) is a debilitating skin condition that is burdensome for patients and healthcare providers. We aimed to describe clinical characteristics, consultation patterns and healthcare resource utilization in real-world US patients with refractory and non-refractory CIU/CSU. Methods: Data was collected from the Adelphi Real World 2015 Urticaria Disease Specific Programme. Physicians completed patient record forms (PRFs) for the next four patients consulting with non-refractory CIU/CSU and the next six with refractory CIU/CSU; patients were considered refractory if symptomatic and on treatment step ≥2. The same patients were asked to complete patient self-completion (PSC) forms describing how CIU/CSU affected them. Results: Seventeen physicians (15 allergists; 2 dermatologists) completed 184 PRFs (108 refractory CIU/CSU; 76 non-refractory CIU/CSU); 140 patients completed PSC forms (93 refractory CIU/CSU; 47 non-refractory CIU/CSU). Mean time from first consultation to diagnosis was 13.5 (SD 28.3) weeks; mean time from diagnosis to first treatment was 16.0 (SD 37.9) weeks. Patients with refractory CIU/CSU were more likely to initially consult primary care physicians than those with non-refractory CIU/CSU (51% and 28%, respectively). The most common symptoms were itching, sleep problems and anxiety/distress, affecting 75%, 23% and 18%, respectively. Patient-perceived disease severity was greater than physician-perceived severity (refractory CIU/CSU kappa 0.1512; non-refractory CIU/CSU 0.1590). Conclusions: Patients with CIU/CSU in this real-world study - particularly those with refractory CIU/CSU - were slow to receive specialist care and had substantial symptom burdens; patient-physician perception of disease severity was discordant. Earlier diagnosis of CIU/CSU may lead to timely use of CIU/CSU therapies. [ABSTRACT FROM AUTHOR]

Objective: To assess asthma control and associations with health-related quality of life (HRQoL) and economic outcomes among patients with asthma and allergic comorbidities treated with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) combination therapy.Methods: Data from the 2011–2013 US National Health and Wellness Survey were used to identify patients with asthma currently treated with ICS and LABA combination therapy (N = 1923). Patients were included if they self-reported a physician diagnosis of asthma and at least one allergic/asthma-related comorbid condition (e.g., nasal allergies, atopic dermatitis). Asthma Control Test scores categorized patients as very poorly (scores ≤ 15; 29.3%), not well (16–19; 25.1%), or well controlled (20–25; 45.7%). Outcomes included HRQoL (SF-36v2; SF-12v2), work productivity and activity impairment, healthcare utilization (HRU), and annual indirect and direct costs. Generalized linear models, controlling for covariates, examined whether outcomes differed by asthma control.Results: Over half of the patients had very poorly or not well-controlled asthma (54.4%). Patients with very poorly controlled versus well-controlled asthma reported significantly greater decreases in HRQoL, greater overall work impairment, and higher HRU (all,p< 0.05). Very poorly controlled patients incurred over double the indirect costs and nearly one and a half times the direct and total costs of well-controlled patients.Conclusions: Increasing level of asthma control was related to improved HRQoL and lower costs. The considerably high prevalence of uncontrolled asthma among patients on ICS and LABA suggests poor treatment adherence or unmet needs in current treatment and may require step-up therapy in appropriate patients according to clinical guidelines. [ABSTRACT FROM AUTHOR]

Objective: To examine treatment patterns, treatment response, and demographic and clinical characteristics of patients with chronic idiopathic urticaria (CIU) newly initiated on omalizumab therapy in real-world practice in the US.Methods: This retrospective observational cohort study used US claims data from the HealthCore Integrated Research Database (HIRD®) augmented with medical record data to identify CIU patients newly-treated with omalizumab (≥4 omalizumab claims within 6 months of initial claim; index date = first omalizumab claim date) between March 21, 2014 and October 31, 2015 and with ≥6 months pre- and ≥12 months post-index health plan eligibility. Study outcomes were captured from medical records for up to 12 months pre-index and up to 24 months post-index. Descriptive statistics were reported.Results: This study consisted of 88 patients with a mean (SD) age of 43.4 (± 13.46) years, 68.2% were female, and 36 patients had ≥18 months post-index eligibility. Among 69 patients with documented index dose, 75.4% received omalizumab 300 mg and 69.6% remained on index dose throughout follow-up. For 52 patients with documented index dosing frequency, 96.2% had every 4-week dosing frequency. Among 86 patients with omalizumab documentation, 83.7% reported CIU improvement after omalizumab initiation and 24.4% discontinued omalizumab. For all patients, the proportion using oral corticosteroids (OCS) decreased pre- to post-index (52.3% vs 39.8%). Similar results were observed for patients with ≥18 months post-index eligibility.Conclusions: In this real-world analysis, the majority of patients remained on omalizumab for ≥12 months, and had a positive response. OCS use decreased following omalizumab initiation. [ABSTRACT FROM AUTHOR]