Benefits of omalizumab treatment were evident early (before week 4) in some patients and persisted to week 24. Use of 300 mg of omalizumab demonstrated best results in controlling CIU/CSU symptoms.

BackgroundInfluenza illness in children causes significant clinical and economic burden. Although some European countries have adopted influenza immunisation policies for healthy children, the debate about paediatric influenza vaccination in most countries of the European Union is ongoing. Our aim was to summarise influenza burden (in terms of health outcomes and economic burden) in children in Western Europe via a systematic literature review.MethodsWe conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library (1970-April 2011) and extracted data on influenza burden in children (defined as aged ≤ 18 years) from 50 publications (13 reporting laboratory-confirmed influenza; 37 reporting influenza-like illness).ResultsChildren with laboratory-confirmed influenza experienced hospitalisations (0.3%-20%), medical visits (1.7-2.8 visits per case), antibiotic prescriptions (7%-55%), and antipyretic or other medications for symptomatic relief (76%-99%); young children and those with severe illness had the highest rates of health care use. Influenza in children also led to absenteeism from day care, school, or work for the children, their siblings, and their parents. Average (mean or median) length of absence from school or day care associated with confirmed influenza ranged from 2.8 to 12.0 days for the children, from 1.3 to 6.0 days for their siblings, and from 1.3 to 6.3 days for their parents. Influenza negatively affected health-related quality of life in children with asthma, including symptoms and activities; this negative effect was smaller in vaccinated children than in non-vaccinated children.ConclusionsInfluenza burden in children is substantial and has a significant direct impact on the ill children and an indirect impact on their siblings and parents. The identified evidence regarding the burden of influenza may help inform both influenza antiviral use in children and paediatric immunisation policies in European countries.

ClinicalTrials.gov Identifier: NCT01922037.

BackgroundChronic idiopathic or spontaneous urticaria (CIU/CSU) impairs patients’ quality of life, and updated information on disease prevalence, treatment patterns, and disease burden is lacking.ObjectivesWe aimed to estimate these figures in a large US real-world claims database via a validated algorithm.MethodsIn this retrospective cross-sectional cohort study, we identified patients with CIU/CSU, estimated disease prevalence, comorbidities, and healthcare use (medications, office visits, emergency department visits, and hospitalizations) and costs (urticaria related and all cause).ResultsWe identified 6350 CIU/CSU patients in a population of just over 5.8 million: 0.11 % prevalence. Women accounted for the majority of sufferers (68.3 %) and had a greater burden of illness than men. Patients had relatively few comorbidities (mean 3.3, standard deviation 2.2). Primary care physicians and allergists were the most common providers of CIU/CSU-related care. Oral corticosteroids were the most commonly prescribed medication, used in 54.7 % of patients. Patients accumulated a mean of 15.1 office visits per year (standard deviation 12.6). The mean all-cause healthcare cost totaled over US$9000 per year.ConclusionsAlthough the disease affects a relatively young population, CIU/CSU carries a substantial cost. Frequent oral corticosteroid use in CIU/CSU patients is a concern because of adverse events associated with the drug.Electronic supplementary materialThe online version of this article (doi:10.1007/s40257-015-0134-8) contains supplementary material, which is available to authorized users.

BackgroundChronic spontaneous/idiopathic urticaria (CSU/CIU) has substantial detrimental effects on health‐related quality of life (HRQoL) with an effect comparable to or worse than many other skin diseases.ObjectiveTo assess the effect of omalizumab on CSU patients' HRQoL, measured by the Dermatology Life Quality Index (DLQI) in three phase III studies ASTERIA I, ASTERIA II and GLACIAL.MethodsA post hoc analysis examined changes in DLQI scores, distribution of patients across DLQI bands and the proportion reaching minimal clinically important difference (MCID) following omalizumab vs. placebo.ResultsOmalizumab 300 mg significantly improved total DLQI scores vs. placebo, with a mean decrease from baseline to week 12 of −10.3 vs. −6.1 (P < 0.0001) in ASTERIA I, −10.2 vs. −6.1 (P = 0.0004) in ASTERIA II and −9.7 vs. −5.1 (P < 0.0001) in GLACIAL. A significant shift from high disease impact on life at baseline towards less impact at week 12 was seen with omalizumab 300 mg vs. placebo (P < 0.001; all studies). The proportion of patients where change in mean total DLQI score from baseline to week 12 reached an MCID of ≥4 was 74.1%, 76.0% and 77.2% in ASTERIA I, II and GLACIAL, respectively (P < 0.01; all studies).LimitationsMaximum duration of omalizumab treatment was 24 weeks.ConclusionThis additional analysis assessed the impact of CSU and benefit of treatment with omalizumab by exploring different facets of DLQI data by treatment arm at multiple assessment points. The original aspects of analysis included applying the concept of the recently validated score for the MCID of the DLQI, changes in DLQI domain scores and in the distribution of subjects based on validated total DLQI score bands. It showed consistently that omalizumab provides significant and clinically relevant improvements in many aspects of HRQoL that are important to patients with CSU. These results contribute to a better understanding of the impact of CSU and its treatment on patients and can support clinical decision‐making in routine medical practice.