Clinical and economic burden of patients with severe uncontrolled asthma (SUA) in a real-world managed-care setting required further documentation.
The objective of this study was to determine the ...characteristics, clinical, and economic burden of SUA in a managed-care setting.
This observational study identified patients with persistent asthma aged 12 years or more (N = 25,935) using the International Classification of Diseases, 9th Revision asthma codes and Healthcare Effectiveness Data and Information Set administrative criteria. An SUA subgroup was identified when all of the following 3 criteria were met in 2012: (1) 2 or more asthma exacerbations; (2) 6 or more medium- or high-dose dispensed canisters of inhaled corticosteroid (ICS) as monotherapy or with long-acting β2-agonist; and (3) 3 or more dispensed non-ICS controllers. Health care utilization and direct costs (all-cause and asthma-related) in 2013 were compared between SUA and non-SUA subgroups using multivariable regression.
Compared with the non-SUA subgroup (N = 25,350, 97.7%), the SUA subgroup (N = 585, 2.3%) at baseline was significantly older and had more comorbidities, asthma specialist care, controller medication dispensed, and asthma exacerbations. During follow-up, patients with SUA exhibited significantly more asthma exacerbations and short-acting β2-agonist use, and higher all-cause and asthma-related costs than patients with non-SUA. The adjusted asthma-related average direct cost per patient at follow-up was significantly higher for SUA (mean ± SE) ($2325 ± $75) than non-SUA ($1261 ± $9) with an incremental cost of $1056 (95% CI, $907-$1205). Asthma drugs accounted for the major difference (incremental cost of $848/patient; 95% CI, $737-$959).
Increases and disparities in health care utilization and direct cost by SUA status suggest that patients with SUA require more intensive therapy, greater attention to adherence and comorbidities, more specialist care, and, possibly, personalized treatment approaches including novel biologic treatments.
Background Currently, the cornerstone of asthma management is the achievement and maintenance of optimal asthma control, but the diagnostic performances of the Asthma Control Test (ACT) and Asthma ...Control Questionnaire (ACQ) have not been evaluated systematically. Objective We explored the diagnostic performances of and statistically compared the ACT and ACQ. Methods Studies that examined the accuracy of the ACT, ACQ, or both in the assessment of asthma control were found by searching PubMed, CENTRAL, Web of Science, Ovid, and Embase. Summary estimates of sensitivity, specificity, and diagnostic odds ratios for the different levels of asthma control were determined by using bivariate random-effects models and hierarchical summary receiver operating characteristic models. Results Twenty-one studies with 11,141 subjects assessed with the ACT and 12,483 assessed with the ACQ were identified. The ACT had good diagnostic accuracy for assessment of controlled and not well-controlled asthma, and the ACQ (ACQ-7 and ACQ-6) had good diagnostic accuracy for assessment of not well-controlled asthma at prespecified cutoff points. The ACT and ACQ had significant differences in the assessment of controlled and not well-controlled asthma after adjusting for potential factors ( P = .001 and P = .015). For assessment of uncontrolled asthma, the ACT had poor accuracy, with a hierarchical summary receiver operating characteristic area under the curve of 0.69, and the cutoff point for the ACQ has not been established. Conclusion The ACT is preferable to the ACQ in clinical practice, and the ACQ requires further cross-validation. Moreover, neither the ACT nor the ACQ is useful for the assessment of uncontrolled asthma.
Background Numerous open trials have demonstrated the beneficial clinical effects of aspirin desensitization (AD) in patients with aspirin-induced asthma (AIA). These beneficial effects might be ...attributable to aspirin's potent anti-inflammatory properties, but that supposition requires further corroboration. Objective We sought to compare the clinical and biochemical responses to chronic oral AD in 20 patients with AIA and 14 patients with aspirin-tolerant asthma (ATA). All of the patients had chronic rhinosinusitis and nasal polyposis, and these responses were investigated in a pilot, double-blind, placebo-controlled study. Methods Twelve patients with AIA and 6 patients with ATA were randomly assigned to receive 624 mg of aspirin, and 8 patients with AIA and 8 patients with ATA received placebo. Both aspirin and placebo were administered once daily for 6 months. Nasal symptoms, Sino-Nasal Outcome Test (SNOT20) scores, peak nasal inspiratory flows, Asthma Control Questionnaire scores, spirometric parameters, peak expiratory flows, blood eosinophilia, and corticosteroid doses were assessed on a monthly basis. Levels of urinary leukotriene E4 and the stable plasma prostaglandin (PG) D2 metabolite 9α,11β-PGF2 were evaluated at baseline and after 1, 3, 5, and 6 months. Results Only the patients with AIA subjected to AD reported improvements in smell and reductions in sneezing and nasal blockade. The SNOT20 and Asthma Control Questionnaire scores of these patients decreased, and their peak nasal inspiratory flows increased. The dosages of inhaled corticosteroids were reduced. There were no changes in leukotriene E4 or 9α,11β-PGF2 levels after AD. Conclusion The clinically beneficial effects of AD on nasal and bronchial symptoms occurred only in the patients with AIA.
Asthma is a respiratory (airway) condition that affects an estimated 300 million people worldwide and is associated with significant morbidity and mortality. Omalizumab is a monoclonal antibody that ...binds and inhibits free serum immunoglobulin E (IgE). It is called an 'anti-IgE' drug. IgE is an immune mediator involved in clinical manifestations of asthma. A recent update of National Institute for Health and Care Excellence (NICE) guidance in 2013 recommends omalizumab for use as add-on therapy in adults and children over six years of age with inadequately controlled severe persistent allergic IgE-mediated asthma who require continuous or frequent treatment with oral corticosteroids.
To assess the effects of omalizumab versus placebo or conventional therapy for asthma in adults and children.
We searched the Cochrane Airways Group Specialised Register of trials for potentially relevant studies. The most recent search was performed in June 2013. We also checked the reference lists of included trials and searched online trial registries and drug company websites.
Randomised controlled trials examining anti-IgE administered in any manner for any duration. Trials with co-interventions were included, as long as they were the same in each arm.
Two review authors independently assessed study quality and extracted and entered data. Three modes of administration were identified from the published literature: inhaled, intravenous and subcutaneous injection. The main focus of the updated review is subcutaneous administration, as this route is currently used in clinical practice. Subgroup analysis was performed by asthma severity. Data were extracted from published and unpublished sources.
In all, 25 trials were included in the review, including 11 new studies since the last update, for a total of 19 that considered the efficacy of subcutaneous anti-IgE treatment as an adjunct to treatment with corticosteroids.For participants with moderate or severe asthma who were receiving background inhaled corticosteroid steroid (ICS) therapy, a significant advantage favoured subcutaneous omalizumab with regard to experiencing an asthma exacerbation (odds ratio (OR) 0.55, 95% confidence interval (CI) 0.42 to 0.60; ten studies, 3261 participants). This represents an absolute reduction from 26% for participants suffering an exacerbation on placebo to 16% on omalizumab, over 16 to 60 weeks. A significant benefit was noted for subcutaneous omalizumab versus placebo with regard to reducing hospitalisations (OR 0.16, 95% CI 0.06 to 0.42; four studies, 1824 participants), representing an absolute reduction in risk from 3% with placebo to 0.5% with omalizumab over 28 to 60 weeks. No separate data on hospitalisations were available for the severe asthma subgroup, and all of these data were reported for participants with the diagnosis of moderate to severe asthma. Participants treated with subcutaneous omalizumab were also significantly more likely to be able to withdraw their ICS completely than those treated with placebo (OR 2.50, 95% CI 2.00 to 3.13), and a small but statistically significant reduction in daily inhaled steroid dose was reported for omalizumab-treated participants compared with those given placebo (weighted mean difference (WMD) -118 mcg beclomethasone dipropionate (BDP) equivalent per day, 95% CI -154 to -84). However, no significant difference between omalizumab and placebo treatment groups was seen in the number of participants who were able to withdraw from oral corticosteroid (OCS) therapy (OR 1.18, 95% CI 0.53 to 2.63).Participants treated with subcutaneous omalizumab as an adjunct to treatment with corticosteroids required a small but significant reduction in rescue beta2-agonist medication compared with placebo (mean difference (MD) -0.39 puffs per day, 95% CI -0.55 to -0.24; nine studies, 3524 participants). This benefit was observed in both the moderate to severe (MD -0.58, 95% CI -0.84 to -0.31) and severe (MD -0.30, 95% CI -0.49 to -0.10) asthma subgroups on a background therapy of inhaled corticosteroids; however, no significant difference between subcutaneous omalizumab and placebo was noted for this outcome in participants with severe asthma who were receiving a background therapy of inhaled plus oral corticosteroids. Significantly fewer serious adverse events were reported in participants assigned to subcutaneous omalizumab than in those receiving placebo (OR 0.72, 95% CI 0.57 to 0.91; 15 studies, 5713 participants), but more injection site reactions were observed (from 5.6% with placebo to 9.1% with omalizumab).To reflect current clinical practice, discussion of the results is limited to subcutaneous use, and trials involving intravenous and inhaled routes have been archived.
Omalizumab was effective in reducing asthma exacerbations and hospitalisations as an adjunctive therapy to inhaled steroids and during steroid tapering phases of clinical trials. Omalizumab was significantly more effective than placebo in increasing the numbers of participants who were able to reduce or withdraw their inhaled steroids. Omalizumab was generally well tolerated, although more injection site reactions were seen with omalizumab. Further assessment in paediatric populations is necessary, as is direct double-dummy comparison with ICS. Although subgroup analyses suggest that participants receiving prednisolone had better asthma control when they received omalizumab, it remains to be tested prospectively whether the addition of omalizumab has a prednisolone-sparing effect. It is also not clear whether there is a threshold level of baseline serum IgE for optimum efficacy of omalizumab. Given the high cost of the drug, identification of biomarkers predictive of response is of major importance for future research.
The prevalence of severe refractory asthma Hekking, Pieter-Paul W., MD; Wener, Reinier R., MD; Amelink, Marijke, MD ...
Journal of allergy and clinical immunology,
04/2015, Volume:
135, Issue:
4
Journal Article
Peer reviewed
Open access
Background Severe asthma is characterized by difficulty to achieve disease control despite high-intensity treatment. However, prevalence figures of severe asthma are lacking, whereas longstanding ...estimates vary between 5% and 10% of all asthmatic patients. Knowing the exact prevalence of severe refractory asthma as opposed to difficult-to-control asthma is important for clinical decision making, drug development, and reimbursement policies by health authorities. Objective We sought to estimate the prevalence of severe refractory asthma as defined by the Innovative Medicine Initiative consensus. Methods Adult patients with a prescription for high-intensity treatment (high-dose inhaled corticosteroids and long-acting β2 -agonists or medium- to high-dose inhaled corticosteroids combined with oral corticosteroids and long-acting β2 -agonists) were extracted from 65 Dutch pharmacy databases, representing 3% of the population (500,500 inhabitants). Questionnaires were sent to 5,002 patients, of which 2,312 were analyzed. The diagnosis of asthma and degree of asthma control were derived from questionnaires to identify patients with difficult-to-control asthma. Inhalation technique was assessed in a random sample of 60 adherent patients (prescription filling, ≥80%). Patients with difficult-to-control asthma, adherence to treatment, and a correct inhalation technique were qualified as having severe refractory asthma. Results were mirrored to the Dutch population. Results Of asthmatic adults, 3.6% (95% CI, 3.0% to 4.1%) qualified for a diagnosis of severe refractory asthma, representing 10.4 patients per 10,000 inhabitants. Conclusion The prevalence of severe refractory asthma might be lower than estimated by expert opinion. This implies that currently recognized severe asthma subphenotypes could meet the criteria of rare diseases.
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