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4-month omalizumab efficacy outcomes for severe allergic asthma: the Dutch National Omalizumab in Asthma Registry.

ABSTRACT: Omalizumab is licensed as add-on therapy for patients with severe allergic asthma. Response is in most studies scored by the physician's global evaluation of treatment effectiveness (GETE). A good clinical and validated parameter for treatment response is currently missing. Also, there are no established criteria for identifying patients who will respond to omalizumab based on pre-treatment characteristics. The Dutch National Omalizumab in Asthma Registry was developed in 2011 to better evaluate inclusion criteria and measure treatment response after 4 months.This is a "real world" prospectively designed, observational data registry in which the outcomes of patients who received omalizumab between 2012 and 2015 were evaluated. Data were collected from all centers in the Netherlands comprising demographic features, criteria for starting treatment, GETE, FEV1, oral corticosteroid use and ACQ.65.5% of the 403 patients had a good or excellent response to omalizumab after 16 weeks according to the treating physician GETE. 64.5% fulfilled all the criteria for prescribing omalizumab at baseline. The mean ACQ improved from 2.96 at baseline to 1.83 at 16 weeks (p < 0.001). 75.3% of the responders showed more than 0.5 points improvement in the ACQ. The mean FEV1 increased from 71.58 to 79.06 (p < 0.001). There was no relationship between patients with a FEV1 <80 and ≥80% at baseline and response (p = 0.981). Most of the responders had a considerable improvement of FEV1 either/or ACQ or OCS use (88.3%). While 86.7% of the responders had an improvement of either ACQ or FEV1. 75.4% of the responders had an improvement of ACQ, while 50.4% had an improvement of FEV1. Finally 11.7% of the patients with no improvement of FEV1, ACQ or OCS use were considered to have a good response.This registry of 403 inadequately controlled severe allergic asthma patients in the Netherlands showed a good or excellent response of 65.5% to omalizumab after 16 weeks, in accordance with previous studies. The assumption that careful registration would lead to higher response rates could not be supported by the data from this registry. Improvement of ACQ appears to be a useful additional assessment tool to measure response in omalizumab treated patients.

SUBMITTER: Snelder SM

PROVIDER: S-EPMC5530516 | biostudies-other | 2017

REPOSITORIES: biostudies-other

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Project description:BackgroundAsthma is a highly prevalent chronic inflammatory airways disease, with a considerable impact on quality of life (QoL). To express the effects of asthma on patients' subjective experience, patient-reported outcomes (PROs) represent an important instrument. The asthma QoL questionnaire (AQLQ) is one of the main PROs among these.Materials and methodsTo identify long-term asthma-related QoL outcomes associated with omalizumab therapy in patients with moderate-to-severe asthma, we developed a systematic review according to the PRISMA guidelines. Published real-world effectiveness studies of adults or adolescents (12 years or older) with moderate-to-severe allergic asthma treated with omalizumab for at least 48 weeks were reviewed. Sources used were Medline ( PubMed), the Cochrane Library and Google Scholar up to February 2018. In addition, a cross-referencing search was conducted to complete the revision.ResultsA total of 255 potential papers were identified in the first search through the database. After full-text viewing, eight articles were finally included in the review. We summarized the results according to the study design, patient baseline characteristics and effectiveness outcomes assessed by AQLQ score results: variation from baseline to the end of study. Results confirmed the long-term benefits of omalizumab as an add-on therapy in patients with uncontrolled moderate-to-severe allergic asthma. Since there is a lot of evidence on omalizumab effectiveness, we aimed to focus on how a therapy can change patient's QoL in a long time period. Data showed long-term effects of omalizumab treatment on subjective (PROs) and objective (lung function, corticosteroid use, hospitalizations, asthma exacerbation) effectiveness measures.ConclusionStudies included in our review were observational trials that, due to their design, present a potential risk of selection bias in the patients included. Beyond this limit, the evaluation of QoL using the AQLQ showed a clear increase over time, following both 48 weeks and 9 years of observation, where QoL improvements still were significant over baseline values.

Project description:BackgroundBronchial thermoplasty (BT) is a recently developed treatment for patients with moderate-to-severe asthma. A few studies have suggested the clinical efficacy of this intervention. However, no study has evaluated the cost-effectiveness of BT compared to other alternative treatments for moderate-to-severe allergic asthma, which currently include omalizumab and standard therapy.ObjectiveTo evaluate the cost-effectiveness of standard therapy, BT, and omalizumab for moderate-to-severe allergic asthma in the USA.MethodsA probabilistic Markov model with weekly cycles was developed to reflect the course of asthma progression over a 5-year time horizon. The study population was adults with moderate-to-severe allergic asthma whose asthma remained uncontrolled despite using high-dose inhaled corticosteroids (ICS, with or without long-acting beta-agonists [LABA]). A perspective of the health-care system was adopted with asthma-related costs as well as quality-adjusted life years (QALYs) and exacerbations as the outcomes.ResultsFor standard therapy, BT, and omalizumab, the discounted 5-year costs and QALYs were $15,400 and 3.08, $28,100 and 3.24, and $117,000 and 3.26, respectively. The incremental cost-effectiveness ratio (ICER) of BT versus standard therapy and omalizumab versus BT was $78,700/QALY and $3.86 million/QALY, respectively. At the willingness-to-pay (WTP) of $50,000/QALY and $100,000/QALY, the probability of BT being cost-effective was 9%, and 67%, respectively. The corresponding expected value of perfect information (EVPI) was $155 and $1,530 per individual at these thresholds. In sensitivity analyses, increasing the costs of BT from $14,900 to $30,000 increased its ICER relative to standard therapy to $178,000/QALY, and decreased the ICER of omalizumab relative to BT to $3.06 million/QALY. Reducing the costs of omalizumab by 25% decreased its ICER relative to BT by 29%.ConclusionsBased on the available evidence, our study suggests that there is more than 60% chance that BT becomes cost-effective relative to omalizumab and standard therapy at the WTP of $100,000/QALY in patients with moderate-to-severe allergic asthma. However, there is a substantial uncertainty in the underlying evidence, indicating the need for future research towards reducing such uncertainty.

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4-month omalizumab efficacy outcomes for severe allergic asthma: the Dutch National Omalizumab in Asthma Registry.

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