Clinical and Economic Impact of a One-Year Treatment With Omalizumab in Patients With Severe Allergic Asthma Within a Drug Programme in Poland

Juan Carlos Ivancevich Thursday, 17 May 2018 12:02

Karina Jahnz-Różyk; Joanna Lis; Marta Warchoł; Aleksandra Kucharczyk

BMC Pulm Med. 2018;18(48) 

Abstract and Introduction

Abstract

Background Allergic asthma is the most prevalent phenotype of severe asthma where treatment with omalizumab (OMB) has been proven to be particularly beneficial. In Poland, OMB therapy is available and reimbursed within a drug programme where strict inclusion and exclusion criteria are defined.

The objective of this study was to present a descriptive analysis regarding the trends in outcomes (clinical, quality of life, costs) among a cohort of patients who satisfy inclusion criteria for the initiation of OMB treatment and who successfully responded to OMB according to a set of objective criteria.

Methods A retrospective analysis of data collected during the 52 weeks of OMB treatment was carried out. The study population was adolescents and adults with severe allergic asthma that was uncontrolled despite a combination of high-dose inhaled corticosteroids (ICS)/long-acting beta-agonists (LABA) and/or other controllers (leukotriene receptor antagonists (LTRA), sustained-release theophylline, and short- or long-acting muscarinic antagonists (SAMA/LAMA), who were the first to finish the one-year treatment. A clinical and cost analysis for patients included in the programme was conducted comparing the one-year pre-treatment period to the one-year treatment period outcomes.

Results Data of 85 patients who completed the first year of therapy were reviewed and analysed. Add-on OMB treatment resulted in a median decrease in exacerbation rate of 66% relative to the baseline and a reduction in oral steroid (OCS) dose by an average of 7.7 mg. At the end of the 52 weeks of therapy the changes in the quality of life questionnaire (AQLQ) and the asthma control questionnaire (ACQ) scores were 1.86 and 1.45 points, respectively. The mean cost of asthma treatment increased by an average of 15,979 EUR per patient per year (baseline period – 802 EUR/patient/year; OMB treatment – 16,781 EUR/patient/year). The cost to avoid one exacerbation was 17721 EUR.

Conclusion The clinical outcomes for the observed subset of patients were highly improved. At the same time, costs of the treatment increased, mainly due to the high OMB costs. Other costs associated with a lower number of hospitalizations and ED and office visits and a reduction in OCS dose decreased. These descriptive data can be used for further investigation in defining patients who benefit the most from OMB treatment in clinical practice.

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Nerve ablation after bronchial thermoplasty and sustained improvement in severe asthma

Juan Carlos Ivancevich Thursday, 17 May 2018 11:56
N. FacciolongoA. DiStefanoV. PietriniC. GaleoneF. BellanovaF. MenzellaN. ScichiloneR. PiroG. L. BajocchiB. BalbiL. AgostiniP. P. SalsiD. Formisano and M. Lusuardi

Abstract

Background

Bronchial thermoplasty (BT) is a non-pharmacological intervention for severe asthma whose mechanism of action is not completely explained by a reduction of airway smooth muscle (ASM). In this study we analyzed the effect of BT on nerve fibers and inflammatory components in the bronchial mucosa at 1 year.

Methods

Endobronchial biopsies were obtained from 12 subjects (mean age 47 ± 11.3 years, 50% male) with severe asthma. Biopsies were performed at baseline (T0) and after 1 (T1), 2 (T2) and 12 (T12) months post-BT, and studied with immunocytochemistry and microscopy methods. Clinical data including Asthma Quality of Life Questionnaire (AQLQ) and Asthma Control Questionnaire (ACQ) scores, exacerbations, hospitalizations, oral corticosteroids use were also collected at the same time points.

Results

A statistically significant reduction at T1, T2 and T12 of nerve fibers was observed in the submucosa and in ASM compared to T0. Among inflammatory cells, only CD68 showed significant changes at all time points. Improvement of all clinical outcomes was documented and persisted at the end of follow up.

Conclusions

A reduction of nerve fibers in epithelium and in ASM occurs earlier and persists at one year after BT. We propose that nerve ablation may contribute to mediate the beneficial effects of BT in severe asthma.

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Loss of bronchoprotection to Salbutamol during sputum induction with hypertonic saline: implications for asthma therapy

Juan Carlos Ivancevich Friday, 11 May 2018 13:50
Hongyu WangMelanie KjarsgaardTerence HoJohn D. Brannan and Parameswaran Nair

Abstract

Background

Sputum induction with hypertonic saline in obstructive airway diseases is generally safe. However, saline induces bronchoconstriction in some patients despite pre-medication with Salbutamol. Our objectives were to investigate the predictors of failure of Salbutamol to protect against saline-induced-bronchoconstriction in patients with asthma and COPD and to evaluate implications for asthma therapy.

Methods

Retrospective survey on a database of 3565 patients with obstructive airway diseases who had sputum induced with hypertonic saline. The effect of baseline FEV1, bronchitis and concomitant medication on saline-induced-bronchoconstriction (≥ 15% drop in FEV1) were examined by logistic regression analysis. A subgroup had this re-examined 8–12 weeks after decreasing long-acting-beta-2-agonist dose or after adding Montelukast, which included an assessment of mast cell activity in sputum.

Results

222 (6.2%) patients had saline-induced-bronchoconstriction despite pre-treatment with inhaled Salbutamol. Baseline airflow obstruction (FEV1% predicted < 60% OR 3.29, p < 0.001) and long-acting-beta-agonist use (OR 2.02, p = 0.001), but not bronchitis, were predictors of saline-induced-bronchoconstriction, which decreased when long-acting-beta-agonist dose was decreased. Refractoriness to subsequent bronchodilation was associated with mast cell activity and was attenuated by Montelukast.

Conclusion

Sputum induction with saline provides information on bronchitis and additional physiological data on tolerance to beta-agonists and mast cell activity that may have implications for clinical therapy.

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Prevalence of asthma among the adult general population of five Middle Eastern countries: results of the SNAPSHOT program

Juan Carlos Ivancevich Monday, 14 May 2018 20:59
Hesham TarrafOmur AydinDilsad MunganMohammad AlbaderBassam MahboubAdam DobleAaicha LahlouLuqman TariqFayaz Aziz and Abdelkader El Hasnaoui

Abstract

Background

Asthma is a common chronic respiratory disease leading to morbidity, mortality and impaired quality of life worldwide. Information on asthma prevalence in the Middle East is fragmented and relatively out-dated. The SNAPSHOT program was conducted to obtain updated information.

Methods

SNAPSHOT is a cross-sectional epidemiological program carried out in five Middle Eastern countries (Egypt, Turkey, Kuwait, Saudi Arabia, and the United Arab Emirates, the latter three grouped into a Gulf cluster) to collect data on asthma, allergic rhinitis, benign prostatic hyperplasia and bipolar disorder. The survey was carried out by telephone in a random sample of the adult general population with quotas defined according to country demographics. The analysis presented in this paper focuses on asthma. Subjects were screened for asthma based on criteria from the global Asthma Insights and Reality studies. Current prevalence (last 12 months) was estimated. Multivariate logistic regression analyses were used to investigate risk factors related to asthma and the association with allergic rhinitis and other co-morbidities. Quality of life was assessed using the three-level EQ-5D questionnaire.

Results

2124 out of the 33,486 subjects enrolled in the SNAPSHOT program fulfilled the criteria for asthma. The adjusted prevalence of asthma ranged from 4.4% [95% CI: 4.0–4.8%] in Turkey, to 6.7% [95% CI: 6.2–7.2%] in Egypt and 7.6% [95% CI: 7.1–8.0%] in the Gulf cluster. Prevalence was higher (p < 0.0001) in women than men and increased with age (p < 0.0001). Co-morbidities occurred more frequently in asthma subjects compared to the non-asthma population (38% vs. 15% p < 0.0001). Subjects with asthma reported a lower (p < 0.0001) EQ-VAS score (68.2 ± 22.9) compared to the general population (78.1 ± 17.5). The risk factors associated with asthma were age, gender, country, and certain co-morbidities, namely respiratory, cardiovascular, gastrointestinal, nervous, and neurological diseases.

Conclusion

The observed adjusted prevalence of asthma in the Middle East ranges from 4.4% to 7.6%, which is comparatively lower than the reported prevalence in Europe and North America. Asthma has a negative impact on quality of life, and is associated with high levels of co-morbid diseases, indicating a need for physicians to check for co-morbidities and ensure they are managed correctly in all asthma patients.

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Role of Immunotherapy in the Treatment of Asthma

Juan Carlos Ivancevich Saturday, 28 April 2018 20:07

SYSTEMATIC REVIEW

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These reports are available in PDF only (Full Report [3.0 MB]; Evidence Summary [370 KB]). People using assistive technology may not be able to fully access information in these files. For additional assistance, please contact us.

Key Messages

Purpose of Review

To assess the efficacy and safety of immunotherapy for treating allergic asthma.

Key Messages

  • Subcutaneous immunotherapy reduces use of long-term control medications. It may also improve quality of life and FEV1, (a measure of the ability to exhale) and reduce the use of quick-relief medications (short-acting bronchodilators) and systemic corticosteroids.
  • Sublingual immunotherapy improves asthma symptoms, quality of life and FEV1, and reduces the use of long-term control medications. It may also reduce the use of quick-relief medications.
  • Local and systemic reactions to subcutaneous immunotherapy and sublingual immunotherapy are common but infrequently required changes in treatment. Life-threatening events (such as anaphylaxis) are reported rarely.

Structured Abstract

Objectives. To evaluate the efficacy and safety of subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) in the treatment of allergic asthma.

Data Sources. We searched PubMed, Embase, and CENTRAL through May 8, 2017.

Methods. Two reviewers independently selected randomized controlled trials (RCTs) of the efficacy of SCIT and SLIT and RCTs, observational studies, and case series or case reports on safety. Two reviewers independently assessed the risk of bias for each study and together graded the strength of the evidence.

Results. We identified 54 RCTs on efficacy: 31 assessed SCIT and 18 assessed SLIT and 5 on SCIT versus SLIT. We included 80 studies on safety: 26 RCTs and 18 non-RCTs for SCIT, 20 RCTs and 10 non-RCTs for SLIT and one non-RCT on SCIT versus SLIT.

SCIT reduces the use of long-term control medications [moderate strength of evidence (SOE)]. SCIT may improve quality of life, reduce the use of quick-relief medications (short-acting bronchodilators), reduce the need for systemic corticosteroids, and improve FEV1 (low SOE). There was insufficient evidence regarding the effect of SCIT on asthma symptoms and health care utilization. Local and systemic allergic reactions were frequent but infrequently required a change in treatment. We are unable to draw conclusions about whether SCIT increased risk of anaphylaxis, primarily because anaphylaxis was not directly measured (insufficient SOE). There was one case report of a death determined possibly to be caused by SCIT.

SLIT improves asthma symptoms (high SOE); decreases use of long-term control medication and improves FEV1 (moderate SOE). SLIT may decrease quick-relief medication use, and may improve quality of life (low SOE). There was insufficient evidence about the effect of SLIT on systemic corticosteroid use and health care utilization. Local and systemic allergic reactions were common but infrequently required changes in treatment. Life-threatening reactions were not commonly reported, with three case reports of anaphylaxis (insufficient SOE) and no deaths (moderate SOE) reported.

There was insufficient evidence to draw conclusions about the comparative effects of SCIT versus SLIT or for differential effects of immunotherapy based on patient age, setting of administration, or type of allergen.

Conclusions. Overall, SLIT and SCIT were beneficial for the majority of asthma-related outcomes assessed in this report. Local and systemic allergic reactions were common but infrequently required changes in treatment. Life-threatening events (such as anaphylaxis) were reported rarely.

Journal Publication

Rice JL, Diette GB, Suarez-Cuervo C, Brigham E, Lin SY, Ramanathan, Jr., M, Robinson KA, Azar A. Allergen-Specific Immunotherapy in the Treatment of Pediatric Asthma:  A Systematic Review[link is external]. Pediatrics. 2018 March 23 [epub ahead of print]. (doi: 10.1542/peds.2017-3833)

Citation

Suggested citation: Lin SY, Azar A, Suarez-Cuervo C, Diette GB, Brigham E, Rice J, Ramanathan M, Gayleard J, Robinson KA. The Role of Immunotherapy in the Treatment of Asthma. Comparative Effectiveness Review No. 196 (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No.290-2015-00006-I). AHRQ Publication No. 17(18)-EHC029-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2018. Posted final reports are located on the Effective Health Care Program search page. DOI: https://doi.org/10.23970/AHRQEPCCER196[link is external].

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Editor: Juan C. Ivancevich, MD

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