25
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study

      research-article
      1 , 2 , 3 , 4 , 5 , 5 , 6 , 7 8
      (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab), (Collab)
      The European Respiratory Journal
      European Respiratory Society

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Omalizumab is a monoclonal anti-IgE antibody used to treat severe allergic asthma (SAA). The aim of the STELLAIR study was to determine the importance of pre-treatment blood eosinophil count as a predictive measure for response to omalizumab.

          This retrospective real-life study was conducted in France between December 2015 and September 2016 using medical records of SAA omalizumab-treated patients. Response to omalizumab was assessed by three criteria: physician evaluation, reduction of ≥40% in annual exacerbation rate and a combination of both. Response rate was calculated according to blood eosinophil count measured in the year prior to omalizumab initiation.

          872 SAA omalizumab-treated patients were included by 78 physicians (723 adults (age ≥18 years) and 149 minors (age 6–17 years)). Blood eosinophil count was ≥300 cells·µL −1 in 52.1% of adults and 73.8% of minors. By physician evaluation, 67.2% of adults and 77.2% of minors were responders and 71.1% adults and 78.5% minors had a ≥40% reduction in the exacerbation rate. In adults, the response rate for combined criteria was 58.4% (95% CI 53.2–63.4%) for blood eosinophils ≥300 cells·µL −1 (n=377) and 58.1% (95% CI 52.7–63.4%) for blood eosinophils <300 cells·µL −1 (n=346).

          This study shows that a large proportion of patients with SAA have a blood eosinophil count ≥300 cells·µL −1, and suggests that omalizumab effectiveness is similar in “high” and “low” eosinophil subgroups.

          Abstract

          Omalizumab is a treatment option for severe allergic asthma irrespective of blood eosinophil count http://ow.ly/7tQh30iXNTW

          Related collections

          Most cited references24

          • Record: found
          • Abstract: found
          • Article: not found

          International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma.

          Severe or therapy-resistant asthma is increasingly recognised as a major unmet need. A Task Force, supported by the European Respiratory Society and American Thoracic Society, reviewed the definition and provided recommendations and guidelines on the evaluation and treatment of severe asthma in children and adults. A literature review was performed, followed by discussion by an expert committee according to the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach for development of specific clinical recommendations. When the diagnosis of asthma is confirmed and comorbidities addressed, severe asthma is defined as asthma that requires treatment with high dose inhaled corticosteroids plus a second controller and/or systemic corticosteroids to prevent it from becoming "uncontrolled" or that remains "uncontrolled" despite this therapy. Severe asthma is a heterogeneous condition consisting of phenotypes such as eosinophilic asthma. Specific recommendations on the use of sputum eosinophil count and exhaled nitric oxide to guide therapy, as well as treatment with anti-IgE antibody, methotrexate, macrolide antibiotics, antifungal agents and bronchial thermoplasty are provided. Coordinated research efforts for improved phenotyping will provide safe and effective biomarker-driven approaches to severe asthma therapy.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE.

            Patients with severe persistent asthma who are inadequately controlled despite Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging population with significant unmet medical need. We determined the effect of omalizumab on clinically significant asthma exacerbations (requiring systemic corticosteroids) in the first omalizumab study to exclusively enrol patients from this difficult-to-treat patient population. Following a run-in phase, patients (12-75 years) inadequately controlled despite therapy with high-dose inhaled corticosteroids (ICS) and long-acting beta(2)-agonists (LABA) with reduced lung function and a recent history of clinically significant exacerbations were randomized to receive omalizumab or placebo for 28 weeks in a double-blind, parallel-group, multicentre study. A total of 419 patients were included in the efficacy analyses. The clinically significant asthma exacerbation rate (primary efficacy variable), adjusted for an observed relevant imbalance in history of clinically significant asthma exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction) during the 28-week treatment phase (P = 0.042). Without adjustment, a similar magnitude of effect was seen (19% reduction), but this did not reach statistical significance. Omalizumab significantly reduced severe asthma exacerbation rate (0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038). Omalizumab significantly improved asthma-related quality of life, morning peak expiratory flow and asthma symptom scores. The incidence of adverse events was similar between treatment groups. In patients with inadequately controlled severe persistent asthma, despite high-dose ICS and LABA therapy, and often additional therapy, omalizumab significantly reduced the rate of clinically significant asthma exacerbations, severe exacerbations and emergency visits. Omalizumab is effective and should be considered as add-on therapy for patients with inadequately controlled severe persistent asthma who have a significant unmet need despite best available therapy.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study

              Elevated sputum eosinophil counts predict asthma exacerbations and responsiveness to inhaled corticosteroids but are impractical to measure in primary care. We investigated the relation between blood eosinophil count and prospective annual asthma outcomes for a large UK cohort.
                Bookmark

                Author and article information

                Journal
                Eur Respir J
                Eur. Respir. J
                ERJ
                erj
                The European Respiratory Journal
                European Respiratory Society
                0903-1936
                1399-3003
                May 2018
                10 May 2018
                : 51
                : 5
                : 1702523
                Affiliations
                [1 ]Université Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France
                [2 ]AP-HP, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France
                [3 ]INSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France
                [4 ]AP-HP, Hôpital Bichat, Service de Pneumologie et Centre de Référence des Maladies Pulmonaires Rares, Dépt Hospitalo-Universitaire FIRE, Université Paris Diderot, INSERM UMR 1152, Paris, France
                [5 ]Novartis Pharma SAS, Rueil-Malmaison, France
                [6 ]Université Paris Sorbonne, AP-HP, Service d'Allergologie Pédiatrique (Centre de l'Asthme), Hôpital Trousseau, Paris, France
                [7 ]Dept of Medical Pharmacology, Université de Bordeaux, INSERM UMR 1219, Bordeaux, France
                [8 ]A list of the STELLAIR investigators can be found in the Acknowledgements section
                Author notes
                Marc Humbert, Service de Pneumologie, Hôpital Bicêtre, 78 Rue du général Leclerc, 94270 Le Kremlin-Bicêtre, France. E-mail: marc.humbert@ 123456aphp.fr
                Article
                ERJ-02523-2017
                10.1183/13993003.02523-2017
                6383600
                29545284
                56be0e91-3086-4778-9490-63e1e786f549
                Copyright ©ERS 2018

                This ERJ Open article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.

                History
                : 05 December 2017
                : 12 March 2018
                Funding
                Funded by: Novartis http://doi.org/10.13039/100004336
                Categories
                Original Articles
                Asthma

                Respiratory medicine
                Respiratory medicine

                Comments

                Comment on this article