Cargando…
Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study
BACKGROUND: Data on the prevalence of perennial versus seasonal allergic asthma in Italy are lacking; moreover, there is limited evidence on the effect of omalizumab on patient-reported outcomes in Italian patients with severe allergic asthma. PROXIMA, an observational, multicenter study, was design...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214174/ https://www.ncbi.nlm.nih.gov/pubmed/30410639 http://dx.doi.org/10.1186/s40413-018-0214-3 |
_version_ | 1783367938921725952 |
---|---|
author | Canonica, Giorgio Walter Rottoli, Paola Bucca, Caterina Zappa, Maria Cristina Michetti, Giovanni Macciocchi, Bruno Caruso, Cristiano Santus, Pierachille Bartezaghi, Marta Rigoni, Laura |
author_facet | Canonica, Giorgio Walter Rottoli, Paola Bucca, Caterina Zappa, Maria Cristina Michetti, Giovanni Macciocchi, Bruno Caruso, Cristiano Santus, Pierachille Bartezaghi, Marta Rigoni, Laura |
author_sort | Canonica, Giorgio Walter |
collection | PubMed |
description | BACKGROUND: Data on the prevalence of perennial versus seasonal allergic asthma in Italy are lacking; moreover, there is limited evidence on the effect of omalizumab on patient-reported outcomes in Italian patients with severe allergic asthma. PROXIMA, an observational, multicenter study, was designed to assess the prevalence of perennial versus seasonal allergic asthma (cross-sectional phase) and the effect of omalizumab on improving illness perception, quality of life (QoL) and asthma control of Italian patients with severe allergic asthma (longitudinal phase). METHODS: The study included a cross-sectional phase (n = 357) and a longitudinal phase (n = 123): during the longitudinal phase, patients received omalizumab (75–600 mg subcutaneously every month) and were followed-up for 12 months. The primary parameter of cross-sectional phase was prevalence of perennial allergic asthma and that of longitudinal phase was proportion of patients with asthma control (assessed using asthma control questionnaire [ACQ]). Secondary parameters assessed were patients’ disease perception, level of asthma control, exacerbation rate during both cross-sectional and longitudinal phases, and patients' compliance to and persistence with omalizumab, and patients' QoL during the longitudinal phase. RESULTS: Most patients (95.8%) had perennial allergies; 81% had polysensitization. Of 99 patients in the per-protocol set, 95 (95.96% [95% CI: 89.98–98.89%]) achieved asthma control (ACQ < 4) at both 6 and 12 months of omalizumab treatment; ACQ score decreased after 6 and 12 months (P < 0.0001). Omalizumab treatment resulted in a significant improvement in QoL and patients’ illness perception and 87% decrease in exacerbation rate. The compliance rate with omalizumab was high (73.2%). No new safety signals were identified during treatment. CONCLUSION: This study demonstrated that in severe allergic asthma, omalizumab improves patient-reported outcomes such as patients’ illness perception and QoL, while confirming improvement of asthma control and exacerbation rate reduction in Italian patients. |
format | Online Article Text |
id | pubmed-6214174 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-62141742018-11-08 Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study Canonica, Giorgio Walter Rottoli, Paola Bucca, Caterina Zappa, Maria Cristina Michetti, Giovanni Macciocchi, Bruno Caruso, Cristiano Santus, Pierachille Bartezaghi, Marta Rigoni, Laura World Allergy Organ J Original Research BACKGROUND: Data on the prevalence of perennial versus seasonal allergic asthma in Italy are lacking; moreover, there is limited evidence on the effect of omalizumab on patient-reported outcomes in Italian patients with severe allergic asthma. PROXIMA, an observational, multicenter study, was designed to assess the prevalence of perennial versus seasonal allergic asthma (cross-sectional phase) and the effect of omalizumab on improving illness perception, quality of life (QoL) and asthma control of Italian patients with severe allergic asthma (longitudinal phase). METHODS: The study included a cross-sectional phase (n = 357) and a longitudinal phase (n = 123): during the longitudinal phase, patients received omalizumab (75–600 mg subcutaneously every month) and were followed-up for 12 months. The primary parameter of cross-sectional phase was prevalence of perennial allergic asthma and that of longitudinal phase was proportion of patients with asthma control (assessed using asthma control questionnaire [ACQ]). Secondary parameters assessed were patients’ disease perception, level of asthma control, exacerbation rate during both cross-sectional and longitudinal phases, and patients' compliance to and persistence with omalizumab, and patients' QoL during the longitudinal phase. RESULTS: Most patients (95.8%) had perennial allergies; 81% had polysensitization. Of 99 patients in the per-protocol set, 95 (95.96% [95% CI: 89.98–98.89%]) achieved asthma control (ACQ < 4) at both 6 and 12 months of omalizumab treatment; ACQ score decreased after 6 and 12 months (P < 0.0001). Omalizumab treatment resulted in a significant improvement in QoL and patients’ illness perception and 87% decrease in exacerbation rate. The compliance rate with omalizumab was high (73.2%). No new safety signals were identified during treatment. CONCLUSION: This study demonstrated that in severe allergic asthma, omalizumab improves patient-reported outcomes such as patients’ illness perception and QoL, while confirming improvement of asthma control and exacerbation rate reduction in Italian patients. BioMed Central 2018-11-01 /pmc/articles/PMC6214174/ /pubmed/30410639 http://dx.doi.org/10.1186/s40413-018-0214-3 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Original Research Canonica, Giorgio Walter Rottoli, Paola Bucca, Caterina Zappa, Maria Cristina Michetti, Giovanni Macciocchi, Bruno Caruso, Cristiano Santus, Pierachille Bartezaghi, Marta Rigoni, Laura Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study |
title | Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study |
title_full | Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study |
title_fullStr | Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study |
title_full_unstemmed | Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study |
title_short | Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study |
title_sort | improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational proxima study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214174/ https://www.ncbi.nlm.nih.gov/pubmed/30410639 http://dx.doi.org/10.1186/s40413-018-0214-3 |
work_keys_str_mv | AT canonicagiorgiowalter improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT rottolipaola improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT buccacaterina improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT zappamariacristina improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT michettigiovanni improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT macciocchibruno improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT carusocristiano improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT santuspierachille improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT bartezaghimarta improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT rigonilaura improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy AT improvementofpatientreportedoutcomesinsevereallergicasthmabyomalizumabtreatmentthereallifeobservationalproximastudy |