B Sposato1, M Scalese2, M Milanese3, S Masieri4, C Cavaliere4, M Latorre5, N Scichilone6, A Matucci7, A Vultaggio7, A Ricci8, A Cresti9, P Santus10, A Perrella11, P L Paggiaro5. 1. Pneumology Department, Misericordia Hospital, Grosseto, Italy. Electronic address: bruno.sposato@uslsudest.toscana.it. 2. Institute of Clinical Phisiology, CNR, Pisa, Italy. 3. Pneumology Department, S.Corona Hospital, Pietra Ligure, Italy. 4. Otorhinolaryngology Clinic, Policlinico Umberto I, "Sapienza" University, Roma, Italy. 5. Cardio Thoracic and Vascular Department, Pathophysiology Unit, University of Pisa, Italy. 6. DIMPEFINU, Unit of Pneumology and Medicine, University of Palermo, Italy. 7. Immunoallergology Unit, Department of Medicine and Geriatric, AOU Careggi, Florence, Italy. 8. Division of Pneumology, Department of Clinical and Molecular Medicine, Sapienza University of Rome, AOU Sant'Andrea, Rome, Italy. 9. Cardiology Department, Misericordia Hospital, Grosseto, Italy. 10. Department of Biomedical And Clinical Sciences (DIBIC), University of Milan, Respiratory Unit, "Luigi Sacco" University Hospital; ASST Fatebenefratelli-Sacco, Milan, Italy. 11. Pneumology Department, Misericordia Hospital, Grosseto, Italy.
Abstract
BACKGROUND: Despite adding Omalizumab to conventional therapy, several severe asthmatics still show poor disease control. We investigated the factors that may affect a reduced Omalizumab response in a large population of severe asthmatics. METHODS: 340 patients were retrospectively evaluated. FEV1%, FVC%, Asthma Control Test (ACT), fractional exhaled nitric oxide (FENO), possible step-downs/step-ups of concomitant therapies, exacerbations, disease control levels, ICS doses and SABA use, observed at the end of treatment, were considered as a response to Omalizumab. RESULTS: Age was an independent risk factor for a reduced response concerning FEV1%, FVC%, ACT and for a lower asthma control. Obesity (vs normal weight) was a determinant condition for exacerbations (OR:3.114[1.509-6.424], p = 0.002), for a disease partial/no control (OR:2.665[1.064-6.680], p = 0.036), for excessive SABA use (OR:4.448[1.837-10.768], p = 0.002) and for an unchanged/increased level of concomitant asthma medications. Furthermore, obesity also reduced the response in FEV1 (β = -6.981,p = 0.04), FVC (β = -11.689,p = 0.014) and ACT (β = -2.585, p = 0.027) and was associated with a higher FENO level (β = 49.045,p = 0.040). Having at least one comorbidity was a risk factor for exacerbations (OR:1.383[1.128-1.697], p = 0.008) and for an ACT <20 (OR:2.410[1.071-3.690], p = 0.008). Specifically, chronic heart disease was associated with both a lower ACT and FVC% whereas gastroesophageal reflux with a partial/no asthma control. Nasal polyps were a predisposing factor leading both to exacerbations and to the use of higher inhaled corticosteroids doses. Moreover, smoking habits, pollen or dog/cat dander co-sensitizations may negatively influence Omalizumab response. CONCLUSION: Age, obesity, comorbidities, smoking habits, nasal polyps, allergic poly-sensitization might reduce Omalizumab effectiveness independently to other asthma-influencing factors.
BACKGROUND: Despite adding Omalizumab to conventional therapy, several severe asthmatics still show poor disease control. We investigated the factors that may affect a reduced Omalizumab response in a large population of severe asthmatics. METHODS: 340 patients were retrospectively evaluated. FEV1%, FVC%, Asthma Control Test (ACT), fractional exhaled nitric oxide (FENO), possible step-downs/step-ups of concomitant therapies, exacerbations, disease control levels, ICS doses and SABA use, observed at the end of treatment, were considered as a response to Omalizumab. RESULTS: Age was an independent risk factor for a reduced response concerning FEV1%, FVC%, ACT and for a lower asthma control. Obesity (vs normal weight) was a determinant condition for exacerbations (OR:3.114[1.509-6.424], p = 0.002), for a disease partial/no control (OR:2.665[1.064-6.680], p = 0.036), for excessive SABA use (OR:4.448[1.837-10.768], p = 0.002) and for an unchanged/increased level of concomitant asthma medications. Furthermore, obesity also reduced the response in FEV1 (β = -6.981,p = 0.04), FVC (β = -11.689,p = 0.014) and ACT (β = -2.585, p = 0.027) and was associated with a higher FENO level (β = 49.045,p = 0.040). Having at least one comorbidity was a risk factor for exacerbations (OR:1.383[1.128-1.697], p = 0.008) and for an ACT <20 (OR:2.410[1.071-3.690], p = 0.008). Specifically, chronic heart disease was associated with both a lower ACT and FVC% whereas gastroesophageal reflux with a partial/no asthma control. Nasal polyps were a predisposing factor leading both to exacerbations and to the use of higher inhaled corticosteroids doses. Moreover, smoking habits, pollen or dog/cat dander co-sensitizations may negatively influence Omalizumab response. CONCLUSION: Age, obesity, comorbidities, smoking habits, nasal polyps, allergic poly-sensitization might reduce Omalizumab effectiveness independently to other asthma-influencing factors.
Authors: Peter G Gibson; Charlene M Prazma; Geoffrey L Chupp; Eric S Bradford; Mark Forshag; Stephen A Mallett; Steve W Yancey; Steven G Smith; Elisabeth H Bel Journal: Respir Res Date: 2021-06-07