FENOMA Study: Achieving Full Control in Patients with Severe Allergic Asthma
Received 28 January 2020
Accepted for publication 10 April 2020
Published 6 May 2020 Volume 2020:13 Pages 159—166
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Dr Amrita Dosanjh
Sheila Cabrejos,1 Ana Moreira,2 Andreina Ramirez,2 Santiago Quirce,3 Gregorio Soto Campos,4 Ignacio Dávila,5 Paloma Campo6
1Allergy Service, Hospital Rafael Mendez de Lorca, Murcia, Spain; 2Novartis Farmacéutica, Barcelona, Spain; 3Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain, CIBER de Enfermedades Respiratorias, CIBERES, Madrid, Spain; 4Pneumology and Allergy Unit, Hospital Universitario de Jerez, Cádiz, Spain; 5Allergy Service, University Hospital of Salamanca and Institute for Biomedical Research of Salamanca (IBSAL), Salamanca, Spain, Biomedical and Diagnosis Science Department, Salamanca University School of Medicine, Salamanca, Spain; 6Allergy Unit, IBIMA-Regional University Hospital of Málaga, ARADyAL, Málaga, Spain
Correspondence: Ignacio Dávila
Allergy Service, University Hospital of Salamanca and Institute for Biomedical Research of Salamanca (IBSAL), Paseo de San Vicente, 58-182, Salamanca 37007, Spain
Tel +34923291100 (55373)
Introduction: A Spanish real-world study in patients with severe persistent asthma who achieved asthma control after a one-year treatment with omalizumab highlighted the phenotypic heterogeneity of these patients (FENOMA study). In this subanalysis, we describe the clinical improvement in patients with severe allergic asthma in this study (positive skin test and IgE level 30– 1500 IU/mL); n=240.
Patients and Methods: FENOMA was an observational, multicentre, retrospective study in 345 patients achieving asthma control according to Spanish guidelines (GEMA). Baseline demographic and asthma-related characteristics were collected. Outcomes analyzed were those included in asthma control definition plus changes in background treatments and in blood eosinophil count (%) and exhaled nitric oxide fraction [FeNO].
Results: At baseline, patients were aged 45.4± 15.0 years; 67% were women. Median (Q1;Q3) IgE levels were 302.5 (154.0; 553.5) IU/mL. After one-year treatment with omalizumab: 43.3% of patients had daytime symptoms vs 97.7% before treatment and 49.6% stopped taking oral corticosteroids. FEV1 increased a median of 12.0 (4.0; 23.0)%; P < 0.0001. The number of non-severe asthma exacerbations decreased a median of − 4.0 (− 7.0; 2.0); P < 0.0001. Median unplanned visits to primary care or specialists and days of school/workplace absenteeism decreased from 4.9 (2.0; 6.0), 1.0 (0.0; 3.0) and 0.0 (0.0; 14.0) to 0.0 (0.0; 1.0), 0.0 (0.0; 0.0) and 0.0 (0.0; 0.0), respectively. Median eosinophil blood count and FeNO decreased from 5.0 (3:0; 8.0)% to 3.0 (2.0; 5.5)% and from 36.0 (23:0; 53.0) ppb to 20.0 (13.0; 34.0) ppb, respectively.
Conclusion: This study highlights the asthma control achieved by patients with severe allergic asthma treated with omalizumab, with relevant benefits on the burden of the disease both on patients and the healthcare system.
Keywords: asthma, omalizumab, allergy, exacerbations, IgE
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