Effects of Omalizumab in Non-Atopic Asthma: Results from a Spanish Multicenter Registry

Abstract

Aim. To evaluate the effectiveness of omalizumab in non-atopic asthma. Methods. Using data from a multicenter registry of severe asthma, we evaluated and compared the clinical outcome of 29 omalizumab-treated severe non-atopic asthmatics with 266 omalizumab-treated severe allergic asthmatics. Effectiveness was assessed by considering severe exacerbations, pulmonary function, the Global Evaluation of Treatment Effectiveness (GETE) scale, and Asthma Control Test (ACT). Results. Omalizumab demonstrated significant improvement in the clinical status of non-atopic asthmatics as measured by GETE, which rose from 1.6 ± 1.1 to 2.8 ± 0.8 at 4 months (p = .0215) to 2.9 ± 0.9 at 1 year (p = .0093) and to 3.4 ± 0.6 at 2 years (p = .0078), and by the ACT, which increased from 13.0 ± 5.5 to 17.5 ± 5.4 at 4 months (p = .0236) to 17.9 ± 4.8 at 1 year (p = .0136) and to 20.6 ± 3.9 at 2 years (p = .0024). Forced expiratory volume in 1 second (FEV₁) improved from 61.0 ± 19.4% to 65.1 ± 17.2 at 4 months to 64.1 ± 24.7 at 1 year and to 67.3 ± 23.0 at 2 years, but without significant differences between initial and follow-up measurements (p = .52, .91, and .45, respectively) and exacerbations decreased from 3.1 ± 3.5 to 1.9 ± 2.8 at 1 year (p = .1709) to 1.8 ± 4.4 at 2 years (p = .2344). The results were not significantly different from those obtained in atopic asthmatics. Conclusion. Anti-IgE therapy can be effective in non-atopic severe asthma.

• efficacy
• IgE-mediated diseases
• non-allergic patients
• omalizumab
• uncontrolled severe asthma

Acknowledgments

Dr Vennera, Dr Picado, and Dr Bardagí contributed to the study design. Dr Pérez de Llano, Dr Vennera, and Dr Picado contributed to the results interpretation and manuscript. All authors have recruited the patients. Dr Pérez de Llano is the guarantor of the entire manuscript. Gerad Traveria from Adknoma Health Research performed the statistical analysis. Dr Ramón Mora from Novartis has supplied all kind of scientific information. Marc Castellví from NICASE (www.bancodatosasma.com) was our Software Product Manager.

Declaration of Interest

Cesar Picado: In the last 5 years, C. Picado has been awarded grants for Research Projects from Uriach SA, Phadia, Chiesi, AstraZeneca, Leti, Novartis, and MSD; and he has participated as investigator in Clinical Trials for Uriach SA and Chiesi. Dr Pérez de Llano L, Dr Vennera M, and Dr Borderías L have received payments from Novartis Farmaceútica for lectures and consultancies and support for attendance of scientific meetings. The rest of the authors declare that they have no competing interests.