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 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.
Competing Interests: The study was conducted in accordance with the ethical principles laid down in the Declaration of Helsinki and the AIFA Guideline for classification and management of observational studies on drugs. All patients provided informed consent before participating in the study.Not applicable.Giorgio Walter Canonica reports having received research grants as well as lecture or advisory board fees from A. Menarini, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, Glaxo Smith Kline, Mundipharma, Novartis, Sanofi-Aventis, Teva. Paola Rottoli reports receiving personal fees and other from Roche, personal fees from Boehringer Ingelheim, grants and personal fees from Novartis, personal fees from TEVA, other from Menarini, from null, outside the submitted work. Bruno Macciocchi reports receiving grants from Boehringer Ingelheim. Pierachille Santus reports receiving personal fees from Astra Zeneca, grants and personal fees from Boehringer ingelheim, grants from Almirall, grants and personal fees from Chiesi Farmaceutici, personal fees from Guidotti, personal fees from GSK, personal fees from Zambon Italia, outside the submitted work. Marta Bartezaghi and Laura Rigoni are the employees of Novartis.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.