Patient-reported outcomes in moderate-to-severe allergic asthmatics treated with omalizumab: a systematic literature review of randomized controlled trials

• Published in: Current medical research and opinion 2018-01, Vol.34 (1), p.65-80
• Main Authors: Corren, Jonathan, Kavati, Abhishek, Ortiz, Benjamin, Vegesna, Ashok, Colby, Jennifer A., Ruiz, Kimberly, Panettieri, Reynold A.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; allergic asthma; Anti-Asthmatic Agents - therapeutic use; Asthma - drug therapy; Child; Humans; IgE response underlying allergic asthma and rhinitis; omalizumab; Omalizumab - therapeutic use; Patient Reported Outcome Measures; patient reported outcomes; Randomized Controlled Trials as Topic
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1080/03007995.2017.1395734

Objective: Randomized controlled trials (RCTs) have established the safety and efficacy of omalizumab on clinical parameters, and have also evaluated its impact on patient-reported outcomes (PROs). The purpose of this systematic literature review was to review published data based on PRO endpoints in order to determine the benefit of omalizumab as add-on therapy to inhaled corticosteroids in patients with moderate-to-severe persistent allergic asthma. Methods: A systematic literature review was conducted of reference databases and recent conferences. RCTs of add-on omalizumab therapy in adults, adolescents, and children with moderate-to-severe persistent asthma were included. Two researchers independently screened and reviewed articles with regards to inclusion and exclusion criteria for relevant studies. Results: Twenty-six trials met the criteria for inclusion. Of these, PRO measures were included in 19 trials to capture the impact of omalizumab on symptoms, 11 assessed patients for health-related quality-of-life (HRQoL), and four evaluated asthma control. Other PROs related to global evaluation of treatment effectiveness and work productivity. Overall, results demonstrated a significant difference across most PROs in favor of omalizumab add-on therapy vs placebo or comparators. Conclusions: PROs are an integral part of outcome assessment in clinical trials related to asthma. The RCTs reviewed demonstrate that omalizumab treatment improves PROs in patients with moderate-to-severe persistent allergic asthma, particularly symptom control and HRQoL.