Patient-reported outcomes in moderate-to-severe allergic asthmatics treated with omalizumab: a systematic literature review of randomized controlled trials. (2nd January 2018)

• Record Type: Journal Article
• Authors: Corren, Jonathan; Kavati, Abhishek; Ortiz, Benjamin; Vegesna, Ashok; Colby, Jennifer A.; Ruiz, Kimberly; Panettieri, Reynold A.
• Is Part Of: Current medical research and opinion. Volume 34:Number 1(2018)
• Page Start: 65
• Page End: 80
• Publication Date: 2018-01-02
• Subjects: IgE response underlying allergic asthma and rhinitis -- allergic asthma -- omalizumab -- patient reported outcome measures -- patient reported outcomes; Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1080/03007995.2017.1395734
• Languages: English
• ISSNs: 0300-7995

Abstract

Abstract: 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.