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

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.

Keywords:

• IgE response underlying allergic asthma and rhinitis
• allergic asthma
• omalizumab
• patient reported outcome measures
• patient reported outcomes

Transparency

Declaration of funding

Novartis Pharmaceuticals Corporation funded this research.

Declaration of financial/other relationships

Drs Kavati, Ortiz, and Vegesna are employees of Novartis Pharmaceuticals Corporation, which funded this research. Drs Kavati, Ortiz, and Vegesna are stock shareholders of Novartis Pharmaceuticals Corporation. Dr Corren has received grant or research funding from 3M Pharmaceuticals, Sanofi, Regeneron, Aimmune Therapeutics, and Circassia. Dr Corren has been a consultant or advisor to MedImmune, AstraZeneca, Vectura Group, and Regeneron, and has participated in speakers bureaus for Teva Pharmaceutical Industries, Genentech, Novartis Pharmaceuticals Corporation, and AstraZeneca. Dr Panettieri has received grant or research funding from Theratrophix, OncoArendi Therapeutics, Amgen, RIFM, Vertex Pharmaceuticals, Bristol-Myers Squibb, Gilead, Genentech, Sanofi, and Regeneron. Dr Panettieri has been a consultant or advisor to AstraZeneca and MedImmune, and has participated in speakers bureaus for Boston Scientific and Teva. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial relationships to disclose.

Acknowledgments

The authors would like to acknowledge Brett Maiese, PhD, MHS for assistance in the data analysis and Ari Gnanasakthy, MBA, MSc, for revising the early versions of this manuscript. Medical writing and editorial assistance in the development of this manuscript were provided by Xcenda, LLC, Palm Harbor, FL, and this service was supported by Novartis Pharmaceuticals Corporation, East Hanover, NJ.