Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review

Abstract

Objective

The efficacy and safety of mepolizumab in patients with severe eosinophilic asthma in randomized controlled trials is well established. Following approval of mepolizumab as add-on therapy for severe eosinophilic asthma in multiple regions worldwide, it is now important to determine its impact in real-world settings in which patients are not subject to stringent eligibility criteria. This systematic literature review assessed published evidence of clinical outcomes, safety, and healthcare resource use among patients with severe asthma receiving mepolizumab in real-world settings.

Data sources

Searches were conducted in Embase, MEDLINE, and MEDLINE In-Process via Ovid.

Study selections

Eligible studies were observational, and enrolled ≥10 patients with asthma who received mepolizumab 100 mg subcutaneously. Data extracted included annualized exacerbation rate, mean daily oral corticosteroid (OCS) dose, proportion of patients using OCS, several measures of lung function, patient-reported asthma control and health-related quality of life (HRQoL), safety, and economic burden.

Results

Twenty-three articles (22 unique studies; 2,040 patients with severe asthma on mepolizumab) were identified. Mepolizumab use was associated with a reduction in annualized exacerbation rates (requiring OCS) of 54–97% (p < 0.05 in all studies), reduced mean/median daily OCS doses, and OCS discontinuation during follow-up (27–84% of patients). Improvements in lung function, asthma control, and HRQoL were also observed. The most commonly reported adverse events included headache and arthralgia; discontinuation of mepolizumab due to adverse events occurred in 0–10.6% of patients.

Conclusion

Findings show that patients with severe asthma consistently demonstrate clinically relevant benefits with mepolizumab treatment in a real-world setting.

Supplemental data for this article is available online at at www.tandfonline.com/ijas .

Keywords:

• Therapy
• treatment
• management/control
• quality of life

Acknowledgements

This study was funded by GlaxoSmithKline (GSK; ID: 213095). Analyses were performed by Evidera, funded by GSK; employees did not receive funding for manuscript development. Editorial support (in the form of writing assistance, including development of the initial draft from the author discussions, assembling tables and figures, collating authors comments, grammatical editing and referencing) was provided by Bianca Paris, PhD, at Fishawack Indicia Ltd, UK, part of Fishawack Health, and was funded by GSK.

Author contributions

SY, PHH, ALM, MK, SGS and RAC all contributed to the conception or design of this study and were involved in the acquisition of data. All authors were involved in the data analysis and interpretation, contributed to the development of the manuscript, and approved the final version for submission. All authors agree to be accountable for all aspects of the work.

Disclosure of interest

EI reports consultancy fees from AB Science, Allergy and Asthma Network, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Equillium, Genentech, GSK, Merck, NHLBI, Novartis, Pneuma Respiratory, PPS Health, Regeneron, Sanofi Genzyme, Sienna Biopharmaceuticals and Teva; receipt of study drug/equipment from Boehringer Ingelheim, Circassia, Genentech, GSK and Teva; clinical research grants from AstraZeneca, Avillion, Circassia, Gossamer Bio, NIH, Novartis and PCORI; advisory board participation for Novartis; royalties from UpToDate and stock options from Vorso; he was a co-ordinating committee member for the National Asthma Education Prevention Program. GWC reports research grants and fees from A.Menarini, Alk-Abello’, Allergy Therapeutics, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, GSK, Hal Allergy, Mylan, Merck, Merck Sharp & Dome, Mundipharma, Novartis, Regeneron, Roche, Sanofi-Aventis, Sanofi-Genzyme, Stallergenes-Greer, UCB Pharma, Uriach Pharma, Valeas and Vibor-Pharma. GB has received honoraria for lectures from AstraZeneca, Boehringer-Ingelheim, Chiesi, GSK, Novartis, Teva and Sanofi; he is a member of advisory boards for Amgen, AstraZeneca, Boehringer-Ingelheim, Chiesi, GSK, Novartis, Sanofi/Regeneron and Teva. SY, PHH, SGS and RAC are employees of GSK and hold stocks/shares. ALM is an employee of Evidera and MK is a former employee of Evidera and a current employee of Xcenda UK Ltd; as Evidera employees, they did not receive any direct payments or honoraria for their services.

Data availability statement

Data recorded in the data extraction template for this systematic literature review are available upon reasonable request from GlaxoSmithKline

Additional information

Funding

This work was funded by GlaxoSmithKline (GSK ID: 213095).