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A systematic review of the steroid sparing effect of biologicals in severe asthma








A systematic review of the steroid sparing effect of biologicals in severe asthma


André Moreira


EPIUnit - Instituto de Saúde Pública, Universidade do Porto, Portugal & Faculdade de Medicina da Universidade do Porto, Portugal & Centro Hospitalar São João, Porto, Portugal






10 February 2022


Contrary to previous treatment strategies, biologicals impact specific pathways and have demonstrated their efficacy and improved outcomes in asthma exacerbations and control. Biologicals are monoclonal antibodies - which are proteins obtained using genetic engineering methods - that act on specific inflammatory molecules or cell receptors to disrupt specific pathways. Moreover, patients with severe asthma are characterized by a high pharmacological burden, particularly, corticosteroids (both inhaled and oral) which have been associated with several adverse effects - increased blood pressure, glaucoma, fluid retention, weight gain - thus, it is relevant to summarize the results obtained for these particular outcomes. In this systematic review and meta-analysis, we intend to gather information on inhaled and oral steroid sparing effects (i.e., steroid dosage reduction) from the published RCTs of biologicals for severe asthma. The review was submitted to the PROSPERO database.



[{ "PostingID": 3792, "Title": "GSK-MEA112997", "Description": "A multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to determine the effect of mepolizumab on exacerbation rates in subjects with severe uncontrolled refractory asthma" },{ "PostingID": 3793, "Title": "GSK-MEA115588", "Description": "MEA115588 A randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe uncontrolled refractory asthma" },{ "PostingID": 3794, "Title": "GSK-MEA115575", "Description": "MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma" },{ "PostingID": 4878, "Title": "GSK-200862", "Description": "A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre 24-week Study to Evaluate the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects with Severe Eosinophilic Asthma on Markers of Asthma Control" },{ "PostingID": 20760, "Title": "NOVARTIS-CIGE025AFR05", "Description": "A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy" },{ "PostingID": 20761, "Title": "NOVARTIS-CIGE025A2313", "Description": "A 24-week, Phase III randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of Xolair® (omalizumab) in patients with moderate to severe persistent allergic asthma who remain not adequately controlled despite GINA (2009) Step 4 therapy" }]

Statistical Analysis Plan