Article type
Abstract
Background: Severe allergic asthma is a condition with significant impact on quality of life and mortality rates. Currently, only omalizumab (a monoclonal antibody against Immunoglobulin E) is available in the Brazilian public health system to treat allergic asthma. Dupilumab is a recombinant monoclonal antibody against IL-4 receptor that works by inhibiting the activation of certain pro-inflammatory cytokines implicated in the pathophysiology of several allergic conditions, showing promising benefits in allergic asthma.
Aim: to compare the efficacy and safety of dupilumab with omalizumab in patients with severe allergic asthma.
Methods: Two systematic reviews were conducted on Medline/Pubmed, EMBASE and Cochrane Central to evaluate the efficacy and safety of dupilumab and omalizumab treatments on patients with allergic severe asthma. Assessment of risk of bias was conducted through Risk of Bias (RoB) 2.0 in all eligible studies. To compare the two biologics, a meta-analysis of indirect comparisons was conducted using a frequentist approach. All analyses were performed using the R software, specifically the meta and netmeta packages. The assessment of evidence quality was conducted using the GRADE system for network meta-analysis.
Results: We identified four studies related to dupilumab and eight studies related to omalizumab following eligibility criteria. To evaluate effectiveness outcomes, studies or study subgroups assessing patients with severe allergic asthma were utilized, generally defined as total IgE equal to or greater than 30 IU/mL and sensitivity to one or more perennial allergens. Dupilumab reduces in 31% the exacerbation rate compared to omalizumab (RR: 0.69; 95%CI: 0.54 to 0.87; low CoE due to risk of bias and indirectness in omalizumab) and enhances FEV-1 levels compared to omalizumab (MD: 0,08 L; 95%CI: 0.03 to 0.13; low CoE due to risk of bias and indirectness in omalizumab). No statistical difference was observed in adverse events leading to treatment discontinuation (RR: 0.74; 95%CI: 0.28 to 1.93; moderate CoE due to imprecision).
Conclusion: In this indirect comparison, dupilumab was associated with lower severe asthma exacerbation rates and greater improvements in lung function than omalizumab.
Aim: to compare the efficacy and safety of dupilumab with omalizumab in patients with severe allergic asthma.
Methods: Two systematic reviews were conducted on Medline/Pubmed, EMBASE and Cochrane Central to evaluate the efficacy and safety of dupilumab and omalizumab treatments on patients with allergic severe asthma. Assessment of risk of bias was conducted through Risk of Bias (RoB) 2.0 in all eligible studies. To compare the two biologics, a meta-analysis of indirect comparisons was conducted using a frequentist approach. All analyses were performed using the R software, specifically the meta and netmeta packages. The assessment of evidence quality was conducted using the GRADE system for network meta-analysis.
Results: We identified four studies related to dupilumab and eight studies related to omalizumab following eligibility criteria. To evaluate effectiveness outcomes, studies or study subgroups assessing patients with severe allergic asthma were utilized, generally defined as total IgE equal to or greater than 30 IU/mL and sensitivity to one or more perennial allergens. Dupilumab reduces in 31% the exacerbation rate compared to omalizumab (RR: 0.69; 95%CI: 0.54 to 0.87; low CoE due to risk of bias and indirectness in omalizumab) and enhances FEV-1 levels compared to omalizumab (MD: 0,08 L; 95%CI: 0.03 to 0.13; low CoE due to risk of bias and indirectness in omalizumab). No statistical difference was observed in adverse events leading to treatment discontinuation (RR: 0.74; 95%CI: 0.28 to 1.93; moderate CoE due to imprecision).
Conclusion: In this indirect comparison, dupilumab was associated with lower severe asthma exacerbation rates and greater improvements in lung function than omalizumab.