(322) Efficacy and safety of biologics in asthma and chronic rhinosinusitis with nasal polyps: a systematic review

Background: Asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), are strongly associated, and patients suffering from both diseases are often difficult to treat. However, the efficacy and safety of biologics for united airway disease (UAD) is limited, with findings presenting a mixed picture.

Objectives: To evaluate the effectiveness and safety of biologicals, including omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab, from a UAD perspective based on recent scientific evidence.

Methods: A systematic search of PubMed, EMBASE, and The Cochrane Library databases was conducted for the clinical studies focused on efficacy and safety of biologics in asthma and CRSwNP from inception to August 31, 2023. Quality assessment was performed with the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool for non-randomized studies, and the Cochrane Risk of Bias tool for the evaluation of randomized trials. Critical and important outcomes related to asthma and CRSwNP were evaluated for each of the biologicals.

Results: In total, 30 publications with 2251 individuals met the inclusion criteria. All the interventions improved the majority of subjective and objective outcomes significantly. Following treatment with biologic agents, patients showed significant improvement in the Asthma Control Questionnaire (ACQ) at 4, 16, 24, 48, and 52 weeks compared to baseline and placebo, with greater improvement observed in asthma patients with nasal polyps compared to those without. Asthma Control Test (ACT) scores significantly improved after 4 and 6 months of biologic therapy compared to baseline. Scores on the 22-item Sinonasal Outcome Test (SNOT-22) significantly improved at 4 weeks, 4 months, 6 months, and 12 months following biologic therapy compared to baseline and placebo, though no statistical difference was observed compared to surgical intervention. Nasal Polyp Score (NPS) significantly improved within 12 months of biologic therapy compared to baseline and placebo. Lund-Mackay CT scores (LMS) significantly improved after 4 and 12 months of biologic therapy compared to baseline and placebo, with controversial improvement observed at 6 months of treatment. Overall, biologic agents for asthma were well-tolerated, with adverse reactions mostly mild, commonly localized injection site reactions, and occasional severe adverse events.

Conclusions: Biologic therapies may potentially be demonstrated to be beneficial and well-tolerated for treating asthma comorbid with CRSwNP.