Chronic Rhinosinusitis with Nasal Polyps and Biologics: A Call for Better Data Standardisation and Presentation in Clinical Studies.

Abstract

Chronic rhinosinusitis with nasal polyps (CRSwNP) is often severe, debilitating and difficult to treat. Recent randomised control trials (RCTs) of biologics that target key inflammatory pathways have demonstrated clinical efficacy in treating CRSwNP. Such RCTs must facilitate meta-analysis. Here we report the need for urgent improvement in double-blind randomised controlled trials of biologics in CRSwNP, having previously undertaken a systematic review and meta-analysis of such studies. The RCTs included in that systematic review did not conform to a standard study design. Patient selection criteria was not consistent in studies with several heterogeneous disease subgroups of CRSwNP patients present in each study. Different durations of treatment and variable outcome measures also made the comparative assessment of efficacy between different biologics difficult. Data presentation to allow extraction for meta-analysis was not always clear, such that on occasion selected data sets or even an entire RCT had to be excluded from further evaluation. As such, the high heterogeneity between studies made the overall interpretation of the findings difficult. We make an urgent call to design and conduct future RCTS of biologics in CRSwNP in a more standardised manner, and to present data in a clear way that is easily extractable. This will facilitate more inclusive and thus robust evaluation and interpretation via meta-analysis, which will in turn enable clearer insight into which CRSwNP patient subgroups might benefit from specific biologics and thus achieve better clinical outcomes.