Distribution of Baseline Type 2 Inflammation Characteristics in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Biologic Clinical Trials: A Comparative Assessment
Abstract
Background: CRSwNP is frequently driven by type 2 inflammation, characterised by the presence of biomarkers (e.g. blood/tissue eosinophil count and iIgE). Type 2 inflammation drives comorbidities such as asthma and non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). CRSwNP patients (pts) with vs without these conditions tend to experience greater disease burden . Method: Distribution of baseline type 2 characteristics was assessed among CRSwNP pts who received biologics in a clinical trial setting. Pts from the SINUS-24/52 (dupilumab, anti-interleukin [IL]-4Rα), POLYP-1/2 (omalizumab, anti-IgE), SYNAPSE (mepolizumab, anti-IL-5), and OSTRO (benralizumab, anti-IL-5Rα) trials were included, as well as pts from the Phase III ANCHOR-1/2 trials. ANCHOR-1/2 investigated efficacy and safety of depemokimab (ultra-long-acting anti-IL-5 administered twice yearly) vs placebo. Assessed type 2 characteristics included reported mean baseline levels of clinical biomarkers (blood eosinophil count [BEC; cells/µL] and IgE [U/mL]) and proportion of pts with comorbid asthma and NSAID-ERD. Results: Mean baseline BEC and IgE levels were generally lower in the ANCHOR-1/2 trials vs pts receiving biologics in other trials (BEC: ANCHOR-1/2=333 cells/µL, POLYP-1/2=340 cells/µL, SYNAPSE=395 cells/µL, SINUS-24/52=430 cells/µL, OSTRO=447 cells/µL; IgE: ANCHOR-1/2=128.1 U/mL, POLYP-1/2=175.5 U/mL, SINUS-24/52=229.2 U/mL, OSTRO=233 U/mL). A lower proportion of pts in ANCHOR-1/2 had asthma (ANCHOR-1/2=55%, POLYP-1/2=57%, SINUS-24/52=59%, OSTRO=68%, SYNAPSE=71%) or NSAID-ERD (ANCHOR-1/2=16%, SYNAPSE=27%, POLYP-1/2=27%, SINUS-24/52=28%, OSTRO=30%) than in the other trials. Conclusion: The ANCHOR-1/2 population included a lower proportion of pts with type 2 characteristics than previous trials for CRSwNP. These differences may be driven by factors including distinct geographic footprints, or biologic availability during the later trials. CRSwNP pts and biomarkers of type 2 inflammation have greater disease burden and comprise a more biologic-treatment responsive population; the proportion of such pts at baseline should be considered when interpreting outcomes from clinical studies of biologics in CRSwNP. Funding: GSK Fig. 1 Publication History Article published online: 04 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Fields of Study & Subjects
Sinusitis and nasal conditions
Asthma and respiratory diseases
Cystic Fibrosis Research Advances
Publication details
- Journal / source
- Pneumologie
- Volume
- 80
- Publication date
- 1 March 2026
- Language
- EN