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. 2025 Apr;42(4):1783-1799.
doi: 10.1007/s12325-025-03120-y. Epub 2025 Feb 19.

Real-world Outcomes Following Biologic Initiation in US Patients with Chronic Rhinosinusitis with Nasal Polyps

Anju Peters  1 , Xiaohui Zhao  2 , Aimee M Near  2 , Joseph Han  3 , Joseph D Spahn  4 , Sze-Jung S Wu  4 , Andrew W Lindsley  5 , Tham T Le  6 , Elizabeth J Wang  2 , Rifat Tuly  2 , Inyoung Lee  2 , Christopher S Ambrose  7   8
Affiliations

Real-world Outcomes Following Biologic Initiation in US Patients with Chronic Rhinosinusitis with Nasal Polyps

Anju Peters et al. Adv Ther. 2025 Apr.

Abstract

Introduction: Chronic rhinosinusitis with nasal polyposis (CRSwNP) is often associated with persistent symptoms and impaired quality of life despite treatment with intranasal corticosteroids. Biologics (dupilumab, mepolizumab, omalizumab) have been recently approved for CRSwNP. This study aims to characterize biologic use and real-world outcomes, including medication use and nasal polyps (NP) surgeries, following biologic treatment in US patients with CRSwNP.

Methods: This retrospective cohort study analyzed linked data from IQVIA longitudinal prescription and medical claims databases (July 2018-June 2023). Patients evaluated included those with ≥ 2 diagnoses of CRSwNP and ≥ 12 months of baseline data (overall cohort, index = first observed CRSwNP diagnosis) as well as patients with CRSwNP who received ≥ 2 consecutive biologic doses and had ≥ 24 months of follow-up data (biologic cohort, index = first biologic).

Results: Of 74,480 patients with CRSwNP, 8716 (12.0%) received a biologic and 2208 met all inclusion criteria. Dupilumab was the most frequently received biologic (89.8%; mepolizumab, 5.3%; omalizumab, 4.8%). Relative to the overall cohort, the biologic cohort was younger (mean age: 52.6 vs. 57.6 years), had more women (54.0% vs. 46.1%) and had a higher baseline prevalence of asthma (72.4% vs. 30.9%), allergic rhinitis (70.6% vs. 37.4%), NP surgery (15.8% vs. 5.8%), oral corticosteroid (OCS) use (84.0% vs. 51.8%), and antibiotic use (84.2% vs. 68.7%). During the 24 months after biologic initiation, 65.6% of patients had ≥ 1 OCS use (≥ 2 OCS uses during months 1-12, 27.0%; during months 13-24, 27.0%) and 77.9% had ≥ 1 antibiotic use; and 7.1% of patients without NP surgery before biologic initiation had ≥ 1 NP surgery during follow-up. Almost half of patients (49.3%) discontinued (≥ 90 days without receipt) their initial biologic during follow-up.

Conclusion: Biologic use was relatively low among US patients with CRSwNP. OCS and antibiotic usage among patients with CRSwNP remained substantial despite use of currently approved biologics, indicating an unmet need for improved treatment options.

Keywords: Allergist/immunologist; Biologics; Chronic rhinosinusitis with nasal polyposis (CRSwNP); Dupilumab; Ear-nose-throat; Mepolizumab; Omalizumab; Otolaryngologist; Real-world data.

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Conflict of interest statement

Declarations. Conflict of Interest: Anju T. Peters has received fees for sponsored research from AstraZeneca, Merck and Sanofi, and consultancy fees from AstraZeneca, Chiesi, GSK, Merck, Eli Lilly, and Sanofi. Joseph K. Han has received consultancy fees from AstraZeneca, Genentech, Gossamer Bio, GSK, Novartis, Regeneron Pharmaceuticals and Sanofi. Joseph D. Spahn, Sze-jung S. Wu, Tham T Le, and Christopher S. Ambrose are employees of AstraZeneca and may own stock or stock options in AstraZeneca. Andrew W. Lindsley is an employee of Amgen and owns stock in Amgen. Rifat Tuly, Elizabeth J. Wang, Xiaohui Zhao and Aimee M. Near are employees of IQVIA, which received funding from AstraZeneca to conduct the research study. Inyoung Lee was an employee of IQVIA during the study conduct and is currently employed by AbbVie. Ethical Approval: As a retrospective study using secondary data, no interventions were made to patients during this study. In compliance with the Health Insurance Portability and Accountability Act (HIPAA), patient data included in the analyses were de-identified; therefore, this study was exempt from Institutional Review Board (IRB) review. Permission was obtained to access and use the data from the IQVIA longitudinal prescription (LRx) and medical claims (Dx) databases, which are owned by IQVIA.

Figures

Fig. 1
Fig. 1
Patient selection process: (1) CRSwNP diagnosis was identified by ICD-10-CM codes of J33.0 and J33.9; (2) clinical trial enrollment was identified by ICD-10-CM code of Z00.6. CRSwNP chronic rhinosinusitis with nasal polyposis, NP nasal polyps
Fig. 2
Fig. 2
Proportion of patients with index biologic discontinuation. NP nasal polyps
Fig. 3
Fig. 3
All-cause oral corticosteroid use across the 24 months following biologic initiation. PPPY per patient per year
Fig. 4
Fig. 4
NP surgery across the 24 months following biologic initiation, stratified by the presence (A) and absence (B) of NP surgery up to 24 months prior to biologic initiation. NP nasal polyps
Fig. 5
Fig. 5
Treatment pathway before and after dupilumab initiation. NP nasal polyps
See this image and copyright information in PMC

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