Data Mining of Free-Text Responses: An Innovative Approach to Analyzing Patient Perspectives on Treatment for Chronic Rhinosinusitis with Nasal Polyps in a Phase IIa Proof-of-Concept Study for Dupilumab

Khan, Asif; Abbé, Adeline; Falissard, Bruno; Carita, Paulo; Bachert, Claus; Mullol, Joaquim; Reaney, Matthew; Chao, Jingdong; Mannent, Leda; Amin, Nikhil; Mahajan, Pooja; Pirozzi, Gianluca; Eckert, Laurent

doi:10.2147/ppa.s320242

Cited by 2 publications

(1 citation statement)

References 38 publications

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“…5 Consequently, patients with CRSwNP often become frustrated with their symptoms, particularly LoS. [6][7][8] Patients with CRSwNP experience a high clinical burden, 1-3 associated with a greater number of physician visits, comorbidities, and increased healthcare costs than the general population. 9 The annual US healthcare cost of CRSwNP is estimated to be $5.7 billion.…”

Section: Introductionmentioning

confidence: 99%

Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial

Máspero¹,

Khan²,

Philpott³

et al. 2023

JAA

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Purpose Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease with a high symptom burden. Data are lacking on the comparative health status of patients with CRSwNP. This analysis compared baseline physical and mental health-related quality of life (HRQoL) and overall health status of patients with severe CRSwNP enrolled in a Phase 3 clinical trial with general population norms and with other chronic diseases. Methods In this post hoc cross-sectional analysis of baseline data from the SINUS-24 study (NCT02912468), HRQoL was measured using the 36-item Short Form (SF-36) questionnaire and general health status was measured using the EuroQol-5 Dimension visual analog scale (EQ-VAS). Analyses included the intention-to-treat (ITT) population and subgroups defined by prior sinonasal surgery, systemic corticosteroid use, and coexisting asthma or non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Scores were compared with published values for population norms (50 for SF-36 physical component summary (PCS) and mental component summary (MCS), 70.4−83.3 for EQ-VAS) and for rheumatoid arthritis, type 2 diabetes, and asthma. Results In the ITT population (n=276), mean SF-36 physical component summary (PCS), SF-36 mental component summary (MCS), and EQ-VAS scores were below general population norms (46.4, 48.6, and 66.0, respectively). Mean SF-36 PCS and EQ-VAS scores were below population norms across all subgroups; mean SF-36 MCS scores were below the population norm in all subgroups except no prior surgery. SF-36 PCS and MCS scores from SINUS-24 were generally similar to other chronic diseases, except SF-36 PCS which was lower in rheumatoid arthritis. EQ-VAS scores in SINUS-24 were lower than in other chronic diseases. HRQoL scores weakly correlated with objective measures of disease severity. Conclusion In patients with severe CRSwNP, including those with coexisting asthma/NSAID-ERD, HRQoL was worse than population norms and as burdensome as diseases such as type 2 diabetes, asthma, and rheumatoid arthritis.

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