Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies

Abstract

Background

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2‐mediated inflammatory disease with high symptom burden and reduced health‐related quality of life (HRQoL). This report aimed to comprehensively understand the effects of dupilumab on domains of HRQoL, their individual elements, and health status in patients with severe CRSwNP from phase 3 SINUS‐24 (NCT02912468) and SINUS‐52 (NCT02898454) trials.

Methods

Patients were randomized to dupilumab ( n = 438) or placebo ( n = 286) for 24 weeks (SINUS‐24), or 52 weeks (SINUS‐52). Disease‐specific HRQoL using 22‐item sino‐nasal outcome test (SNOT‐22), and health status using EuroQoL‐visual analog scale (EQ‐VAS) was evaluated in the pooled intention‐to‐treat (ITT) population (Week 24), SINUS‐52 ITT (Week 52) and in the subgroups with/without asthma; non‐steroidal anti‐inflammatory drug‐exacerbated respiratory disease (NSAID‐ERD); and prior sinus surgery.

Results

At baseline, patients had poor disease‐specific HRQoL and general health status and identified “Decreased sense of smell/taste” and “Nasal blockage” as the most important symptoms. Dupilumab significantly improved SNOT‐22 total, domain (Nasal, Sleep, Function, Emotion, and Ear/facial), and 22‐item scores, and EQ‐VAS, at Week 24 vs placebo (all p < .0001), with continued improvements to Week 52 in SINUS‐52. Improvements occurred irrespective of comorbid asthma, NSAID‐ERD, or prior surgery. A significantly greater proportion of dupilumab‐treated patients exceeded clinically meaningful thresholds for SNOT‐22 total score and EQ‐VAS vs placebo (all subgroups p < .05 except patients without surgery at Week 24).

Conclusions

Dupilumab treatment led to significant clinically meaningful improvements across all aspects of disease‐specific HRQoL, and general health status in patients with severe CRSwNP.

Abstract

CRSwNP is a predominantly type 2‐mediated inflammatory disease with high symptom burden that impacts HRQoL. In the SINUS‐24 and SINUS‐52 studies, patients with CRSwNP were randomized to dupilumab or placebo. Dupilumab led to significant clinically meaningful improvements across all aspects of disease‐specific HRQoL and general health status in patients with CRSwNP, irrespective of comorbid asthma, NSAID‐ERD, or prior NP surgery.Abbreviations: CRSwNP, chronic rhinosinusitis with nasal polyps; EQ‐VAS, EuroQoL‐visual analog scale; HRQoL, health‐related quality of life; ITT, intent to treat; NSAID‐ERD, non‐steroidal anti‐inflammatory drug‐exacerbated respiratory disease; NP, nasal polyp; SINUS‐24 and SINUS‐52, two placebo‐controlled clinical studies assessing dupilumab in patients with chronic rhinosinusitis with nasal polyps over 24 and 52 weeks, respectively; SNOT‐22, 22‐item Sino‐Nasal Outcome Test