Mild and symptom-free months in patients with chronic rhinosinusitis with nasal polyps treated with dupilumab.

BACKGROUND

Commonly reported outcomes of clinical trials in chronic rhinosinusitis with nasal polyps (CRSwNP) may have limited relatability for patients.

OBJECTIVE

To enhance the patient relatability of outcomes in dupilumab clinical trials for CRSwNP, daily symptom scores were used to determine new patient‑centered endpoints: mild-to-no-symptom months (MSM) and symptom-free months (SFM).

METHODS

Post hoc analysis of patients receiving dupilumab 300 mg or placebo every 2 weeks for 24 weeks (SINUS-24 study; NCT02912468) or 52 weeks (SINUS‑52; NCT02898454). Patients recorded symptom severity scores daily for each of nasal congestion, loss of smell, and anterior and posterior rhinorrhea on a scale of 0-3 (0 = no symptoms; 1 = mild; 2 = moderate; 3 = severe). We assessed the proportions of patients reporting only mild or no symptoms (MSM) or no symptoms (SFM) throughout the 28‑day periods prior to randomization, Week 24 (pooled studies), and Week 52 (SINUS‑52).

RESULTS

Significantly more dupilumab‑treated than placebo-treated patients achieved MSM for all four symptoms (Week 24: 31.0% vs 4.4%; OR 12.9 [6.4, 25.8]; Week 52: 38.3% vs 2.6%; OR 15.6 [5.9, 41.0]; both P < .0001). Additionally, significantly more dupilumab-treated than placebo‑treated patients achieved SFM for at least one of the four symptoms (Week 24: 35.4% vs 10.8%; odds ratio [OR] 4.9 [95% confidence interval 3.1, 7.8]; Week 52: 50.0% vs 9.2%; OR 9.1 [4.6, 17.9]; both P < .0001).

CONCLUSION

One-third of patients with severe CRSwNP treated with dupilumab achieved MSM for all four cardinal symptoms (nasal congestion, loss of smell, and anterior and posterior rhinorrhea). Moreover, half of patients achieved SFM for at least one of the four symptoms. These results support the benefit of dupilumab in improving patient‑centered outcomes.

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Copyright © 2024. Published by Elsevier Inc.