Dupilumab effectiveness and safety in patients with chronic rhinosinusitis with nasal polyps: Two-year results from the Assessing long-teRm Outcomes in dupiluMAb registry.
Anju T Peters, Andrew A White, Shigeharu Fujieda et al.
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In 30 seconds
The phase 4, prospective, global AROMA registry followed adults with chronic rhinosinusitis with nasal polyps (CRSwNP) initiating dupilumab in real-world practice. Among 691 patients enrolled by May 2024, symptom and quality-of-life measures improved from baseline, with changes evident by month 3 and sustained through month 24. Mean nasal congestion scores fell from 1.8 to 0.5, loss-of-smell scores from 2.2 to 0.9, and 22-item Sino-Nasal Outcome Test scores from 45.9 to 18.4 at month 24. During the first 6 months, 20.7% reported at least one treatment-emergent adverse event.
Key findings
- Mean nasal congestion score decreased from 1.8 (0.86) at baseline to 0.5 (0.66) at month 24.
- Mean loss-of-smell score decreased from 2.2 (1.06) to 0.9 (0.96) at month 24.
- Mean 22-item Sino-Nasal Outcome Test score decreased from 45.9 (21.37) to 18.4 (14.55) at month 24.
- In the first 6 months, 20.7% of patients reported at least one treatment-emergent adverse event.
Why it matters
CRSwNP can substantially impair symptoms and health-related quality of life, while long-term real-world evidence for dupilumab has been limited. These registry findings describe sustained improvement in patient-reported symptoms and quality of life over 24 months in a population that commonly had asthma and previous sinonasal surgery, alongside reported early treatment-emergent adverse events.
What to keep in mind
The registry is observational and has no comparator group, so improvements cannot be attributed to dupilumab with the certainty of a randomised comparison. The reported follow-up results extend to 24 months, although the study aims to follow patients for up to 36 months.