A significantly greater proportion of patients with chronic rhinosinusitis with nasal polyps reported symptom-free days for at least 1 symptom when treated with dupilumab vs placebo in the 28 days preceding 24-week and 52-week analysis intervals.
A significantly greater proportion of patients with chronic rhinosinusitis with nasal polyps (CRSwNP) reported symptom-free days when treated with dupilumab vs placebo over 52 weeks, according to findings reported at the 2022 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting and published in The Journal of Allergy and Clinical Immunology.
Dupilumab, a fully human monoclonal antibody that blocks 2 key and central drivers of type 2 inflammation, interleukin (IL)-4 and IL-13, has been shown in prior studies to improve health-related quality of life (HRQOL) and general health status of patients with severe CRSwNP.
Additionally, it has demonstrated significant reduction in olfactory dysfunction, one of most common and troublesome symptoms affecting the health of patients with CRSwNP.
Researchers of the present abstract sought to investigate the number of symptom-free days achieved with dupilumab. They conducted a post hoc analysis of patients with symptom-free days in the phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) studies.
Use of dupilumab 300 mg every 2 weeks or placebo for the treatment of CRSwNP was investigated to week 24 (pooled) and week 52 (SINUS-52). Patients recorded symptom severity for nasal congestion, anterior and posterior rhinorrhea, and decreased/loss of smell on a scale of 0 to 3, ranging from no symptoms (0) to severe (3).
Proportions of patients with symptom-free days, measured by a score of 0 in the 28-day period before randomization at weeks 24 and 52, were compared for dupilumab and placebo. Patients with data for less than 21 days in each 28-day period were excluded.
A total of 723 patients with CRSwNP randomized to either dupilumab (n = 437) or placebo (n = 286) were included in the analysis at baseline. In the 28-day period prerandomization, only 0% to 3.3% of patients had symptom-free days for the 4 individual symptoms.
Participants randomized to dupilumab were found to be greater than 5 times more likely to report symptom-free days for at least 1 symptom in the 28 days before week 24 than those given placebo (36.3% vs 10.9%; odds ratio [OR], 5.28; 95% CI, 3.05-9.14; nominal P < .0001).
Moreover, this significant difference was shown to increase at the 28-day period before week 52 with patients with CRSwNP exhibiting a near 10-fold greater likelihood of reporting symptom-free days with dupilumab treatment vs placebo (50.5% vs 8.3%; OR, 9.98; 95% CI, 4.59-21.69; nominal P < .0001). Significant differences vs placebo (nominal P < .0001) were observed for each symptom individually.
“A greater proportion of patients with CRSwNP achieved symptom-free days for at least one symptom at week 24 with dupilumab treatment vs placebo, with additional improvement at week 52,” concluded researchers.
Hopkins C, Han J, Fokkens W, et al. Symptom free days in patients with severe chronic rhinosinusitis with nasal polyps treated with dupilumab. J Allergy Clin Immunol. Published online February 1, 2022. doi:10.1016/j.jaci.2021.12.484