Patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who receive dupilumab are likely to have symptom-free days by week 24 of treatment compared with those receiving placebo, according to study results presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) 2022 Annual Meeting and OTO Experience, held from September 10 to 14, 2022, in Philadelphia, Pennsylvania.
Researchers conducted a post-hoc analysis of the phase 3 SINUS-24 (Clinicaltrials.gov Identifier: NCT02912468) and SINUS-52 (Clinicaltrials.gov Identifier: NCT02898454) trials. Patients received dupilumab 300 mg or placebo every 2 weeks until week 24 or 52 in the SINUS-24 and SINUS-52 trials, respectively. Patients self-reported symptom severity for nasal congestion (NC), decreased smell or loss of smell (LoS), and anterior and posterior rhinorrhea on a scale of 0 to 3 (0=no symptoms, 3=severe). Those with data for less than 21 days in each 28 period were excluded from the study.
A total of 723 patients were included, of which 437 and 286 received dupilumab and placebo, respectively. During the 28-day period prior to randomly assigning patients, only 0% to 3.3% of patients had symptom-free days for the 4 individual symptoms. In the 28 days before week 24 of treatment, patients who received dupilumab were significantly more likely to have symptom-free days for at least 1 symptom (35.4% vs 10.8% in placebo; odds ratio [OR], 4.9; 95% CI, 3.1-7.8; nominal P <.0001). In the 28 days before week 52, this difference increased (50.0% vs 9.2% in placebo; OR, 9.1; 95% CI, 4.6-17.9; nominal P <.0001) compared with placebo.
Significant differences between the treatment and placebo groups were also observed for symptom-free days for in patients with NC and decreased smell or LoS in the 28 days before week 24 (24.1% vs 3.6%; OR, 9.4; 95% CI, 4.5-19.5; P <.0001) and week 52 (27.3% vs 3.4%; OR, 12.2; 95% CI, 4.1-35.9; P <.0001).
The researchers concluded, “Greater proportions of patients with CRSwNP achieved SFD [symptom free days] for at least 1 of the key symptoms of CRSwNP at week 24 with dupilumab treatment vs placebo, with additional improvements at week 52.”
Bachert C, Hopkins CL, Han JK, Fokkens WJ, Nash S, Khan AH. Symptom-free days in patients with severe CRSwNP treated with dupilumab. Otolaryngol Head Neck Surg. 2022;167(suppl 1):P150.