Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) often present extensive bilateral sinus disease, which may not be adequately controlled by standard-of-care treatment with intranasal corticosteroids (INCS). Researchers compared the effect of INCS plus dupilumab versus INCS plus placebo in patients with CRSwNP from the phase III SINUS-24 study and found the former treatment to be superior. The outcomes were published as part of the AAAAI Annual Meeting.
Patients with severe CRSwNP were given daily INCS plus either dupilumab 300 mg every two weeks (n=143) or placebo (n=133) for 24 weeks. Sinus computed tomography (CT) scans were conducted at baseline, week 24, and 24 weeks after treatment cessation. Blinded, independent reviewers measured opacity using the Lund-Mackay (LMK) CT score, ranging from zero to 12 on each side.
Baseline characteristics did not largely differ between the groups. LMK-CT total scores at baseline were 9.82 (left) and 9.73 (right) in the placebo group and 9.33 (left) and 9.22 (right) in the dupilumab group. After 24 weeks, opacification significantly improved in the dupilumab group compared with the placebo cohort (least squares mean reductions in LMK-CT score, –3.56 [left] and –3.92 [right]; P<0.001 for both), as did all individual sinuses (LMK-CT score reductions from −0.36 [left maxillary sinus] to −0.82 [right osteomeatal complex]; P<0.0001 for all). The placebo group showed no significant changes in LMK-CT scores. Opacification in the dupilumab group worsened 24 weeks after treatment cessation, but LMK-CT scores were still better than in the placebo group. Overall, dupilumab was well-tolerated.
“Compared with placebo [plus] INCS, dupilumab [plus] INCS significantly improved sinus disease in all individual sinuses bilaterally to week 24. Cessation of dupilumab therapy resulted in worsening opacification despite continuing daily INCS treatment,” the study authors summarized.