A study that was published as part of the AAAAI Annual Meeting examined the effect of dupilumab on blood, urine, and nasal biomarkers of type 2 inflammation in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Data from the phase III SINUS-52 study were examined. A total of 448 adult patients with CRSwNP were randomized 1:1:1 to receive subcutaneous dupilumab 300 mg every two weeks (q2w) for 52 weeks; dupilumab 300 mg q2w for 24 weeks, then every four weeks (q4w) for 28 weeks; or placebo q2w for 52 weeks. Outcomes included on-treatment biomarkers in blood, urine, and nasal secretion.
There were no significant differences in baseline median biomarker values among the groups. After 24 weeks, the median percent change from baseline for dupilumab versus placebo was: serum total immunoglobulin E (IgE), −57.92 versus −3.13; periostin, −31.02 versus 1.98; thymus and activation-regulated chemokine, −39.01 versus −1.01; and plasma eotaxin-3, −50.46 versus −4.19 (P<0.0001 for all). The outcomes persisted up to week 52. No changes in median blood eosinophil counts were observed. At week 24, reductions were: urinary leukotriene E4, −45.67 versus 0.00; nasal-secretion total IgE, −29.17 versus 0.00; periostin, −93.73 versus −50.81; eotaxin-3, −93.97 versus −4.48; and interleukin-5, −85.86 versus 0.00 (P<0.01 for all). The most common adverse event was injection-site reaction and was more common in both dupilumab groups than the placebo group (q2w, 14.8%; q2w/q4w, 18.9%; placebo, 13.3%).
“Consistent with its mechanism of action, dupilumab reduced systemic (blood, urine) and local (nasal secretion) biomarkers of type 2 inflammation in patients with CRSwNP and was well tolerated,” the study authors summarized.