[Impact of prior sinus surgery on the efficacy of stapokibart in refractory chronic rhinosinusitis with nasal polyps: a post hoc analysis of the CROWNS-2 trial].

Objective

To investigate the impact of prior sinus surgery on the efficacy of stapokibart in patients with refractory chronic rhinosinusitis with nasal polyps（RCRSwNP）.

Methods

This post hoc analysis was based on data from the phase III CROWNS-2 trial. A total of 179 patients with RCRSwNP who received at least one dose of stapokibart or placebo were included and categorized into two groups according to their history of prior sinus surgery（114 with prior sinus surgery and 65 without）. Intergroup differences in the efficacy of stapokibart and its ability to reduce the need for surgery were compared.

Results

Of the 179 patients, 114（63.7%） had a history of prior sinus surgery. Among those with prior surgery, 77.2%（88/114） had undergone only one procedure, and 78.9%（90/114） had their most recent surgery ≥3 years before enrollment. Regardless of prior sinus surgery, number of prior surgeries, or time since the last surgery, the stapokibart group demonstrated significantly greater improvements in all efficacy endpoints at week 24 compared with the placebo group, including polyp size, nasal congestion, quality of life, olfactory function, and radiologic scores. For most endpoints, treatment effects were not influenced by surgical history; however, greater improvements in nasal congestion, quality of life, total symptom scores, and radiologic outcomes were observed among patients with a history of sinus surgery（P for interaction<0.05）. Notably, regardless of prior sinus surgery, stapokibart significantly reduced the predicted need for further surgery compared with placebo, and these treatment-by-subgroup interactions were not statistically significant.

Conclusion

Regardless of prior sinus surgery, stapokibart significantly reduces nasal polyp burden, improves symptoms and quality of life, and decreases the predicted need for further surgery in patients with RCRSwNP.