Omalizumab improves outcomes in chronic rhinosinusitis with nasal polyps
Treatment with omalizumab, an anti-IgE monoclonal antibody, significantly improves outcomes in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP), regardless of asthma status, based on a pooled analysis of the POLYP 1 and POLYP 2* studies presented at AAAAI 2020.
“CRSwNP and asthma frequently coexist,” said lead author Dr Claus Bachert from Ghent University in Ghent, Belgium.
“Although … omalizumab … demonstrated efﬁcacy in patients with CRSwNP with comorbid asthma, whether there is a difference in patients with or without comorbid asthma is an important remaining question,” Bachert and his team noted.
The phase III, POLYP 1 and POLYP 2 trials involved 265 adult patients with corticosteroid-refractory CRSwNP (mean age 51.0 years), of whom 151 had comorbid asthma and 114 did not. Participants were randomized to receive subcutaneous omalizumab 75–600 mg Q2W/Q4W or a matching placebo for 24 weeks. Patients continued on intranasal mometasone furoate during the entire study period. Nasal Polyps Score (NPS), Nasal Congestion Score (NCS), and Sino-Nasal Outcome Test-22 (SNOT-22) Questionnaire were evaluated at 24 weeks. [AAAAI 2020, abstract 476]
Of the 57.0 percent patients with asthma, 35.1 percent were mild, 58.3 percent were moderate, and 6.6 percent were severe according to the physician’s assessment.
At 24 weeks, patients with and without asthma who received omalizumab had a significantly greater improvement from baseline in NPS (-0.98; p<0.0001 and -0.72; p=0.0054, respectively), NCS (-0.52; p=0.0003 and -0.56; p=0.0007), and SNOT-22 scores (-14.82; p<0.0001 and -16.14; p<0.0001) than those on placebo.
In another prespecified subgroup analysis of POLYP 1 and 2 studies, patients with CRSwNP and comorbid asthma treated with omalizumab also demonstrated a significantly higher SNOT-22 score, indicating an improved quality of life, compared with placebo at week 24 (mean change from baseline, 23.2 vs -8.4; p<0.0001). [AAAAI 2020, abstract 813]
Both POLYP 1 and 2 studies showed comparable adverse events in both treatment arms.
“[In conclusion,] among patients with CRSwNP, omalizumab improved NPS, NCS, and SNOT-22 scores in those with and without comorbid asthma, and there were no marked differences in response between groups,” said Bachert and his team.
“[However,] as most patients had mild-to-moderate asthma, it is unclear whether these results extend to the more severe asthma population,” they highlighted.
*POLYP 1/POLYP 2: A clinical trial of omalizumab in participants with chronic rhinosinusitis with nasal polyps