Treatment improves outcomes in patients with CRSwNP, a hallmark of obstructive pulmonary disease


In the phase 3 SINUS-24 and SINUS-52 trials, dupilumab improved clinical and health-related quality of life (HRQOL) in patients with clinical features of chronic sinusitis with nasal polyps (CRSwNP) and obstructive pulmonary disease. ) improved outcomes. The post hoc analysis results are: Journal of Asthma and Allergyalso suggest that dupilumab can improve lung function in patients with a history of asthma.

CRSwNP is an inflammatory disease that causes chronic symptoms such as nasal congestion, runny nose, anosmia, headache, pain, sinusitis, and nasal polyps. Inflammation in such cases is often type 2, involving interleukin (IL)-4 and IL-13. Dupilumab blocks IL-4 and IL-13 receptors and reduces inflammation caused by these cytokines.

Dupilumab was effective in reducing the endoscopic, radiological, clinical and HRQOL effects of severe CRSwNP compared with placebo in the randomized phase 3 SINUS-24 and SINUS-52 trials demonstrated the sex. According to the authors, these results suggest that type 2 inflammation may trigger CRSwNP.

A post hoc analysis of the SINUS-24 and SINUS-52 populations, the current study provides insight into the potential response of chronic obstructive pulmonary disease (COPD) patients in a surrogate population of patients exhibiting features of obstructive pulmonary disease It is intended to .

Both studies included a total of 724 severe CRSwNP patients, of whom 131 (18%) met broad criteria for features of obstructive pulmonary disease. To meet the broad definition, the patient had clinical features of obstructive pulmonary disease with any of the following criteria: her pre-bronchodilator forced expiratory volume in 1 second (FEV);1)/forced vital capacity (FVC) <0.70 with history of smoking, patient-reported history of COPD, or >10 pack-years of smoking asthma.

Additionally, 115 patients (16%) met narrow criteria, including broad criteria 1 or 2.

Of the patients meeting the broad definition, 90 (69%) also had asthma. In the narrow group, 74 (64%) also had asthma.

CRSwNP outcomes and patient HRQOL improved when treated with dupilumab compared with placebo in both broad and narrow patient subgroups. The least squares mean difference in nasal polyp score (NPS) from baseline to week 24 was -1.72 (95% CI, -2.27 to -1.16). Differences in University of Pennsylvania Olfactory Discrimination Test (UPSIT) scores also improved, with a least squares mean difference from baseline to week 24 of 9.25 (95% CI, 6.52–11.99).

The mean nasal outcome test (SNOT-22), a measure of HRQOL in CRSwNP, also improved in the broad group. From baseline to week 8, the least squares mean difference between dupilumab and placebo was -13.14 (95% CI, -19.77 to -6.52) and by week 24 was -15.45 (95% CI, -21.88 to – 9.02).

Dupilumab had similar effects on NPS, UPSIT and SNOT-22 scores in the narrow and global asthma groups.

Dupilumab improved pre-bronchodilator FEV in both broad and narrow patient subgroups1 and FEV1The improvement in ratio to FVC at week 16 was sustained through week 24 of the study.

“In this analysis, based on pooled data from the randomized phase 3 SINUS-24 and SINUS-52 studies, dupilumab treatment improved CRSwNP outcomes and clinical features of obstructive pulmonary disease in patients with CRSwNP, and demonstrated that pulmonary It was associated with improved function,” included among patients with CRSwNP, clinical features of obstructive pulmonary disease, and self-reported asthma,” the authors concluded.

Limitations of the post hoc analysis included heterogeneity of subgroups with clinical features of obstructive pulmonary disease, reliance on retrospective data, and use of patient surrogate populations.

Although these results are exploratory and may not be applicable to patients with clinically determined COPD, the results are consistent with the mechanism of dupilumab and are consistent with a population with COPD and type 2 inflammation. This supports further research in

reference

Maspero JF, Butchart C, Martinez FJ, et al. Clinical efficacy in patients with clinical features of chronic sinusitis and obstructive pulmonary disease with nasal polyps: a post hoc analysis of the phase III SINUS-24 and SINUS-52 studies. J Asthma Allergy. 2023; 16:333-342. Doi: 10.2147/JAA.S357393



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