Baseline factors impact odds for clinical remission with dupilumab in asthma
Key takeaways:
- This is a post hoc analysis of the QUEST study.
- Baseline factors that positively impacted clinical remission odds on dupilumab included heightened blood eosinophil counts and fractional exhaled nitric oxide.
SAN DIEGO — Researchers found increased odds for clinical remission on dupilumab with high blood eosinophil and fractional exhaled nitric oxide levels in a moderate to severe asthma cohort, according to a poster presented here.
This finding was presented at the 2025 American Academy of Allergy, Asthma and Immunology/World Allergy Organization Joint Congress.
In a post hoc analysis of the 52-week phase 3 LIBERTY ASTHMA QUEST study, researchers assessed 1,530 patients with moderate to severe asthma to determine if there are links between clinical remission achievement and three baseline characteristics: blood eosinophil count, fractional exhaled nitric oxide (FeNO) level and pre-bronchodilator FEV1.
“[This is] first evidence of dupilumab reaching ‘clinical remission,’ an innovative multicriteria tool to evaluate efficacy of a treatment in severe asthma,” Giorgio Walter Canonica, FERS, FEAACI, FAAAAI, FACAAI, professor at Humanitas University and senior consultant at the Personalized Medicine Asthma and Allergy Clinic at Humanitas Research Hospital, told Healio.
“So, not just a single parameter, such as symptoms, but a four-criteria tool: no asthma exacerbations (attacks), no symptoms, no oral corticosteroid (OCS) and stable or improved lung function at 12 months of treatment,” he continued. “[This is] a more reliable way to evaluate the effect of a treatment, as in other chronic diseases.”
Notably, the poster defined stable/improved lung function as a less than 5% reduction in pre- or post-bronchodilator FEV1 from baseline. Additionally, the no symptoms part of the clinical remission criteria was represented by a 5-item Asthma Control Questionnaire (ACQ-5) score of less than 1.5, which signaled well-controlled asthma.
The study included 1,011 patients who received 200 mg/300 mg add-on dupilumab every 2 weeks and 519 who received placebo.
Within the dupilumab cohort, 387 patients (mean age, 46.2 years; 57.1% women; 81.1% white) met the criteria for clinical remission at week 52, whereas the remaining 624 (mean age, 49 years; 63.6% women; 84.6% white) did not meet the criteria.
In the placebo cohort, 136 patients (mean age, 46.6 years; 61.8% women; 88.2% white) achieved clinical remission at the 52-week mark, and the remaining 383 (mean age, 48.7 years; 65.5% women; 85.4% white) did not.
Between the dupilumab group and the placebo group, a greater proportion of patients receiving dupilumab met the criteria for clinical remission (38.3% vs. 26.2%), according to the abstract.
Following adjustment for several covariates (treatment, age, region, baseline eosinophil strata and baseline ICS dose), researchers found significantly increased odds for clinical remission achievement with dupilumab vs. placebo among those who had baseline blood eosinophil counts of at least 150 cells/µL (adjusted OR = 2.17; 95% CI, 1.64-2.86; P < .0001), at least 300 cells/µL (aOR = 2.74; 95% CI, 1.92-3.92; P < .0001) and at least 500 cells/µL (aOR = 4.04; 95% CI, 2.45-6.68; P < .0001).
In terms of FeNO levels, the poster reported that patients receiving dupilumab vs. placebo had significantly greater odds for remission achievement at week 52 when they had heightened FeNO levels at baseline: at least 20 ppb (aOR = 2.35; 95% CI, 1.74-3.16; P < .0001) and at least 50 ppb (aOR = 2.26; 95% CI, 1.38-3.7; P = .0013).
When assessing four different combinations of blood eosinophil counts and FeNO levels (< 150 cells/µL + < 20 ppb; < 150 cells/µL + 20 ppb; 150 cells/µL + < 20 ppb; and 150 cells/µL + 20 ppb), only one reached significance. Researchers observed significantly increased odds for remission achievement with dupilumab vs. placebo among those with a blood eosinophil count of at least 150 cells/µL plus a FeNO level of at least 20 ppb (aOR = 2.63; 95% CI, 1.88-3.66; P < .0001).
For baseline pre-bronchodilator FEV1, researchers grouped patients as those with 1.75 L or less and those with greater than 1.75 L. Compared with patients in the placebo group, patients in the dupilumab group had significantly elevated odds for remission achievement with a baseline pre-bronchodilator FEV1 of 1.75 L or less (aOR = 1.9; 95% CI, 1.36-2.66; P = .0002). Similarly, the dupilumab group also had significantly heightened odds for this outcome with a baseline pre-bronchodilator FEV1 greater than 1.75 L vs. the placebo group (aOR = 1.61; 95% CI, 1.15-2.24; P = .0051), according to the poster.
“This new approach can be ‘translated’ in clinical practice as already proposed by our team in Journal of Asthma,” Canonica told Healio.
“‘Clinical remission’ will possibly be ‘the’ primary outcome of future severe asthma trials, as for other chronic diseases, ie, ulcerative colitis where the FDA [has been] indicating ‘clinical remission’ as a primary outcome since 2016,” Canonica said.
For more information:
Giorgio Walter Canonica, FERS, FEAACI, FAAAAI, FACAAI, can be reached at giorgio_walter.canonica@hunimed.eu.