Children age 6-11 with uncontrolled, moderate-to-severe asthma and a type 2 inflammatory asthma phenotype who received add-on dupilumab (Dupixent, Regeneron) had significant improvements in lung function at week 12 of therapy, according to research presented at Chest 2021.
In the phase 3, double-blind, placebo-controlled LIBERTY ASTHMA VOYAGE study (NCT02948959), add-on dupilumab every 2 weeks (q2w) demonstrated significant improvements in percent predicted (pp) pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)by an additional 5.21 percentage points vs placebo at Week 12 in children aged 6 to 11 years with uncontrolled, moderate-to-severe asthma and a type 2 inflammatory asthma phenotype (defined as blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 ppb at baseline). The research reports effects on additional lung function parameters.
In the study presented at CHEST 2021, children were randomized (2:1) to receive add-on dupilumab 200 mg or 100 mg q2w based on body weight (>30 kg or ≤30 kg), or matched placebo q2w for 52 weeks. Absolute and percent predicted changes in pre-BD FEV 1, post-BD FEV 1, pre-BD forced expiratory flow 25–75% (FEF 25–75%), and forced vital capacity (FVC) from baseline over the treatment period were analyzed in patients with a type 2 inflammatory asthma phenotype.
Of 408 patients, 350 met the type 2 phenotype criteria (dupilumab: 236; placebo: 114). At baseline, mean (SD) pre-BD FEV1 (L) and pre-BD FEV1pp was 1.53 (0.46)L and 78.36 (14.51)/1.48 (0.39)L and 77.66 (14.38) in placebo/dupilumab groups, respectively. Pre-BD FEV1 (L) improved from baseline in dupilumab vs placebo with a least squares (LS) mean (95% CI) difference at week 2 of 0.06L (0.01–0.12; P=0.025); and by 0.17L (0.09–0.24; P<0.0001) at week 52. Similar benefits were seen in post-BD FEV1, (baseline mean [SD] of 1.74 [0.49]L/1.75 [0.43]L in placebo/dupilumab groups, respectively) with an LS mean difference (95% CI) vs placebo of 0.09L (0.02–0.16, P=0.015) at week 52.
Additionally, dupilumab vs placebo improved:
- post-BD FEV1pp (baseline mean [SD]: 89.66 [15.54]/93.36 [14.7] for placebo/dupilumab) by week 52 (LS mean difference [95% CI]: 4.37percentage points [0.95–7.78]; P=0.012),
- FEF25-75% (baseline mean [SD]: 1.28 [0.53]/1.27 [0.54] for placebo/dupilumab; week 52 LS mean difference [95% CI]: 0.30 L/s [0.17–0.44], P<0.0001),
- ppFEF25-75% (baseline mean [SD]: 54.67 [19.79]/54.82 [20.94] for placebo/dupilumab; week 52 LS mean difference [95% CI]: 12.02 percentage points [6.70–17.33], P<0.0001), and
- FVC (baseline mean [SD]: 2.08 [0.57]/2.00 [0.48] for placebo/dupilumab; week 52 LS mean difference [95% CI]: 0.10L [0.03–0.17], P=0.007).
“These findings indicate that Dupilumab led to significant, rapid, and sustained improvements in multiple aspects of lung function in children aged 6–11 years,” said Leonard Bacharier, MD, lead researcher and CHEST 2021 presenter.