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Lebrikizumab decreases type 2 inflammatory biomarker levels in patients with asthma: data from randomized phase 3
Stanley Szefler1, Jonathan Corren2, Jonathan I Silverberg3
1The Breathing Institute and Pediatric Pulmonary and Sleep Medicine Section, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO, USA.
Aim:
Lebrikizumab is an interleukin (IL)-13 inhibitor that specifically blocks IL-13 signaling. Here, we report the effects of lebrikizumab on asthma serum biomarkers in 2 phase 3 clinical studies.
Methods:
LAVOLTA I and LAVOLTA II are replicate, double-blind, placebo-controlled trials with 52-week placebo-controlled treatment periods that evaluated lebrikizumab 37.5- and 125-mg doses every 4 weeks. Patients were aged 18-75 years with uncontrolled asthma on stable background therapy. Biomarkers assessed included immunoglobulin E (IgE), periostin, CC motif chemokine ligand (CCL)13, and CCL17. Statistical significance was assessed for difference in fold-change for lebrikizumab versus placebo using a mixed-effects model for repeated measures.
Results:
At early time points in LAVOLTA I and II (weeks 1 and 4), decreases in periostin and CCL13 were statistically significant versus placebo (all p < 0.001) for both lebrikizumab doses. For the 125-mg lebrikizumab dose at week 1 in LAVOLTA I, the decrease in CCL17 was statistically significant (p = 0.001). Reductions in periostin, CCL13, and CCL17 were maintained throughout the trial duration. Significant decreases versus placebo (p ≤ 0.001) were seen in IgE by weeks 12 and 24 in LAVOLTA I and LAVOLTA II, respectively.
Conclusion:
Significant reductions in relevant inflammatory biomarkers were observed in the LAVOLTA I and LAVOLTA II studies.
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