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.
Keywords: CCL13; CCL17; IL-13; IgE; Th2 asthma; eosinophilic asthma; lebrikizumab; periostin.
This paper discusses how a medication called lebrikizumab leads to changes in certain blood markers in patients with asthma. Lebrikizumab targets a specific protein in the body that plays a role in asthma. The LAVOLTA I and II studies included patients with uncontrolled asthma who were given either lebrikizumab or a placebo (a substance with no active medication) every 4 weeks for 1 year. The studies looked at how lebrikizumab changed certain markers in the patients’ blood that are linked to asthma inflammation. The researchers measured different markers in the blood, like immunoglobulin E (IgE), periostin, CC motif chemokine ligand (CCL)13, and CCL17, to see if there were any changes. The results showed that lebrikizumab lowered levels of periostin and CCL13 early in the treatment, while IgE levels dropped later in treatment. The effects on CCL17 were mixed. Overall, lebrikizumab reduced inflammation markers in the blood associated with asthma, suggesting it may help treat asthma.