Efficacy of Lebrikizumab in improving rate of asthma exacerbations and lung function in patients with moderate-to-severe asthma
In a subset of patients with asthma, standard-of-care treatment does not achieve disease control, highlighting the need for novel therapeutic approaches.
Lebrikizumab is a humanised, monoclonal antibody that binds to and blocks interleukin-13 activity.
LUTE and VERSE were replicate, randomised, double-blind, placebo-controlled studies, evaluating multiple doses of Lebrikizumab in patients with uncontrolled asthma despite the use of medium-to-high-dose inhaled corticosteroid and a second controller.
Patients received Lebrikizumab 37.5, 125, 250 mg or placebo subcutaneously every four weeks.
The primary endpoint was the rate of asthma exacerbations during the placebo-controlled period.
Analyses were performed on prespecified subgroups based on baseline serum periostin levels.
Following the discovery of a host-cell impurity in the study drug material, protocols were amended to convert from phase III to phase IIb. Subsequently, dosing of study medication was discontinued early as a precautionary measure.
The data collected for analysis were from a placebo-controlled period of variable duration and pooled across both studies.
The median duration of treatment was approximately 24 weeks.
Treatment with Lebrikizumab reduced the rate of asthma exacerbations, which was more pronounced in the periostin-high patients ( all doses: 60% reduction ) than in the periostin-low patients ( all doses: 5% reduction ); no dose–response was evident.
Lung function also improved following Lebrikizumab treatment, with greatest increase in FEV1 in periostin-high patients ( all doses: 9.1% placebo-adjusted improvement ) compared with periostin-low patients ( all doses: 2.6% placebo-adjusted improvement ).
Lebrikizumab was well tolerated and no clinically important safety signals were observed.
In conclusion, these data are consistent with, and extend, previously published results demonstrating the efficacy of Lebrikizumab in improving rate of asthma exacerbations and lung function in patients with moderate-to-severe asthma who remain uncontrolled despite current standard-of-care treatment. ( Xagena )
Hanania NA et al, Thorax 2015; Online first
Data on 53 patients treated with investigational antiviral Remdesivir through the compassionate use program
The detailed results of an analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the...
The European Commission has approved Dupixent ( Dupilumab ) for use in adults and adolescents 12 years and older as...
LIBERTY ASTHMA QUEST study: Dupilumab reduces severe exacerbations and improves lung function in late-onset, uncontrolled, moderate-to-severe asthma patients
Dupilumab ( Dupixent ), a fully human VelocImmune-derived anti-interleukin-4 ( IL-4 ) receptor alpha monoclonal antibody, inhibits signaling of IL-4...
The FDA ( U.S. Food and Drug Administration ) has approved Dupixent ( Dupilumab ) for use with other medicines...
The European Commission has approved a label update for the use of once-daily Relvar Ellipta ( Fluticasone furoate / Vilanterol,...
FDA has approved Inbrija, Levodopa inhalation powder, for intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with Carbidopa / Levodopa
FDA ( U.S. Food and Drug Administration ) has approved Inbrija ( Levodopa inhalation powder ) for intermittent treatment...
Tiotropium noninferior to Salmeterol in patients with moderate to severe asthma who were not adequately controlled by inhaled corticosteroids or inhaled corticosteroids / Salmeterol
The role of Tiotropium for the treatment of asthma has not yet been clearly defined. The aim of a systematic...
Adults with asthma: bolus-dose Vitamin D3 supplementation does not influence time to exacerbation or upper respiratory infection
Asthma exacerbations are commonly precipitated by viral upper respiratory infections ( URIs ). Vitamin D insufficiency associates with susceptibility to...
The role of Tiotropium ( Spiriva ) for the treatment of adolescents with asthma has not yet been clearly defined....