INTRODUCTION: In a subset of @entity1 with @entity565 , 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 @entity4047 activity. METHODS: LUTE and VERSE were replicate, randomised, double-blind, placebo-controlled studies, evaluating multiple doses of lebrikizumab in @entity1 with uncontrolled @entity565 despite the use of medium-to-high-dose inhaled @entity228 and a second controller. @entity1 received lebrikizumab 37.5, 125, 250   mg or placebo subcutaneously every four   weeks. The primary endpoint was the rate of @entity565 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. RESULTS: The median duration of treatment was approximately 24   weeks. Treatment with lebrikizumab reduced the rate of @entity565 exacerbations, which was more pronounced in the periostin-high @entity1 (all doses: 60% reduction) than in the periostin-low @entity1 (all doses: 5% reduction); no dose-response was evident. Lung function also improved following lebrikizumab treatment, with greatest increase in FEV1 in periostin-high @entity1 (all doses: 9.1% placebo-adjusted improvement) compared with periostin-low @entity1 (all doses: 2.6% placebo-adjusted improvement). Lebrikizumab was well tolerated and no clinically important safety signals were observed. CONCLUSIONS: These data are consistent with, and extend, previously published results demonstrating the efficacy of lebrikizumab in improving rate of @entity565 exacerbations and lung function in @entity1 with moderate-to-severe @entity565 who remain uncontrolled despite current standard-of-care treatment. TRIAL REGISTRATION NUMBERS: The LUTE study was registered under NCT01545440 and the VERSE study under NCT01545453 at http://www.clinicaltrials.gov.

Lebrikizumab in moderate-to-severe XXXX : pooled data from two randomised placebo-controlled studies.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity565 :: ('MESH:D001249', 'Disease') :: ['asthma'] @entity228 :: ('CHEBI:50858', 'Chemical') :: ['corticosteroid'] @entity4047 :: ('3596', 'Gene') :: ['interleukin-13']
@entity565 :: (MESH:D001249,Disease) :: ['asthma']
