GLORIA

GEOMAR Library Ocean Research Information Access

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 1
    In: Thorax, BMJ, Vol. 70, No. 8 ( 2015-08), p. 748-756
    Abstract: 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. Methods 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. Results 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 FEV 1 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. Conclusions 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. Trial registration numbers The LUTE study was registered under NCT01545440 and the VERSE study under NCT01545453 at http://www.clinicaltrials.gov
    Type of Medium: Online Resource
    ISSN: 0040-6376 , 1468-3296
    Language: English
    Publisher: BMJ
    Publication Date: 2015
    detail.hit.zdb_id: 1481491-2
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 2
    Online Resource
    Online Resource
    SAGE Publications ; 2023
    In:  Chronic Respiratory Disease Vol. 20 ( 2023-01), p. 147997312311596-
    In: Chronic Respiratory Disease, SAGE Publications, Vol. 20 ( 2023-01), p. 147997312311596-
    Abstract: Different ages of asthma onset can lead to similar clinical symptoms but have different underlying mechanisms that may influence treatment response. This post-hoc analysis assessed response to omalizumab in relation to the age of asthma onset. Using pooled data from two phase III studies (patients 12–75 years), changes in exacerbation rates, forced expiratory volume in 1 second (FEV 1 ) and inhaled corticosteroids (ICS) were assessed by age of asthma onset ( 〈 18 [ n = 574], 18–40 [ n = 360] , 〉 40 years [ n = 136]). Exacerbations (week 16) were reduced with omalizumab versus placebo in all subgroups (relative rate reduction [95% confidence interval] : 〈 18, −53.1% [–73.6,–16.6]; 18–40, −68.3% [–85.5,–31.0] ; 〉 40, −38.4% [–77.3,67.4]). FEV 1 increased with omalizumab in all subgroups; increases were sustained in 〈 18 and 18–40 years subgroups, but not in 〉 40 years subgroup. ICS dose reductions (week 28) were greater with omalizumab versus placebo, regardless of age of asthma onset, as were percentages of patients with ICS doses reduced by at least 50% and 100%. In conclusion, omalizumab-treated patients had lower exacerbation rates and were more frequently able to reduce/discontinue ICS versus placebo, regardless of age of asthma onset, therefore omalizumab may be beneficial to all eligible patients with allergic asthma. Trial registration These studies were conducted before clinical trial registration was required; therefore, clinical trial registration numbers are not available.
    Type of Medium: Online Resource
    ISSN: 1479-9731 , 1479-9731
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2222367-8
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 3
    In: Arthritis Research & Therapy, Springer Science and Business Media LLC, Vol. 16, No. 2 ( 2014-4)
    Type of Medium: Online Resource
    ISSN: 1478-6354
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2014
    detail.hit.zdb_id: 2041668-4
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...