PMID- 24131304
OWN - NLM
STAT- MEDLINE
DCOM- 20140808
LR  - 20211021
IS  - 1365-2222 (Electronic)
IS  - 0954-7894 (Print)
IS  - 0954-7894 (Linking)
VI  - 44
IP  - 1
DP  - 2014 Jan
TI  - The effects of lebrikizumab in patients with mild asthma following whole lung 
      allergen challenge.
PG  - 38-46
LID - 10.1111/cea.12220 [doi]
AB  - BACKGROUND: Interleukin 13 (IL13) is a T-helper type 2 (Th2) cytokine associated 
      with inflammation and pathology in allergic diseases such as bronchial asthma. We 
      have shown that treatment with lebrikizumab, an anti-IL13 monoclonal antibody, 
      significantly improves prebronchodilator forced expiratory volume in 1 s (FEV(1)) 
      in a subset of subjects with uncontrolled asthma. OBJECTIVE: To evaluate efficacy 
      and safety of lebrikizumab in subjects with mild asthma who underwent bronchial 
      allergen challenge. METHODS: Twenty-nine subjects were randomized 1 : 1-5 mg/kg 
      lebrikizumab (n = 13) or placebo (n = 16) administered subcutaneously every 4 
      weeks over 12 weeks, a total of four doses. Primary efficacy outcome was late 
      asthmatic response (LAR) at Week 13, defined as area under the curve of FEV1 
      measured 2-8 h following inhaled allergen challenge. Serum biomarkers were 
      measured to verify IL13 pathway inhibition and identify patients with an 
      increased response to lebrikizumab. RESULTS: At Week 13, the LAR in lebrikizumab 
      subjects was reduced by 48% compared with placebo subjects, although this was not 
      statistically significant (95% confidence interval, -19%, 90%). Exploratory 
      analysis indicated that lebrikizumab-treated subjects with elevated baseline 
      levels of peripheral blood eosinophils, serum IgE, or periostin exhibited a 
      greater reduction in LAR compared with subjects with lower baseline levels of 
      these biomarkers. Lebrikizumab exerted systemic effects on markers of Th2 
      inflammation, reducing serum immunoglobulin E (IgE), chemokine ligands 13 and 17 
      by approximately 25% (P < 0.01). Lebrikizumab was well tolerated. CONCLUSION AND 
      CLINICAL RELEVANCE: Lebrikizumab reduced the LAR in subjects with mild asthma. 
      Clinical trial number NCT00781443.
CI  - (c) 2013 John Wiley & Sons Ltd.
FAU - Scheerens, H
AU  - Scheerens H
AD  - Genentech, South San Francisco, CA, USA.
FAU - Arron, J R
AU  - Arron JR
FAU - Zheng, Y
AU  - Zheng Y
FAU - Putnam, W S
AU  - Putnam WS
FAU - Erickson, R W
AU  - Erickson RW
FAU - Choy, D F
AU  - Choy DF
FAU - Harris, J M
AU  - Harris JM
FAU - Lee, J
AU  - Lee J
FAU - Jarjour, N N
AU  - Jarjour NN
FAU - Matthews, J G
AU  - Matthews JG
LA  - eng
SI  - ClinicalTrials.gov/NCT00781443
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Clin Exp Allergy
JT  - Clinical and experimental allergy : journal of the British Society for Allergy 
      and Clinical Immunology
JID - 8906443
RN  - 0 (Allergens)
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Biomarkers)
RN  - 0 (Interleukin-13)
RN  - U9JLP7V031 (lebrikizumab)
SB  - IM
CIN - Clin Exp Allergy. 2014 Jan;44(1):2-5. PMID: 24355015
MH  - Adult
MH  - Allergens/*immunology
MH  - Anti-Asthmatic Agents/adverse effects/pharmacology/*therapeutic use
MH  - Antibodies, Monoclonal/adverse effects/pharmacology/*therapeutic use
MH  - Asthma/blood/*drug therapy/*immunology
MH  - Biomarkers/blood
MH  - Bronchial Provocation Tests
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Humans
MH  - Interleukin-13
MH  - Lung/immunology/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Th2 Cells/immunology/metabolism
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC4204278
OTO - NOTNLM
OT  - IL13
OT  - Th2 inflammation
OT  - allergen challenge
OT  - asthma
OT  - biomarkers
OT  - lebrikizumab
EDAT- 2013/10/18 06:00
MHDA- 2014/08/13 06:00
CRDT- 2013/10/18 06:00
PHST- 2012/10/17 00:00 [received]
PHST- 2013/10/07 00:00 [revised]
PHST- 2013/10/10 00:00 [accepted]
PHST- 2013/10/18 06:00 [entrez]
PHST- 2013/10/18 06:00 [pubmed]
PHST- 2014/08/13 06:00 [medline]
AID - 10.1111/cea.12220 [doi]
PST - ppublish
SO  - Clin Exp Allergy. 2014 Jan;44(1):38-46. doi: 10.1111/cea.12220.