Effects of Interleukin-13 Blockade on Allergen-induced Airway Responses in Mild Atopic Asthma.

Rationale: Extensive evidence in animal models supports a role for IL-13 in the pathobiology of asthma. IMA-638 and IMA-026 are fully humanized IgG(1) antibodies that bind to different epitopes and neutralize IL-13 bioactivity. Objectives: We hypothesized that anti-IL-13 treatment would inhibit alle...

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Publicado en:American Journal of Respiratory & Critical Care Medicine Vol. 183; no. 8; pp. 1007 - 1015
Autores principales: Gauvreau GM, Boulet LP, Cockcroft DW, Fitzgerald JM, Carlsten C, Davis BE, Deschesnes F, Duong M, Durn BL, Howie KJ, Hui L, Kasaian MT, Killian KJ, Strinich TX, Watson RM, Y N, Zhou S, Raible D, O'Byrne PM
Formato: research randomized controlled trial Journal Article
Publicado: Oxford University Press / USA 4/15/2011
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 4/15/2011
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      pub: Oxford University Press / USA
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        2011013816
        10.1164/rccm.201008-1210OC
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        atl: Effects of Interleukin-13 Blockade on Allergen-induced Airway Responses in Mild Atopic Asthma.
      aug:
        au:
          Gauvreau GM
          Boulet LP
          Cockcroft DW
          Fitzgerald JM
          Carlsten C
          Davis BE
          Deschesnes F
          Duong M
          Durn BL
          Howie KJ
          Hui L
          Kasaian MT
          Killian KJ
          Strinich TX
          Watson RM
          Y N
          Zhou S
          Raible D
          O'Byrne PM
        affil: HSC 3U26, McMaster University, 1200 Main St West, Hamilton, ON, L8N 3Z5 Canada. gauvreau@mcmaster.ca.
      sug:
        subj:
          Antibodies Therapeutic Use
          Asthma Drug Therapy
          Interleukins Antagonists and Inhibitors
          Adolescence
          Adult
          Allergens Immunology
          Antibodies Blood
          Antibodies Immunology
          Double-Blind Studies
          Female
          Forced Expiratory Volume
          Human
          Immunoglobulins Blood
          Immunoglobulins Immunology
          Immunoglobulins Therapeutic Use
          Interleukins Blood
          Interleukins Immunology
          Male
          Middle Age
          Randomized Controlled Trials
          Sputum
          Sputum Immunology
          Treatment Outcomes
          Young Adult
          Adolescent: 13-18 years
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Female
          Male
      ab: Rationale: Extensive evidence in animal models supports a role for IL-13 in the pathobiology of asthma. IMA-638 and IMA-026 are fully humanized IgG(1) antibodies that bind to different epitopes and neutralize IL-13 bioactivity. Objectives: We hypothesized that anti-IL-13 treatment would inhibit allergen-induced late-phase asthmatic responses, airway hyperresponsiveness, and inflammation in subjects with asthma. Methods: Fifty-six subjects with mild, atopic asthma were recruited for two double-blind, randomized, placebo-controlled, parallel group trials to compare IMA-638 and IMA-026 IL-13 antibody treatments with placebo treatment. Drug was administered on Days 1 and 8, and allergen challenges were performed on Days 14 and 35. The primary outcome variable was the late-phase area under the curve (AUC), and secondary outcome variables were the early- and late-phase maximum percent fall in FEV(1), early AUC, allergen-induced shift in airway hyperresponsiveness, and sputum eosinophils. Measurements and Main Results: The treatment difference with IMA-638 on Day 14 was -19.1 FEV(1) x hour (95% confidence interval: -36.2, -1.9) for the allergen-induced early AUC and -23.8 FEV(1) x hour (95% confidence interval: -46.4, -1.2) for the late AUC (both P < 0.05), but this effect was lost by Day 35. Treatment with IMA-026 did not attenuate the asthmatic responses on Day 14 or Day 35. There was no effect of either antibody on allergen-induced airway hyperresponsiveness or sputum eosinophils. The frequency of adverse events after administration of the IL-13 antibodies was similar to placebo. Conclusions: IL-13 has a role in allergen-induced airway responses in humans. Further study is required to determine whether anti-IL-13 monoclonal antibodies will be beneficial clinically. Clinical trial registered with www.clinicaltrials.gov (NCT 00410280 and NCT 00725582).
      pubtype: Academic Journal
      doctype:
        research
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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