2010
DOI: 10.1164/rccm.200909-1448oc
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A Randomized, Controlled, Phase 2 Study of AMG 317, an IL-4Rα Antagonist, in Patients with Asthma

Abstract: AMG 317 did not demonstrate clinical efficacy across the overall group of patients. Clinically significant improvements were observed in several outcome measures in patients with higher baseline ACQ scores. AMG 317 was safe and well tolerated in this study population. Clinical trial registered with www.clinicaltrials.gov (NCT 00436670).

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Cited by 283 publications
(167 citation statements)
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“…Like lebrikizumab, it appeared to perform better in patients with detectable sputum IL-13 levels [60]. A study in moderate-to-severe asthma of a monoclonal antibody to the IL-4 receptor-a, that blocks both IL-4 and IL-13, was negative [160]. Whether prior biological phenotyping would have yielded different results is unclear.…”
Section: Remarksmentioning
confidence: 99%
“…Like lebrikizumab, it appeared to perform better in patients with detectable sputum IL-13 levels [60]. A study in moderate-to-severe asthma of a monoclonal antibody to the IL-4 receptor-a, that blocks both IL-4 and IL-13, was negative [160]. Whether prior biological phenotyping would have yielded different results is unclear.…”
Section: Remarksmentioning
confidence: 99%
“…Although early clinical trials of mepolizumab in relatively unselected patients with asthma were unsuccessful, the results of clinical trials of mepolizumab improved with patient selection based on the presence of sputum eosinophilia (23,24). Similarly, one early clinical study of a therapeutic that targets the IL-4 receptor (thereby blocking the effects of both IL-4 and IL-13) did not show clinical efficacy in unselected patients with asthma (25). However, a phase 2 trial of a monoclonal antibody targeting the IL-4 receptor now reports efficacy in patients with asthma who were selected on the basis of peripheral blood or sputum eosinophilia (26).…”
mentioning
confidence: 99%
“…Agents such as anti-IL-4 mAb, anti-IL-5 mAb, and anti-CCR3 mAb blocked the formation of airway inflammation in animal models of asthma, but failed in clinical trials (Antoniu, 2009;Busse et al, 2010;Corren et al, 2010;Castro et al, 2011;Pavord et al, 2012). It is likely that in preclinical studies, these agents were effective as preventative therapy, but not necessarily able to reverse established disease.…”
Section: Fig 6 Effect Of Anti-cd69 Mab On Ova-induced Ahrmentioning
confidence: 99%