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A randomized trial of the efficacy and safety of quilizumab in adults with
inadequately controlled allergic asthma
#MMPMID26993628
Harris JM
; Maciuca R
; Bradley MS
; Cabanski CR
; Scheerens H
; Lim J
; Cai F
; Kishnani M
; Liao XC
; Samineni D
; Zhu R
; Cochran C
; Soong W
; Diaz JD
; Perin P
; Tsukayama M
; Dimov D
; Agache I
; Kelsen SG
Respir Res
2016[Mar]; 17
(?): 29
PMID26993628
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BACKGROUND: Quilizumab, a humanized IgG1 monoclonal antibody, targets the
M1-prime segment of membrane-expressed IgE, leading to depletion of IgE-switched
and memory B cells. In patients with mild asthma, quilizumab reduced serum IgE
and attenuated the early and late asthmatic reaction following whole lung
allergen challenge. This study evaluated the efficacy and safety of quilizumab in
adults with allergic asthma, inadequately controlled despite high-dose inhaled
corticosteroids (ICS) and a second controller. METHODS: Five hundred
seventy-eight patients were randomized to monthly or quarterly dosing regimens of
subcutaneous quilizumab or placebo for 36 weeks, with a 48-week safety follow-up.
Quilizumab was evaluated for effects on the rate of asthma exacerbations, lung
function, patient symptoms, serum IgE, and pharmacokinetics. Exploratory analyses
were conducted on biomarker subgroups (periostin, blood eosinophils, serum IgE,
and exhaled nitric oxide). RESULTS: Quilizumab was well tolerated and reduced
serum total and allergen-specific IgE by 30-40 %, but had no impact on asthma
exacerbations, lung function, or patient-reported symptom measures. At Week 36,
the 300 mg monthly quilizumab group showed a 19.6 % reduction (p?=?0.38) in the
asthma exacerbation rate relative to placebo, but this was neither statistically
nor clinically significant. Biomarker subgroups did not reveal meaningful
efficacy benefits following quilizumab treatment. CONCLUSIONS: Quilizumab had an
acceptable safety profile and reduced serum IgE. However, targeting the IgE
pathway via depletion of IgE-switched and memory B cells was not sufficient for a
clinically meaningful benefit for adults with allergic asthma uncontrolled by
standard therapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT01582503.
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