The University of Southampton
University of Southampton Institutional Repository

Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma

Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma
Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma
Study objective: To determine baseline characteristics predictive of response to omalizumab, an anti-IgE antibody, in patients with allergic asthma.
Design: Pooled analysis of two multicenter, double-blind, randomized, placebo-controlled phase III studies with omalizumab.
Patients: One thousand seventy allergic asthma patients symptomatic despite moderate-to-high doses (mean, 725 µg/d) of inhaled beclomethasone dipropionate (BDP).
Interventions: Omalizumab (n = 542) or placebo (n = 528) were administered at a 4-weekly subcutaneous dose of at least 0.016 mg/kg/IgE (IU/mL) for 16 weeks in addition to stable BDP therapy.
Measurements and results: Univariate logistic regression was performed to explore baseline variables predictive of best response. Various aspects of response (reduced symptom scores, reduced usage of rescue medication, improved lung function, improved quality of life [QoL]) were explored as well as a composite definition of response (response in at least one of these four aspects with no asthma exacerbation during 16 weeks of treatment). Time to onset of response as well as the ability to predict eventual response were also determined for the composite definition of response. A consistent pattern of predictive covariates was seen over all definitions of response (except for QoL). For the composite definition, a history of emergency asthma treatment in the past year was the factor most predictive (p = 0.015) of best response on active treatment (response rate for those with such history was 67% for omalizumab and 42% for placebo; for those without a history the response rates were 63% and 54%, respectively). Another factor predictive of best response on active treatment was high BDP dose (p = 0.037; response rate for those treated with ? 800 µg/d was 65% for omalizumab and 40% for placebo; for those treated with < 800 µg/d, the response rates were 63% and 55%, respectively). A low FEV1 was also predictive (p = 0.072; response rates for those with FEV1 ? 65% predicted were 60% for omalizumab and 40% for placebo; for those with FEV1 ? 65% predicted, the response rates were 67% and 53%, respectively). Seventy-six percent of patients had at least one of these factors. This subgroup showed odds of being a responder (composite definition) 2.25 times higher (95% confidence interval, 1.68 to 3.01) than placebo. Some 38% of patients treated with omalizumab showed a response (composite definition) at the first evaluation time point at 4 weeks, increasing to 64% at week 16 (vs 48% for placebo; p < 0.001). Among omalizumab responders at 16 weeks, only 61% had responded at 4 weeks whereas 87% had responded at 12 weeks.
Conclusions: Patients who benefit most when omalizumab is administered as add-on therapy are those receiving high doses of BDP, those with a history of frequent emergency asthma treatment, and those with poor lung function. Patients should be treated with omalizumab for a minimum duration of 12 weeks.
allergic asthma, anti-IgE antibody, omalizumab
0012-3692
1378-1386
Bousquet, Jean
8065d130-faa7-4c8e-bf40-8d2899980c21
Wenzel, Sally
44144acf-90ab-4666-b420-3aeb42586483
Holgate, Stephen
2e7c17a9-6796-436e-8772-1fe6d2ac5edc
Lumry, William
68658c0f-34a2-4f11-9042-ae917395562b
Freeman, Peter
3136550d-1c42-4b5a-8807-8ce3be5ed741
Fox, Howard
d4fc08da-30fa-472f-93fa-3b4e9fbcb5db
Bousquet, Jean
8065d130-faa7-4c8e-bf40-8d2899980c21
Wenzel, Sally
44144acf-90ab-4666-b420-3aeb42586483
Holgate, Stephen
2e7c17a9-6796-436e-8772-1fe6d2ac5edc
Lumry, William
68658c0f-34a2-4f11-9042-ae917395562b
Freeman, Peter
3136550d-1c42-4b5a-8807-8ce3be5ed741
Fox, Howard
d4fc08da-30fa-472f-93fa-3b4e9fbcb5db

Bousquet, Jean, Wenzel, Sally, Holgate, Stephen, Lumry, William, Freeman, Peter and Fox, Howard (2004) Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma. Chest, 125 (4), 1378-1386.

Record type: Article

Abstract

Study objective: To determine baseline characteristics predictive of response to omalizumab, an anti-IgE antibody, in patients with allergic asthma.
Design: Pooled analysis of two multicenter, double-blind, randomized, placebo-controlled phase III studies with omalizumab.
Patients: One thousand seventy allergic asthma patients symptomatic despite moderate-to-high doses (mean, 725 µg/d) of inhaled beclomethasone dipropionate (BDP).
Interventions: Omalizumab (n = 542) or placebo (n = 528) were administered at a 4-weekly subcutaneous dose of at least 0.016 mg/kg/IgE (IU/mL) for 16 weeks in addition to stable BDP therapy.
Measurements and results: Univariate logistic regression was performed to explore baseline variables predictive of best response. Various aspects of response (reduced symptom scores, reduced usage of rescue medication, improved lung function, improved quality of life [QoL]) were explored as well as a composite definition of response (response in at least one of these four aspects with no asthma exacerbation during 16 weeks of treatment). Time to onset of response as well as the ability to predict eventual response were also determined for the composite definition of response. A consistent pattern of predictive covariates was seen over all definitions of response (except for QoL). For the composite definition, a history of emergency asthma treatment in the past year was the factor most predictive (p = 0.015) of best response on active treatment (response rate for those with such history was 67% for omalizumab and 42% for placebo; for those without a history the response rates were 63% and 54%, respectively). Another factor predictive of best response on active treatment was high BDP dose (p = 0.037; response rate for those treated with ? 800 µg/d was 65% for omalizumab and 40% for placebo; for those treated with < 800 µg/d, the response rates were 63% and 55%, respectively). A low FEV1 was also predictive (p = 0.072; response rates for those with FEV1 ? 65% predicted were 60% for omalizumab and 40% for placebo; for those with FEV1 ? 65% predicted, the response rates were 67% and 53%, respectively). Seventy-six percent of patients had at least one of these factors. This subgroup showed odds of being a responder (composite definition) 2.25 times higher (95% confidence interval, 1.68 to 3.01) than placebo. Some 38% of patients treated with omalizumab showed a response (composite definition) at the first evaluation time point at 4 weeks, increasing to 64% at week 16 (vs 48% for placebo; p < 0.001). Among omalizumab responders at 16 weeks, only 61% had responded at 4 weeks whereas 87% had responded at 12 weeks.
Conclusions: Patients who benefit most when omalizumab is administered as add-on therapy are those receiving high doses of BDP, those with a history of frequent emergency asthma treatment, and those with poor lung function. Patients should be treated with omalizumab for a minimum duration of 12 weeks.

Full text not available from this repository.

More information

Published date: 2004
Keywords: allergic asthma, anti-IgE antibody, omalizumab

Identifiers

Local EPrints ID: 26950
URI: https://eprints.soton.ac.uk/id/eprint/26950
ISSN: 0012-3692
PURE UUID: ce732c5e-0726-4ba4-b1ac-69bae1ba9114

Catalogue record

Date deposited: 25 Apr 2006
Last modified: 15 Jul 2019 19:13

Export record

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×