Real-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria

M Hew; A Gillman; M Sutherland; P Wark; J Bowden; M Guo; H K Reddel; C Jenkins; G B Marks; F Thien; J Rimmer; G P Katsoulotos; M Cook; I Yang; C Katelaris; S Bowler; D Langton; C Wright; M Bint; V Yozghatlian; S Burgess; P Sivakumaran; K Y Yan; V Kritikos; M Peters; M Baraket; A Aminazad; P Robinson; A Jaffe; H Powell; J W Upham; V M McDonald; P G Gibson

doi:10.1111/cea.12774

Real-life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria

Clin Exp Allergy. 2016 Nov;46(11):1407-1415. doi: 10.1111/cea.12774. Epub 2016 Jul 22.

Authors

M Hew¹, A Gillman², M Sutherland³, P Wark⁴, J Bowden⁵, M Guo⁶, H K Reddel⁷, C Jenkins⁸, G B Marks⁹, F Thien¹⁰, J Rimmer¹¹, G P Katsoulotos¹², M Cook¹³, I Yang¹⁴, C Katelaris¹⁵, S Bowler¹⁶, D Langton¹⁷, C Wright¹⁸, M Bint¹⁸, V Yozghatlian¹⁹, S Burgess²⁰, P Sivakumaran²¹, K Y Yan⁷, V Kritikos⁷, M Peters⁸, M Baraket⁹, A Aminazad¹¹, P Robinson²², A Jaffe²³, H Powell⁴, J W Upham²⁴, V M McDonald⁴, P G Gibson⁴

Affiliations

¹ The Alfred Hospital & Monash University, Melbourne, Vic., Australia. m.hew@alfred.org.au.
² The Alfred Hospital & Monash University, Melbourne, Vic., Australia.
³ Austin Hospital, Heidelberg, Vic., Australia.
⁴ Hunter Medical Research Institute, John Hunter Hospital, University of Newcastle, New Lambton Heights, NSW, Australia.
⁵ Flinders Medical Centre, Bedford Park, SA, Australia.
⁶ Woolcock Institute of Medical Research, Glebe, University of Sydney NSW, Australia.
⁷ Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
⁸ Concord Hospital, Concord, NSW, Australia.
⁹ Liverpool Hospital, Liverpool, NSW, Australia.
¹⁰ Box Hill Hospital, Box Hill, Vic., Australia.
¹¹ St Vincent's Clinic, Darlinghurst, NSW, Australia.
¹² St George Specialist Centre, Kogarah, NSW, Australia.
¹³ Canberra Hospital, Woden, ACT, Australia.
¹⁴ The Prince Charles Hospital, Chermside, Qld, Australia.
¹⁵ Campbelltown Hospital, Campbelltown, NSW, Australia.
¹⁶ Mater Adult Hospital, South Brisbane, Qld, Australia.
¹⁷ Frankston Hospital, Frankston, Vic., Australia.
¹⁸ Nambour Hospital, Nambour, Qld, Australia.
¹⁹ St George Hospital, Kogarah, NSW, Australia.
²⁰ QLD Children's Lung and Sleep Specialists, Woolloongabba, Qld, Australia.
²¹ Gold Coast District Hospital, Southport, Qld, Australia.
²² Children's Hospital at Westmead, Westmead, NSW, Australia.
²³ School of Women's & Children's Health, UNSW Medicine, Randwick, NSW, Australia.
²⁴ Princess Alexandra Hospital, Woolloongabba, Qld, Australia.

PMID: 27377155
DOI: 10.1111/cea.12774

Abstract

Background: Omalizumab (Xolair) dosing in severe allergic asthma is based on serum IgE and bodyweight. In Australia, patients eligible for omalizumab but exceeding recommended ranges for IgE (30-1500 IU/mL) and bodyweight (30-150 kg) may still receive a ceiling dose of 750 mg/4 weeks. About 62% of patients receiving government-subsidized omalizumab are enrolled in the Australian Xolair Registry (AXR).

Objectives: To determine whether AXR participants above the recommended dosing ranges benefit from omalizumab and to compare their response to within-range participants.

Methods: Data were stratified according to dose range status (above-range or within-range). Further sub-analyses were conducted according to the reason for being above the dosing range (IgE only vs. IgE and weight).

Results: Data for 179 participants were analysed. About 55 (31%) were above recommended dosing criteria; other characteristics were similar to within-range participants. Above-range participants had higher baseline IgE [812 (IQR 632, 1747) IU/mL vs. 209 (IQR 134, 306) IU/mL] and received higher doses of omalizumab [750 (IQR 650, 750) mg] compared to within-range participants [450 (IQR, 300, 600) mg]. At 6 months, improvements in Juniper 5-item Asthma Control Questionnaire (ACQ-5, 3.61 down to 2.01 for above-range, 3.47 down to 1.93 for within-range, P < 0.0001 for both) and Asthma Quality of Life Questionnaire (AQLQ mean score (3.22 up to 4.41 for above-range, 3.71 up to 4.88 for within-range, P < 0.0001) were observed in both groups. Forced expiratory volume in one second (FEV₁ ) improved among above-range participants. There was no difference in response between above-range and within-range participants. Above-range participants due to either IgE alone or IgE and weight had similar improvements in ACQ-5, AQLQ and FEV₁ .

Conclusions and clinical relevance: Patients with severe allergic asthma above recommended dosing criteria for omalizumab have significantly improved symptom control, quality of life and lung function to a similar degree to within-range participants, achieved without dose escalation above 750 mg.

Keywords: asthma; dosing range; omalizumab.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Allergens / immunology
Anti-Asthmatic Agents / administration & dosage*
Asthma / diagnosis
Asthma / drug therapy*
Asthma / immunology
Female
Humans
Immunoglobulin E / immunology
Male
Middle Aged
Omalizumab / administration & dosage*
Respiratory Function Tests
Severity of Illness Index
Treatment Outcome

Substances

Allergens
Anti-Asthmatic Agents
Omalizumab
Immunoglobulin E