Reassessment of Omalizumab-Dosing Strategies and Pharmacodynamics in Inner-City Children and Adolescents

Background Treatment regimens for omalizumab are guided by a dosing table that is based on total serum IgE and body weight. Limited data exist about onset and offset of omalizumab efficacy in children and adolescents or subgroups that most benefit from treatment. Objectives Post hoc analyses were co...

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Veröffentlicht in:The journal of allergy and clinical immunology in practice (Cambridge, MA) MA), 2013-03, Vol.1 (2), p.163-171
Hauptverfasser: Sorkness, Christine A., PharmD, Wildfire, Jeremy J., MS, Calatroni, Agustin, MA, MS, Mitchell, Herman E., PhD, Busse, William W., MD, O'Connor, George T., MD, MS, Pongracic, Jacqueline A., MD, Ross, Kristie, MD, Gill, Michelle A., MD, PhD, Kattan, Meyer, MD, CM, Morgan, Wayne J., MD, CM, Teach, Stephen J., MD, MPH, Gergen, Peter J., MD, MPH, Liu, Andrew H., MD, Szefler, Stanley J., MD
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Sprache:eng
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Zusammenfassung:Background Treatment regimens for omalizumab are guided by a dosing table that is based on total serum IgE and body weight. Limited data exist about onset and offset of omalizumab efficacy in children and adolescents or subgroups that most benefit from treatment. Objectives Post hoc analyses were conducted to (1) examine patient characteristics of those eligible and ineligible for omalizumab, (2) describe onset of effect after initiation of omalizumab and offset of treatment effect after stopping therapy, and (3) determine whether the efficacy differs by age, asthma severity, dosing regimen, and prespecified biomarkers. Methods Inner-city children and adolescents with persistent allergic asthma were enrolled in the Inner-City Anti-IgE Therapy for Asthma trial that compared omalizumab with placebo added to guidelines-based therapy for 60 weeks. Results Two hundred ninety-three of 889 participants (33%) clinically suitable for omalizumab were ineligible for dosing according to a modified dosing table specifying IgE level and body weight criteria. Baseline symptoms were comparable among those eligible and ineligible to receive omalizumab, but other characteristics (rate of health care utilization and skin test results) differed. The time of onset of omalizumab effect was 1300 IU/mL. Omalizumab reduced asthma symptoms and exacerbations rapidly; features associated with efficacy can be identified to guide patient selection.
ISSN:2213-2198
2213-2201
DOI:10.1016/j.jaip.2013.01.011