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Published ahead of print on March 20, 2003, doi:10.1164/rccm.200206-525OC
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American Journal of Respiratory and Critical Care Medicine Vol 167. pp. 1655-1659, (2003)
© 2003 American Thoracic Society

Original Article

Effect of SCH55700, a Humanized Anti-Human Interleukin-5 Antibody, in Severe Persistent Asthma

A Pilot Study

Johan C. Kips, Brian J. O'Connor, Stephen J. Langley, Ashley Woodcock, Huib A. M. Kerstjens, Dirkje S. Postma, Mel Danzig, Francis Cuss and Romain A. Pauwels

Ghent University Hospital, Ghent, Belgium; Guy's, King's, and St Thomas's School of Medicine, London; Medicines Evaluation Unit, North West Lung Centre, Manchester, United Kingdom; University Hospital Groningen, Groningen, The Netherlands; and Schering-Plough Research Institute, Kenilworth, New Jersey

Correspondence and requests for reprints should be addressed to Johan C. Kips, M.D., Ph.D., Department of Respiratory Diseases, Ghent University Hospital, De Pintelaan 185, B 9000 Ghent, Belgium. E-mail: johan.kips{at}rug.ac.be

Antagonizing the effect of interleukin (IL)-5 is a potential new treatment strategy in allergic disorders. We evaluated the safety, biological activity, and pharmacokinetics of SCH55700, a humanized anti-human IL-5 antibody, in subjects with severe persistent asthma treated with oral or high doses of inhaled steroids. In a double-blind, randomized, multicenter trial, a rising single dose of SCH55700 (0.03 mg/kg [n = 2], 0.1 mg/kg [n = 4], 0.3 mg/kg [n = 6], or 1.0 mg/kg [n = 12]) or placebo (n = 8) was administered intravenously. SCH55700 dose dependently reduced circulating eosinophil counts. At a dose of 1.0 mg/kg, the decrease remained significant up to Day 30 [(0.07 ± 0.01) x 109/L versus (0.23 ± 0.04) x 109/L at baseline] (mean ± SEM) (p = 0.05). After administration of SCH55700 at 0.3 and 1.0 mg/kg, a trend toward improvement in baseline FEV1 was observed, which reached significance 24 hours after the 0.3-mg/kg dose (p = 0.019 versus placebo). No significant changes occurred in other clinical indices of disease activity. Adverse events were not different between active treatment and placebo. We conclude that SCH55700 is a biologically active anti-human IL-5 antibody that can be safely used in severe steroid-treated asthma. Its therapeutic potential needs to be addressed in specifically designed efficacy trials.

Key Words: anti-human interleukin-5 antibody • asthma • eosinophil • glucocorticosteroids • interleukin-5




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