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Published ahead of print on March 20, 2003, doi:10.1164/rccm.200206-525OC

Am. J. Respir. Crit. Care Med., Volume 167, Number 12, June 2003, 1655-1659

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Submitted on June 7, 2002
Accepted on March 18, 2003

The effect of SCH55700, a humanized anti-hIL-5 antibody in severe persistent asthma : a pilot study

Johan C Kips1*, O'Connor J Brian2, Stephen J Langley3, Ashley Woodcock3, Huib, A. M. Kerstjens4, Dirkje S Postma4, Mel Danzig5, Francis Cuss5, and Romain A Pauwels1

1 Pulmonary Diseases, Ghent University Hospital, Ghent, Belgium, 2 Respiratory Medicine and Allergy, Guy's King's and Saint Thomas Hospital, London, United Kingdom, 3 Medicines Evaluation Unit, North West Lung Centre, Manchester, United Kingdom, 4 Pulmonary Diseases, University Hospital Groningen, Groningen, The Netherlands, 5 Biological Research Allergy and Immunology, Schering Plough Research Institute, Kenilworth, New Jersey, USA

* To whom correspondence should be addressed. E-mail: johan.kips{at}rug.ac.be.

Antagonizing the effect of 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 (n=2), 0.1 (n=4), 0.3 (n=6) or 1 mg/kg (n=12)] or placebo (n=8) was administered intravenously. SCH55700 dose dependently reduced circulating eosinophil counts. At a dose of 1 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 0.3 and 1 mg/kg SCH55700, a trend towards improvement in baseline FEV1 was observed, which reached significance at 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 antihuman 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: asthma, eosinophil, glucocorticosteroids, interleukin-5, anti-human IL-5 antibody




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