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Published ahead of print on July 13, 2006, doi:10.1164/rccm.200601-072OC

Am. J. Respir. Crit. Care Med., Volume 174, Number 7, October 2006, 753-762

A more recent version of this article appeared on October 1, 2006
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Submitted on January 17, 2006
Accepted on July 12, 2006

The Effects of a Monoclonal Antibody Directed Against Tumour Necrosis Factor-{alpha} (TNF-{alpha}) in Asthma

Edward M Erin1, Brian R Leaker2, Grant C Nicholson1, Andrew J Tan1, Linda M Green1, Helen Neighbour1, Angela S Zacharasiewicz1, Jackie Turner1, Elliot S Barnathan3, Onn Min Kon4, Peter J Barnes5, and Trevor T Hansel1*

1 Clinical Studies Unit, Imperial College, Royal Brompton Hospital, National Heart and Lung Institute (NHLI), London, United Kingdom, 2 Department of Nephrology, Royal Free Hospital, London, United Kingdom, 3 Centocor, Inc., Malvern, PA, USA, 4 Department of Respiratory Medicne, St. Mary's Hospital, London, United Kingdom, 5 Department of Thoracic Medicine, Imperial College, London, United Kingdom

* To whom correspondence should be addressed. E-mail: t.hansel{at}imperial.ac.uk.

Rationale: Neutralisation of tumour necrosis factor alpha (TNF-{alpha}) is an effective anti-inflammatory therapy for several chronic inflammatory diseases. Methods and Objectives: We undertook a double-blind, placebo-controlled, parallel-group design study in 38 patients with moderate asthma treated with inhaled corticosteroids but who were symptomatic during a run-in phase. Infliximab (5 mg/kg) or placebo was administered by intravenous infusion at weeks 0, 2, and 6. We assessed clinical response by monitoring lung function, symptoms, and inhaled {beta}2-agonist usage using hand-held electronic devices. Results: The primary endpoint, change in morning PEF at days 50-56 compared to the last 7 days of the run-in, was not significantly different on treatment. However, infliximab was associated with a decrease in mean diurnal variation of PEF at week 8 (p=0.02; 95% CI -8.1 to -0.72). Furthermore, there was a decrease in the number of patients with exacerbations of asthma (p=0.01; 95% CI 4.4 to 52.7), and an increased probability of freedom from exacerbation with time (p=0.03), in patients on infliximab (n=14) compared to placebo (n=18). In addition, infliximab decreased levels of TNF-{alpha} (p=0.01) and other cytokines in sputum supernatants. There were no serious adverse events related to study agent. Conclusions: Treatment with infliximab was well tolerated and caused a decrease in the number of patients with exacerbations in symptomatic moderate asthma. The promising preliminary findings underscore the need to evaluate therapy directed against TNF-{alpha} in larger trials enrolling patients with more severe asthma. Key words: Pharmacology, asthma, TNF-{alpha}, monoclonal antibody
Key words: Pharmacology, asthma, TNF-alpha, monoclonal antibody




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