The 114-patient, randomized, double blind, placebo-controlled clinical trial revealed multiple daclizumab advantages:

• mean increase in FEV1 (4.4% versus mean decrease of 1.5%, p=0.05)
• increased time to asthma exacerbation requiring oral corticosteroid rescue (p=0.024)
• peripheral eosinophil count reductions (p=0.04)
• favorable FEV1/FVC, FEF25-75% responses.

Daclizumab, but not placebo, recipients improved throughout the trial in terms of diary symptom scores as well as morning and nighttime peak expiratory flow rates. The construct’s tolerability and adverse event profiles were reassuring.

Daclizumab is an anti-CD25 (IL-2 receptor alpha, Tac) antibody currently marketed as Zenapax by Roche (Swiss: ROG) for kidney transplant patients. In March 2002, PDLI halted development of daclizumab for psoriasis after disappointing phase II results. Results for ulcerative colitis have been equivocal.

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