Bristol Area Study of Basiliximab in Ulcerative Colitis (BASBUC) Investigators: R. A. Mountford, J. Brown, R. Valori, I. Shaw, R. Harvey, J. Anderson, I. Crossley, J. Smithson, S. Hughes, M. Davis, J. Perry, D. Robertson, J. M. Farrant, J. Linehan and D. Panagiotakopoulos.
Basiliximab for the treatment of steroid-resistant ulcerative colitis: further experience in moderate and severe disease
Article first published online: 28 APR 2006
Alimentary Pharmacology & Therapeutics
Volume 23, Issue 10, pages 1435–1442, May 2006
How to Cite
CREED, T. J., PROBERT, C. S. J., NORMAN, M. N., MOORGHEN, M., SHEPHERD, N. A., HEARING, S. D., DAYAN, C. M. and THE BASBUC INVESTIGATORS (2006), Basiliximab for the treatment of steroid-resistant ulcerative colitis: further experience in moderate and severe disease. Alimentary Pharmacology & Therapeutics, 23: 1435–1442. doi: 10.1111/j.1365-2036.2006.02904.x
- Issue published online: 28 APR 2006
- Article first published online: 28 APR 2006
- Publication data Received 25 October 2005 First decision 26 November 2005 Resubmitted 20 February 2006 Accepted 24 February 2006
Preliminary data have suggested that interleukin-2 receptor blockade with basiliximab may increase steroid sensitivity. We have previously reported a small case series demonstrating the potential of basiliximab as a novel agent for the treatment of steroid-resistant ulcerative colitis.
To report further experience of the efficacy and safety of treatment with the interleukin-2 receptor blocking monoclonal antibody basiliximab, in addition to steroids, for the treatment of severe and moderate steroid-resistant ulcerative colitis.
Twenty patients were enrolled – 13 patients with moderate steroid-resistant ulcerative colitis (Ulcerative Colitis Symptom Score: ≥6) and seven patients with severe steroid-resistant ulcerative colitis. All were given a single dose of 40 mg basiliximab plus standard steroid therapy in an open-label, uncontrolled trial. Primary end point was clinical remission within 8 weeks (Ulcerative Colitis Symptom Score: ≤2).
Within 8 weeks, 10 of 20 (50%) patients achieved clinical remission (seven of 13 moderate, and three of seven severe). At 24 weeks, 13 of 20 (65%) patients were in clinical remission. Five patients required colectomy (four severe, one moderate ulcerative colitis) and one required rescue ciclosporin (moderate ulcerative colitis). Two patients developed herpes zoster, but treatment was generally well tolerated.
Basiliximab appears to promote prolonged remission after a single treatment. Taken in combination with previously reported data, basiliximab shows particular promise in moderate steroid-resistant ulcerative colitis.