Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis

Sands, Bruce E., Sandborn, William J., Creed, Tom J., Dayan, Colin Mark ORCID: https://orcid.org/0000-0002-6557-3462, Dhanda, Ashwin D., Van Assche, Gert A., Greguš, Miloš, Sood, Ajit, Choudhuri, Gourdas, Stempien, Mary Jean, Levitt, Daniel and Probert, Christopher S. 2012. Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis. Gastroenterology 143 (2) , pp. 356-364. 10.1053/j.gastro.2012.04.043

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Abstract

Background & AIMS. Basiliximab is a chimeric monoclonal antibody that binds CD25 and thereby inhibits interleukin (IL)-2–mediated proliferation of lymphocytes. IL-2 might contribute to the resistance of T cells to corticosteroids. We investigated the efficacy and safety of basiliximab as a corticosteroid-sensitizing agent in patients with corticosteroid-refractory ulcerative colitis (UC). Methods. We studied 149 patients with moderate to severe UC (Mayo score ≥6 and endoscopic subscore ≥2) despite treatment for at least 14 days with oral prednisone (40–50 mg/day). Subjects were randomly assigned to groups that were given 20 mg (n = 46) or 40 mg (n = 52) basiliximab or placebo (n = 51) at weeks 0, 2, and 4. All subjects received 30 mg/day prednisone through week 2; the dose was reduced by 5 mg each week to 20 mg/day, which was maintained until week 8. At week 8, we compared the rates of clinical remission (Mayo score ≤2, no subscore >1) for patients given basiliximab with the rate for patients given placebo. Results. Twenty-eight percent of patients given placebo, 29% of those given the 40-mg dose of basiliximab, and 26% of those given the 20-mg dose of basiliximab achieved clinical remission (P = 1.00 vs placebo for each dose). Basiliximab was generally well tolerated. Six subjects who received basiliximab had serious adverse events (6.1%) compared with 2 who received placebo (3.9%; P = .72). In subjects given basiliximab, incomplete saturation of CD25 (<50%) on peripheral T cells was associated with the presence of anti-basiliximab antibodies (odds ratio, 21; 95% confidence interval, 2.4–184). Conclusions. Basiliximab does not increase the effect of corticosteroids in the induction of remission in outpatients with corticosteroid-resistant moderate to severe UC.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine Systems Immunity Research Institute (SIURI)
Subjects:	R Medicine > R Medicine (General)
Uncontrolled Keywords:	basiliximab; randomized clinical trial; IBD; immune response
Publisher:	Elsevier
ISSN:	0016-5085
Last Modified:	21 Oct 2022 10:58
URI:	https://orca.cardiff.ac.uk/id/eprint/41950

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