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Low‐dose oral microemulsion ciclosporin for severe, refractory ulcerative colitis
Author(s) -
SAUSSURE P.,
SORAVIA C.,
MOREL P.,
HADENGUE A.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02552.x
Subject(s) - ciclosporin , medicine , ulcerative colitis , gastroenterology , refractory (planetary science) , tolerability , colitis , surgery , chemotherapy , adverse effect , physics , disease , astrobiology
Summary Background: The optimal modalities of treatment with oral microemulsion ciclosporin in patients with severe, steroid‐refractory ulcerative colitis are uncertain. Aim: To assess the applicability, in terms of efficacy and tolerability, of a standard oral microemulsion ciclosporin treatment protocol targeting relatively low blood ciclosporin concentrations, in patients with severe, steroid‐resistant ulcerative colitis. Patients and methods: Patients with a severe attack of ulcerative colitis and no satisfactory response to intravenous corticosteroids were started on oral microemulsion ciclosporin. Dosages were adapted according to a standard protocol, targeting a blood predose ciclosporin concentration ( C 0 ) of 100–200 ng/mL. Patients without a clinical response on day 8 were scheduled for colectomy. Results: Sixteen patients were enrolled. A clinical response was observed in 14/16 (88%). The mean clinical activity index scores and concentrations of C‐reactive protein on days 0, 4 and 8 were 11.8, 6.7 and 4.1, and 50.3, 19.3 and 9.7 mg/L respectively. The mean C 0 (days 0–8) was 149 pg/mL. The mean creatinine clearance rates on days 0 and 8 were 88 and 96 mL/min. One patient had an acute elevation of transaminases that resulted in discontinuing ciclosporin. Conclusions: Even when dosed for a target C 0 of 100–200 ng/mL, oral microemulsion ciclosporin for severe, steroid‐refractory ulcerative colitis achieves an efficacy similar to that attained with higher, potentially more toxic levels. The oral route should replace intravenous treatment in this clinical setting.