Erythrocytes-mediated delivery of dexamethasone 21-phosphate in steroid-dependent
ulcerative colitis: a randomized, double-blind Sham-controlled study.
Author(s): Bossa F(1), Annese V, Valvano MR, Latiano A, Martino G, Rossi L, Magnani M,
Palmieri O, Serafini S, Damonte G, De Santo E, Andriulli A.
Affiliation(s): Author information:
(1)Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San
Giovanni Rotondo, Italy. f.bossa@operapadrepio.it
Publication date & source: 2013, Inflamm Bowel Dis. , 19(9):1872-9
BACKGROUND: Efficacy of erythrocyte-mediated delivery of dexamethasone
21-phosphate in patients with steroid-dependent ulcerative colitis.
METHODS: Thirty-seven patients with steroid-dependent ulcerative colitis were
randomized to infusions of dexamethasone 21-phosphate encapsulated into
autologous erythrocytes (n = 19) or to sham infusions (n = 18). Each infusion was
given monthly for 6 months. The primary endpoint was the proportion of patients
able to discontinue oral corticosteroids during treatment while maintaining
clinical remission or stable disease. Secondary endpoint was the proportion of
patients with disappearance of steroid-related adverse events.
RESULTS: At each infusion, a mean of 9.8 ± 4.6 mg dexamethasone 21-phosphate was
administered at each infusion, which allowed steady-state plasma levels of 8
ng/mL for the following 28 days. Thirteen patients in the dexamethasone
21-phosphate group and 4 sham-treated patients attained the primary outcome of
the study, i.e., maintaining a stable condition despite oral steroids withdrawal
(P = 0.008). In the remaining patients (6 and 15 in the 2 experimental groups,
respectively), the treatment was prematurely withdrawn because of clinical
deterioration while tapering oral steroids. At endoscopy, mucosal healing was
ascertained in 4 patients and 1 patient of the 2 experimental groups,
respectively (P = 0.339). At inclusion, 14 and 13 patients in the 2 experimental
groups complained of steroid-related adverse events; at end of the treatment,
events were still present in 5 and 13 patients, respectively (P = 0.008).
CONCLUSIONS: In patients with steroid-dependent ulcerative colitis, 6-month
therapy with low dose of dexamethasone 21-phosphate allowed the withdrawal of
oral steroids and the reversal of steroid-related adverse events in most patients
while maintaining clinical remission (ClinicalTrials.gov number, NCT01171807).
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