title: Erythrocytes-mediated delivery of dexamethasone 21-phosphate in steroid-dependent ulcerative colitis: a randomized, double-blind Sham-controlled study.
abstract: 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 In the remaining patients (6 and 15 in the 2 experimental groups, respectively), the treatment was prematurely withdrawn because of clinical deterioration while tapering oral steroids.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).
authors.affiliation: Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy. f.bossa@operapadrepio.it
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Bossa
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: Valvano
authors.forename: Anna
authors.initials: A
authors.lastname: Latiano
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Martino
authors.forename: Luigia
authors.initials: L
authors.lastname: Rossi
authors.forename: Mauro
authors.initials: M
authors.lastname: Magnani
authors.forename: Orazio
authors.initials: O
authors.lastname: Palmieri
authors.forename: Sonja
authors.initials: S
authors.lastname: Serafini
authors.forename: Gianluca
authors.initials: G
authors.lastname: Damonte
authors.forename: Ermelinda
authors.initials: E
authors.lastname: De Santo
authors.forename: Angelo
authors.initials: A
authors.lastname: Andriulli
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000328:Adult; D016022:Case-Control Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003907:Dexamethasone / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D004311:Double-Blind Method; D004912:Erythrocytes; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage*; D011379:Prognosis; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D005938:Glucocorticoids; C004180:dexamethasone 21-phosphate; D003907:Dexamethasone; D011239:Prednisolone