Adsorptive Granulocyte/Monocyte Apheresis for the Maintenance of Remission in Patients with Ulcerative Colitis: A Prospective Randomized, Double Blind, Sham-Controlled Clinical Trial.
- Author:
Ken FUKUNAGA
1
;
Yoko YOKOYAMA
;
Koji KAMOKOZURU
;
Kazuko NAGASE
;
Shiro NAKAMURA
;
Hiroto MIWA
;
Takayuki MATSUMOTO
Author Information
1. Division of Lower Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan. kazuko@hyo-med.ac.jp
- Publication Type:Clinical Trial ; Randomized Controlled Trial ; Original Article ; Controlled Clinical Trial
- Keywords:
Granulocyte monocyte apheresis;
Inflammatory bowel diseases;
Maintenance treatment;
Randomized controlled trial;
Ulcerative colitis
- MeSH:
Adsorption;
Arm;
Blood Component Removal;
Colitis, Ulcerative;
Extracorporeal Circulation;
Humans;
Inflammatory Bowel Diseases;
Prednisolone;
Prospective Studies;
Recurrence;
Remission Induction;
Salicylamides;
Ulcer
- From:Gut and Liver
2012;6(4):427-433
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND/AIMS: Weekly granulocyte/monocyte adsorption (GMA) to deplete elevated and activated leucocytes should serve as a non-pharmacological intervention to induce remission in patients with ulcerative colitis (UC). This trial assessed the efficacy of monthly GMA as a maintenance therapy to suppress UC relapse. METHODS: Thirty-three corticosteroid refractory patients with active UC received 10 weekly GMA sessions as a remission induction therapy. They were then randomized to receive one GMA session every 4 weeks (True, n=11), extracorporeal circulation without the GMA column every 4 weeks (Sham, n=11), or no additional intervention (Control, n=11). The primary endpoint was the rate of avoiding relapse (AR) over 48 weeks. RESULTS: At week 48, the AR rates in the True, Sham, and Control groups were 40.0%, 9.1%, and 18.2%, respectively. All patients were steroid-free, but no statistically significant difference was seen among the three arms. However, in patients who could taper their prednisolone dose to <20 mg/day during the remission induction therapy, the AR in the True group was better than in the Sham (p<0.03) or Control (p<0.05) groups. CONCLUSIONS: Monthly GMA may potentially prevent UC relapse in patients who have achieved remission through weekly GMA, especially in patients on <20 mg/day PSL at the start of the maintenance therapy.
