Objective: Leukocytapheresis (LCAP) is a nonpharmacologic therapy that has recently been used to treat ulcerative colitis (UC). This multicenter open-label study prospectively assessed the efficacy and safety of LCAP in pediatric patients with UC.
Patients and Methods: Twenty-three patients ages 8 to 16 years with moderate (n = 19) to severe (n = 4) steroid-resistant UC were enrolled. One of 2 LCAP columns with different volumes (model EX and the half-volume model EI) was selected, according to body weight. LCAP was performed once per week for 5 consecutive weeks. Clinical and laboratory data were collected at predetermined time points. The primary endpoint was decreased stool frequency/hematochezia score, and secondary endpoints were clinical, laboratory, and endoscopic improvements.
Results: The stool frequency/hematochezia score decreased significantly from 4.5 ± 1.2 before treatment to 1.6 ± 1.9 after the fifth treatment. Clinical parameters, including stool frequency, presence of visible blood, abdominal pain, and body temperature, were significantly improved. Fecal calprotectin decreased significantly. Endoscopic findings evaluated using Matts score also improved (P < 0.01). The steroid dose decreased from 1.1 ± 0.4 mg/kg before treatment to 0.8 ± 0.5 mg/kg after treatment. There were no significant differences in changes between the EX and EI columns. The incidence of adverse effects was 61%, although none was serious. The most common adverse effects were decreased hematocrit and hemoglobin concentration.
Conclusions: The present study showed that LCAP was well tolerated in children with UC, mostly moderate, and was as effective as in adults. The types of pediatric patients best suited to LCAP remain to be determined.
*Departments of Pediatrics, Gunma University Graduate School of Medicine, Gunma, Japan
†Osaka General Medical Center, Japan
‡Saitama Children's Medical Center, Japan
§Juntendo University School of Medicine, Japan
||Osaka Medical College, Japan
¶Kurume University Medical Center, Japan
#Departments of Gastroenterology and Pediatric Surgery, Mie University Hospital, Japan
**Mirai Children's Clinic, Japan
††Miyagi Children's Hospital, Japan
‡‡Departments of Pediatrics, Sapporo Kosei General Hospital, Japan
§§Morioka Children's Hospital, Japan
||||Departments of Pediatrics, Tokyo West Tokushukai Hospital, Japan
¶¶Showa University, Toyosu Clinic, Japan.
Received 14 August, 2010
Accepted 10 January, 2011
Address correspondence and reprint requests to Takeshi Tomomasa, MD, Department of Pediatrics, Gunma University Graduate School of Medicine, 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan (e-mail: firstname.lastname@example.org).
Financial support for the present study was provided by Asahi Kasei Kuraray Medical Co, Ltd, Tokyo, Japan.
The authors report no conflicts of interest.