P581. Baseline clinical activity index appears to predict clinical and endoscopic response in patients with ulcerative colitis undergoing intensive granulocyte and monocyte apheresis
A. Aisaka1, B. Iiduka1, A. Ito1, M. Takahashi1, T. Ohmori1, M. Yonezawa1, 1Tokyo Women's Medical University Hospital, Gastroenterology, Tokyo, Japan
Granulocyte and monocyte apheresis (GMA) therapy with an Adacolumn in patients with ulcerative colitis (UC) has shown good safety profile, and is recommended for patients who do not respond well to baseline medications with 5-aminisalicylic acid and corticosteroids, or have become corticosteroid dependent. Additionally, more frequent GMA involving two sessions per week has been associated with a higher efficacy rate in a shorter time as compared with weekly GMA. However, the efficacy and safety of daily GMA is not widely known.
This study was designed to give consecutive UC patients daily GMA sessions in an inpatient setting as opposed to weekly GMA sessions. Treatment efficacy was to be related to patients' entry demographic variables with the aim of identifying predictors of response to GMA. Twenty-two patients with moderate UC, Lichtiger's clinical activity index (CAI) equal or greater than 7 were included. Six of 22 patients received 5 GMA sessions over 5 consecutive days and sixteen patients received 10 GMA sessions over two weeks. CAI equal or less than 4 meant clinical remission, while a decrease of at least 4 points in the CAI defined clinical response to GMA. Additionally, endoscopy was done at entry and within 2 weeks after the last GMA session according to Iizuka's endoscopic index (EI) score.
Based on CAI, 13 patients (59%) achieved clinical remission, 4 responded and 5 did non respond. Three patients (14%) experienced fatigue or fever as adverse events (AE), but none of the AE was serious, and all patients completed their GMA sessions. With respect to EI (n = 20), 12 patients (60%) showed significant improvement in EI score (P < 0.01). Most responders were steroid naïve or steroid dependent patients. There were significant corticosteroid sparing (P < 0.05), and an increase in bodyweight (P < 0.05). Regarding responders and non-responders to GMA, there was no significant difference in demographic variables or laboratory tests (total white blood cell count, haemoglobin, albumin and C-reactive protein) between patients who achieved remission and those who did not, except a significant difference in CAI at baseline (P < 0.01).
In this study, baseline CAI appeared to predict clinical and endoscopic response to intensive, daily GMA. During GMA therapy, CAI decreased after three days, or just after two GMA sessions, while an improvement in EI could take several weeks to be seen, requiring a long follow-up time.