P643 Safety and efficacy of daily granulocyte and monocyte adsorptive apheresis in 50 consecutive patients with active ulcerative colitis: a prospective study
T. Yamamoto*, T. Shimoyama, S. Umegae, K. Matsumoto
Yokkaichi Hazu Medical Centre, Inflammatory Bowel Disease Centre, Yokkaichi, Japan
In Japan, granulocyte and monocyte adsorptive apheresis (GMA) has been approved as 1 treatment option for active ulcerative colitis (UC). Several clinical trials have shown that GMA is safe and effective. However, the optimal treatment regimen in terms of the number and frequency of GMA sessions remains to be established. Theoretically, intensive treatment may be more effective, in a shorter time, but the risk of serious adverse event (AE) might increase. There have been few studies investigating the outcomes of daily GMA in patients with UC. This prospective study was to assess safety and efficacy of daily GMA therapy in patients with active UC.
Fifty consecutive patients with moderately or severely active UC received daily GMA treatment (5 sessions over 5 consecutive days) with the Adacolumn. GMA was administered daily, every 24 ± 3 hours. The GMA session time was 90 minutes/session, at 30 mL/minute. AE, patient tolerability, and clinical symptoms were monitored daily.
In total, 21 patients (42%) experienced AE during at least 1 GMA session. The most frequent AE was mild headache (19/250 sessions), followed by fatigue (12/250 sessions), and fever (10/250 sessions). None of the AE were serious, and all patients completed the 5 consecutive GMA sessions. Clinical symptoms (stool frequency and/or rectal bleeding) were significantly improved in 33 patients (66%) during the course of GMA therapy. Clinical remission, defined as normal stool frequency and no rectal bleeding, was achieved in 10 patients (20%) after 5 GMA sessions. Ten of 38 patients (26%) with moderately active disease achieved clinical remission, whereas none of the 12 patients with severely active disease achieved clinical remission. Age, gender, duration of UC, duration of current exacerbation, medications for the current exacerbation, and the extent of UC did not appear to affect the likelihood of clinical remission. Total and differential leukocyte counts, platelet count and haemoglobin level did not significantly change during the course of GMA therapy.
Daily GMA was safe and well tolerated without serious AE. Daily GMA was associated with rapid improvement of clinical symptoms in patients with moderately active UC. However, controlled trials are warranted to assess a definite efficacy for daily GMA therapy.