Background: Patients with active ulcerative colitis (UC) are known to have elevated myeloid lineage leucocytes including the CD14+CD16+ monocyte phenotype known to release tumour necrosis factor-α. Accordingly granulomonocytapheresis (GMA) with an Adacolumn has been applied to deplete inflammatory cytokine releasing leucocytes as a remission induction therapy. In general, patients who respond well continue responding and favour GMA over pharmacologics. However, published data indicate that patients with extensive deep ulcers and loss of the mucosal tissue at the affected sites may not respond well to GMA, while steroid naïve patients respond well. We have focused on GMA frequency and long term efficacy as supported by endoscopic findings.
Methods: In a retrospective setting, and with interest on long term mucosal healing, we assessed the efficacy of the Adacolumn GMA in patients with active UC treated at different GMA frequencies in the past 10 years. In our data base, we found 99 corticosteroid naive patients who had received GMA at one session per week (n=18, group 1), at 2 to 4 sessions per week (n=31, group 2) or daily (intensive) GMA (n=50, group 3). Each patient could have received up to 11 GMA sessions. Initial efficacy evaluations were undertaken within 10 days following the last GMA session. Clinical activity index (CAI) ≤4 meant remission, while Mayo 0 or 1 meant mucosal healing. The included patients had been followed for ≥12 months on maintenance mesalamine.
Results: The average baseline CAI in groups 1 to 3 were 7.9, 7.8, and 8.4, respectively; the number of GMA sessions were 9.1, 9.7 and 10.1 sessions, respectively; the GMA treatment periods were 55.1, 26.5 and 15.5 days, respectively. The mean CAI after the conclusion of GMA treatment courses were 2.5±2.7, 3.4±3.1 and 3.5±2.7, respectively. The rates of mucosal healing were 76.9%, 60.% and 61.8%, respectively. At 12 months, 40.0% in group 1, 57.1% in group 2 and 61.9% in group 3 had maintained mucosal healing. No GMA related serious adverse event was observed.
Conclusions: This efficacy evaluation undertaking in steroid naïve patients with active UC showed that for an equal number of GMA sessions, the clinical efficacy was not significantly affected by the frequency of GMA sessions, but the time to remission and the rate of mucosal healing at 12 months were significantly better for intensive GMA. However, the efficacy outcomes in our 99 patients are higher than reported for GMA in patients with severe UC refractory to the current pharmacologicals, reflecting the fact that GMA is more effective in steroid naïve patients who have mild or moderately active UC, but not so effective in patients with severe UC in whom drug therapy has failed.