Background: Granulocyte and monocyte apheresis (GMA) has shown therapeutic efficacy in patients with active ulcerative colitis (UC). We thought that in patients with pouchitis, GMA should produce immunoregulatory effects in the intestinal mucosa, and improve clinical symptoms. With this in mind, we undertook a prospective study to evaluate the efficacy of GMA for antibiotic refractory pouchitis after proctocolectomy for UC.
Methods: Thirteen patients with pouchitis disease activity index (PDAI) >7 unresponsive to 2 weeks of optimal antibiotic therapy were included. All patients received 10 GMA sessions with the Adacolumn at two sessions/week over five consecutive weeks. The primary endpoints were response, as a decrease of ≥3 points in the PDAI score and remission (PDAI <4). Secondary endpoints included reduction of white blood cells (WBC), C-reactive protein (CRP), faecal markers (calprotectin and lactoferrin), reduction of the PDAI endoscopic subscore, and GMA treatment safety.
Results: The median PDAI score was significantly decreased from 11 (range, 9–15) at entry to 9 (range, 6–13) assessed within one week after the last GMA session (p=0.02). Six patients (46%) responded to the treatment, but none of the patients achieved remission. The median endoscopic subscore (maximum: 6) was 5 (range, 4–6) at entry and 5 (range, 1–6) after the treatment (p=0.10). None of the laboratory markers (WBC, CRP, faecal calprotectin and lactoferrin) significantly changed during the treatment. Transient adverse events (AEs) were observed in two patients (15%), dyspnoea in one and headache in one. The AEs were not serious, and all patients including the 2 with AEs completed the 10 GMA sessions.
Conclusions: GMA has a good safety profile, but its efficacy appears to be limited in the management of chronic drug refractory pouchitis. However, a large controlled study is warranted to fully evaluate the efficacy of GMA in patients with pouchitis, at an earlier clinical stage.