Five or ten cycles of granulocyte-monocyte apheresis (GMA) show equivalent efficacy and safety in ulcerative colitis

Axel U Dignass (1) , Anders Eriksson , Anders Kilander , Aldis Pukitis , Jonathan Rhodes , Stephan Vavricka

1 Department of Medicine I

BACKGROUND: Ulcerative colitis is characterized by leukocyte infiltration into the colonic mucosa. Apheresis depletes these cells. Aim: To assess the non-inferiority of 5 to 10 apheresis treatments in patients with steroid-dependent or steroid-refractory ulcerative colitis. METHODS: 196 adults with moderate-severe ulcerative colitis were randomized 1:1 to 5 (n=96), or 10 (n=90) open label apheresis treatments. The primary endpoint was non-inferiority of clinical activity index (CAI) score after 12 weeks. RESULTS: The intent-to-treat population comprised 82 and 80 patients for the 5- and 10-treatment groups, respectively. The difference between the two groups in mean CAI was 0.24 with an upper 95% confidence intervall of 1.17, which was below a predefined non-inferiority threshold of 1.33. CAI score improved from baseline in both groups (from 8.7 to 5.6 with 5 treatments, and from 8.8 to 5.4 with 10), with no significant difference between the groups (P=0.200). Outcomes for the 5- and 10-treatment groups were similar: Clinical remission: 44% and 40%, respectively (P=0.636); clinical response: 56% and 59%, respectively (P=0.753). Treatment was well tolerated in both groups. CONCLUSIONS: This first prospective study comparing apheresis regimens in ulcerative colitis demonstrates that 5 treatments were not inferior to 10 treatments in steroid-refractory or -dependent ulcerative colitis.

Mots clés: Medicine

Axel U Dignass, Anders Eriksson, Anders Kilander, Aldis Pukitis, Jonathan Rhodes, et al.. Five or ten cycles of granulocyte-monocyte apheresis (GMA) show equivalent efficacy and safety in ulcerative colitis. Alimentary Pharmacology and Therapeutics, 2010, 31 (12), pp.1286. ⟨10.1111/j.1365-2036.2010.04295.x⟩. ⟨hal-00552546⟩