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P556 A randomized, multicentre, clinical trial to compare prednisone plus granulocyte and monocyte apheresis (GMA) versus prednisone alone for inducing steroid-free remission in patients with steroid dependent Ulcerative Colitis (UC)

E. Domènech*1, J. Panés2, J. Hinojosa3, V. Annese4, F. Magro5, R. Lafuente6, on behalf of the ATICCA study of GETECCU7

1Hospital Germans Trias i Pujol, Gastroenterology, Badalona, Spain, 2Hospital Clínic, Gastroenterology, Barcelona, Spain, 3Hospital Manises, Gastroenterology, Valencia, Spain, 4AOU Careggi Hospital, Gastroenterology, Firenze, Italy, 5Centro Hospitalar São João, Gastroenterology, Porto, Portugal, 6Otsuka Pharmaceuticals, Medical Department, Barcelona, Spain, 7Hospital Son Espases, Gastroenterology, Palma de Mallorca, Spain

Background

Steroid-dependency occurs in up to 30% of UC patients responding to systemic corticosteroids. Thiopurines and anti-TNF drugs have demonstrated efficacy in inducing steroid-free remission but up to 50% of patients are intolerant or fail to respond to these drugs.

Methods

This was a randomized, multicentre, open trial promoted by the Spanish Working Group on IBD (GETECCU), that compared 7 weekly sessions of GMA plus oral prednisone (40mg/day and tapering) to prednisone alone in patients with mild-to-moderate active UC (Mayo score 4-10) were steroid-dependent (inability to withdraw corticosteroids in 3 months or relapse within the first 3 months after discontinuation). Patients were stratified by concomitant use of thiopurines at inclusion, and the same 9-week prednisone tapering schedule was pre-established in both study groups. The primary end-point was steroid-free remission (as defined by a Mayo score equal or less than 2 with no individual subscore higher than 1) at week 24, with no reintroduction of corticosteroids during the study period.

Results

One hundred and twenty-three patients were included (63 GMA group, 62 prednisone alone). 27% of patients concomitantly used thiopurines and 55% were taking steroids during the screening period. In the ITT analysis, steroid-free remission at week 24 was achieved in 13% of the GMA group vs. 6% in the control group (P=0.11). No differneces were found in the per protocol analysis. However, time to relapse was significantly longer in the GMA group (HR 1.7 [1.16-2.48], P=0.005). In the subpopulation of thiopurine-naïve patients, steroid-free remission rates were significantly higher in the GMA group (13% vs. 0%, P=0.03). Steroid-related adverse events were significantly less among patients in the GMA group (6% vs. 20%, P<0.05).

Conclusion

The addition of 7 weekly sessions of GMA to a conventional course of oral prednisone in patients with active steroid-dependent UC does not increase steroid-free remission although it significantly delays clinical relapse.