P615 Efficacy and safety of granulocyte, monocyte/macrophage adsorptive apheresis in steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biological therapies (the ART trial): final results
A. Dignass*1, A. Akbar2, B. Bonaz3
1Agaplesion Markus Hospital, Department of Medicine I, Frankfurt, Germany, 2St Mark’s Hospital, Gastroenterology, London, United Kingdom, 3CHU de Grenoble, Clinique Universitaire d’Hépato-Gastroentérologie, Grenoble, France
Treatment options in steroid-dependent, chronic-active ulcerative colitis (UC) with insufficient response or intolerance to immunosuppressants and/or biologicals are limited. The ART trial intended to document efficacy and to describe difficult-to-treat UC subpopulations which could benefit from Granulocyte/ Monocyte adsorptive (GMA) apheresis (Adacolumn®).
This was an open-label, uncontrolled, multicentre trial conducted in the United Kingdom, France, and Germany, including 95 patients (18–75 years) with steroid-dependent active UC (clinical activity index [CAI] ≥ 6; endoscopic activity index [EAI] ≥ 4, and insufficient response or intolerance to immunosuppressants (IS) and/or tumour necrosis factor (TNF) inhibitors. Patients received at least 5 and up to 10 GMA aphereses in a single induction series over up to 10 weeks. Primary endpoint was the remission rate (CAI ≤ 4) at week 12. Secondary efficacy endpoints included clinical response (reduction in CAI of ≥ 3), steroid-free remission, and colectomy rates. Patients were followed-up until week 48.
In the ITT population (N = 95), remission and response rates were 37.2% and 53.2%, respectively, at week 12. At weeks 24 and 48, remission rates were 34% and 33%, respectively; response rates were 44.7% and 39.4%, respectively. For 30 patients who failed IS and anti-TNF, 30%, 33.3% and 20% were in remission at weeks 12, 24, and 48, respectively. Steroid-free remission at weeks 12, 24, and 48 was achieved by 19.2%, 19.2%, and 18.1%, respectively. Sustained remission or response was observed in 27.7% of patients at 48 weeks. IS medication was kept stable during the trial; steroids were significantly reduced. Quality of life (QoL) improved throughout the trial. Further 13 out of 94 (13.8%) patients had a colectomy by week 48. No patient died. No life-threatening opportunistic infection occurred. In addition, 80 patients (84.2%) experienced mild-to-moderate AEs (majority UC-related or headache); 22 subjects experienced SAEs, but none related to treatment; 26 patients (27.4%) discontinued the study because of AEs (UC-related, 21.1%; and poor vascular access, 13.7%).
We describe a cohort of steroid-dependent moderate-to-severe active UC patients with failure or intolerance to previous treatment with IS and/or anti-TNF, treated with GMA apheresis induction therapy. Clinical benefit was seen in over 50%, 44.7%, and 39.4% of patients at weeks 12, 24, and 48, respectively. Colectomy rates up to 48 weeks (13.8%) in these non-preselected patients were comparable to published results for anti-TNF treatment at 1 year.1 GMA apheresis might be a safe alternative treatment option in UC patients with failure or intolerance to immunosuppressants and TNF inhibitors.
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