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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

Background

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®).

Methods

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.

Results

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%).

Conclusion

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.

References

[1] Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF: Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60. doi: 10.1053/j.gastro.2009.06.061.