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P500. Efficacy and safety of granulocyte, monocyte/macrophage adsorptive apheresis in steroid-dependent active UC with insufficient response or intolerance to immunosuppressants and/or biological therapies (the ART trial): Results at 12 weeks

A. Dignass1, A. Akbar2, B. Bonaz3, 1Agaplesion Markus Hospital, Department of Medicine I, Frankfurt, Germany, 2St Mark's Hospital, Dept. of Medicine, Harrow, United Kingdom, 3CHU de Grenoble, Clinique Universitaire d'Hépato-Gastroentérologie, Grenoble, France

Background

The current medical treatment options for patients with steroid-dependent, active ulcerative colitis (UC) with insufficient response or intolerance to immunosuppressants (IS) and/or biologicals are limited and not evidence-based. The clinical use of Granulocyte, Monocyte/Macrophage Adsorptive (GMA) apheresis with Adacolumn® has previously indicated a potential benefit in this specific subgroup of UC patients. The present study intended to generate further clinical data to document efficacy and to identify subpopulations of this difficult-to-treat UC population that would benefit from GMA apheresis.

Methods

This was an uncontrolled, open-label, multicenter trial conducted in the UK, France and Germany (ART, NCT01481142). Consecutive eligible patients (18–75 years) with steroid-dependent active UC with a Rachmilewitz (CAI) index ≥6 and an Endoscopic Activity Index (EAI) ≥4, and insufficient response or intolerance to IS and/or biologicals were included. Patients received at least 5 weekly GMA aphereses. Evaluation visits were planned at Week 12, 24 and 48. The primary endpoint was the remission rate (CAI ≤4) at Week 12 in the Intention-to-treat (ITT) population.

Results

We report interim results from the 12 Week visit. The ITT population comprised 84 enrolled and treated patients at cutoff date. At Week 12, 33 (39.3%) subjects had achieved remission. Out of 30 patients with prior failure of IS and/or biologicals, the remission rate was 30%. Secondary efficacy parameters were clinical response defined as a reduction in CAI of ≥3, and steroid-free remission and response. 47 patients (55.9%) achieved response; steroid-free remission was reached by in 23% and steroid-free response was seen in 36% of the subjects. In clinical remitters, EAI dropped from 8.2 to 4.4; in clinical responders the EAI decreased from 8.6 to 5.3. Quality of life improved in parallel. The majority of Adverse Events (AEs) were of mild or moderate intensity. Six (7.1%) of 85 subjects in the Safety Population experienced serious adverse events (SAEs), all occurring during the treatment-emergent period; however, none of those SAEs was considered related to study treatment. No new safety signals were seen.

Conclusion

This study describes a larger cohort of steroid-dependent active UC patients with intolerance to IS and/or biologicals treated with GMA apheresis. GMA apheresis with Adacolumn® showed benefit in more than 50% of patients with moderate to severe, active, steroid-dependent UC and insufficient response or intolerance to IS and/or biological agents. Further controlled studies are needed to confirm these data.

This trial was sponsored by Otsuka Pharmaceuticals Europe, Ltd.