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P511 Efficacy and safety of granulocyte/monocyte adsorptive apheresis in steroid-dependent Active Ulcerative Colitis with insufficient response or intolerance to immunosuppressants and/or biological therapies (the ART trial): Results at 24 and 48 weeks

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 uncontrolled, open-label, multicenter trial conducted in the UK, France and Germany. 86 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 TNF inhibitors were included. Patients received up to 8 GMA aphereses in a single induction series over up to 8 weeks. Primary endpoint was the remission rate (CAI ≤ 4) at Week 12; secondary efficacy endpoints were clinical response (reduction in CAI of ≥ 3), and steroid-free remission and response rates in the Intention-to-treat (ITT) population. Patients remained enrolled for the duration of the follow-up; concomitant medication changes were recorded. Endpoint analyses up to 48 Weeks used a conservative approach including additional analyses of sustained remission and response, defined as the respective events observed at Weeks 12, and 24, and 48.

Results

As previously reported [1], among 84 patients in ITT, remission and response rates were 39.3% and 55.9% in Week 12. We now report remission rates of 34.5% in Week 24 and 33.3% in Week 48; response was seen in 46.4% and 39.3%, respectively. Out of 30 patients with prior failure of IS and biologicals, 33.3% were in remission in Week 24 and 20% at Week 48. Steroid-free remission at Week 24 was achieved by 19%, and 15.5% at Week 48. Sustained remission or response was seen in 29.8 % of patients at 48 Weeks. Concomitant IS medication was kept stable, steroid dose equivalents were reduced, and QoL improved further. 30 patients (41.7%) experienced at least 1 AE during follow-up; fifteen subjects experienced SAEs. None of the SAEs was related to the treatment. No new safety signals were seen.

Conclusion

We describe a cohort of steroid-dependent moderate to severe active UC patients with ineffectivity or intolerance to IS and/or biologicals treated with GMA apheresis induction therapy. Cinical benefit was seen in over 50% of patients at Week 12, in 46.4% at Week 24, and in 39.3% at Week 48. GMA apheresis may be a safe alternative treatment option in patients with UC failing or intolerant to immunosuppressants and TNF-inhibitors. Further randomized controlled clinical trials seem warranted to identify the place of GMA in the current treatment algorithms of UC.

References:

[1] Dignass, et al., (2014), Efficacy and safety of GMA apheresis in steroid-dependent active UC with insufficient response or intolerance to immunosuppressants and/or biological therapies (the ART trial): Results at 12 weeks , P500, ECCO 2014 Copenhagen