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Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis

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posted on 2018-03-07, 14:29 authored by Axel Dignass, Ayesha Akbar, Daniel C. Baumgart, Gilles Bommelaer, Guillaume Bouguen, Guillaume Cadiot, Anton Gillessen, Jean-Charles Grimaud, Ailsa Hart, Syed Hoque, Richard Makins, Christophe Michiels, Jacques Moreau, Purushothaman Premchand, Wolfgang Ramlow, Stefan Schanz, Sreedhar Subramanian, Christian von Tirpitz, Bruno Bonaz

Objectives: Current options for patients with steroid-dependent, chronic-active ulcerative colitis (UC) with insufficient response/intolerance to immunosuppressants (ISs) and/or biologics are limited. The aim of this study was to assess the long-term outcome of granulocyte/monocyte adsorptive (GMA) apheresis (Adacolumn®) in this population.

Materials and methods: Ninety five adults with steroid-dependent active UC and insufficient response/intolerance to IS and/or TNF inhibitors received 5–8 aphereses in a single induction series of ≤10 weeks. Endpoints included rates of remission (clinical activity index [CAI] ≤ 4) at weeks 24 and 48.

Results: Of 94 patients (ITT population), remission and response rates were 34.0% and 44.7% at week 24, and 33.0% and 39.4% at week 48. Among 30 patients with prior failure of IS and biologics, 33.3% and 20.0% were in remission at weeks 24 and 48. At both weeks, 19.2% of patients achieved steroid-free remission. Sustained remission or response occurred in 27.7% of patients at 48 weeks. The cumulative colectomy rate at week 96 was 23.4%. Safety was consistent with previous findings.

Conclusions: This study confirms findings of the 12-week interim analysis and demonstrates that GMA apheresis provides a safe and beneficial long-term outcome for patients with chronic active UC resistant/intolerant to IS and/or TNF inhibitors.

Funding

This study was funded by Otsuka Pharmaceuticals, Ltd. Data analysis (Dr Karola Köhler, PREMIER RESEARCH) and writing support (Jon Viney, PhD, Succinct Medical Communications) were funded by Otsuka Pharmaceuticals, Ltd.

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    Scandinavian Journal of Gastroenterology

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