Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results

Journal of Crohn's & Colitis
A U DignassBruno Bonaz

Abstract

Patients with active, steroid-dependent ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologic therapies have limited treatment options. Adacolumn, a granulocyte/monocyte adsorptive apheresis device, has shown clinical benefit in these patients. This study aimed to provide additional clinical data regarding the safety and efficacy of Adacolumn in this patient subgroup. This single-arm, open-label, multicentre trial [ART] was conducted at 18 centres across the UK, France, and Germany. Eligible patients were 18-75 years old with moderate-to-severe, steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics. Patients received ≥ 5 weekly apheresis sessions with Adacolumn. The primary endpoint was clinical remission rate [clinical activity index ≤ 4] at Week 12. In all, 86 patients were enrolled. At Week 12, 33/84 [39.3%] of patients in the intention-to-treat population achieved clinical remission, with 47/84 [56.0%] achieving a clinical response [clinical activity index reduction of ≥ 3]. Clinical remission was achieved in 30.0% of patients with previous immunosuppressant and biologic failure; steroid-free clinical remissio...Continue Reading

References

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Citations

Mar 1, 2018·Journal of Crohn's & Colitis·Eugeni DomènechUNKNOWN ATTICA Study Group by the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa [listed at the end of the artic
Mar 8, 2018·Scandinavian Journal of Gastroenterology·Axel DignassBruno Bonaz
Jul 25, 2018·Immunopharmacology and Immunotoxicology·Qiang WuBaotian Kan
Sep 18, 2018·Expert Opinion on Pharmacotherapy·Nicolò MezzinaSandro Ardizzone
Feb 1, 2020·Journal of the Anus, Rectum and Colon·Shinji OkabayashiToshifumi Hibi
May 22, 2020·World Journal of Gastrointestinal Pathophysiology·Xiu-Li ChenYing-De Wang
Apr 23, 2017·Digestive Diseases and Sciences·Esteban Sáez-GonzálezBelén Beltrán
Oct 9, 2020·Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy·Yoh IshiguroMasahiro Iizuka
Jun 25, 2021·Clinical and Experimental Gastroenterology·An Outtier, Marc Ferrante

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Methods Mentioned

BETA
granulocytapheresis
pharmacotherapy

Clinical Trials Mentioned

NCT01481142

Software Mentioned

SAS

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