Universität zu Köln

Kruis, Wolfgang, Morgenstern, Julia, Ramlow, Wolfgang, Dignass, Axel, Stallmach, Andreas and Drebber, Uta (2019). Novel Leucocyte/Thrombocyte Apheresis for Induction of Steroid-Free Remission in Ulcerative Colitis: A Controlled Randomized Pilot Study. J. Crohns Colitis, 13 (7). S. 949 - 954. OXFORD: OXFORD UNIV PRESS. ISSN 1876-4479

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Abstract

Background and Aims: In active ulcerative colitis [UC] refractory to mesalazine, escalation to either steroids or immunosuppression is common practice. The efficacy and safety of alternative escalation therapy with a novel leukocyte apheresis device were studied. Methods: This was a prospective, randomized, controlled multicentre pilot study comparing leukocyte apheresis with prednisolone in refractory UC (disease activity index [DAI] >= 4 and <= 8). Group A received weekly apheresis over five consecutive weeks. Group P received oral prednisolone 40 mg/day tapered to 0 mg at week 6. The primary end point was steroid-free clinical remission [DAI <= 2] at week 12. Clinical response was also analysed. Results: Twenty-four patients were enrolled, 13 of whom were randomized into group A and 11 into group P. Clinical remission off steroids at week 12 was achieved in 3/12 patients [25.0%] with apheresis and 2/10 [20.0%] with prednisolone [p = 1.0]. The response rate after 12 weeks was 75.0% in group A and 50.0% in group P. Mean DAI scores improved in both treatment groups [p = 0.008]. C-reactive protein decreased from 6.0 +/- 5.3 to 3.8 +/- 3.7 mg/L at 12 weeks in group A and increased from 5.2 +/- 6.0 to 6.3 +/- 7.9 mg/mL in group P. Both treatments were well tolerated. No unexpected serious adverse events were seen in group A. In group P one symptomatic infection with Clostridium difficile occurred. Conclusions: In patients with active UC refractory to mesalazine a novel leukocyte apheresis showed promising results. A comparison with prednisolone revealed similar therapeutic effectivity and excellent safety, providing the chance to escalate without systemic steroids.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kruis, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Morgenstern, Julia UNSPECIFIED UNSPECIFIED UNSPECIFIED Ramlow, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Dignass, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Stallmach, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Drebber, Uta UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-135795
DOI:	10.1093/ecco-jcc/jjz005
Journal or Publication Title:	J. Crohns Colitis
Volume:	13
Number:	7
Page Range:	S. 949 - 954
Date:	2019
Publisher:	OXFORD UNIV PRESS
Place of Publication:	OXFORD
ISSN:	1876-4479
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CYTAPHERESIS; MODERATE Multiple languages Gastroenterology & Hepatology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/13579