Novel Leucocyte/Thrombocyte Apheresis for Induction of Steroid-Free Remission in Ulcerative Colitis: A Controlled Randomized Pilot Study

Evangelisches Krankenhaus Kalk, University of Cologne, Germany. Apheresis Center Rostock (ACR), Rostock, Germany. Department of Medicine I, Agaplesion Markus Hospital and Crohn Colitis Clinical Research Center Rhein-Main, Frankfurt/Main, Germany. Department of Internal Medicine IV (Gastroenterology, Hepatology, Infectious Diseases), University Hospital of Jena, Jena, Germany. Department of Pathology, University of Cologne, Germany.

Journal of Crohn's & colitis. 2019
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. CIV-12-01-003581.
Study details
Language : eng
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