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A randomised, double-blind, sham-controlled study of granulocyte/monocyte apheresis for moderate to severe Crohn's disease
  1. Bruce E Sands1,
  2. Seymour Katz2,
  3. Douglas C Wolf3,
  4. Brian G Feagan4,5,
  5. Tao Wang6,
  6. Lisa-Marie Gustofson6,
  7. Cindy Wong5,
  8. Margaret K Vandervoort5,
  9. Stephen Hanauer7
  1. 1Division of Gastroenterology, Mount Sinai Medical Center and Mount Sinai School of Medicine, New York, New York, USA
  2. 2Long Island Clinical Research Associates, Great Neck, New York, USA
  3. 3Atlanta GI Associates, Atlanta, Georgia, USA
  4. 4Department of Medicine, Epidemiology, and Biostatistics, University of Western Ontario, London, Ontario, Canada
  5. 5Robarts Research Institute, University of Western Ontario, London, Ontario, Canada
  6. 6Otsuka America Pharmaceutical, Inc, Rockville, Maryland, USA
  7. 7Section of Gastroenterology, Hepatology, and Nutrition, University of Chicago, Chicago, Illinois, USA
  1. Correspondence to Dr Bruce E Sands, Division of Gastroenterology, Mount Sinai School of Medicine, One Gustave L Levy Place, Box 1069, New York, NY 10029, USA; bruce.sands{at}mssm.edu

Abstract

Objectives Activated granulocytes and monocytes may contribute to the pathogenesis of Crohn's disease (CD). In small, uncontrolled studies, granulocyte/monocyte apheresis (GMA) has shown promise in treating CD. We conducted a randomised, double-blind study to compare GMA with a sham procedure in patients with moderate to severe CD.

Design Patients with active CD as defined by a Crohn's Disease Activity Index (CDAI) of 220–450 were randomly allocated in a 2:1 ratio to treatment with GMA using the Adacolumn Apheresis System (JIMRO, Takasaki, Japan) or sham apheresis. Ten apheresis sessions were scheduled over a 9-week period, and efficacy was evaluated at week 12. The primary end point was the proportion of patients achieving clinical remission (CDAI score ≤150 without use of prohibited drugs).

Results Clinical remission was achieved by 17.8% of patients in the GMA group (n=157) compared with 19.2% of those in the sham control group (n=78) (absolute difference −1.4% (95% CI−12.8% to 8.5%), p=0.858). Clinical response (defined as a ≥100-point decrease in CDAI) was achieved by 28.0% and 26.9% of patients in the GMA and sham groups, respectively (p=1.000). The two treatments produced similar changes from baseline in CDAI and quality of life, as well as in disease severity assessed endoscopically. The incidence and types of adverse events did not differ between groups.

Conclusions GMA was well tolerated, but this study did not demonstrate its effectiveness over a sham procedure in inducing clinical remission or response in patients with moderate to severe CD.

Clinical trial registration number Clinical Trials.gov identifier NCT00162942.

  • Blood component removal
  • remission induction
  • granulocytes
  • monocytes
  • inflammatory bowel disease

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Footnotes

  • Funding This study was designed and funded by the sponsor, Otsuka America Pharmaceuticals, in collaboration with the investigators.

  • Competing interests TW and L-MG are employees of Otsuka America Pharmaceuticals (OAPI), the sponsor of the study. BGF, CW and MKV are employed by Robarts Research Institute and received funding from OAPI for this study. BES, SK, DCW and SH received research grants from OAPI to perform the research. In addition, BES received a consulting fee for service on the scientific advisory committee for OAPI and SH is an ad hoc consultant to OAPI.

  • Ethics approval Ethics approval was provided by Partners Human Research Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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