Treating ulcerative colitis by Adacolumn therapeutic leucocytapheresis: Clinical efficacy and safety based on surveillance of 656 patients in 53 centres in Japan

Digestive and Liver Disease

Volumn 41, Issue 8, 2009, Pages 570-577

  Hibi, T ^a   Sameshima, Y ^b   Sekiguchi, Y ^c   Hisatome, Y ^c   Maruyama, F ^c   Moriwaki, K ^c   Shima, C ^c   Saniabadi, A R ^c   Matsumoto, T ^d  

^a KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b Sameshima Hospital   (Japan)

^c JAPAN IMMUNORESEARCH LABORATORIES   (Japan)

^d HYOGO COLLEGE OF MEDICINE   (Japan)

Author keywords

Adacolumn; Corticosteroid tapering; Granulocyte and monocyte adsorption; Inflammatory bowel disease; Large population based data; Patient surveillance

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; C REACTIVE PROTEIN; HEPARIN; IMMUNOMODULATING AGENT; LOW MOLECULAR WEIGHT HEPARIN; NAFAMSTAT MESILATE; PREDNISOLONE; SALICYLIC ACID DERIVATIVE;

ABDOMINAL PAIN; ANEMIA; ARTICLE; CHILL; COLONOSCOPY; CONTROLLED STUDY; DIARRHEA; DISEASE ACTIVITY; DISEASE SEVERITY; DYSPNEA; FEVER; GRANULOCYTE; HEADACHE; HUMAN; HYPOTENSION; JAPAN; LEUKAPHERESIS; LEUKOCYTE COUNT; LEUKOPENIA; LIVER DYSFUNCTION; LOW BACK PAIN; MACROPHAGE; MAJOR CLINICAL STUDY; MALAISE; MONOCYTE; NAUSEA AND VOMITING; PATIENT SAFETY; PERIANAL ABSCESS; POSTMARKETING SURVEILLANCE; PREDICTION; PRIORITY JOURNAL; RASH; REMISSION; THORAX PAIN; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT OUTCOME; ULCERATIVE COLITIS;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; COLITIS, ULCERATIVE; COLONOSCOPY; FEMALE; GRANULOCYTES; HUMANS; LEUKAPHERESIS; MALE; MIDDLE AGED; MONOCYTES; REMISSION INDUCTION; TREATMENT OUTCOME; YOUNG ADULT;

EID: 67649643627     PISSN: 15908658     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.dld.2008.11.020     Document Type: Article

References (64)

1. In: Allison M.C., Dhillon A.P., Lewis W.G., and Pounder R.E. (Eds). Inflammatory bowel disease (1998), Mosby, London 9-95
2. Podolsky D.K. Inflammatory bowel disease. N Engl J Med 347 (2002) 417-419
3. Kornbluth A., Marion J.F., Salomon P., and Janowitz H.D. How effective is current medical therapy for severe ulcerative colitis?. J Clin Gastroenterol 20 (1995) 280-284
4. Taffet S.L., and Das K.M. Sulphasalazine-adverse effects and desensitization. Dig Dis Sci 28 (1983) 833-842
5. Present D.H. How to do without steroids in inflammatory bowel disease. Inflamm Bowel Dis 6 (2000) 48-57
6. Hanauer S.B. Medical therapy of ulcerative colitis. Gastroenterology 126 (2004) 1582-1592
7. Truelove S.C., and Jewell D.P. Intensive intravenous regimens for severe attacks of ulcerative colitis. Lancet 1 (1974) 1067-1070
8. Jarnerot G., Rolny P., and Sandberg-Gertzen H. Intensive intravenous treatment of ulcerative colitis. Gastroenterology 89 (1985) 1005-1013
9. D'Haens G., Lemmens L., and Geboes K. Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis. Gastroenterology 120 (2001) 1323-1329
10. Rutgeerts P., Sandborn W.J., and Feagan B. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 353 (2005) 2462-2476
11. Seegers D., Bouma G., and Pena A.S. Review article: a critical approach to new forms of treatment of Crohn's disease and ulcerative colitis. Alimnt Pharmacol Ther 16 Suppl 4 (2002) 53-58
12. Brown S.L., Greene M.H., Gershon S.K., Edwards E.T., and Mraun M.M. Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum 46 (2002) 3151-3158
13. Saniabadi A.R., Hanai H., Sawada K., Adachi T., Bjarnason I., Lofberg R., et al. Adacolumn, an adsorptive carrier based granulocyte and monocyte apheresis device for the treatment of inflammatory and refractory diseases associated with leukocytes. Ther Apher Dial 7 (2003) 48-59
14. Heimann T.M., and Aufses Jr. A.H. The role of peripheral lymphocytes in the prediction of recurrence in Crohn's disease. Surg Gynecol Obstet 160 (1985) 295-298
15. Suzuki Y., Yoshimura N., Saniabadi A.R., and Saito Y. Selective neutrophil and monocyte adsorptive apheresis as a first line treatment for steroid naïve patients with active ulcerative colitis: a prospective uncontrolled study. Dig Dis Sci 49 (2004) 565-571
16. Aoki H., Nakamura K., Yoshimatsu Y., Shirai K., and Suzuki Y. Adacolumn selective leukocyte adsorption apheresis in patients with active ulcerative colitis: clinical efficacy, effects on plasma IL-8 and the expression of toll like receptor 2 on granulocytes. Dig Dis Sci 52 (2007) 1427-1433
17. McCarthy D.A., Rampton D.S., and Liu Y.-C. Peripheral blood neutrophils in inflammatory bowel disease: morphological evidence of in vivo activation in active disease. Clin Exp Immunol 86 (1991) 489-493
18. Brannigan A.E., O'Connell P.R., and Hurley H. Neutrophil apoptosis is delayed in patients with inflammatory bowel disease. Shock 13 (2000) 361-366
19. Lee A., Whyte M., and Haslett C. Inhibition of apoptosis and prolongation of neutrophil functional longevity by inflammatory mediators. J Leukoc Biol 54 (1993) 283-288
20. Meagher L.C., Cousin J.M., Seckl J.R., and Haslett C. Opposing effects of glucocorticoids on the rate of appoptosis in neutrophilic and eosinophilic granulocytes. J Immunol 156 (1996) 4422-4428
21. Tibble J.A., Sigthorsson G., Bridger D., Fagerhol M.K., and Bjarnason I. Surrogate markers of intestinal inflammation are predictive of relapse in patients with inflammatory bowel disease. Gastroenterology 119 (2000) 15-22
22. Schreiber S., Nikolaus S., and Hampe J. Tumour necrosis factor alpha and interleukin 1beta in relapse of Crohn's disease. Lancet 353 (1999) 459-461
23. Papadakis K.A., and Targan S.R. Role of cytokines in the pathogenesis of inflammatory bowel disease. Annu Rev Med 51 (2000) 289-298
24. Cassatella M.A. The production of cytokines by polymorphonuclear neutrophils. Immunol Today 16 (1995) 21-26
25. Nikolaus S., Bauditz J., and Gionchetti P. Increased secretion of pro-inflammatory cytokines by circulating polymorphonuclear neutrophils and regulation by interleukin-10 during intestinal inflammation. Gut 42 (1998) 470-476
26. Neurath M.F. IL-23: a master regulator in Crohn's disease. Nat Med 13 (2007) 26-28
27. Saniabadi A.R., Hanai H., Sawada K., Fukunaga K., Bjarnason I., Lofberg R., et al. Adacolumn for selective leukocytapheresis as a non-pharmacological treatment for patients with disorders of the immune system: an adjunct or an alternative to drug therapy?. J Clin Apher 20 (2005) 171-184
28. Saniabadi A.R., Hanai H., Fukunaga K., Sawada K., Bjarnason I., Lofberg R., et al. Therapeutic leucocytapheresis for inflammatory bowel disease. Transf Aphere Sci 37 (2007) 191-200
29. Kanke K., Nakano M., Hiraishi H., and Terano A. Evaluation of granulocyte/monocyte apheresis therapy for active ulcerative colitis. Dig Liv Dis 36 (2004) 512-518
30. Shimoyama T., Sawada K., Kashiwagi N., and Saniabadi A. Safety and efficacy of granulocyte and monocyte apheresis in patients with active ulcerative colitis: a multicenter study. J Clin Aphere 16 (2001) 1-9
31. Hanai H., Watanabe F., Takeuchi K., Saniabadi A., and Bjarnason I. Leukcocyte adsorptive apheresis for the treatment of active ulcerative colitis: a prospective uncontrolled pilot study. Clin Gastroenterol Hepatol 1 (2003) 28-35
32. Hanai H., Iida T., and Saniabadi A. Effects of Adacolumn selective leukocytapheresis on plasma cytokines during active disease in patients with ulcerative colitis. World J Gastroenterol 12 (2006) 3393-3399
33. Yamamoto T., Saniabadi A.R., Umegae S., and Matsumoto K. Impact of selective leukocytapheresis on mucosal inflammation and ulcerative colitis: Cytokine profiles and endoscopic findings. Inflamm Bowel Dis 12 (2006) 719-726
34. D'Arrigo C., Candal-Couto J.J., Greer M., Veale D.J., and Woof J.M. Human neutrophil Fc receptor mediated adhesion under flow: a hallow fiber model of intravascular arrest. Clin Exp Immunol 100 (1994) 173-179
35. Hiraishi K., Takeda Y., and Saniabadi A. Studies on the mechanisms of leukocyte adhesion to cellulose acetate beads: an in vitro model to assess the efficacy of cellulose acetate carrier-based granulocyte and monocyte adsorptive apheresis. Ther Aphere Dial 7 (2003) 334-340
36. Munakata A. A new criteria for diagnosis of ulcerative colitis. Annual Report of the Research Committee of Inflammatory Bowel Disease, the Ministry of Health and Welfare of Japan; 1998. p. 96-9.
37. Truelove S.C., and Witts L.J. Cortisone in the treatment of ulcerative colitis: final report on a therapeutic trial. Br Med J 2 (1955) 1041-1048
38. Rachmilewitz D., and on behalf of an international study group. Coated mesalazine (5-aminisalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. Br Med J 298 (1989) 82-86
39. Matts S.G.F. The value of rectal biopsy in the diagnosis of ulcerative colitis. Q J Med 30 (1961) 393-407 [New Ser XXX 120]
40. Shimoyama T., Sawada Y., and Tanaka T. Granulocyte and monocyte apheresis in the treatment of active ulcerative colitis. Jpn J Aphere 18 (1999) 117-131 [English abstract]
41. Fukuda Y., Matsui T., and Suzuki Y. Granulocyte and monocyte apheresis for refractory Crohn's disease: an open multicenter prospective study. J Gastroenterol 39 (2004) 1158-1164
42. Ang Y.S., Mahmud N., and White B. Randomized comparison of unfractionated heparin with corticosteroids in severe active inflammatory bowel disease. Alimnt Pharmacol Ther 14 (2000) 1015-1022
43. Panés J., Esteve M., and Cabré E. Comparison of heparin and steroids in the treatment of moderate and severe ulcerative colitis. Gastroenterology 119 (2000) 903-908
44. Loonsk J.W. BioSense- a national initiative for early detection and quantification of public health emergencies. MMWR Morb Mortal Wkly Rep 53 Suppl (2004) 53-55
45. Kroesen S., Widmer A.F., Tyndall A., and Hasler P. Serious bacterial infections in patients with rheumatoid arthritis under anti-TNF-alpha therapy. Rheumatology 42 (2003) 617-621
46. Gomez-Reino J.J., Carmona L., Valverde V.R., Mola E.M., Montero M.D., and BIOBADASER Group. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum 48 (2003) 2122-2127
47. Devos S.A., Van Den Bossche N., De Vos M., and Naeyaert J.M. Adverse skin reactions to anti-TNF-α. Dermatology 206 (2003) 388-390
48. Bongartz T., Sutton A.J., Sweeting M.J., Buchan I., Matteson E.L., and Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. J. Am. Med. Assoc. 295 (2006) 2275-2285
49. Hanai H., Watanabe F., Yamada M., and Saniabadi A. Adsorptive granulocyte and monocyte apheresis versus prednisolone in patients with corticosteroid dependent moderately severe ulcerative colitis. Digestion 70 (2004) 36-44
50. Hanai H., Iida T., Taleuchi K., Watanabe F., Maruyama Y., Kageoka M., et al. Intensive granulocyte and monocyte adsorption versus intravenous prednisolone in patients with severe ulcerative colitis: an unblinded randomised multi-centre controlled study. Dig Liver Dis 40 (2008) 433-440
51. Hanai H. Leucocytapheresis for inflammatory bowel disease in the era of biologic therapy. Eur J Gastroenterol Hepatol 20 (2008) 596-600
52. Tanaka T., Okanobu H., Yoshimi S., Murakami E., Kogame A., Imagawa H., et al. Adsorptive depletion of granulocytes and monocytes impacts mucosal level of neutrophils and clinically is most effective in steroid naïve patients. Dig Liver Dis 40 (2008) 731-736
53. Yamamoto T., Saniabadi A.R., Maruyama Y., Umegae S., and Matsumoto K. Factors affecting clinical and endoscopic efficacies of selective leucocytapheresis for ulcerative colitis. Dig Liver Dis 39 (2007) 626-633
54. Domenech E., Hinojosa J., Esteve-Comas M., and Spanish Group for the Study of Crohn's Disease and Ulcerative Colitis (GETECCU). Granulocyteaphaeresis in steroid-dependent inflammatory bowel disease: a prospective, open, pilot study. Aliment Pharmacol Ther 20 (2004) 1347-1352
55. Caprilli R., and D'Ovidio V. Leukocytapheresis as promising therapy for inflammatory bowel disease. Dig Liver Dis 39 (2007) 435-437
56. Takemoto K., Kato J., Kuriyama M., Nawa T., Kurome M., Okada H., et al. Predictive factors of efficacy of leukocytapheresis for steroid-resistant ulcerative colitis patients. Dig Liver Dis 39 (2007) 422-429
57. Panés J., Guilera M., Ginard D., Hinojosa J., González-Carro P., González-Lara V., et al. Treatment cost of ulcerative colitis is apheresis with Adacolumn cost-effective?. Dig Liver Dis 39 (2007) 617-625
58. Maiden L., Takeuchi K., Bjarnason I., et al. Selective white cell apheresis reduces relapse rates in patients with IBD at significant risk of clinical relapse. Inflamm Bowel Dis 14 (2008) 1413-1418
59. Bresci G., Parisi G., Mazzoni A., Scatena F., and Capria A. Treatment of patients with acute ulcerative colitis: conventional corticosteroid therapy (MP) versus granulocytapheresis (GMA): a pilot study. Dig Liver Dis 39 (2007) 430-434
60. Cohen R.D. Treating ulcerative colitis without medications-"Look Mom No Drugs!". Gastroenterology 128 (2005) 235-236
61. Sands B.E., Sandborn W.J., Feagan B., Löfberg R., Hibi T., Wang T., et al. A randomized, double-blind, sham-controlled study of granulocyte/monocyte apheresis for active ulcerative colitis. Gastroenterology 135 (2008) 400-409
62. Suzuki Y., Yoshimora N., Saito Y., and Saniabadi A. A retrospective search for predictors of clinical response to selective granulocyte and monocyte apheresis in patients with ulcerative colitis. Dig Dis Sc 51 (2006) 2031-2038
63. Nishise S., Takeda Y., Takeda, Ishihama, Fukui T., and Kawata S. Complement activation is involved in biological responses to leukocyte adsorptive apheresis. Dig Dis Sci 51 (2006) 934-941
64. Takeda Y., Shiobara N., Saniabadi A.R., Adachi M., and Hiraishi K. Adhesion dependent release of hepatocyte growth factor and interleukin-1 receptor antagonist from human blood granulocytes and monocytes: Evidence for the involvement of plasma IgG, complement C3 and β2 integrin. Inflamm Res 53 (2004) 277-283