Extracorporeal Photopheresis for the Treatment of Refractory Crohn's Disease: Results of an Open-label Pilot Study

被引:35
作者
Abreu, Maria T. [1 ]
von Tirpitz, Christian [2 ]
Hardi, Robert [3 ]
Kaatz, Martin [4 ]
Van Assche, Gert [5 ]
Rutgeerts, Paul [5 ]
Bisaccia, Emil [6 ]
Goerdt, Sergi [7 ]
Hanauer, Stephen [8 ]
Knobler, Robert [9 ]
Mannon, Peter [10 ]
Mayer, Lloyd [11 ]
Ochsenkuhn, Thomas [12 ]
Sandborn, William J. [13 ]
Parenti, Dennis [14 ]
Lee, Kevin [14 ]
Reinisch, Walter [15 ]
机构
[1] Univ Miami, Miller Sch Med, Miami, FL 33136 USA
[2] Univ Ulm, Dept Digest Dis, Ulm, Germany
[3] Chevy Chase Clin Res, Chevy Chase, MD USA
[4] Univ Jena, Dept Gastroenterol, Jena, Germany
[5] Univ Leuven, Dept Internal Med, Dept Gastroenterol, Louvain, Belgium
[6] Morristown Mem Hosp, Morristown, NJ USA
[7] Univ Mannheim, Dept Gastroenterol, Mannheim, Germany
[8] Univ Chicago, Div Gastroenterol Hepatol & Nutr, Chicago, IL 60637 USA
[9] Univ Vienna, Dept Dermatol, Vienna, Austria
[10] NIAID, Bethesda, MD 20892 USA
[11] Mt Sinai Sch Med, Inst Immunol, New York, NY USA
[12] Univ Munich, Dept Gastroenterol, Munich, Germany
[13] Mayo Clin, Div Gastroenterol & Hepatol, Rochester, MN USA
[14] Therakos Inc, Exton, PA USA
[15] Univ Vienna, Dept Gastroenterol, Vienna, Austria
关键词
extracorporeal photopheresis; 8-methoxypsoralen; anti-TNF therapy; immunomodulators; Crohn's disease; VERSUS-HOST-DISEASE; REGULATORY T-CELLS; CERTOLIZUMAB PEGOL; APOPTOTIC CELLS; LONG-TERM; PHOTOCHEMOTHERAPY; INFLIXIMAB; LYMPHOMA; THERAPY; 6-MERCAPTOPURINE;
D O I
10.1002/ibd.20833
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background: Extracorporeal photopheresis (ECP) is effective in immune-mediated disorders. A prospective, uncontrolled pilot study was conducted to evaluate the safety and efficacy of ECP in patients with active Crohn's disease (CD) who were refractory to or intolerant of immunosuppressants and/or anti-TNF therapies. Methods: Patients with moderate-to-severely active CD (Crohn's Disease Activity Index [CDAI] 220-450 points) underwent 12 weeks of ECP treatment (Weeks 1-4: twice weekly, every week; Weeks 5-12: twice weekly, every other week). Clinical response was defined as a decrease in the CDAI of : 100 points or remission (CDAI < 150 points) at Week 12. Patients who responded at Week 12 could receive an additional 12 weeks of ECP treatment (twice weekly, every other week) in an extension Study. Results: Twenty-eight patients were enrolled with a mean baseline CDAI score of 314 (range 207-457). At Week 12, 14 patients (50%) responded; 13 patients responded within 6 weeks. Seven patients (25%) attained remission by Week 12. Three of 5 patients with open fistulae at baseline had fistula closure. Response was similar among patients naive to anti-TNF agents and patients who had previously been refractory or intolerant to anti-TNF agents. Of the 12 patients who entered the extension study, 9 (75%) maintained their response at Week 24. Conclusions: In patients with moderate-to-severely active CD who were refractory to or intolerant of immunosuppressants and/or anti-TNF agents, ECP was well tolerated and induced clinical response (50%) and remission (25%) in patients. Most patients were able to maintain a response with Continued treatments.
引用
收藏
页码:829 / 836
页数:8
相关论文
共 39 条
[21]   Evidence-based practice of photopheresis 1987-2001: a report of a workshop of the British Photodermatology Group and the UK Skin Lymphoma Group [J].
McKenna, KE ;
Whittaker, S ;
Rhodes, LE ;
Taylor, P ;
Lloyd, J ;
Ibbotson, S ;
Russell-Jones, R .
BRITISH JOURNAL OF DERMATOLOGY, 2006, 154 (01) :7-20
[22]   Peripheral CD4+CD25+ TREG cell counts and the response to extracorporeal photopheresis in lung transplant recipients [J].
Meloni, F. ;
Cascina, A. ;
Miserere, S. ;
Perotti, C. ;
Vitulo, P. ;
Fietta, A. M. .
TRANSPLANTATION PROCEEDINGS, 2007, 39 (01) :213-217
[23]   Potential mechanisms of photopheresis in hematopoietic stem cell transplantation [J].
Peritt, D .
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION, 2006, 12 (01) :7-12
[24]   TREATMENT OF CROHNS-DISEASE WITH 6-MERCAPTOPURINE - A LONG-TERM, RANDOMIZED, DOUBLE-BLIND-STUDY [J].
PRESENT, DH ;
KORELITZ, BI ;
WISCH, N ;
GLASS, JL ;
SACHAR, DB ;
PASTERNACK, BS .
NEW ENGLAND JOURNAL OF MEDICINE, 1980, 302 (18) :981-987
[25]   Clinical and radiological responses after infliximab treatment for perianal fistulizing Crohn's disease [J].
Rasul, I ;
Wilson, SR ;
MacRae, H ;
Irwin, S ;
Greenberg, GR .
AMERICAN JOURNAL OF GASTROENTEROLOGY, 2004, 99 (01) :82-88
[26]   Extracorporeal photochemotherapy in patients with steroid-dependent Crohn's disease:: a prospective pilot study [J].
Reinisch, W ;
Nahavandi, H ;
Santella, R ;
Zhang, Y ;
Gasché, C ;
Moser, G ;
Waldhör, T ;
Gangl, A ;
Vogelsang, H ;
Knobler, R .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2001, 15 (09) :1313-1322
[27]   Photopheresis: Clinical applications and mechanism of action [J].
Rook, AH ;
Suchin, KR ;
Kao, DMF ;
Yoo, EK ;
Macey, WH ;
DeNardo, BJ ;
Bromely, PG ;
Geng, YM ;
Junkins-Hopkins, JM ;
Lessin, SR .
JOURNAL OF INVESTIGATIVE DERMATOLOGY SYMPOSIUM PROCEEDINGS, 1999, 4 (01) :85-90
[28]   Adalimumab induction therapy for Crohn disease previously treated with infliximab - A randomized trial [J].
Sandborn, William J. ;
Rutgeerts, Paul ;
Enns, Robert ;
Hanauer, Stephen B. ;
Colombel, Jean-Frederic ;
Panaccione, Remo ;
D'Haens, Geert ;
Li, Ju ;
Rosenfeld, Marie R. ;
Kent, Jeffrey D. ;
Pollack, Paul F. .
ANNALS OF INTERNAL MEDICINE, 2007, 146 (12) :829-838
[29]   Certolizumab pegol for the treatment of Crohn's disease [J].
Sandborn, William J. ;
Feagan, Brian G. ;
Stoinov, Simeon ;
Honiball, Pieter J. ;
Rutgeerts, Paul ;
Mason, David ;
Bloomfield, Ralph ;
Schreiber, Stefan .
NEW ENGLAND JOURNAL OF MEDICINE, 2007, 357 (03) :228-238
[30]   Infliximab maintenance therapy for fistulizing Crohn's disease [J].
Sands, BE ;
Anderson, FH ;
Bernstein, CN ;
Chey, WY ;
Feagan, BG ;
Fedorak, RN ;
Kamm, MA ;
Korzenik, JR ;
Lashner, BA ;
Onken, JE ;
Rachmilewitz, D ;
Rutgeerts, P ;
Wild, G ;
Wolf, DC ;
Marsters, PA ;
Travers, SB ;
Blank, MA ;
van Deventer, SJ .
NEW ENGLAND JOURNAL OF MEDICINE, 2004, 350 (09) :876-885