Combining therapeutic antibodies using basiliximab and etanercept for severe steroid-refractory acute graft-versus-host disease: A multi-center prospective study

References

• Ferrara JL, Levine JE, Reddy P, Holler E. Graft-versus-host disease. Lancet 2009; 373(9674):1550-61; PMID:19282026; http://dx.doi.org/10.1016/S0140-6736(09)60237-3
   PubMed Web of Science ®Google Scholar
• Martin PJ, Schoch G, Fisher L, Byers V, Anasetti C, Appelbaum FR et al. A retrospective analysis of therapy for acute graft-versus-host disease: initial treatment. Blood 1990; 76(8):1464-72; PMID:2207321
   PubMed Web of Science ®Google Scholar
• Roy J, McGlave PB, Filipovich AH, Miller WJ, Blazar BR, Ramsay NK et al. Acute graft-versus-host disease following unrelated donor marrow transplantation: failure of conventional therapy. Bone Marrow Transpl 1992; 10(1):77-82; PMID:1515883
   PubMed Web of Science ®Google Scholar
• Deeg HJ. How I treat refractory acute GVHD. Blood 2007; 109(10):4119-26; PMID:17234737; http://dx.doi.org/10.1182/blood-2006-12-041889
   PubMed Web of Science ®Google Scholar
• Martin PJ, Rizzo JD, Wingard JR, Ballen K, Curtin PT, Cutler C et al. First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the American Society of Blood and Marrow Transplantation. Biol Blood Marrow Transpl 2012; 18(8):1150-63; PMID:22510384; http://dx.doi.org/10.1016/j.bbmt.2012.04.005
   PubMed Web of Science ®Google Scholar
• Xiao HW, Lai XY, Luo Y, Shi JM, Tan YM, He JS et al. Relationship between TNFA, TNFB and TNFRII gene polymorphisms and outcome after unrelated hematopoietic cell transplantation in a Chinese population. Bone Marrow Transpl 2011; 46(3):400-7; PMID:20548340; http://dx.doi.org/10.1038/bmt.2010.135
   PubMed Web of Science ®Google Scholar
• Xiao H, Cao W, Lai X, Luo Y, Shi J, Tan Y et al. Immunosuppressive cytokine gene polymorphisms and outcome after related and unrelated hematopoietic cell transplantation in a Chinese population. Biol Blood Marrow Transpl 2011; 17(4):542-9; PMID:20457266; http://dx.doi.org/10.1016/j.bbmt.2010.04.013
   PubMed Web of Science ®Google Scholar
• Xiao H, Luo Y, Lai X, Fu S, Shi J, Tan Y et al. Genetic variations in T-cell activation and effector pathways modulate alloimmune responses after allogeneic hematopoietic stem cell transplantation in patients with hematologic malignancies. Haematologica 2012; 97(12):1804-12; PMID:22733023; http://dx.doi.org/10.3324/haematol.2012.066159
   PubMed Web of Science ®Google Scholar
• Massenkeil G, Rackwitz S, Genvresse I, Rosen O, Dorken B, Arnold R. Basiliximab is well tolerated and effective in the treatment of steroid-refractory acute graft-versus-host disease after allogeneic stem cell transplantation. Bone Marrow Transpl 2002; 30(12):899-903; PMID:12476283; http://dx.doi.org/10.1038/sj.bmt.1703737
   PubMed Web of Science ®Google Scholar
• Schmidt-Hieber M, Fietz T, Knauf W, Uharek L, Hopfenmuller W, Thiel E et al. Efficacy of the interleukin-2 receptor antagonist basiliximab in steroid-refractory acute graft-versus-host disease. Br J Haematol 2005; 130(4):568-74; PMID:16098072; http://dx.doi.org/10.1111/j.1365-2141.2005.05631.x
   PubMed Web of Science ®Google Scholar
• Funke VA, de Medeiros CR, Setubal DC, Ruiz J, Bitencourt MA, Bonfim CM et al. Therapy for severe refractory acute graft-versus-host disease with basiliximab, a selective interleukin-2 receptor antagonist. Bone Marrow Transpl 2006; 37(10):961-5; PMID:16565744; http://dx.doi.org/10.1038/sj.bmt.1705306
   PubMed Web of Science ®Google Scholar
• Busca A, Locatelli F, Marmont F, Ceretto C, Falda M. Recombinant human soluble tumor necrosis factor receptor fusion protein as treatment for steroid refractory graft-versus-host disease following allogeneic hematopoietic stem cell transplantation. Am J Hematol 2007; 82(1):45-52; PMID:16937391; http://dx.doi.org/10.1002/ajh.20752
   PubMed Web of Science ®Google Scholar
• Yang J, Cheuk DK, Ha SY, Chiang AK, Lee TL, Ho MH et al. Infliximab for steroid refractory or dependent gastrointestinal acute graft-versus-host disease in children after allogeneic hematopoietic stem cell transplantation. Pediatr Transpl 2012; 16(7):771-8; PMID:22905718; http://dx.doi.org/10.1111/j.1399-3046.2012.01756.x
   PubMed Web of Science ®Google Scholar
• Luo Y, Xiao H, Lai X, Shi J, Tan Y, He J et al. T-cell-replete haploidentical HSCT with low-dose anti-T-lymphocyte globulin compared with matched sibling HSCT and unrelated HSCT. Blood 2014; 124(17):2735-43; PMID:25214441; http://dx.doi.org/10.1182/blood-2014-04-571570
   PubMed Web of Science ®Google Scholar
• Ascioglu S, Rex JH, de Pauw B, Bennett JE, Bille J, Crokaert F, Denning DW, Donnelly JP, Edwards JE, Erjavec Z et al. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis 2002; 34(1):7-14; PMID:11731939; http://dx.doi.org/10.1086/323335
   PubMed Web of Science ®Google Scholar
• Via CS, Finkelman FD. Critical role of interleukin-2 in the development of acute graft-versus-host disease. Int Immunol 1993; 5(6):565-72; PMID:8102248; http://dx.doi.org/10.1093/intimm/5.6.565
   PubMed Web of Science ®Google Scholar
• Przepiorka D, Kernan NA, Ippoliti C, Papadopoulos EB, Giralt S, Khouri I, Lu JG, Gajewski J, Durett A, Cleary K et al. Daclizumab, a humanized anti-interleukin-2 receptor alpha chain antibody, for treatment of acute graft-versus-host disease. Blood 2000; 95(1):83-9; PMID:10607689
   PubMed Web of Science ®Google Scholar
• Perales MA, Ishill N, Lomazow WA, Weinstock DM, Papadopoulos EB, Dastigir H, Chiu M, Boulad F, Castro-Malaspina HR, Heller G et al. Long-term follow-up of patients treated with daclizumab for steroid-refractory acute graft-vs-host disease. Bone Marrow Transpl 2007; 40(5):481-6; PMID:17618322; http://dx.doi.org/10.1038/sj.bmt.1705762
   PubMed Web of Science ®Google Scholar
• Dignan FL, Clark A, Amrolia P, Cornish J, Jackson G, Mahendra P, Scarisbrick JJ, Taylor PC, Hadzic N, Shaw BE et al. Diagnosis and management of acute graft-versus-host disease. Br J Haematol 2012; 158(1):30-45; PMID:22533831; http://dx.doi.org/10.1111/j.1365-2141.2012.09129.x
   PubMed Web of Science ®Google Scholar
• Xhaard A, Rocha V, Bueno B, de Latour RP, Lenglet J, Petropoulou A, Rodriguez-Otero P, Ribaud P, Porcher R, Socié G et al. Steroid-refractory acute GVHD: lack of long-term improved survival using new generation anticytokine treatment. Biol Blood Marrow Transpl 2012; 18(3):406-13; PMID:21736868; http://dx.doi.org/10.1016/j.bbmt.2011.06.012
   PubMed Web of Science ®Google Scholar
• Cheng G, Yu A, Malek TR. T-cell tolerance and the multi-functional role of IL-2R signaling in T-regulatory cells. Immunol Rev 2011; 241(1):63-76; PMID:21488890; http://dx.doi.org/10.1111/j.1600-065X.2011.01004.x
   PubMed Web of Science ®Google Scholar
• Chakupurakal G, Garcia-Marquez MA, Shimabukuro-Vornhagen A, Theurich S, Holtick U, Hallek M, Scheid C, von Bergwelt-Baildon M. Immunological effects in patients with steroid-refractory graft-versus-host disease following treatment with basiliximab, a CD25 monoclonal antibody. Eur J Haematol 2016; 97(2):121-7; PMID:26492560; http://dx.doi.org/10.1111/ejh.12691
   PubMed Web of Science ®Google Scholar
• Blazar BR, Murphy WJ, Abedi M. Advances in graft-versus-host disease biology and therapy. Nat Rev Immunol 2012; 12(6):443-58; PMID:22576252; http://dx.doi.org/10.1038/nri3212
   PubMed Web of Science ®Google Scholar
• Krystufkova E, Sekerkova A, Striz I, Brabcova I, Girmanova E, Viklicky O. Regulatory T cells in kidney transplant recipients: the effect of induction immunosuppression therapy. Nephrol Dial Transpl 2012; 27(6):2576-82; PMID:22167587; http://dx.doi.org/10.1093/ndt/gfr693
   PubMed Web of Science ®Google Scholar
• Bluestone JA, Liu W, Yabu JM, Laszik ZG, Putnam A, Belingheri M, Gross DM, Townsend RM, Vincenti F. The effect of costimulatory and interleukin 2 receptor blockade on regulatory T cells in renal transplantation. Am J Transpl 2008; 8(10):2086-96; PMID:18828769; http://dx.doi.org/10.1111/j.1600-6143.2008.02377.x
   PubMed Web of Science ®Google Scholar
• Okita R, Yamaguchi Y, Ohara M, Hironaka K, Okawaki M, Nagamine I, Ikeda T, Emi A, Hihara J, Okada M. Targeting of CD4+CD25high cells while preserving CD4+CD25 low cells with low-dose chimeric anti-CD25 antibody in adoptive immunotherapy of cancer. Int J Oncol 2009; 34(2):563-72; PMID:19148493; http://dx.doi.org/10.3892/ijo_00000182
   PubMed Web of Science ®Google Scholar
• Bhutani D, Dyson G, Manasa R, Deol A, Ratanatharathorn V, Ayash L, Abidi M, Lum LG, Al-Kadhimi Z, Uberti JP. Incidence, risk factors, and outcome of cytomegalovirus viremia and gastroenteritis in patients with gastrointestinal graft-versus-host disease. Biol Blood Marrow Transpl 2015; 21(1):159-64; PMID:25445637; http://dx.doi.org/10.1016/j.bbmt.2014.10.004
   PubMed Web of Science ®Google Scholar
• Cantoni N, Hirsch HH, Khanna N, Gerull S, Buser A, Bucher C, Halter J, Heim D, Tichelli A, Gratwohl A et al. Evidence for a bidirectional relationship between cytomegalovirus replication and acute graft-versus-host disease. Biol Blood Marrow Transpl 2010; 16(9):1309-14; PMID:20353832; http://dx.doi.org/10.1016/j.bbmt.2010.03.020
   PubMed Web of Science ®Google Scholar
• Wikstrom ME, Fleming P, Kuns RD, Schuster IS, Voigt V, Miller G, Clouston AD, Tey SK, Andoniou CE, Hill GR et al. Acute GVHD results in a severe DC defect that prevents T-cell priming and leads to fulminant cytomegalovirus disease in mice. Blood 2015; 126(12):1503-14; PMID:26130706; http://dx.doi.org/10.1182/blood-2015-01-622837
   PubMed Web of Science ®Google Scholar
• Wolff D, Roessler V, Steiner B, Wilhelm S, Weirich V, Brenmoehl J, Leithaeuser M, Hofmeister N, Junghanss C, Casper J et al. Treatment of steroid-resistant acute graft-versus-host disease with daclizumab and etanercept. Bone Marrow Transpl 2005; 35(10):1003-10; PMID:15806135; http://dx.doi.org/10.1038/sj.bmt.1704929
   PubMed Web of Science ®Google Scholar
• Rager A, Frey N, Goldstein SC, Reshef R, Hexner EO, Loren A, Luger SM, Perl A, Tsai D, Davis J et al. Inflammatory cytokine inhibition with combination daclizumab and infliximab for steroid-refractory acute GVHD. Bone Marrow Transpl 2011; 46(3):430-5; PMID:20498647; http://dx.doi.org/10.1038/bmt.2010.117
   PubMed Web of Science ®Google Scholar
• Nadeau M, Perreault S, Seropian S, Foss F, Isufi I, Cooper DL. The use of basiliximab-infliximab combination for the treatment of severe gastrointestinal acute GvHD. Bone Marrow Transpl 2016; 51(2):273-6; PMID:26479982; http://dx.doi.org/10.1038/bmt.2015.247
   PubMed Web of Science ®Google Scholar
• van Groningen LF, Liefferink AM, de Haan AF, Schaap NP, Donnelly JP, Blijlevens NM, van der Velden WJ. Combination therapy with inolimomab and etanercept for severe steroid-refractory acute graft-versus-host disease. Biol Blood Marrow Transpl 2016; 22(1):179-82; PMID:26386320; http://dx.doi.org/10.1016/j.bbmt.2015.08.039
   PubMed Web of Science ®Google Scholar
• Locksley RM, Killeen N, Lenardo MJ. The TNF and TNF receptor superfamilies: integrating mammalian biology. Cell 2001; 104(4):487-501; PMID:11239407; http://dx.doi.org/10.1016/S0092-8674(01)00237-9
   PubMed Web of Science ®Google Scholar
• Takeshita M, Suzuki K, Kikuchi J, Izumi K, Kurasawa T, Yoshimoto K, Amano K, Takeuchi T. Infliximab and etanercept have distinct actions but similar effects on cytokine profiles in rheumatoid arthritis. Cytokine 2015; 75(2):222-7; PMID:26095743; http://dx.doi.org/10.1016/j.cyto.2015.04.011
   PubMed Web of Science ®Google Scholar
• Messina C, Faraci M, de Fazio V, Dini G, Calo MP, Calore E. Prevention and treatment of acute GvHD. Bone Marrow Transpl 2008; 41(Suppl 2):S65-70; PMID:18545247; http://dx.doi.org/10.1038/bmt.2008.57
   PubMed Web of Science ®Google Scholar
• Alousi AM, Weisdorf DJ, Logan BR, Bolanos-Meade J, Carter S, Difronzo N, Pasquini M, Goldstein SC, Ho VT, Hayes-Lattin B et al. Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network. Blood 2009; 114(3):511-7; PMID:19443659; http://dx.doi.org/10.1182/blood-2009-03-212290
   PubMed Web of Science ®Google Scholar
• Te Boome LC, Mansilla C, van der Wagen LE, Lindemans CA, Petersen EJ, Spierings E, Thus KA, Westinga K, Plantinga M, Bierings M et al. Biomarker profiling of steroid-resistant acute GVHD in patients after infusion of mesenchymal stromal cells. Leukemia 2015; 29(9):1839-46; PMID:25836589; http://dx.doi.org/10.1038/leu.2015.89
   PubMed Web of Science ®Google Scholar
• Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 consensus conference on acute GVHD grading. Bone Marrow Transpl 1995; 15(6):825-8; PMID:7581076
   PubMed Web of Science ®Google Scholar
• MacMillan ML, DeFor TE, Weisdorf DJ. The best endpoint for acute GVHD treatment trials. Blood 2010; 115(26):5412-7; PMID:20388871; http://dx.doi.org/10.1182/blood-2009-12-258442
   PubMed Web of Science ®Google Scholar
• Bolanos-Meade J, Logan BR, Alousi AM, Antin JH, Barowski K, Carter SL, Goldstein SC, Hexner EO, Horowitz MM, Lee SJ et al. Phase 3 clinical trial of steroids/mycophenolate mofetil vs steroids/placebo as therapy for acute GVHD: BMT CTN 0802. Blood 2014; 124(22):3221-7; quiz 335; PMID:25170121; http://dx.doi.org/10.1182/blood-2014-06-577023
   PubMed Web of Science ®Google Scholar