A randomised, blinded, placebo-controlled, dose escalation study of the tolerability and efficacy of filgrastim for haemopoietic stem cell mobilisation in patients with severe active rheumatoid arthritis

Bone Marrow Transplantation

Volumn 22, Issue 11, 1998, Pages 1035-1041

  Snowden, J A ^a,c   Biggs, J C ^a   Milliken, S T ^a   Fuller, A ^a   Staniforth, D ^a   Passuello, F ^b   Renwick, J ^b   Brooks, P M ^a  

^a ST VINCENT S HOSPITAL   (Australia)

^b Amgen Australia   (Australia)

^c ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

Author keywords

Granulocyte colony stimulating factor; Rheumatoid arthritis; Stem cell transplantation

Indexed keywords

ALKALINE PHOSPHATASE; C REACTIVE PROTEIN; CD34 ANTIGEN; LACTATE DEHYDROGENASE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RHEUMATOID FACTOR;

ADULT; ARTICLE; BONE PAIN; CLINICAL ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; COLONY FORMING UNIT GM; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; HUMAN CELL; LABORATORY TEST; LEUKAPHERESIS; MALE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS;

EID: 0031760745     PISSN: 02683369     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bmt.1701486     Document Type: Article

References (55)

1. Marmont A. Immune ablation followed by allogeneic or autologous bone marrow transplantation: a new treatment for severe autoimmune disease? Stem Cells 1994; 12: 125-135.
2. Marmont AM, van Bekkum DW. Stem cell transplantation for severe autoimmune diseases: new proposals but still unanswered questions. Bone Marrow Transplant 1995; 16: 497-498.
3. Brooks PM, Atkinson K, Hamilton JA. Stem cell transplantation in autoimmune disease. J Rheumatol 1995; 22: 1809- 1811.
4. Hamilton JA, Biggs JC, Atkinson K, Brooks PM. Bone marrow transplantation in autoimmune disease. Ballière's Clin Rheumatol 1995; 9: 673-687.
5. van Bekkum DW, Marmont A, Tyndall A et al. Severe autoimmune diseases: a new target for bone marrow transplantation. Stem Cells 1996; 14: 460-472.
6. Tyndall A, Gratwohl A. Blood and marrow stem cell transplants in autoimmune disease. A consensus report written on behalf of the European League against Rheumatism (EULAR) and the European Group for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant 1997; 19: 643-645.
7. Wicks I, Cooley H, Szer J. Autologous hemopoietic stem cell transplantation: a possible cure for rheumatoid arthritis? Arth Rheum 1997; 40: 1005-1011.
8. Messner RP. The potential of bone marrow stem cell transplantation in the treatment of autoimmune diseases. J Rheumatol 1997; 24: 819-821.
9. Snowden JA, Brooks PM, Biggs JC. Haemopoietic stem cell transplantation for autoimmune diseases. Br J Haematol 1997; 99: 9-22.
10. Atkinson K, Dodds A, Milliken S et al. Autologous blood stem cell transplantation:treatment related mortality of 2%, ANZ J Med 1995; 25: 483-489.
11. To LB, Haylock DN, Simmons PJ, Juttner CA. The biology and clinical uses of blood stem cells. Blood 1997; 89: 2233-2258.
12. Markenson JA. World wide trends in the socioeconomic impact and long-term prognosis of rheumatoid arthritis. Semin Arthr Rheum 1991; 21 (Suppl 1): 4-12.
13. Wilske KR, Healey LA. The need for aggressive therapy of rheumatoid arthrits. Rheum Dis Clin NA 1993; 19: 153-161.
14. Miyahara H, Hotoebuchi T, Saikawa I et al. The effects of recombinant human granulocyte colony-stimulating factor on passive collagen arthritis transferred with anti-type II collagen antibody. Clin Immunol Immunopathol 1993; 69: 69-76.
15. Campbell IK, Bendele A, Smith DA, Hamilton JA. Granulocyte-macrophage colony-stimulating factor exacerbates collagen-induced arthritis in mice. Ann Rheum Dis 1997; 56: 364-368.
16. Hazenberg BPC, van Leeuwen MA, van Rijswijk MH et al. Correction of granulocytopenia in Felty's syndrome by granulocyte-macrophage colony-stimulating factor. Simultaneous induction of interleukin-6 release and flare-up of the arthritis. Blood 1989; 74: 2769-2770.
17. Silberberg JM. Effectiveness of GM-CSF (GM) in the therapy of neutropenia of Felly's syndrome (abstract). Blood 1991; 78 (S1): 1709.
18. Yasuda M, Kihara T, Wada T et al. Granulocyte colony-stimulating factor induction of improved leukocytopenia with inflammatory flare in a Felly's syndrome patient. Arth Rheum 1994; 338: 517-518.
19. Vidarsson B, Geirsson A, Onundarson PT. Reactivation of rheumatoid arthritis and development of leukocytoclastic vasculitis in a patient receiving granulocyte colony-stimulating factor for Felty syndrome. Am J Med 1995; 98: 589-591.
20. Schots R, Verbruggen LA, Demanet C. G-CSF in Felty's syndrome: correction of neutropenia and effects on cytokine release, Clin Rheumatol 1995; 14: 116-119.
21. Hayat SQ, Hearth-Holmes M, Wolf RE. Flare of arthritis with successful treatment of Felty's syndrome with granulocyte colony-stimulating factor (G-CSF). Clin Rheumatol 1995; 14: 211-212.
22. deVries EGE, Williemse PHB, Biesma B et al. Flare up of rheumatoid arthritis during GM-CSF treatment after chemotherapy. Lancet 1991; 338: 517-518.
23. Nakashima H, Kawabe K, Ohtsuka T et al. Rheumatoid arthritis exacerbation by G-CSF treatment for bucillamine induced agranulocytosis. Clin Exp Rheumatol 1995; 13: 677-679.
24. Dreicer R, Schiller JH, Carbone PP. Granulocyte-macrophage colony-stimulating factor and vasculitis. Ann Intern Med 1989; 111: 91-92.
25. Schliesser G, Pralle H, Lohmeyer J. Leukocytoclastic vasculitis complicating granulocyte colony-stimulating factor (G- CSF) induced neutrophil recovery in T gamma lymphocytosis with severe neutropenia. Ann Haematol 1992; 65: 151-152.
26. Negrin RS, Haeuber DH, Nagler A et al. Treatment of myelodysplastic syndromes with recombinant human granulocyte colony-stimulating factor. A phase I-II trial. Ann Intern Med 1989; 110: 976-984.
27. Ross HJ, Moy LA, Kaplan R, Figlin RA. Bullous pyoderma gangrenosum after granulocyte colony-stimulating factor treatment. Cancer 1991; 68: 441-443.
28. Park JW, Mehrotra B, Barnett BO et al. The Sweet syndrome during therapy with granulocyte colony-stimulating factor. Ann Intern Med 1992; 116: 996-998.
29. de Haas M, Kerst JM, van der Scoot E et al. Granulocyte colony-stimulating factor administration to healthy volunteers: analysis of the immediate activating effects on circulating neutrophils. Blood 1994; 84: 3885-3894.
30. Lubbe AS, Schwella N, Riess H, Huhn D. Improvement of pneumonia and arthritis in Felty's syndrome by treatment with granulocyte-macrophage colony-stimulating factor (GM- CSF). Blut 1990; 61: 379-380.
31. Henley SE, Rowe JM, Klee DF et al. G-CSF for severe Felty's syndrome: use in acute state and for prophylactic maintenance. Blood 1992; 80 (Suppl. 1): 415 (Abstr.).
32. Kaiser U, Klaussmann M, Richter G, Pfluger KA. GM-CSF vs G-CSF in the treatment of infectious complications of Felty's syndrome - a case report. Ann Haematol 1992; 64: 205-206.
33. Ito T, Miyairi Y, Kuwabara T et al. Granulocyte colony-stimulating factor corrects granulocytopenia in Felty's syndrome. Am J Hematol 1992; 40: 318-319.
34. Kuipers EJ, Vellenga E, de Wolf JT, Hazenberg BP. Sulfasalazine induced agranulocytosis treated with granulocyte-macrophage colony-stimulating factor. J Rheumatol 1992; 19: 621-622.
35. Choi V, Mant M, Aaron S. Treatment of refractory Felty's syndrome with G-CSF and cyclophosphamide. Arth Rheum 1992; (Suppl. 9); PO335 (Abstr.).
36. Neilsen H, Mejer J. Remission of neutropenia in a case of Felty's syndrome by rhG-CSF. Scand J Rheumatol 1992; 21: 305-307.
37. Collins DA, Tobias JH, Hill RP, Bourke BE. Reversal of gold- induced neutropenia with granulocyte colony-stimulating factor (G-CSF). Br J Rheumatol 1993; 32: 518-520.
38. Bhalla K, ROSS R, Jeter E et al. G-CSF improves granulocytopenia in Felty's syndrome without flare-up arthritis. Am J Haematol 1993; 42: 230-231.
39. Fraser DD, Sartiano GP, Butler TW, Treadwell EL. Neutropenia of Felty's syndrome successfully treated with granulocyte colony-stimulating factor. J Rheumatol 1993; 20: 1447-1448.
40. Wandt H, Seifert M, Falge C, Gallmeier WM. Long-term correction of neutropenia in Felty's syndrome with granulocyte colony-stimulating factor. Ann Haematol 1993; 66: 265-266.
41. Moore DF, Vadhan-Raj S. Sustained response in Felty's syndrome to prolonged administration of recombinant human granulocyte-tnacrophage colony-stimulating factor (rhGM-CSF). Am J Med 1995; 98: 591-594.
42. Graham KE, Coodley GO. A prolonged use of granulocyte colony-stimulating factor in Felty's syndrome. J Rheumatol 1995; 22: 174-176.
43. Markusse HM, Breedveld FC, Fibbe WE, Stern AC. Granulocyte-macrophage colony-stimulating factor treatment of neutropenia associated with Felty's syndrome. Arth Rheum 1990; 33: 1865-1867.
44. Hamilton JA. Rheumatoid arthritis: opposing actions of haemopoietic growth factors and slow acting anti-rheumatic drugs. Lancet 1993; 342: 536-539.
45. Mills KC, Gross TG, Varney ML et al. Immunologic phenotype and function in human bone marrow, blood stem cells and umbilical cord blood. Bone Marrow Transplant 1996; 18: 53-61.
46. Arnett FC, Edworthy SM, Bloch DA et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arth Rheum 1988; 31: 315- 324.
47. + cell determination by flow cytometry. J Hematother 1996; 5: 213-226.
48. Eaves CJ. Assays of hemopoietic progenitor cells. In: E Beutler, MA Lichtman, BS Coller, TJ Kipps (eds). Williams Hematology 5. McGraw-Hill: New York, 1995, pp L22-L26.
49. McGonagle D, Rawstron A, Richards S et al. A phase I study to address the safety and efficacy of granulocyte colony-stimulating factor for the mobilization of hematopoietic progenitor cells in active rheumatoid arthritis. Arth Rheum 1997; 40: 1838-1842.
50. Passweg JR, Fassas A, Black CM et al. Autologous stem cell transplantation for autoimmune disease. A preliminary report. Blood 1997; 90 (Suppl. 1): 233a.
51. Milligan DW, Ruiz de Elvira C, Taghipour G et al MDS and secondary leukaemia after autografting for lymphoma. A final report from the EBMT registry. Bone Marrow Transplant 1997; 19 (Suppl. 1): S209 (Abstr.).
52. Cibere J, Sibley J, Haga M. Rheumatoid arthritis and the risk of malignancy. Arth Rheum 1997; 40: 1580-1586.
53. Joske DJL, Ma DT, Langlands DR, Owen ET. Autologous bone marrow transplantation for rheumatoid arthritis. Lancet 1997; 350: 337-338.
54. Durez P, Toungouz M, Schandené L et al. Remission and immune reconstitution after T cell-depleted stem cell transplantation for rheumatoid arthritis. Lancet 1998; 352: 881.
55. Snowden JA, Biggs JC, Milliken ST et al. A phase I/II dose escalation study of intensified cyclophosphamide and autologous blood stem cell rescue in patients with severe active rheumatoid arthritis. Arthr Rheum (submitted).