Preliminary evaluation of safety and activity of recombinant human interleukin 11 in patients with active Crohn's disease

Gastroenterology

Volumn 117, Issue 1, 1999, Pages 58-64

  Sands, B E ^a   Bank, S ^a   Sninsky, C A ^a   Robinson, M ^a   Katz, S ^a   Singleton, J W ^a   Miner P B , Jr ^a   Safdi, M A ^a   Galandiuk, S ^a   Hanauer, S B ^a   Varilek, G W ^a   Buchman, A L ^a   Rodgers, V D ^a   Salzberg, B ^a   Cai, B ^a   Loewy, J ^a   Debruin, M F ^a   Rogge, H ^a   Shapiro, M ^a   Schwertschlag, U S ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOKINE ANTIBODY; RECOMBINANT INTERLEUKIN 11;

ADULT; ANTIINFLAMMATORY ACTIVITY; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROHN DISEASE; DISEASE ACTIVITY; DOSE CALCULATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; IMMUNOTHERAPY; INJECTION PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN MANIFESTATION; SUBCUTANEOUS DRUG ADMINISTRATION; THROMBOCYTE COUNT; THROMBOCYTOPENIA;

EID: 0032989443     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0016-5085(99)70550-0     Document Type: Article

References (35)

1. SR Targan SB Hanauer SJH van Deventer L Mayer DH Present T Braakman KL DeWoody TF Schaible PJ Rutgeerts A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor α for Crohn's disease N Engl J Med 337 1997 1029 1035
2. X Du DA Williams Interleukin-11: review of molecular, cell biology, and clinical use Blood 89 1997 3897 3908
3. TY Neben J Loebelenz L Hayes K McCarthy J Stoudemire R Schaub SJ Goldman Recombinant human interleukin-11 stimulates megakaryocytopoiesis and increases peripheral platelets in normal and splenectomized mice Blood 81 1993 901 908
4. MS Gordon WJ McCaskill-Stevens LA Battiato J Loewy D Loesch E Breeden R Hoffman KJ Beach B Kuca J Kaye GW Sledge Jr A phase I trial of recombinant human interleukin-11 (Neumega rhIL-11 growth factor) in women with breast cancer receiving chemotherapy Blood 87 1996 3615 3624
5. I Tepler L Elias JW Smith 2nd M Hussein G Rosen AY Chang JO Moore MS Gordon B Kuca KJ Beach JW Loewy MB Garnick JA Kaye A randomized placebo-controlled trial of recombinant human interleukin-11 in cancer patients with severe thrombocytopenia due to chemotherapy Blood 87 1996 3607 3614
6. C Isaacs NJ Robert FA Bailey MW Schuster B Overmoyer M Graham B Cai KJ Beach JW Loewy JA Kaye Randomized placebo-controlled study of recombinant human interleukin-11 to prevent chemotherapy-induced thrombocytopenia in patients with breast cancer receiving dose-intensive cyclophosphamide and doxorubicin J Clin Oncol 15 1997 3368 3377
7. C Booth CS Potten Effects of IL-11 on the growth of intestinal epithelial cells in vitro Cell Prolif 28 1995 581 594
8. XX Du CM Doerschuk A Orazi DA Williams A bone marrow stromal-derived growth factor, interleukin-11, stimulates recovery of small intestinal mucosal cells after cytoablative therapy Blood 83 1994 33 37
9. JC Keith Jr L Albert ST Sonis CJ Pfeiffer RG Schaub IL-11, a pleiotropic cytokine: exciting new effects of IL-11 on gastrointestinal mucosal biology Stem Cells 12 1994 79 89 [discussion 89–90]
10. CS Potten Protection of the small intestinal clonogenic stem cells from radiation-induced damage by pretreatment with interleukin 11 also increases murine survival time Stem Cells 14 1996 452 459
11. JC Keith Jr. L Albert RG. Schaub rhIL-11 decreases the severity of acetic acid-induced colonic injury in rats (abstr) Gastroenterology 106 1994 A708
12. BS Qiu CJ Pfeiffer JC Keith Jr Protection by recombinant human interleukin-11 against experimental TNB-induced colitis in rats Dig Dis Sci 41 1996 1625 1630
13. JC Keith Jr. LM Albert TJ Ferranti JE Erickson LE Mason LH Donnelly BR Misra RB Schaub Recombinant human interleukin-11 (rhIL-11) decreases inflammatory bowel disease in HLA-B27 transgenic rats (abstr) Gastroenterology 108 1995 A846
14. LM Albert TJ Ferranti JE Erickson LH Donnelly RG Schaub JC Keith Jr Dose response and schedule studies of recombinant human interleukin-11 in acetic acid–induced colonic injury in rats (abstr) Gastroenterology 108 1995 A768
15. WR Best JM Becktel JW Singleton F Kern Jr Development of a Crohn's disease activity index: national cooperative Crohn's disease study Gastroenterology 70 1976 439 444
16. DH Present BI Korelitz N Wisch JL Glass DB Sachar BS Pasternack Treatment of Crohn's disease with 6-mercaptopurine: a long-term, randomized, double-blind study N Engl J Med 302 1980 981 987
17. SAS/STAT Users Guide Version 6 1st ed 1990 SAS Institute, Inc Carey, NC
18. JP Leonard CM Quinto MK Kozitza TY Neben SJ Goldman Recombinant human interleukin-11 stimulates multilineage hematopoietic recovery in mice after a myelosuppressive regimen of sublethal irradiation and carboplatin Blood 83 1994 1499 1506
19. A Orazi X Du Z Yang M Kashai DA Williams Interleukin-11 prevents apoptosis and accelerates recovery of small intestinal mucosa in mice treated with combined chemotherapy and radiation Lab Invest 75 1996 33 42
20. S Sonis A Muska J O'Brien A Van Vugt P Langer-Safer J Keith Alteration in the frequency, severity and duration of chemotherapy-induced mucositis in hamsters by interleukin-11 Eur J Cancer B Oral Oncol 31B 1995 261 266
21. ST Sonis AG Van Vugt J McDonald E Dotoli U Schwertschlag P Szklut J Keith Mitigating effects of interleukin 11 on consecutive courses of 5-fluorouracil–induced ulcerative mucositis in hamsters Cytokine 9 1997 605 612
22. RL Peterson MM Bozza AJ Dorner Interleukin-11 induces intestinal epithelial cell growth arrest through effects on retinoblastoma protein phosphorylation Am J Pathol 149 1996 895 902
23. WL Trepicchio M Bozza G Pedneault AJ Dorner Recombinant human IL-11 attenuates the inflammatory response through down-regulation of proinflammatory cytokine release and nitric oxide production J Immunol 157 1996 3627 3634
24. WL Trepicchio L Wang M Bozza AJ Dorner IL-11 regulates macrophage effector function through the inhibition of nuclear factor kappa B J Immunol 159 1997 5661 5670
25. JE de Vries Immunosuppressive and anti-inflammatory properties of interleukin 10 Ann Med 27 1995 537 541
26. P Wang P Wu MI Siegel RW Egan MM Billah Interleukin (IL)-10 inhibits nuclear factor kappa B (NF kappa B) activation in human monocytes: IL-10 and IL-4 suppress cytokine synthesis by different mechanisms J Biol Chem 270 1995 9558 9563
27. SJH van Deventer CO Elson RN Fedorak Multiple doses of intravenous interleukin 10 in steroid-refractory Crohn's disease Gastroenterology 113 1997 383 389
28. JP Kelly GJ Bancroft Administration of interleukin-10 abolishes innate resistance to Listeria monocytogenes Eur J Immunol 26 1996 356 364
29. SM Opal JC Keith Jr JE Palardy N Parejo Recombinant human interleukin-11 (IL-11) has anti-inflammatory action yet does not exacerbate systemic Listeria infection Presented at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA September 24–27, 1998
30. Neumega, package insert. Genetics Institute, Inc., Cambridge, MA.
31. S Neben K Turner The biology of interleukin 11 Stem Cells 11 1993 156 162
32. M Camilleri M Proano Advances in the assessment of disease activity in inflammatory bowel disease Mayo Clin Proc 64 1989 800 807
33. RW Talbot J Heppell RR Dozois RW Beart Jr Vascular complications of inflammatory bowel disease Mayo Clin Proc 61 1986 140 145
34. JA Kaye J Loewy J Blume A Clendaniel A Egan MB Garnick J Mitchell C Knowles KA Ault Recombinant human interleukin eleven (Neumega rhIL-11 growth factor) increases plasma von Willebrand factor and fibrinogen concentrations in normal subjects (abstr) Blood 84 1994 276A
35. KK Wu Hemostatic tests in the prediction of atherothrombotic disease Int J Clin Lab Res 27 1997 145 152