Anakinra

BioDrugs

Volumn 16, Issue 4, 2002, Pages 303-311

  Cvetkovic, Risto S ^a   Keating, Gillian ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

METHOTREXATE; PLACEBO; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT;

ANIMAL EXPERIMENT; ANIMAL MODEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDICATION; DRUG MECHANISM; DRUG TOLERABILITY; ECCHYMOSIS; ERYTHEMA; HUMAN; INFECTION; INJECTION PAIN; MAJOR CLINICAL STUDY; NONHUMAN; PRIORITY JOURNAL; PRURITUS; RAT; REVIEW; RHEUMATOID ARTHRITIS;

EID: 0036382723     PISSN: 11738804     EISSN: None     Source Type: Journal    
DOI: 10.2165/00063030-200216040-00005     Document Type: Review

References (63)

1. Wolfe F, Cush JJ, O'Dell JR, et al. Consensus recommendations for the assessment and treatment of rheumatoid arthritis. J Rheumatol 2001 Jun; 28 (6): 1423-30
2. Lipsky PE. Rheumatoid arthritis. In: Wilson JD, Braunwald E, Isselbacher KJ, et al, editors. Harrison's principles of internal medicine. 12th ed. New York (NY): McGraw-Hill, Inc., 1991: 1437-43
3. Mowat AG. Hematologic abnormalities in rheumatoid arthritis. Semin Arthritis Rheum 1971: 1: 195-219
4. Maury CPJ, Andersson LC, Teppo AM, et al. Mechanisms of anaemia in rheumatoid arthritis: demonstration of raised interleukin-1β in anaemic patients and of interleukin-1 mediated suppression of normal erythropoiesis and proliferation of human erythroleukaemia (HEL) cells in vitro. Ann Rheum Dis 1988; 47: 972-87
5. Maury CPJ, Andersson LC, Partanen S, et al. Mechanism of anaemia of rheumatoid arthritis: evidence for a role of interleukin 1. Clin Rheumatol 1988; 7 (1): 141
6. Paulus HE, Egger MJ, Ward JR, et al. Analysis of improvement in individual rheumatoid arthritis patients treated with disease-modifying antirheumatic drugs, based on the findings in patients treated with placebo. Arthritis Rheum 1990 Apr; 33 (4): 477-84
7. Arend WP, Dayer J-M. Inhibition of the production and effects of interleukin-1 and tumor necrosis factor α in rheumatoid arthritis. Arthritis Rheum 1995 Feb; 38 (2): 151-60
8. Dinarello CA. Role of pro- and anti-inflammatory cytokines during inflammation: experimental and clinical findings. J Biol Regul Homeost Agents 1997 Jul-1997 30; 11: 91-103
9. Roux-Lombard P, Modoux C, Vischer T, et al. Inhibitors of interleukin 1 activity in synovial fluids and in cultured synovial fluid mononuclear cells. J Rheumatol 1992 Apr; 19 (4): 517-23
10. Rang HP, Dale MM, Ritter JM. Local hormones, inflammation and allergy. Pharmacology. 4th ed. Edinburgh: Churchill Livingstone, 1999: 198-228
11. Smith RJ, Chin JE, Sam LM, et al. Biological effects of an interleukin-1 receptor antagonist protein on interleukin-1-stimulated cartilage erosion and chondrocyte responsiveness. Arthritis Rheum 1991 Jan; 34 (1): 78-83
12. Henderson B, Thompson RC, Hardingham T, et al. Inhibition of interleukin-1-induced synovitis and articular cartilage proteoglycan loss in the rabbit knee by recombinant human interleukin-1 receptor antagonist. Cytokine 1991 May; 3 (3): 246-9
13. Joosten LAB, Helsen MMA, van de Loo FAJ, et al. Anticytokine treatment of established type II collagen-induced arthritis in DBA/1 mice. Arthritis Rheum 1996 May; 39: 797-809
14. Bakker AC, Joosten LAB, Arntz OJ, et al. Prevention of murine collagen-induced arthritis in the knee and ipsilateral paw by local expression of human interleukin-1 receptor antagonist protein in the knee. Arthritis Rheum 1997 May; 40: 893-900
15. Bendele A, McAbee T, Woodward M, et al. Effects of interleukin-1 receptor antagonist in a slow-release hylan vehicle on rat type II collagen arthritis. Pharm Res 1998 Oct; 15 (10): 1557-61
16. Bendele A, McAbee T, Sennello G, et al. Efficacy of sustained blood levels of interleukin-1 receptor antagonist in animal models of arthritis: comparison of efficacy in animal models with human clinical data. Arthritis Rheum 1999 Mar; 42 (3): 498-506
17. Bendele AM, Chlipala ES, Scherrer J, et al. Combination benefit of treatment with the cytokine inhibitors interleukin-1 receptor antagonist and PEGylated soluble tumor necrosis factor receptor type I in animal models of rheumatoid arthritis. Arthritis Rheum 2000 Dec; 43 (12): 2648-59
18. Matsushima K, Akahoshi T, Yamada M, et al. Properties of a specific interleukin 1 (IL 1) receptor on human Epstein Barr virus-transformed B lymphocytes: identity of the receptor for IL 1-α and 1-β. J Immunol 1986 Jun 15; 136 (12): 4496-502
19. Arend WP, Coll BP. Interaction of recombinant monocyte-derived interleukin 1 receptor antagonist with rheumatoid synovial cells. Cytokine 1991 Sep; 3 (5): 407-13
20. Dinarello CA. Biologic basis for interleukin-1 in disease. Blood 1996 Mar 15; 87 (6): 2085-147
21. Firestein GS, Boyle D, Yu C, et al. Synovial interleukin-1 receptor antagonist and interleukin-1 balance in rheumatoid arthritis. Arthritis Rheum 1994 May; 37 (5): 644-52
22. Amgen. FDA approves Kineret™ for the treatment of rheumatoid arthritis [media release 2001 Nov 14]. Available from URL: http//www.amgen.com [Accessed 2002 Aug 16]
23. Amgen. European Commission approves Amgen's Kineret® for the treatment of rheumatoid arthritis [media release 2002 Mar 13]. Available from URL: http//www.amgen.com [Accessed 2002 Aug 16]
24. Amgen. Product monograph: Kineret™ (anakinra). Thousand Oaks (CA): Amgen Inc. 2002 May 24: 1-25
25. Eisenberg SP, Evans RJ, Arend WP, et al. Primary structure and functional expression from complementary DNA of a human interleukin-1 receptor antagonist. Nature 1990 Jan 25; 343: 341-6
26. Amgen. Package insert: Kineret™ (anakinra). Thousand Oaks (CA): Amgen Inc. 2001 Nov 14: 1-11
27. Arend WP, Welgus HG, Thompson RC, et al. Biological properties of recombinant human monocyte-derived interleukin 1 receptor antagonist. J Clin Invest 1990 May; 85: 1694-7
28. Stylianou E, O'Neill LAJ, Rawlinson L, et al. Interleukin 1 induces NF-κB through its type I but not type II receptor in lymphocytes. J Biol Chem 1992 Aug 5; 267 (22): 15836-41
29. Chizzonite R, Truitt T, Kilian P, et al. Two high-affinity interleukin 1 receptors represent separate gene products. Proc Natl Acad Sci U S A 1989 Oct; 86: 8029-33
30. Chin J, Rupp E, Cameron PM, et al. Identification of a high-affinity receptor for interleukin 1α and interleukin 1β on cultured human rheumatoid synovial cells. J Clin Invest 1988 Aug; 82: 420-6
31. Dower SK, Kronheim SR, March CJ, et al. Detection and characterization of high affinity plasma memebrane receptors for human interleukin 1. J Exp Med 1985; 162 (2): 501-15
32. Hannum CH, WIlcox CJ, Arend WP, et al. Interleukin-1 receptor antagonist activity of a human interleukin-1 inhibitor. Nature 1990 Jan 25; 343: 336-40
33. Trentham DE, Townes AS, Kang AH. Autoimmunity to type II collagen: an experimental model of arthritis. J Exp Med 1977 Sep 1; 146 (3): 857-68
34. Cunnane G, Madigan A, Murphy E, et al. The effects of treatment with interleukin-1 receptor antagonist on the inflamed synovial membrane in rheumatoid arthritis. Rheumatology (Oxf) 2001; 40: 62-9
35. Yang BB, Frazier J, McCabe D, et al. Population pharmacokinetics of recombinant interleukin-1 receptor antagonist (anakinra) in subjects with rheumatoid arthritis [abstract and poster]. Arthritis Rheum 2000 Sep; 43 (9 Suppl.): S153
36. Martin SW, Nguyen L, Stouch BJ, et al. Pharmacokinetics (PK) of neither anakinra (interleukin-1 receptor antagonist, IL-1ra) nor pegylated soluble tumor necrosis factor receptor type (PEG sTNF-RI) were altered after combination treatment in subjects with rheumatoid arthritis (RA) [abstract]. Arthritis Rheum 2001 Sep; 44 (9 Suppl.): S79
37. Yang B, Baughman S, Frazier BS, et al. Pharmacokinetics (PK) of anakinra in subjects with various degrees of renal function [abstract]. Clin Pharmacol Ther 2002 Feb; 71 (2): p14
38. Bresnihan B, Alvaro-Gracia JM, Cobby M, et al. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 1998 Dec; 41 (12): 2196-204
39. Jiang Y, Genant HK, Watt I, et al. A multicenter, double-blind, dose-ranging, randomized, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis: radiologic progression and correlation of Genant and Larsen scores. Arthritis Rheum 2000 May; 43: 1001-9
40. Bresnihan B, Chan WW, Woolley JM. Productivity improvement in patients with rheumatoid arthritis receiving anakinra (IL-1ra) treatment [abstract no. 0074 and poster]. Annual European Congress of Rheumatology EULAR; 2002 Jun 12-15; Stockholm
41. Kay J, Bryant S, Cravets M, et al. IL-I receptor antagonist (IL-1ra) treatment is associated with improvement of anemia in rheumatoid arthritis [abstract and poster]. Arthritis Rheum 2000 Sep; 43 (9 Suppl.): S289
42. Amgen. Kinemt™ (anakinra): FDA Arthritis Drugs Advisory Committee briefing package. Thousand Oaks (CA): Amgen Inc. 2001 Jul 17: 1-185
43. Cohen S, Hurd E, Cush JJ, et al. Treatment of interleukin-1 receptor antagonist in combination with methotrexate (MTX) in rheumatoid arthritis (RA) patients. Arthritis Rheum 1999 Sep; 42 (9 Suppl.): S273
44. Cohen SB, Moreland LW, Cush JJ, et al. Anakinra (recombinant interleukin-1 receptor antagonist): a large, placebo controlled efficacy trial of anakinra in patients with erosive rheumatoid arthritis disease [abstract]. Arthritis Rheum 2001 Dec; 44 (12): 2946
45. Cohen S, Hurd E, John C, et al. Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin-1 receptor antagonist, in combination with methotrexate. Results of a twenty-four-week, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002 Mar; 46 (3): 614-24
46. Cohen S, Nakelsky S, Mulani P, et al. The impact of anakinra therapy on patient-centered outcomes in rheumatoid arthritis [abstract]. Arthritis Rheum 2001 Sep; 44 (9 Suppl.): S77
47. Cohen S, Nakelsky S, Mulani P, et al. The impact of Kineret™ (anakinra) therapy on patient-reported outcomes in rheumatoid arthritis [poster]. Annual European Congress of Rheumatology EULAR; 2002 Jun 12-15; Stockholm
48. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988 Mar; 31 (3): 315-24
49. Genant HK, Bresnihan B, Ng E, et al. Treatment with anakinra reduces the rate of joint destruction and shows accelerated benefit in the second 6 months of treatment for patients with rheumatoid arthritis [abstract and poster]. Arthritis Rheum 2000 Sep; 43 Suppl.: 288
50. Felson DT, Anderson JJ, Boers M, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum 1993 Jun; 36 (6): 729-40
51. Fries JF, Spitz P, Kraines RG, et al. Measurement of patient outcome in arthritis. Arthritis Rheum 1980 Feb; 23 (2): 137-45
52. Pincus T, Olsen NJ, Russell IJ, et al. Multicenter study of recombinant human erythropoietin in correction of anemia in rheumatoid arthritis. Am J Med 1990 Aug; 89: 161-8
53. Sharp JT, Lidsky MD, Collins LC, et al. Methods of scoring the progression of radiographic changes in rheumatoid arthritis. Correlation of radiologic, clinical and laboratory abnormalities. Arthritis Rheum 1971 Nov-1971 31; 14 (6): 706-20
54. Genant HK. Methods of assessing radiographic change in rheumatoid arthritis. Am J Med 1983 Dec 30; 75: 35-47
55. Larsen A, Thoen J. Hand radiography of 200 patients with rheumatoid arthritis repeated after an interval of one year. Scand J Rheumatology 1987; 16: 395-401
56. Sharp JT. Radiologic assessment as an outcome measure in rheumatoid arthritis. Arthritis Rheum 1989 Feb; 32 (2): 221-9
57. Fries JF, Bloch DA, Sharp JT, et al. Assessment of radiologic progression in rheumatoid arthritis. A randomized, controlled trial. Arthritis Rheum 1986 Jan; 29 (1): 1-9
58. Larsen A, Dale K, Eek M. Radiographic evaluation of rheumatoid arthritis and related conditions by standard reference films. Acta Radiol Diagn (Stockh) 1977 Jul 4; 18: 481-91
59. Genant HK, Jiang Y, Peterfy C, et al. Assessment of rheumatoid arthritis using a modified scoring method on digitized and original radiographs. Arthritis Rheum 1998 Sep; 41 (9): 1583-90
60. Felson DT, Anderson JJ, Lange MLM, et al. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent? Arthritis Rheum 1998 Sep; 41 (9): 1564-70
61. Campion GV, Lebsack ME, Lookabaugh J, et al. Dose-range and dose-frequency study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis. Arthritis Rheum 1996 Jul; 39: 1092-101
62. Schiff MH, Bulpitt K, Weaver AA, et al. Safety of combination therapy with anakinra and etanercept in patients with rheumatoid arthritis [abstract]. Arthritis Rheum 2001 Sep; 44 (9 Suppl.): S79
63. Fleischman R, Tesser J, Schrechtman J, et al. A safety trial of anakinra: recombinant interleukin-1 receptor antagonist (IL-1RA), in a large, placebo controlled heterogeneous population of patients with rheumatoid arthritis [abstract]. Arthritis Rheum 2001 Sep; 44 (9 Suppl.): S84