Adalimumab: A review of its use in rheumatoid arthritis

BioDrugs

Volumn 18, Issue 2, 2004, Pages 121-139

  Bang, Lynne M ^a   Keating, Gillian M ^a  

^a ADIS INTERNATIONAL INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ANTIRHEUMATIC AGENT; METHOTREXATE; MONOCLONAL ANTIBODY; PLACEBO; TUMOR NECROSIS FACTOR ALPHA;

ABDOMINAL PAIN; APPENDICITIS; BACKACHE; BLEEDING; CLINICAL FLARE REACTION; CLINICAL TRIAL; DEMYELINATING DISEASE; DIARRHEA; DISEASE COURSE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG RESPONSE; DRUG TOLERABILITY; FLU LIKE SYNDROME; HEADACHE; HEART FAILURE; HUMAN; IMMUNOHISTOLOGY; IN VITRO STUDY; INJURY; JOINT BIOPSY; LYMPHOMA; MONOTHERAPY; NAUSEA; NONHUMAN; PHARMACODYNAMICS; PNEUMONIA; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZATION; RASH; REVIEW; RHEUMATOID ARTHRITIS; RHINITIS; SIDE EFFECT; SINUSITIS; SKIN ALLERGY; SKIN EDEMA; SKIN INFECTION; TREATMENT CONTRAINDICATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION;

ADULT; ANTIBODIES, MONOCLONAL; AREA UNDER CURVE; ARTHRITIS, RHEUMATOID; BIOLOGICAL AVAILABILITY; DRUG THERAPY, COMBINATION; HALF-LIFE; HUMANS; METHOTREXATE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS; TISSUE DISTRIBUTION; TREATMENT OUTCOME;

EID: 1942473539     PISSN: 11738804     EISSN: None     Source Type: Journal    
DOI: 10.2165/00063030-200418020-00005     Document Type: Review

References (62)

1. Rau R. Adalimumab (a fully human anti-tumour necrosis factor α monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials. Ann Rheum Dis 2002 Nov; 61 Suppl 2: ii70-3
2. Pearce GJ, Chikanza IC. Targeting tumour necrosis factor in the treatment of rheumatoid arthritis. Biodrugs 2001; 15 (3): 139-49
3. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis. Arthritis Rheum 2002 Feb; 46 (2): 328-46
4. Choy EHS, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med 2001 Mar 22; 344 (12): 907-16
5. Sorbera LA, Rabasseda X, Castañer RM. Adalimumab: antiarthritic treatment of IBD. Drugs Future 2001; 26 (7): 639-46
6. Santora LC, Krull IS, Grant K. Characterization of recombinant human monoclonal tissue necrosis factor-α antibody using cation-exchange HPLC and capillary isoelectric focusing. Anal Biochem 1999; 275: 98-108
7. Machold KP, Smolen JS. Adalimumab: a new TNF-α antibody for treatment of inflammatory joint disease. Expert Opin Biol Ther 2003 Apr; 3 (2): 351-60
8. Scheinfeld N. Adalimumab (Humira): a review. J Drugs Dermatol 2003 Aug; 2 (4): 375-7
9. Abbott Laboratories. Humira™ (adalimumab) prescribing information [online]. Available from URL: http://www.abbott.com [Accessed 2003 Dec 10]
10. Salfeld J, Kaymakcalan Z, Tracey D, et al. Generation of fully human anti-TNF antibody D2E7 [abstract no. 147]. Arthritis Rheum 1998 Sep; 41 (9 Suppl.): S57
11. Kaymakcalan Z, Haralambous S, Tracey D, et al. Prevention of polyarthritis in human TNF transgenic mice by D2E7: a fully human anti-human TNF monoclonal antibody [abstract no. 390]. Arthritis Rheum 1998 Sep; 41 (9 Suppl.): S97
12. Kaymakcalan Z, Beam C, Salfeld J. Murine model for assessing adalimumab, infliximab, and etanercept to prevent polyarthritis [abstract]. Ann Rheum Dis 2003; 62 Suppl. 1: 136-7
13. Barrera P, Joosten LAB, den Broeder AA, et al. Effects of treatment with a fully human anti-tumour necrosis factor α monoclonal antibody on the local and systemic homeostasis of interleukin 1 and TNFα in patients with rheumatoid arthritis. Ann Rheum Dis 2001 Jul; 60 (7): 660-9
14. den Broeder AA, Joosten LAB, Saxne T, et al. Long term anti-tumour necrosis factor α monotherapy in rheumatoid arthritis: effect on radiological course and prognostic value of markers of cartilage turnover and endothelial activation. Ann Rheum Dis 2002 Apr; 61 (4): 311-8
15. Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum 2003 Jan; 48 (1): 35-45
16. Kavanaugh A, Greenwald M, Zizic T, et al. Immune response is not affected by adalimumab therapy [abstract no. THU0196]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 169
17. den Broder A, Wanten G, van Riel P, et al. PMN reactive oxygen species production and chemotaxis in patients with RA treated with the fully human anti-TNFa antibody D2E7 [abstract no. POS-423]. Ann Rheum Dis 2000 Jul; 59 Suppl. 1: 165
18. Awni WM, Cascella P, Oleka NA, et al. Steady-state pharmacokinetics (PK) of adalimumab (HUMIRA™, Abbott) following 40 mg subcutaneous (sc) injection every other week (eow) in rheumatoid arthritis (RA) patients with and without methotrexate (MTX) background therapy [abstract no. 255]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S140
19. den Broeder A, van de Putte LBA, Rau R. A single dose, placebo controlled study of the fully human anti-tumor necrosis factor-α antibody adalimumab (D2E7) in patients with rheumatoid arthritis. J Rheumatol 2002 Nov; 29 (11): 2288-98
20. Weisman MH, Moreland LW, Furst DE, et al. Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study. Clin Ther 2003 Jun; 25 (6): 1700-21
21. Velagapudi RB, Noertersheuser PA, Awni WM, et al. Effect of methotrexate (MTX) coadministration on the pharmacokinetics (PK) of adalimumab (Humira™, Abbott) following a single intravenous injection [abstract no. 258]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S141
22. Weinblatt ME, Keystone EC, Furst DE, et al. The ARMADA trial: sustained improvement and tolerability in long-term follow-up of patients treated with adalimumab (HUMIRA) [abstract no. 738]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S314 plus poster presented at the ACR/ARHP 67th Annual Scientific Meeting; 2003 Oct 23-28; Orlando (FL)
23. Keystone E, Kavanaugh AF, Sharp J, et al. Adalimumab (D2E7), a fully human anti-TNF-α monoclonal antibody, inhibits the progression of structural joint damage in patients with active RA despite concomitant methotrexate therapy [abstract no. 468 plus oral proceedings]. Arthritis Rheum 2002 Sep; 46 (9 Suppl.): S205
24. Furst DE, Schiff MH, Fleischmann RM, et al. Adalimumab, a fully human anti-tumor necrosis factor-α monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis). J Rheumatol 2003 Dec; 30 (12): 2563-71
25. van de Putte LBA, Rau R, Breedveld FC, et al. Efficacy and safety of the fully human anti-tumour necrosis factor a monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study. Ann Rheum Dis 2003 Dec; 62 (12): 1168-77
26. van de Putte LBA, Atkins C, Malaise M, et al. Adalimumab (DE27) monotherapy in the treatment of patients with severely active rheumatoid arthritis [abstract no. 467]. Arthritis Rheum 2002 Sep; 46 (9 Suppl.): S205
27. Schattenkirchner M, Krüger K, Sander O, et al. Efficacy and tolerability of weekly subcutaneous injections of the fully human anti-TNF-antibody D2E7 in patients with rheumatoid arthritis - results of a phase I study [poster]. 62nd Annual Scientific Meeting of the American College of Rheumatology; 1998 Nov 8-12; San Diego (CA)
28. van de Putte LBA, Rau R, Breedveld FC, et al. One year efficacy results of the fully human anti-TNF antibody D2E7 in rheumatoid arthritis [abstract no. 1218]. Arthritis Rheum 2000 Sep; 43 (9 Suppl.): S269
29. Burmester GR, van de Putte LBA, Rau R, et al. Long-term efficacy and safety of adalimumab (D2E7) monotherapy in patients with DMARD-refractory rheumatoid arthritis: results from a 2-year study [abstract no. 1436]. Arthritis Rheum 2002 Sep; 46 (9 Suppl): S537
30. Keystone EC, Kavanaugh A, Sharp JT, et al. Sustained radiographic inhibition with adalimumab (HUMIRA™) over 2 years in patients with long standing rheumatoid arthritis (RA) [abstract no. 741]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S315
31. Weinblatt M, Keystone E, Furst D, et al. The Armada trial: efficacy and safety of adalimumab in patients with active RA at 24 months [abstract no. OP0107]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 98
32. Burmester GR, van de Putte LBA, Rau R, et al. Sustained efficacy of adalimumab monotherapy for more than four years in DMARD-refractory RA [abstract]. Ann Rheum Dis 2003; 62 Suppl. 1: 3
33. Schiff M, Furst D, Kavanaugh A, et al. Efficacy of adalimumab measured by the disease activity score 28 (DAS28) and EULAR response criteria [abstract no. THU0200]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 170
34. Rau R, Herborn G, Van de Putte LB. Adalimumab inhibits radiographic disease progression in long-standing, rapidly progressive rheumatoid arthritis [abstract no. THU0271]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 191
35. Strand V, Weisman MH, Nichol MB, et al. Adalimumab improves health-related quality of life in rheumatoid arthritis patients [abstract no. SAT0246]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 356
36. Strand V, Chartash E, Sengupta N, et al. Improvement in health-related quality of life, health utility, and fatigue in patients with active rheumatoid arthritis (RA) on adalimumab (Humira™, Abbott) therapy [abstract no. 991]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S402
37. Revicki D, van de Putte LBA, Atkins C, et al. Treatment with adalimumab (D2E7), a fully human anti-TNF monoclonal antibody, improves physical function, vitality, and mental health while reducing bodily pain in patients with active rheumatoid arthritis [abstract no. 1437]. Arthritis Rheum 2002 Sep; 46 (9 Suppl.): S537
38. Wellborne F, Keystone EC, Kivitz A, et al. Adalimumab (D2E7), a fully human anti-TNF-α monoclonal antibody, improved health-related quality of life in patients with active rheumatoid arthritis despite concomitant methotrexate therapy [abstract no. 1384]. Arthritis Rheum 2002 Sep; 46 (9 Suppl.): S518
39. Keystone E, Kavanaugh AF, Fischkoff S. Response to adalimumab in patients with early versus late rheumatoid arthritis [abstract no. THU0201]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 170
40. Rau R, Sander O, den Broeder A, et al. Long term efficacy and tolerability of multiple I.V. doses of the fully human anti-TNF antibody D2E7 in patients with rheumatoid arthritis [poster]. 62nd Annual Scientific Meeting of the American College of Rheumatology; 1998 Nov 8-12; San Diego (CA)
41. Rau R, Simianer S, Weier R, et al. Effective combination of the fully human anti-TNF antibody D2E7 and methotrexate in active rheumatoid arthritis [poster]. XIV European League Against Rheumatism Congress; 1999 Jun 6-11; Glasgow
42. Furst DE, Weinblatt ME, Kavanaugh A, et al. Improvement of the individual ACR components in ACR20 responders in an adalimumab (HUMIRA™) RA clinical trial [abstract no. 165]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S106
43. Wells AF, Kupper H, Fischkoff S, et al. Injection-site reactions in adalimumab rheumatoid arthritis (RA) pivotal clinical trials [abstract no. ABO0166]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 411
44. Schiff M, van de Putte LBA, Breedveld FC, et al. Rates of infection in adalimumab rheumatoid arthritis clinical trials [abstract no. THU0246]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 184
45. Schiff MH, Gelhorn AJ, Chartash E, et al. Malignancies in rheumatoid arthritis (RA) clinical trials with adalimumab (HUMIRA™) [abstract no. 1832]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S700
46. European Agency for Evaluation of Medicinal Products. Adalimumab: summary of product characteristics [online]. Available from URL: http://www.emea.eu.int [Accessed 2003 Dec 2]
47. Furst DE, Breedveld FC, Kalden JR, et al. Updated consensus statement on biological agents for the treatment of rheumatoid arthritis and other immune mediated inflammatory diseases (May 2003). Ann Rheum Dis 2003; 62 Suppl. II: ii2-9
48. Lorenz HM. Technology evaluation: adalimumab, Abbott Laboratories. Curr Opin Mol Ther 2002 Apr; 4 (2): 185-90
49. Aletaha D, Smolen JS. Effectiveness profiles and dose dependent retention of traditional disease modifying antirheumatic drugs for rheumatoid arthritis: an observational study. J Rheumatol 2002; 29 (8): 1631-8
50. Wolfe F, Michaud M. Lymphoma in rheumatoid arthritis: the effect of methotrexate and anti-TNF therapy in 18,572 patients [abstract no. 543]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S242
51. Culy CR, Keating GM. Etanercept: an updated review of its use in rheumatoid arthritis, psoriatic arthritis and juvenile rheumatoid arthritis. Drugs 2002; 62 (17): 2493-537
52. Keating GM, Perry CM. Infliximab: an updated review of its use in Crohn's disease and rheumatoid arthritis. Biodrugs 2002; 16 (2): 111-48
53. Immunex Corportion. Enbrel® (etanercept) prescribing information [online]. Available from URL: http://www.immunex.com [Accessed 2003 Nov 25]
54. Centocor Inc. Remicade® (infliximab) prescribing information [online]. Available from URL: http://www.remicade.com [Accessed 2003 Dec 10]
55. Genovese MC, Cohen SB, Moreland LW, et al. A randomized double-blind controlled study evaluating the safety and efficacy of etanercept vs etanercept plus anakinra in patients with rheumatoid arthritis [abstract no. OP0007]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 66
56. Working Party of the British Society for Rheumatology. Guidelines for prescribing TNF-α blockers in adults with rheumatoid arthritis [online]. Available from URL: http://www.rheumatolgoy.org.uk [Accessed 2004 Jan 8]
57. Bansback NJ, Brennan A, Sengupta N, et al. Cost effectiveness of adalimumab (Humira™, Abbott) in the treatment of patients with moderate to severe rheumatoid arthritis [abstract no. 470]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S215
58. Bansback NJ, Brennan A, Ghatnekar O, et al. The cost-effectiveness of adalimumab (Humira™, Abbott) in patients with rheumatoid arthritis: a Swedish analysis [abstract no. 1586]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S611
59. Malone DC, Singh A, Wanke LA, et al. A cost-efficacy comparison of adalimumab and etanercept in the treatment of rheumatoid arthritis [abstract no. 0640]. Ann Rheum Dis 2003 Jul; 62 Suppl. 1: 537
60. Chiou CF, Wanke LA, Reyes C, et al. Biologies in rheumatoid arthritis: cost-efficacy based on clinically meaningful improvement in health assessment questionnarie scores [abstract no. 597]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S263
61. Chiou CF, Wanke LA, Reyes C, et al. Comparison of the cost-efficacy of biologies in the treatment of rheumatoid arthritis [abstract no. 598]. Arthritis Rheum 2003 Sep; 48 (9 Suppl.): S263
62. Barrera P, van der Maas A, van Ede AE, et al. Drug survival, efficacy and toxicity of monotherapy with a fully human anti-tumour necrosis factor-α antibody compared with methotrexate in long-standing rheumatoid arthritis. Rheumatology (Oxford) 2002 Apr; 41: 430-9