New mechanisms and expanded indications for biologic therapies: A perspective on immunology research and development

Drug Discovery World

Volumn 11, Issue 4, 2010, Pages 87-98

  Dillon, Susan B ^a  

^a JOHNSON AND JOHNSON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ADALIMUMAB; AIN 457; ALD 518; ALEFACEPT; AMG 827; AZATHIOPRINE; BELIMUMAB; BENYLSTA; CELL RECEPTOR; CERTOLIZUMAB PEGOL; CNTO 136; CYTOKINE; EFALIZUMAB; ETANERCEPT; GOLIMUMAB; IMMUNOLOGIC AGENT; INFLIXIMAB; INTERLEUKIN 6; INTERLEUKIN 7; LY 2439821; MONOCLONAL ANTIBODY; OTELIXIZUMAB; PLACEBO; RITUXIMAB; TEPLIZUMAB; TOCILIZUMAB; TUMOR NECROSIS FACTOR; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; UNCLASSIFIED DRUG; USTEKINUMAB;

ADAPTIVE IMMUNITY; ANGIOFOLLICULAR LYMPH NODE HYPERPLASIA; ANKYLOSING SPONDYLITIS; ASTHMA; AUTOIMMUNE DISEASE; CLINICAL TRIAL; COLITIS; CROHN DISEASE; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG APPROVAL; DRUG EFFICACY; DRUG MECHANISM; DRUG RESEARCH; DRUG TARGETING; GENE EXPRESSION; GENE MUTATION; GENETIC ASSOCIATION; GENETIC VARIABILITY; HUMAN; IMMUNOCOMPETENT CELL; IMMUNOTHERAPY; INNATE IMMUNITY; INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PSORIASIS; PSORIASIS VULGARIS; PSORIATIC ARTHRITIS; REVIEW; RHEUMATOID ARTHRITIS; SARCOIDOSIS; SYSTEMIC LUPUS ERYTHEMATOSUS; TREATMENT RESPONSE; ULCERATIVE COLITIS;

EID: 78049257495     PISSN: 14694344     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (83)

1. Remicade® (infliximab). [prescribing information]. Malvern, PA: Centocor Ortho Biotech Inc.; 2009.
2. Enbrel® (etanercept) [prescribing information]. Thousand Oaks, CA: Immunex Corporation; 2010.
3. Humira® (adalimumab). [Prescribing information]. North Chicago, IL: Abbott; 2010.
4. Simponi (golimumab) [prescribing information]. Horsham, PA: Centocor Ortho Biotech Inc; 2010.
5. Cimzia® (Certolizumab perol) [prescribing information]. Smyrna, GA:UCB, Inc; 2009.
6. Rubbert-Roth, A, Finckh, A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther. 2009;11 Suppl 1:S1.
7. Ma, MH, Scott, IC, Kingsley, GH, Scott DL Remission in early rheumatoid arthritis. J Rheumatol. Jul;37(7):1444-1453.
8. Marotte, H, Arnaud, B, Diasparra, J, Zrioual, S, Miossec, P. Association between the level of circulating bioactive tumor necrosis factor alpha and the tumor necrosis factor alpha gene polymorphism at -308 in patients with rheumatoid arthritis treated with a tumor necrosis factor alpha inhibitor. Arthritis Rheum. May 2008;58(5):1258-1263. (Pubitemid 351705914)
9. Wijbrandts, CA, Dijkgraaf, MG, Kraan, MC et al. The clinical response to infliximab in rheumatoid arthritis is in part dependent on pretreatment tumour necrosis factor alpha expression in the synovium. Ann Rheum Dis. Aug 2008;67(8):1139-1144.
10. Julia et al. PLoS ONE 2009, 4(10): e7556.
11. Bienkowska et al. Genomics 2009, 94(6): 423-32.
12. Van Baarsen et al. Arthritis Research & Therapy 2010, 12:R11.
13. Arijs, I, Li, K, Toedter, G et al. Mucosal gene signatures to predict response to infliximab in patients with ulcerative colitis. Gut. Dec 2009;58(12):1612-1619.
14. Smolen, JS, Kay, J, Doyle, MK et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet Jul 18 2009;374(9685):210-221.
15. Colombel, JF, Sandborn, WJ, Reinisch, W et al. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. Apr 15, 2010;362(15):1383-1395.
16. Lichtenstein, GR, Hanauer, SB, Sandborn, WJ. Management of Crohn's disease in adults. Am J Gastroenterol. Feb 2009;104(2):465-483; quiz 464, 484.
17. Groves, RW, Allen, MH, Ross, EL, Barker, JN, MacDonald, DM. Tumour necrosis factor alpha is pro-inflammatory in normal human skin and modulates cutaneous adhesion molecule expression. Br J Dermatol. Mar 1995;132(3):345-352.
18. Charles, P, Elliott, MJ, Davis, D et al. Regulation of cytokines, cytokine inhibitors, and acute-phase proteins following anti-TNF-alpha therapy in rheumatoid arthritis. J Immunol. Aug 1 1999;163(3):1521-1528.
19. Paleolog, EM, Hunt M, Elliott MJ, Feldmann, M, Maini, RN, Woody, JN. Deactivation of vascular endothelium by monoclonal anti-tumor necrosis factor alpha antibody in rheumatoid arthritis. Arthritis Rheum. Jul 1996;39(7):1082-1091.
20. Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. Mar 22 2001;344(12):907-916.
21. Stern, AS, Podlaski, FJ, Hulmes, JD et al. Purification to homogeneity and partial characterization of cytotoxic lymphocyte maturation factor from human B-lymphoblastoid cells. Proc Natl Acad Sci U S A. Sep 1990;87(17):6808- 6812.
22. Kobayashi, M, Fitz, L, Ryan, M et al. Identification and purification of natural killer cell stimulatory factor (NKSF), a cytokine with multiple biologic effects on human lymphocytes. J Exp Med. Sep 1 1989;170(3):827-845. (Pubitemid 19226667)
23. Kastelein, RA, Hunter, CA, Cua, DJ. Discovery and biology of IL-23 and IL-27: related but functionally distinct regulators of inflammation. Annu Rev Immunol. 2007;25:221-242.
24. Wilson, NJ, Boniface, K, Chan JR et al. Development cytokine profile and function of human interleukin 17-producing helper T cells. Nat Immunol. Sep 2007;8(9):950-957.
25. Langrish, CL, Chen, Y, Blumenschein, WM et al. IL-23 drives a pathogenic T cell population that induces autoimmune inflammation J Exp Med. Jan 17 2005;201(2):233-240.
26. Murphy, KM, Stockinger, B. Effector T cell plasticity: flexibility in the face of changing circumstances. Nat Immunol. August 2010;11(8):674-80.
27. Cargill, M, Schrodi, SJ, Chang, M, Garcia, VE, Brandon, R et al. A large-scale genetic association study confirms IL12B and leads to the identification of IL23R as psoriasis-risk genes. Am J Hum Genet. February 2007;80(2):273-90.
28. Capon, F, Di Meglio, P, Szaub, J, Prescott, NJ et al. Sequence variants in the genes for the interleukin-23 receptor (IL23R) and its ligand (IL12B) confer protection against psoriasis. Hum Genet. September 2007;122(2):201-6.
29. Duerr, RH, Taylor, KD, Brant SR, Rioux, JD, Silverberg, MS et al. A genome-wide association study identifies IL23R as an inflammatory bowel disease gene. Science. December 1, 2006;314(5804):1461-3.
30. Stelara® (ustekinumab) [prescribing information]. Horsham, PA: Centocor Biotech Inc; 2009.
31. Leonardi, CL, Kimball, AB, Papp, KA et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet May 17 2008;371(9625):1665-1674.
32. Papp, KA, Langley, RG, Lebwohl, M et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. May 17 2008;371(9625):1675-1684.
33. Gordon, K, Leonardi, C, Griffiths, CE et al. Ustekinumab safety update: cumulative experience from longer term follow-up of patients treated in the ustekinumab psoriasis clinical program. J Eur Acad Dermatol Venereol. July 2010;24(s4):1-83.
34. Krueger, J. Oral presentation at Psoriasis: From Gene to Clinic, Dec 4-6 2008, London.
35. Reddy, M, Torres, G, McCormick, T et al. Positive treatment effects of ustekinumab in psoriasis: Analysis of lesional and systemic parameters. J Dermatol. May 2010:37(5):413-425.
36. Sandborn, WJ, Feagan, BG, Fedorak, RN et al. A randomized trial of Ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology. October 2008: 135(4):1130-41.
37. Gottlieb, A, Menter, A, Mendelsohn, A et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. February 2009:374(9664):633-640.
38. Cua, D and Tato, CM. Innate IL-17 producing cells: the sentinels of the immune system. Nat Rev Immunol. 2010 Jul;10(7):479-89.
39. Kolls, JK, Linden, A. Interleukin-17 family members and inflammation. Immunity. Oct 2004;21(4):467-476.
40. Alcorn, JF, Crowe, CR, Kolls, JK. TH17 cells in asthma and COPD. Annu Rev Physiol. March 2010:17;72:495-516.
41. Khader, SA, Gaffen, SL, Kolls, JK. Th17 cells at the crossroads of innate and adaptive immunity against infectious diseases at the mucosa. Mucosal Immunol. 2009 Sep;2(5):403-11.
42. Novartis Pharmaceuticals; Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[September 9, 2010]. Available from: http://clinicaltrials.gov/ct2/show/ NCT00928512?term=AIN457&rank=3. Identifier: NCT00928512.
43. Novartis Pharmaceuticals; AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [Sept 9, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT00941031?term=AIN457&rank=1. Identifier: NCT00941031.
44. Novartis Pharmaceuticals; Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [September 11, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT01169844?term= AIN457&rank=11. Identifier: NCT01169844.
45. Novartis Pharmaceuticals; Efficacy of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [September 9, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT00809159?term= AIN457&rank=13. Identifier: NCT00809159.
46. Novartis Pharmaceuticals; Safety and Efficacy of AIN457 in Noninfectious Uveitis. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [September 9, 2010]. Available from: http://clinicaltrials. gov/ct2/show/NCT00685399?term=AIN457&rank=10. Identifier: NCT00685399.
47. Genovese, MC, Van den Bosch, F, Roberson, SA et al. LY2439821, a humanized anti-interleukin-17 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I randomized, double-blind, placebo-controlled, proof-of-concept study. Arthritis Rheum. April 2010:62(4):929-939.
48. Tak, PP, Durez, P, Gomez-Reino, JJ, Wittmer, B. Chindalore, V, Di Padova, F, Wright, AM, Bruin, G, Hueber, W. AIN457 Shows a Good Safety Profile and Clinical Benefit in Patients with Active Rheumatoid Arthritis (RA) Despite Methotrexate Therapy: 16-Weeks Results From a Randomized Proof-of-Concept Trial. Paper presented at: American College of Rheumatology Scientific Meeting; October 20, 2009; Philadelphia, PA.
49. Rose-John, S, Scheller, J, Elson, G, Jones, SA. Interleukin-6 biology is coordinated by membrane-bound and soluble receptors: role in inflammation and cancer. J Leukoc Biol. Aug 2006;80(2):227-236.
50. Bettelli, E, Carrier, Y, Gao, W et al. Reciprocal developmental pathways for the generation of pathogenic effector TH17 and regulatory T cells. Nature. May II 2006;441(7090):235-238.
51. Spath-Schwalbe, E, Hansen, K, Schmidt, F et al. Acute effects of recombinant human interleukin-6 on endocrine and central nervous sleep functions in healthy men. J Clin Endocrinol Metab. May 1998;83(5):1573-1579.
52. Nemeth, E, Rivera, S, Gabayan, V et al. IL-6 mediates hypoferremia of inflammation by inducing the synthesis of the iron regulatory hormone hepcidin. J Clin Invest May 2004;113(9):1271-1276. (Pubitemid 39069926)
53. Lally, F, Smith, E, Filer, A et al. A novel mechanism of neutrophil recruitment in a coculture model of the rheumatoid synovium. Arthritis Rheum. Nov 2005;52(11):3460-3469.
54. Solis-Herruzo, JA, Rippe, RA, Schrum, LW et al. Interleukin-6 increases rat metalloproteinase-13 gene expression through stimulation of activator protein I transcription factor in cultured fibroblasts. J Biol Chem. Oct 22 1999;274(43):30919-30926.
55. De Benedetti, F, Rucci, N, Del Fattore, A et al. Impaired skeletal development in interleukin-6-transgenic mice: a model for the impact of chronic inflammation on the growing skeletal system. Arthritis Rheum. Nov 2006;54(11):3551-3563.
56. Genovese, MC, McKay, JD, Nasonov, EL et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. Oct 2008;58(10):2968-2980.
57. Garnero, P, Thompson, E, Woodworth, T, Smolen, JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. Jan;62(1):33-43.
58. Nishimoto, N, Kanakura, Y, Aozasa, K et al. Humanized anti-interleukin-6 receptor antibody treatment of multicentric Castleman disease. Blood. 2005 Oct 15;106(8):2627-32.
59. van Rhee, F, Fayad, L, Voorhees, P, Furman, R, Lonial, S et al. Siltuximab, a novel anti-interleukin-6 monoclonal antibody, for Castleman's disease J Clin Oncol. 2010 Aug 10;28(23):3701-8.
60. Zhang, J, Roschke, V, Baker, KP et al. Cutting edge: a role for B lymphocyte stimulator in systemic lupus erythematosus. J Immunol. Jan 1 2001;166(1):6-10.
61. Human Genome Sciences, GlaxoSmithKline; A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-52). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [September 10, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT00424476?term= NCT00424476&rank=1. Identifier: NCT00424476.
62. Human Genome Sciences, GlaxoSmithKline; A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [September 10, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT00410384?term= NCT00410384&rank=1. Identifier: NCT00410384.
63. GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus. GlaxoSmithKline. August 19, 2010. [Internet] Accessed September 10, 2010. Available from: http://www.gsk.com/media/pressreleases/2010/ 2010-pressrelease-10083.htm.
64. Baughman, RP, Lower, EE, du Bois, RM. Sarcoidosis. Lancet Mar 29 2003;361(9363):1111-1118.
65. Antoniu, SA. Targeting the TNF-alpha pathway in sarcoidosis. Expert Opin Ther Targets. 2010 Jan;14(1):21-9.
66. Hata, M, Sugisaki, K, Miyazaki, E, Kumamoto, T, Tsuda, T. Circulating IL-12 p40 is increased in the patients with sarcoidosis, correlation with clinical markers. Intern Med. 2007;46(17):1387-93. (Pubitemid 47455762)
67. Centocor Ortho Biotech, Inc.; A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[September 10, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT00955279?term=NCT00955279&rank=1. Identifier: NCT00955279.
68. Arcalyst® (rilonacept) [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.;2009.
69. Maris® (canakinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals;2009.
70. Church, LD, Savic, S, McDermott, MF. Long term management of patients with cryopyrin-associated periodic syndromes (CAPS): focus on rilonacept (IL-1 Trap). Biologics. Dec 2008;2(4):733-742.
71. Herold, KC, Hagopian, W, Auger, J et al. Anti-CD3 Monoclonal Antibody in New-Onset Type I Diabetes Mellitus. N Engl J Med. May 2002;346(22):1692-8.
72. MacroGenics and Eli Lilly and Company; Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type I Diabetes Mellitus. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [September 10, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT00920582?term=CD3+diabetes&phase= 2&rank=1. Identifier: NCT00920582.
73. Tolerx Inc. and Juvenile Diabetes Research Foundation/GlaxoSmithKline; Proteg Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type I Diabetes Mellitus (Autoimmune): DEFEND-2. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[September 10, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT01123083?term= CD3+diabetes&phase=2&rank=4. Identifier: NCT01123083.
74. Wenzel, SE, Barnes, PJ, Bleecker, ER et al. A randomized, double-blind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med. April 1, 2009;179(7):549-58.
75. Barnes, PJ. New Therapies for asthma: is there any progress? Trends Pharmacol Sci. 2010 Jul;31(7):335-43.
76. Ablynx. Pipeline. Available at: http://www.ablynx.com/research/pipeline. htm. Accessed September 10, 2010.
77. Pfizer; Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX (ORAL 1069). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [September 10, 2010]. Available from: http://clinicaltrials.gov/ct2/show/ NCT01039688?term=JAK+rheumatoid+arthritis&phase=2&rank=2. Identifier: NCT01039688.
78. Rigel Pharmaceuticals; Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[September 10, 2010]. Available from: http://clinicaltrials.gov/ct2/show/NCT00665925?term= R788&rank=1. Identifier: NCT00665925.
79. Orencia® (abatacept) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; 2009.
80. Rituxan® (rituximab) [prescribing information]. South San Francisco, CA: Benentech, Inc. 2010. Jointly marketed by Biogen Idee Inc and Genentech USA, Inc.
81. Raptiva (efalizumab) [prescribing information]. South San Francisco, CA: Genentech, Inc. 2009. (withdrawn).
82. Amevive® (alefacept) [prescribing information]. Deerfield, IL:Astellas Pharma US, Inc; 2003.
83. Tysabri® (natalizumab) [prescribing information]. Cambridge, MA: Biogen Idec, Inc. 2010. Distributed by Elan Pharmaceuticals, Inc.