Ustekinumab for the treatment of psoriatic arthritis

Expert Review of Clinical Immunology

Volumn 10, Issue 2, 2014, Pages 189-202

  Wofford, Jay ^a   Menter, Alan ^a,b  

^a BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^b BAYLOR RESEARCH INSTITUTE   (United States)

Author keywords

biologic therapy; IL 12; IL 23; immunotherapy; inflammatory arthritis; monoclonal antibody; psoriatic arthritis; ustekinumab

Indexed keywords

INTERLEUKIN 12; INTERLEUKIN 17; INTERLEUKIN 23; INTERLEUKIN 23 RECEPTOR; METHOTREXATE; STAT PROTEIN; TUMOR NECROSIS FACTOR INHIBITOR; USTEKINUMAB;

ARTICLE; BASAL CELL CARCINOMA; BLEEDING; CEREBROVASCULAR ACCIDENT; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG EFFICACY; DRUG MARKETING; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; FAINTNESS; HEART DISEASE; HUMAN; IMMUNOTHERAPY; MOLECULAR WEIGHT; NATURAL KILLER CELL; OPPORTUNISTIC INFECTION; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPIRATORY TRACT INFECTION; SIGNAL TRANSDUCTION; STOMACH ULCER; TH17 CELL; THORAX PAIN; TUBERCULOSIS;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; ARTHRITIS, PSORIATIC; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; EUROPE; HUMANS; IMMUNOTHERAPY; TUMOR NECROSIS FACTOR-ALPHA; UNITED STATES;

EID: 84893079702     PISSN: 1744666X     EISSN: 17448409     Source Type: Journal    
DOI: 10.1586/1744666X.2014.878649     Document Type: Article

References (78)

1. Zachariae H. Prevalence of joint disease in patients with psoriasis: Implications for therapy. Am J Clin Dermatol 2003;4:441
2. Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol 2005;53:573
3. Brockbank J, Gladman DD. Diagnosis and management of psoriatic arthritis. Drugs 2002;62:2447
4. Gladman DD, Shuckett R, Russell ML, et al. Psoriatic arthritis (PsA): An analysis of 220 patients. Q J Med 1987;62:127
5. Gladman DD. Current concepts in psoriatic arthritis. Curr Opin Rheumalol 2002;14:361
6. Madland TM, Apalset EM, Johannessen AE, et al. Prevalence, disease manifestations, and treatment of psoriatic arthritis in Western Norway. J Rheumatol 2005;32: 1918
7. Alamanos Y, Voulgari PV, Drosos AA. Incidence and prevalence of psoriatic arthritis: A systematic review. J Rheumatol 2008;35:1354
8. Christophers E, Barker JN, Griffiths CE, et al. The risk of psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in European dermatology clinics. J Eur Acad Dermatol Venereol 2010;24:548
9. Reich K, Kruger K, Mossner R, Augustin M. Epidemiology and clinical pattern of psoriatic arthritis in Germany: A prospective interdisciplinary epidemiological study of 1511 patients with plaque-Type psoriasis. Br J Dermatol 2009;160:1040
10. Taylor W, Gladman D, Helliwell P, et al. Classification criteria for psoriatic arthritis: Development of new criteria from a large international study. Arthritis Rheum 2006;54:2665-73
11. Ibrahim G, Waxman R, Helliwell PS. The prevalence of psoriatic arthritis in people with psoriasis. Arthritis Rheum 2009;61:1373
12. Eder L, Chandran V, Shen H, et al. Incidence of arthritis in a prospective cohort of psoriasis patients. Arthritis Care Res (Hoboken) 2011;63:619
13. McGonagle D, Ash Z, Dickie L, et al. The early phase of psoriatic arthritis. Ann Rheum Dis 2011;70(Suppl 1):i71
14. Partsch G, Steiner G, Leeb BF, et al. Highly increased levels of tumor necrosis factor-Alpha and other proinflammatory cytokines in psoriatic arthritis synovial fluid. J Rheumatol 1997;24:518
15. Van Kuijk AW, Reinders-Blankert P, Smeets TJ, et al. Detailed analysis of the cell infiltrate and the expression of mediators of synovial inflammation and joint destruction in the synovium of patients with psoriatic arthritis: Implications for treatment. Ann Rheum Dis 2006;65:1551
16. Tassiulas I, Duncan SR, Centola M, et al. Clonal characteristics of T cell infiltrates in skin and synovium of patients with psoriatic arthritis. Hum Immunol 1999;60:479
17. Costello P, Bresnihan B, O'Farrelly C, FitzGerald O. Predominance of CD8+ T lymphocytes in psoriatic arthritis. J Rheumatol 1999;26:1117
18. Raychaudhuri SP, Raychaudhuri SK, Genovese MC. IL-17 receptor and its functional significance in psoriatic arthritis. Mol Cell Biochem 2012;359:419
19. Soriano ER, McHugh NJ. Therapies for peripheral joint disease in psoriatic arthritis: A systematic review. J Rheumatol 2006;33:1422
20. Kaltwasser JP, Nash P, Gladman DD, et al. Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and psoriasis: A multinational, double-blind, randomized, placebo-controlled clinical trial. Arthritis Rheum 2004;50:1939
21. Salvarani C, Macchioni P, Olivieri I, et al. A comparison of cyclosporine, sulfasalazine, and symptomatic therapy in the treatment of psoriatic arthritis. J Rheumatol 1996;28:2274
22. Fraser AD, Van Kuijk AW, Westhovens R, et al. A randomized, double-blind, placebo-controlled, multicenter trial of combination therapy with methotrexate plus cyclosporine in patients with active psoriatic arthritis. Ann Rheum Dis 2005;64:859
23. Kavanaugh AF, Ritchlin CT; GRAPPA Treatment Guideline Committee. Systematic review of treatments for psoriatic arthritis: An evidence based approach and basis for treatment guidelines. J Rheumatol 2006;33:1417
24. Heiberg MS, Kauffman C, Rodevand E, et al. The comparative effectiveness of anti-TNF therapy and methotrexate in patients with psoriatic arthritis: 6 month results from a longitudinal, observational, multicenter study. Ann Rheum Dis 2007;66:1038
25. Saad AA, Symmons DP, Noyce PR, Ashcroft DM. Risks and benefits of tumor necrosis factor-Alpha inhibitors in the management of psoriatic arthritis: Systematic review and meta-Analysis of randomized controlled trials. J Rheumatol 2008;35:883
26. Antoni CE, Kavanaugh A, Kirkham B, et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: Results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheum 2005;52:1227
27. Kavanaugh A, Antoni CE, Gladman DD, et al. The infliximab multinational psoriatic arthritis controlled trial (IMPACT): Results of radiographic analyses after 1 year. Ann Rheum Dis 2006;65:1038
28. Gladman DD, Mease PH, Ritchlin CT, et al. Adalimumab for long-Term treatment of psoriatic arthritis: Forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum 2007;56:476
29. US FDA approves Cimzia (certolizumab pegol) for active psoriatic arthritis. (30 September 2013). Available from: Www.news-medical.net/news/ 20130930/ FDA-Approves-Cimzia-(certolizumab-pegol)-for-Active-psoriatic- Arthritis.aspx [Last accessed 11 October 2013
30. Goulabchand R, Mouterde G, Barnetche T, et al. Effect of tumor necrosis factor blockers on radiographic progression of psoriatic arthritis: A systematic review and meta-Analysis of randomized controlled trials. Ann Rheum Dis 2013; Epub ahead of print
31. Eder L, Thavaneswaran A, Chandran V, Gladman DD. Tumor necrosis factor alpha blockers are more effective than methotrexate in the inhibition of radiographic joint damage progression among patients with psoriatic arthritis. Ann Rheum Dis 2013. [Epub ahead of print
32. Mease PJ, Goffe BS, Metz J, et al. Etanercept in the treatment of psoriatic arthritis and psoriasis: A randomized trial. Lancet 2000;356:385-90
33. Antoni C, Dechant C, Hanns-Martin Lorenz PD, et al. Open label study of infliximab treatment for psoriatic arthritis: Clinical and magnetic resonance imaging measurements of reduction of inflammation. Arthritis Rheum 2002;47: 506-12
34. Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:3279-89
35. Kavanaugh A, Van Der Heijde D, McInnes IB, et al. Golimumab in psoriatic arthritis: One-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial. Arthritis Rheum 2012;64:2504-17
36. Leonardi C, Matheson R, Zachariae C, et al. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med 2012;366: 1190-9
37. Papp KA, Leonardi C, Menter A, et al. Brodalumab, an anti-interleukin-17- receptor antibody for psoriasis. N Engl J Med 2012;366:1181-9
38. McInnes I, Sieper J, Braun J. Anti-interleukin 17A monoclonal antibody secukinumab reduces signs and symptoms of psoriatic arthritis in a 24-week multicenter, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2011;63:S306
39. Mease P, Genovese MC, Gladstein G, et al. Abatacept in the treatment of patients with psoriatic arthritis: Results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum 2011;63:939
40. 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 randomized, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008;371:1665-74
41. Barrie AM, Plevy SE. The interleukin-12 family of cytokines: Therapeutic targets for inflammatory disease mediation. Clin Applied Immunol Rev 2005;5:225-40
42. Trinchieri G. Interleukin-12 and the regulation of innate resistance and adaptive immunity. Nat Rev Immunol 2003;3: 133-46
43. Parham C, Chirica M, Timans J, et al. A receptor for the heterodimeric cytokine IL-23 is composed of IL-12Rbeta1 and a novel cytokine receptor subunit, IL-23R. J Immunol 2002;168:5699-708
44. Spadaro A, Rinaldi T, Riccieri V, et al. Interleukin 13 in synovial fluid and serum of patients with psoriatic arthritis. Ann Rheum Dis 2002;61:174-6
45. Luo J, Wu SJ, Lacy ER, et al. Structural basis for the dual recognition of IL-12 and IL-23 by ustekinumab. J Mol Biol 2010;402:797-812
46. Reddy M, Davis C, Wong J, et al. Modulation of CLA, IL-I2R, CD40L, and IL-2R alpha expression and inhibition of IL-12-And IL-23-induced cytokine secretion by CNTO 1275. Cell Immunol 2007;247: 1-11
47. Gottlieb AB, Cooper KD, McCormick TS, et al. A phase 1, double-blind, placebo-controlled study evaluating single subcutaneous administrations of a human interleukin-12/23 monoclonal antibody in subjects with plaque psoriasis. Curr Med Res Opin 2007;23:1081-92
48. Weber J, Keam SJ. Ustekinumab. BioDrugs 2009;23:53-61
49. Croxtall JD. Ustekinumab: A Review of its use in the management of moderate to severe plaque psoriasis. Drugs 2011;71: 1733-53
50. Centocor Ortho Biotech Inc. Stelara (ustekinumab) injection: US prescribing information. 2013. Available from: Www. stelarainfo.com/pdf/ PrescribingInformation. pdf [Last accessed 15 September 2013
51. Zhu Y, Hu C, Lu M, et al. Population pharmacokinetic modeling of ustekinumab: A human monoclonal antibody targeting IL-12/23 p40 in patients with moderate to severe plaque psoriasis. J Clin Pharmacol 2009.49:162-75
52. Zhou H, Hu C, Zhu Y, et al. Population-based exposure: Efficacy modeling of ustekinumab in patients with moderate to severe plaque psoriasis. J Clin Pharmacol 2010;50:257-67
53. Kauffman C, Aria N, Toichi E, et al. A phase I study evaluating the safety, pharmacokinetics, and clinical response of a human IL-12 p40 antibody in subjects with plaque psoriasis. J Invest Dermatol 2004;123:1037-44
54. Gottlieb A, Menter A, Mendelsohn A, et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: Randomized, double-blind, placebo-controlled, crossover trial. Lancet 2009;373:633-40
55. McInnes IB, Kavanaugh A, Gottlieb AB, et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicenter, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet 2013;382:780-9
56. Ritchlin C, Gottlieb AB, McInnes IB, et al. Ustekinumab in active psoriatic arthritis including patients previously treated with anti-TNF agents: Results of a phase 3, multicenter, double-blind, placebo-controlled study. Arthritis Rheum 2012;64:S1080
57. De Souza A, Ali-Shaw T, Reddy SM, et al. Inflammatory arthritis following ustekinumab treatment for psoriasis: A report of two cases. Br J Dermatol 2013;168:210-12
58. Stamell EF, Kutner A, Viola K, Cohen SR. Ustekinumab associated with flares of psoriatic arthritis. JAMA Dermatol 2013; 149(12):1410-13
59. Scarpa R, Ayala F, Caporaso N, Olivieri I. Psoriasis, psoriatic arthritis, or psoriatic disease. J Rheumatol 2006;33:210-12
60. Costa L, Caso F, D'Elia L, et al. Psoriatic arthritis is associated with increased arterial stiffness in the absence of known cardiovascular risk factors: A case control study. Clin Rheumatol 2012;31:711-15
61. Prodanovich S, Prodanowich S, Ma F, et al. Methotrexate reduces incidence of vascular diseases in veterans with psoriasis or rheumatoid arthritis. J Am Acad Dermatol 2005;52:262
62. Wu JJ, Poon KY, Channual JC, Shen AY. Association between tumor necrosis factor inhibitor therapy and myocardial infarction risk in patients with psoriasis. Arch Dermatol 2012;148:1244-50
63. Costa L, Caso F, Atteno M, et al. Impact of 24-month treatment with etanercept, adalimumab, or methotrexate on metabolic syndrome components in a cohort of 210 psoriatic arthritis patients. Clin Rheumatol 2013; Epub ahead of print
64. Pfizer. A phase 3, randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of tofacitinib (cp-690,550) or adalimumab in subjects with active psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01877668. Available from: Www. clinicaltrials.gov/ct2/show/NCT01877668? term=psoriatic+arthritis&recr=Open&type=Intr&rank=2 [Last accessed 21 July 2013
65. Pfizer. A phase 3, randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of tofacitinib (cp-690,550) in subjects with active psoriatic arthritis and an inadequate response to at least one TNF Inhibitor. ClinicalTrials.gov Identifier: NCT01882439. Available from: Www. clinicaltrials.gov/ct2/show/record/ NCT01882439?term= psoriatic+arthritis&recr=Open&type=Intr&rank=3 [Last accessed 21 July 2013
66. Pfizer. A phase 3, multi site, randomized, double blind study of the long-Term safety, tolerability and efficacy of 2 oral doses of cp-690,550 in subjects with moderate to severe plaque psoriasis and/or psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01519089. Available from: Www. clinicaltrials.gov/ct2/show/NCT01519089? term=psoriatic+arthritis&recr= Open&type=Intr&rank=10 [Last accessed 21 July 2013
67. Novartis Pharmaceuticals. A three-year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01892436. Available from: Www.clinicaltrials.gov/ct2/show/ NCT01892436?term= psoriatic+arthritis&recr=Open&type=Intr&rank=4 [Last accessed 21 July 2013
68. Novartis Pharmaceuticals. A phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01752634. Available from: Www. clinicaltrials.gov/ct2/show/NCT01752634? term= psoriatic+arthritis&recr=Open&type=Intr&rank=8 [Last accessed 21 July 2013
69. Novartis. A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01392326. Available from: Www. clinicaltrials.gov/ct2/show/NCT01392326? term=psoriatic+arthritis&recr=Active%2C+not+recruiting&type= Intr&rank=6 [Last accessed 21 July 2013
70. Eli Lilly and Co. A multicenter, randomized, double-blind, active and placebo-controlled 24-week study followed by long term evaluation of efficacy and safety of ixekizumab (ly2439821) in biologic disease-modifying anti-rheumatic drug-naive patients with active psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01695239. Available from: Www. clinicaltrials.gov/ct2/show/NCT01695239? term=psoriatic+arthritis&recr= Open&type=Intr&rank=5 [Last accessed 21 July 2013
71. Bristol-Myers Squibb. A phase 3 randomized placebo-controlled study to evaluate the efficacy and safety of abatacept subcutaneous injection in adults with active psoriatic arthritis. ClinicalTrials. gov Identifier: NCT01860976. Available from: Www.clinicaltrials.gov/ct2/show/ NCT01860976?term= psoriatic+arthritis&recr=Open&type=Intr &rank=7 [Last accessed 21 July 2013
72. Bristol-Myers Squibb. A phase IIb, multi-dose, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of abatacept versus placebo in the treatment of psoriatic arthritis. ClinicalTrials.gov Identifier: NCT00534313. Available from: Www. clinicaltrials.gov/ct2/show/record/ NCT00534313?term= Abatacept%3B+psoriatic+arthritis&type=Intr&rank=2 [Last accessed 21 July 2013
73. Bristol-Myers Squibb. A phase 2b, randomized, double-blind, placebo-controlled, dose ranging, multi-center study to evaluate the efficacy and safety of bms-945429 subcutaneous injection in adults with active psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01490450. Available from: Www. clinicaltrials.gov/ct2/show/NCT01490450? term=psoriatic+arthritis&recr= Open&type=Intr&rank=12 [Last accessed 21 July 2013
74. Amgen. A randomized, double-blinded, placebo-controlled, multiple-dose study with an open label extension to evaluate the safety and efficacy of amg 827 in subjects with psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01516957. Available from: Www.clinicaltrials.gov/ct2/show/ NCT01516957?term=psoriatic+arthritis&recr=Active%2C+not+recruiting&type= Intr&rank=1 [Last accessed 21 July 2013
75. Celgene. A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of two doses of apremilast (cc-10004) in subjects with active psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01172938. Available from: Www. clinicaltrials.gov/ct2/show/NCT01172938? term=psoriatic+arthritis&recr= Active%2C+not+recruiting&type=Intr&rank=2 [Last accessed 21 July 2013
76. Celgene. A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of two doses of apremilast (cc-10004) in subjects with active psoriatic arthritis. ClinicalTrials.gov Identifier: NCT01212757. Available from: Www. clinicaltrials.gov/ct2/show/NCT01212757? term=psoriatic+arthritis&recr= Active%2C+not+recruiting&type=Intr&cond=% 22Arthritis%2C+Psoriatic%22&rank=4 [Last accessed 21 July 2013
77. Celgene. A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of two doses of apremilast (cc-10004) in subjects with active psoriatic arthritis and a qualifying psoriasis lesion. ClinicalTrials.gov Identifier: NCT01212770. Available from: Www. clinicaltrials.gov/ct2/show/NCT01212770? term=psoriatic+arthritis&recr=Active%2C+not+recruiting&type= Intr&cond=% 22Arthritis%2C+Psoriatic%22&rank=5 [Last accessed 21 July 2013
78. Celgene. A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of two doses of apremilast (cc-10004) in subjects with active psoriatic arthritis who have not been previously treated with disease modifying anti-rheumatic drugs. ClinicalTrials.gov Identifier: NCT01307423. Available from: Www.clinicaltrials. gov/ct2/show/ NCT01307423? term=NCT01307423&rank=1 [Last accessed 21 July 2013