Ustekinumab: A review of its use in the management of moderate to severe plaque psoriasis

Drugs

Volumn 71, Issue 13, 2011, Pages 1733-1753

  Croxtall, Jamie D ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Plaque psoriasis; Ustekinumab

Indexed keywords

CD45RA ANTIGEN; CD45RO ANTIGEN; CHEMOKINE RECEPTOR CXCR; ETANERCEPT; GAMMA INTERFERON; INTERLEUKIN 10; INTERLEUKIN 12; INTERLEUKIN 12 RECEPTOR BETA1; INTERLEUKIN 12 RECEPTOR BETA2; INTERLEUKIN 17; INTERLEUKIN 17 ANTIBODY; INTERLEUKIN 23; INTERLEUKIN 23 RECEPTOR; INTERLEUKIN 8; MESSENGER RNA; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; USTEKINUMAB;

BACKACHE; CD25+ T LYMPHOCYTE; DEPRESSION; DIZZINESS; DRUG EFFICACY; DRUG TOLERABILITY; EPISODIC CLUSTER HEADACHE; ERYTHEMA; FATIGUE; HEADACHE; HUMAN; IMMUNOGENICITY; MYALGIA; PRURITUS; PSORIASIS VULGARIS; PSORIATIC ARTHRITIS; QUALITY OF LIFE; REVIEW; RHINOPHARYNGITIS; SIGNAL TRANSDUCTION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION;

ANTIBODIES, MONOCLONAL; DERMATOLOGIC AGENTS; HUMANS; PSORIASIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 80052623228     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11207530-000000000-00000     Document Type: Review

References (79)

1. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008 May; 58 (5): 826-50 (Pubitemid 351509656)
2. Jagou M, Bastuji-Garin S, Bourdon-Lanoy E, et al. Poor agreement between self-reported and dermatologists' diagnoses for five common dermatoses. Br J Dermatol 2006 Nov; 155 (5): 1006-12 (Pubitemid 44564512)
3. Schon MP, Boehncke WH. Psoriasis. N Engl J Med 2005 May 5; 352 (18): 1899-912 (Pubitemid 40627816)
4. Kurd SK, Gelfand JM. The prevalence of previously diagnosed and undiagnosed psoriasis in US adults: results from NHANES 2003-2004. J Am Acad Dermatol 2009 Feb; 60 (2): 218-24
5. Canadian Psoriasis Guidelines Committee. Canadian guidelines for the management of plaque psoriasis [online]. Available from URL: http://www.dermatology.ca/guidelines/cdnpsoriasisguidelines.pdf [Accessed 2011 Apr 18]
6. Langley RG, Dauden E. Treatment and management of psoriasis with nail involvement: a focus on biologic therapy. Dermatology 2010; 221 Suppl. 1: 29-42
7. Gelfand JM, Gladman DD, Mease PJ, et al. Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol 2005 Oct; 53 (4): 573
8. Nijsten T, Wakkee M. Complexity of the association between psoriasis and comorbidities. J Invest Dermatol 2009 Jul; 129 (7): 1601-3
9. Chen YJ, Wu CY, Shen JL, et al. Psoriasis independently associated with hyperleptinemia contributing to metabolic syndrome. Arch Dermatol 2008 Dec; 144 (12): 1571-5
10. Krueger G, Koo J, LebwohlM, et al. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol 2001 Mar; 137 (3): 280-4 (Pubitemid 32240779)
11. Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol 1998 Nov; 139 (5): 846-50 (Pubitemid 28520293)
12. Russo PA, Ilchef R, Cooper AJ. Psychiatric morbidity in psoriasis: a review. Australas J Dermatol 2004 Aug; 45 (3): 155-9; quiz 160-1
13. Magin PJ, Pond CD, Smith WT, et al. A cross-sectional study of psychological morbidity in patients with acne, psoriasis and atopic dermatitis in specialist dermatology and general practices. J Eur Acad Dermatol Venereol 2008 Dec; 22 (12): 1435-44
14. Kurzeja M, Rudnicka L, OlszewskaM. New interleukin 23-pathway inhibitors in dermatology: ustekinumab, briakinumab and secukinumab. Am J Clin Derm 2011 Jan; 12 (2): 113-25
15. Alwawi EA, Krulig E, Gordon KB. Long-term efficacy of biologics in the treatment of psoriasis: what do we really know? Dermatol Ther 2009; 22 (5): 431-40
16. Garcia-Valladares I, Cuchacovich R, Espinoza LR. Comparative assessment of biologics in treatment of psoriasis: drug design and clinical effectiveness of ustekinumab. Drug Des Devel Ther 2011; 5: 41-9
17. Nickoloff BJ. Cracking the cytokine code in psoriasis. Nat Med 2007 Mar; 13 (3): 242-4 (Pubitemid 46376653)
18. Kimball AB, Gordon KB, Langley RG, et al. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol 2008 Feb; 144 (2): 200-7 (Pubitemid 351287002)
19. Torti DC, Feldman SR. Interleukin-12, interleukin-23, and psoriasis: current prospects. J Am Acad Dermatol 2007 Dec; 57 (6): 1059-68
20. Cargill M, Schrodi SJ, Chang M, 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 2007 Feb; 80 (2): 273-90 (Pubitemid 46175676)
21. Trinchieri G. Interleukin-12 and the regulation of innate resistance and adaptive immunity. Nat Rev Immunol 2003 Feb; 3 (2): 133-46 (Pubitemid 37328691)
22. Aggarwal S, Ghilardi N, Xie MH, et al. Interleukin-23 promotes a distinct CD4 T cell activation state characterized by the production of interleukin-17. J Biol Chem 2003 Jan 17; 278 (3): 1910-4 (Pubitemid 36801431)
23. Oppmann B, Lesley R, Blom B, et al. Novel p19 protein engages IL-12p40 to form a cytokine, IL-23, with biological activities similar as well as distinct from IL-12. Immunity 2000 Nov; 13 (5): 715-25
24. Yeilding N, Szapary P, Brodmerkel C, et al. Development of the IL-12/23 antagonist ustekinumab in psoriasis: past, present, and future perspectives. Ann N Y Acad Sci 2011 Mar; 1222 (1): 30-9
25. Sa SM, Valdez PA, Wu J, et al. The effects of IL-20 subfamily cytokines on reconstituted human epidermis suggest potential roles in cutaneous innate defense and pathogenic adaptive immunity in psoriasis. J Immunol 2007 Feb 15; 178 (4): 2229-40 (Pubitemid 46233421)
26. Toichi E, Torres G, McCormick TS, et al. An anti-IL-12p40 antibody down-regulates type 1 cytokines, chemokines, and IL-12/IL-23 in psoriasis. J Immunol 2006 Oct 1; 177 (7): 4917-26 (Pubitemid 44469828)
27. Lyakh L, Trinchieri G, Provezza L, et al. Regulation of interleukin-12/interleukin-23 production and the T-helper 17 response in humans. Immunol Rev 2008 Dec; 226: 112-31
28. Presky DH, Yang H, Minetti LJ, et al. A functional interleukin 12 receptor complex is composed of two beta-type cytokine receptor subunits. Proc Natl Acad Sci USA 1996 Nov 26; 93 (24): 14002-7
29. 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 Jun 1; 168 (11): 5699-708 (Pubitemid 34556153)
30. Centocor Ortho Biotech Inc. Stelara (ustekinumab) injection: US prescribing information [online]. Available from URL: http://www.stelarainfo. com/pdf/PrescribingInform ation.pdf [Accessed 2011 Jul 24]
31. European Medicines Agency. Stelara (ustekinumab) 45mg solution for injection: summary of product characteristics [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/documentlibrary/EPAR-ProductInforma tion/human/000958/WC500058513.pdf [Accessed 2011 Jul 23]
32. Luo J, Wu SJ, Lacy ER, et al. Structural basis for the dual recognition of IL-12 and IL-23 by ustekinumab. JMol Biol 2010 Oct 8; 402 (5): 797-812
33. Reddy M, Davis C, Wong J, et al. Modulation of CLA, IL-12R, CD40L, and IL-2Ralpha expression and inhibition of IL-12-and IL-23-induced cytokine secretion by CNTO,1275. Cell Immunol 2007 May; 247 (1): 1-11 (Pubitemid 47464175)
34. 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 May; 23 (5): 1081-92 (Pubitemid 46799592)
35. European Medicines Agency. Stelara (ustekinumab): public assessment report [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/ documentlibrary/EPAR-Public-assessmentreport/human/000958/WC500058511.pdf [Accessed 2011 Aug 1]
36. Yates CC, Whaley D, Kulasekeran P, et al. Delayed and deficient dermal maturation in mice lacking the CXCR3 ELR-negative CXC chemokine receptor. Am J Pathol 2007 Aug; 171 (2): 484-95 (Pubitemid 47344681)
37. Reddy M, Torres G, McCormick T, et al. Positive treatment effects of ustekinumab in psoriasis: analysis of lesional and systemic parameters. J Dermatol 2010 May; 37 (5): 413-25
38. Brodmerkel C, Zhu Y, Jiao Q, et al. Effects of ustekinumab administration on primate/human antigen-recall and humoral immune response functions. J Drugs Dermatol 2010 Jun; 9 (6): 677-83
39. Weber J, Keam SJ. Ustekinumab. Biodrugs 2009; 23 (1): 53-61
40. Zhu Y, Hu C, Lu M, et al. Population pharmacokinetic modeling of ustekinumab, a human monoclonal antibody targeting IL-12/23p40, in patients with moderate to severe plaque psoriasis. J Clin Pharmacol 2009 Feb; 49 (2): 162-75
41. Zhou H, Hu C, Zhu Y, et al. Population-based exposureefficacy modeling of ustekinumab in patients with moderate to severe plaque psoriasis. J Clin Pharmacol 2010 Mar; 50 (3): 257-67
42. 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 2008 May 17; 371 (9625): 1665-74 (Pubitemid 351671883)
43. 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 2008 May 17; 371 (9625): 1675-84 (Pubitemid 351671884)
44. Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for moderate-tosevere psoriasis. N Engl J Med 2010 Jan 14; 362 (2): 118-28
45. Ghislain P, Poulin Y, Wasel N, et al. Maintenance of longterm efficacy of ustekinumab through year 3 for patients with moderate-to-severe psoriasis [abstract no. P589]. 19th Congress of the European Academy of Dermatology and Venerology; 2010 Oct 6-10; Gothenburg
46. Rich P, Guzzo C, Wang Y, et al. Improvement in nail psoriasis with ustekinumab, a new anti-IL-12/23p40 monoclonal antibody: results from a phase 3 trial. American Academy of Dermatology Summer Academy Meeting; 2008 Jul 30-Aug 3; Chicago (IL)
47. Lebwohl M, Papp K, Han C, et al. Ustekinumab improves health-related quality of life in patients with moderate-tosevere psoriasis: results from the PHOENIX 1 trial. Br J Dermatol 2010 Jan; 162 (1): 137-46
48. Langley RG, Feldman SR, Han C, et al. Ustekinumab significantly improves symptoms of anxiety, depression, and skin-related quality of life in patients with moderate-tosevere psoriasis: results from a randomized, double-blind, placebo-controlled phase III trial. J Am Acad Dermatol 2010 Sep; 63 (3): 457-65
49. Guenther L, Han C, Szapary P, et al. Impact of ustekinumab on health-related quality of life and sexual difficulties associated with psoriasis: results from two phase III clinical trials. J Eur Acad Dermatol Venereol 2011 Apr 27; 25 (7): 851-7
50. Reich K, Schenkel B, Zhao N, et al. Ustekinumab decreases work limitations, improves work productivity, and reduces work days missed in patients with moderate-to-severe psoriasis: results from PHOENIX 2. J Dermatolog Treat. Epub 2010 Oct 31
51. Lebwohl M, Yeilding N, Szapary P, et al. Impact of weight on the efficacy and safety of ustekinumab in patients with moderate to severe psoriasis: rationale for dosing recommendations. J Am Acad Dermatol 2010 Oct; 63 (4): 571-9
52. Gottlieb A, Menter A, Mendelsohn A, et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebocontrolled, crossover trial. Lancet 2009 Feb; 373 (9664): 633-40
53. Gottlieb A, Mendelsohn A, Shen Y-K, et al. Ustekinumab, a human interleukin-12/23 monoclonal antibody, significantly improves overall skin response and health related quality of life in patients with psoriatic arthritis [abstract no. FP1333]. 17th Congress of the European Academy of Dermatology and Venereology; 2008 Sep 17-21; Paris
54. Gottlieb A, Menter A, Mendelsohn A, et al. Efficacy of ustekinumab, a human interleukin-12/23 monoclonal antibody, in psoriatic arthritis patients with baseline Creactive protein >=0.4 vs
55. Rich P, Feldman S, Vender R, et al. Ustekinumab demonstrates rapid onset of efficacy in the treatment of moderateto-severe psoriasis [abstract no. P 040]. J Eur Acad Dermatol Venerol 2010 Jul; 24 Suppl. 4: 1-83
56. Krueger G, Langley R, Leonardi C, et al. A human interleukin-12/23 monolclonal antibody for the treatment of psoriasis. N Engl J Med 2007; 356 (6): 580-92 (Pubitemid 46220818)
57. Reich K, Langley RG, Lebwohl M, et al. Cardiovascular safety of ustekinumab in patients with moderate-to-severe psoriasis: results of integrated analyses of data from phase II and III clinical studies. Br J Dermatol 2011 Feb 17; 164 (4): 862-72
58. Gordon K, Menter A, Szapary PO, et al. Infection rates in ustekinumab-treated psoriasis patients: observations with up to 3 years of follow-up and comparisons to a large health care claims database [abstract no. P 051]. J Eur Acad Dermatol Venerol 2010 Jul; 24 Suppl. 4: 1-83
59. Reich K, Leonardi C, Griffiths C, et al. Update on the cumulative safety experience of ustekinumab: results from the ustekinumab psoriasis clinical development program with up to 4 years of follow-up [abstract no. FC07-03]. 22nd World Congress of Dermatology; 2011 May 24-29; Seoul
60. Papp K, Ho V, Yeilding N, et al. Malignancies in ustekinumab-treated moderate-to-severe psoriasis patients: observations with up to 3 years of follow-up and comparisons to the general United States population [abstract no. P554]. 19th Congress of the European Academy of Dermatology and Venereology; 2010 Oct 6-10; Gothenburg
61. Gordon K, Baker D, Guenther L, et al. Sustained efficacy of ustekinumab for the treatment of moderate to severe psoriasis in initial responders continuing with maintenance therapy through year 3 [abstract no. P3345]. J Am Acad Dermatol 2011 Feb; 64 (2 Suppl. 1): AB156
62. Bissonnette R, Lambert J, Yeilding N, et al. Effect of ustekinumab on commonlymeasured laboratory parameters: three year results from the PHOENIX 1 trial [abstract no. P 048]. Congress of the Psoriasis International Network; 2010 Jul 1-4; Paris
63. Callen JP, Krueger GG, Lebwohl M, et al. AAD consensus statement on psoriasis therapies. J Am Acad Dermatol 2003 Nov; 49 (5): 897-9 (Pubitemid 37314880)
64. Papp KA. The long-term efficacy and safety of new biological therapies for psoriasis. Arch Dermatol Res 2006 Jun; 298 (1): 7-15 (Pubitemid 43725207)
65. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J AmAcad Dermatol 2011 Jul; 65 (1): 137-74
66. Nijsten T, Margolis DJ, Feldman SR, et al. Traditional systemic treatments have not fully met the needs of psoriasis patients: results from a national survey. J Am Acad Dermatol 2005 Mar; 52 (3 Pt 1): 434-44
67. Naldi L, Griffiths CE. Traditional therapies in the management of moderate to severe chronic plaque psoriasis: an assessment of the benefits and risks. Br J Dermatol 2005 Apr; 152 (4): 597-615 (Pubitemid 40571289)
68. Menter A, Griffiths CE. Current and future management of psoriasis. Lancet 2007 Jul 21; 370 (9583): 272-84 (Pubitemid 47071926)
69. Tsourounis C, Cheng C. Biologic therapies for the treatment of chronic plaque psoriasis. Formulary 2005; 40 (6): 184-99 (Pubitemid 40943838)
70. Croom KF, McCormack PL. Adalimumab: in plaque psoriasis. Am J Clin Dermatol 2009; 10 (1): 43-50
71. Gall JS, Kalb RE. Infliximab for the treatment of plaque psoriasis. Biologics 2008 Mar; 2 (1): 115-24
72. Goldsmith DR, Wagstaff AJ. Etanercept: a review of its use in the management of plaque psoriasis and psoriatic arthritis. Am J Clin Dermatol 2005; 6 (2): 121-36 (Pubitemid 40529756)
73. Frampton J, Wagstaff A. Alefacept. Am J Clin Dermatol 2003; 4 (4): 277-86; discussion 287 (Pubitemid 36506432)
74. Centocor Ortho Biotech Services. Psoriasis Longitudinal Assessment and Registry (PSOLAR) [ClinicalTrials.gov indentifier NCT00508547]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http://clinicaltrials.gov [Accessed 2011 Jul 29]
75. Shear NH. Fulfilling an unmet need in psoriasis: do biologicals hold the key to improved tolerability? Drug Saf 2006; 29 (1): 49-66 (Pubitemid 43213895)
76. Fraser K. 68th Annual Meeting of the American Academy of Dermatology: Miami Beach, Florida, USA, 5-9 March 2010. Am J Clin Dermatol 2010;11(3):223-4
77. National Institute for Health and Clinical Excellence. Ustekinumab for the treatment of adults with moderate to severe psoriasis [online]. Available from URL: http://www. nice.org.uk/nicemedia/live/12235/45461/45461.pdf [Accessed 2011 Jul 29]
78. Smith CH, Anstey AV, Barker JN, et al. British Association of Dermatologists' guidelines for biologic interventions for psoriasis 2009. Br J Dermatol 2009 Nov; 161 (5): 987-1019
79. Martin S, Feldman SR, Augustin M, et al. Cost per responder analysis of ustekinumab and etanercept for moderate to severe plaque psoriasis. J Dermatolog Treat 2011; 22 (3): 138-43