Unmet needs in the treatment of psoriasis

European Journal of Dermatology

Volumn 24, Issue 5, 2014, Pages 523-532

  Kragballe, Knud ^a   Van De Kerkhof, Peter C M ^b   Gordon, Kenneth B ^c  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^c NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Biologics; Interleukin 17 blockers; Interleukin 23 blockers; Psoriasis; Psoriasis Area and Severity Index; Secukinumab

Indexed keywords

ADALIMUMAB; APREMILAST; BRODALUMAB; CD4 ANTIGEN; CYCLOSPORIN; ETANERCEPT; GUSELKUMAB; HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN; INFLIXIMAB; INTERLEUKIN 17; INTERLEUKIN 2 RECEPTOR ALPHA; INTERLEUKIN 23; IXEKIZUMAB; JANUS KINASE; LOW DENSITY LIPOPROTEIN; METHOTREXATE; ORILOTIMOD; PHOSPHODIESTERASE IV; SECUKINUMAB; TILDRAKIZUMAB; TOFACITINIB; TUMOR NECROSIS FACTOR RECEPTOR; USTEKINUMAB; IMMUNOLOGIC FACTOR; JANUS KINASE 3; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT; PROTEIN KINASE INHIBITOR; TUMOR NECROSIS FACTOR ALPHA;

BACTERIAL ARTHRITIS; BIOLOGICAL THERAPY; CHOLESTEROL BLOOD LEVEL; CLINICAL DEVELOPMENT PLAN; CONTROLLED CLINICAL TRIAL (TOPIC); CUTANEOUS T CELL LYMPHOMA; DISEASE ASSOCIATION; DISEASE SEVERITY; DRUG FATALITY; HEADACHE; HEART FAILURE; HODGKIN DISEASE; HUMAN; IMMUNITY; INFECTION RISK; INFESTATION; INFLAMMATORY BOWEL DISEASE; INJECTION SITE ERYTHEMA; INJECTION SITE REACTION; MAINTENANCE THERAPY; MENTAL DISEASE; META ANALYSIS (TOPIC); NON MELANOMA SKIN CANCER; PAIN; PATIENT SAFETY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PSORIASIS; PSORIASIS AREA AND SEVERITY INDEX; PSORIATIC ARTHRITIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; REVIEW; RHINOPHARYNGITIS; SQUAMOUS CELL CARCINOMA; SURVIVAL; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; ANTAGONISTS AND INHIBITORS; DRUG RESISTANCE; MAINTENANCE CHEMOTHERAPY; SEVERITY OF ILLNESS INDEX;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIBODIES, MONOCLONAL; DRUG RESISTANCE; HUMANS; IMMUNOLOGIC FACTORS; INTERLEUKIN-17; JANUS KINASE 3; MAINTENANCE CHEMOTHERAPY; PROTEIN KINASE INHIBITORS; PSORIASIS; REMISSION INDUCTION; SEVERITY OF ILLNESS INDEX; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84919394318     PISSN: 11671122     EISSN: 19524013     Source Type: Journal    
DOI: 10.1684/ejd.2014.2403     Document Type: Review

References (80)

1. Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009; 361: 496-509
2. National Psoriasis Foundation. About psoriasis: statistics. Available at: http://www.psoriasis.org/learn_statistics. (accessed 7 Jan 2014).
3. Pathirana D, Ormerod AD, Saiag P, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol 2009; 23(suppl 2): 1-70
4. Mrowietz U, Kragballe K, Reich K, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res 2011; 303: 1-10
5. Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol 2008; 58: 106-15
6. Saurat JH, Stingl G, Dubertret L, et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol 2008; 158: 558-66
7. Reich K, Nestle FO, Papp K, et al. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicenter, double-blind trial. Lancet 2005; 366: 1367-74
8. Menter A, Feldman SR, Weinstein GD, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2007; 56: e1-15
9. 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
10. 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 randomized, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 2008; 371: 1675-84
11. Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003; 349: 2014-22
12. Papp KA, Tyring S, Lahfa M, et al. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol 2005; 152: 1304-12
13. Griffiths CE, Strober BE, van de Kerkhoh P, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med 2010; 362: 118-28
14. Barker J, Hoffmann M, Wozel G, et al. Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active controlled, randomized trial (RESTORE1). Br J Dermatol 2011; 165: 1109-17
15. Reich K, Burden AD, Eaton JN, Hawkins NS. Efficacy of biologics in the treatment of moderate to severe psoriasis: a network meta-analysis of randomized controlled trials. Br J Dermatol 2012; 166: 179-88
16. Bansback N, Sizto S, Sun H, Feldman S, Willian MK, Anis A. Efficacy of systemic treatments for moderate to severe plaque psoriasis: systemic review and meta-analysis. Dermatology 2009; 219: 209-18
17. Menter A, Korman NJ, Elmets C, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol 2011; 65: 137-74
18. Nast A, Sporbeck B, Rosumeck S, et al. Which antipsoriatic drug has the fastest onset of action?: Systematic review on the rapidity of the onset of action. J Invest Dermatol 2013; 133: 1963-70
19. Moore A, Gordon K, Kang S, Gottleib A, et al. A randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis. J Am Acad Dermatol 2007; 56: 598-603
20. Ortonne J-P, Taieb A, Ormerod A, et al. Patients with moderateto- severe psoriasis recapture clinical response during re-treatment with etanercept. Br J Dermatol 2009; 161: 1190-5
21. Papp K, Crowley J, Ortonne J-P, Leu J, et al. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol 2011; 164: 434-41
22. Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Longterm efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an openlabel extension study for patients from REVEAL. J Am Acad Dermatol 2012; 66: 241-51
23. Gniadecki R, Kragballe K, Dam TN, Skov L. Comparison of drug survival rates for adalimumab, etanercept and infliximab in patients with psoriasis vulgaris. Br J Dermatol 2011; 164: 1091-6
24. Mazzotta A, Esposito M, Costanzo A, Chimenti S. Efficacy and safety of etanercept in psoriasis after switching from other treatments: an observational study. Am J Clin Dermatol 2009; 10: 319- 24
25. Wolff RT, Smith CH, Robertson K, Barker JN. Switching to adalimumab in patients with moderate to severe psoriasis who have failed on etanercept: a retrospective case cohort study. Br J Dermatol 2010; 163: 889-92
26. Bissonnette R, Bolduc C, Poulin Y, Guenther L, Lynde CW, Maari C. Efficacy and safety of adalimumab in patients with plaque psoriasis who have shown an unsatisfactory response to etanercept. J Am Acad Dermatol 2010; 63: 228-34
27. Strober BE, Poulin Y, Kerdel FA, et al. Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: efficacy and safety results from an open-label study. J Am Acad Dermatol 2011; 64: 671-81
28. Gordon K, Korman N, Frankel E, et al. Efficacy of etanercept in an integrated database of patients with psoriasis. J Am Acad Dermatol 2006; 54(3 suppl 2): S101-11
29. Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol 2010; 63: 448-56
30. Kimball AB, Bensimon AG, Guerin A, et al. Efficacy and safety of adalimumab among patients with moderate to severe psoriasis with co-morbidities: subanalysis of results from a randomized, double-blind, placebo-controlled, phase III trial. Am J Clin Dermatol 2011; 12: 51- 62
31. Hoffmann JH, Hartmann M, Enk AH, Hadaschik EN. Autoantibodies in psoriasis as predictors for loss of response and anti-infliximab antibody induction. Br J Dermatol 2011; 165: 1355-8
32. Golberg O, Osborne JE, Hutchinson PE. Antinuclear antibodies associated with loss of response to antitumour necrosis factor- a therapy in psoriasis but do not necessarily predict treatment failure. Br J Dermatol 2011; 164: 459-60
33. Quaglino P, Ortoncelli M, Comessatti A, et al. Circulating CD4+CD25 bright FOXP3+ T cells are up-regulated by biological therapies and correlate with the clinical response in psoriasis patients. Dermatology 2009; 219: 250-8
34. Richetta AG, Mattozzi C, Salvi M, et al. CD4+ CD25+ Tregulatory cells in psoriasis. Correlation between their numbers and biologics-induced clinical improvement. Eur J Dermatol 2011; 21: 344- 8
35. Stelara® (ustekinumab) prescribing information. Janssen Biotech, Horsham, Pennsylvania, USA. 2013
36. Remicade (infliximab) prescribing information. Janssen Biotech, Horsham, Pennsylvania, USA. 2013
37. Humira (adalimumab) prescribing information. AbbVie Inc., North Chicago, Illinois, USA. 2013
38. Enbrel® (etanercept) prescribing information. Amgen Inc., Thousand Oaks, California, USA. 2013
39. Galloway JB, Hyrich KL, Mercer LK, et al. Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatology 2011; 50: 124-31
40. Beyaert R, Beaugerie L, Van Assche G, et al. Cancer risk in immune-mediated inflammatory diseases (IMID). Mol Cancer 2013; 12: 98
41. Askling J, Fahrbach K, Nordstrom B, Ross S, Schmid CH, Symmons D. Cancer risk with tumor necrosis factor a (TNF) inhibitors: meta-analysis of randomized controlled trials of adalimumab, etanercept, and infliximab using patient level data. Pharmacoepidemiol Drug Saf 2011; 20: 119-30
42. Wakkee M, de Vries E, van den Haak P, Nijsten T. Increased risk of infectious disease requiring hospitalization among patients with psoriasis: a population-based cohort. J Am Acad Dermatol 2011; 65: 1135-44
43. Menter A, Reich K, Gottlieb AB, et al. Adverse drug events in infliximab-treated patients compared with the general and psoriasis populations. J Drugs Dermatol 2008; 7: 1137-46
44. Burmester GR, Mease P, Dijkmans BA, et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis 2009; 68: 1863-9
45. Pariser DM, Leonardi CL, Gordon K, et al. Integrated safety analysis: short- and long-term safety profiles of etanercept in patients with psoriasis. J Am Acad Dermatol 2012; 67: 245-56
46. Gordon KB, Papp KA, Langley RG, et al. Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (part II of II): results from analyses of infections and malignancy in pooled phase II and III clinical trials. J Am Acad Dermatol 2012; 66: 742-51
47. Greenberg JD, Reed G, Kremer JM, et al. Association of methotrexate and tumour necrosis factor antagonists with risk of serious infectious outcomes including opportunistic infections in the CORRONA registry. Ann Rheum Dis 2010; 69: 380-6
48. Gelfand JM, Shin DB, Neimann AL, Wang X, Margolis DJ, Troxel AB. The risk of lymphoma in patients with psoriasis. J Invest Dermatol 2006; 126: 2194-201
49. Stern RS, Lunder EJ. Risk of squamous cell carcinoma and methoxsalen (psoralen) and UV-A radiation (PUVA). A meta-analysis. Arch Dermatol 1998; 134: 1582-5
50. Paul CF, Ho VC, McGeown C, et al. Risk of malignancies in psoriasis patients treated with cyclosporine: a 5 y cohort study. J Invest Dermatol 2003; 120: 211-6
51. Burmester GR, Panaccione R, Gordon KB, McIlraith MJ, Lacerda AP. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, and Crohn’s disease. Ann Rheum Dis 2013; 72: 517-24
52. Prey S, Paul C, Bronsard V, et al. Assessment of the risk of psoriatic arthritis in patients with plaque psoriasis: a systematic review of the literature. J Eur Acad Dermatol Venereol 2010; 24(suppl 2): 31-5
53. Weng X, Liu L, Barcellos LF, Allison JE, Herrinton LJ. Clustering of inflammatory bowel disease with immune mediated diseases among members of a Northern California-managed care organization. Am J Gastroenterol 2007; 102: 1429-35
54. Gerdes S, Mrowietz U. Impact of comorbidities on the management of psoriasis. Curr Probl Dermatol 2009; 38: 21-36
55. Krathen M, Gottlieb A, Mease P. Pharmacologic immunomodulation and cutaneous malignancy in rheumatoid arthritis, psoriasis, and psoriatic arthritis. J Rheumatol 2010; 37: 2205-15
56. Elewski B, Lebwohl M, Papp K, et al. Secukinumab in patients with moderate-to-severe plaque psoriasis: Results from the Efficacy of Response And Safety of 2 fixed secUkinumab REgimens in psoriasis (ERASURE). Abstract presented at: 22nd Congress of the European Academy of Dermatology and Venereology; Istanbul, Turkey; 2-6 October 2013
57. Mrowietz U, Leonardi C, Girolomoni G, et al. Secukinumab ‘fixedinterval’ versus ‘retreatment as needed’ regimen for moderate-to-severe plaque psoriasis: Results from the Study Comparing secukinumab Use in Long-term Psoriasis maintenance therapy: fixed regimens versus reTreatment Upon start of Relapse (SCULPTURE). Abstract presented at: 22nd Congress of the European Academy of Dermatology and Venereology; Istanbul, Turkey; 2-6 October 2013
58. Thaçi D, Humeniuk J, Frambach Y, et al. Secukinumab in moderate-to-severe plaque psoriasis: Results from Secukinumab Trial Analyzing the potential of intravenous administration To Upgrade the REsponse in psoriasis (STATURE). Abstract presented at: 22nd Congress of the European Academy of Dermatology and Venereology; Istanbul, Turkey; 2-6 October 2013
59. Langley R, Reich K, Griffiths C, et al. Secukinumab compared with placebo and etanercept: The first 52-week head-to-head comparison of two biologics in a randomized, double-blind phase 3 study in patients with moderate-to-severe psoriasis (FIXTURE). Abstract presented at: 22nd Congress of the European Academy of Dermatology and Venereology; Istanbul, Turkey; 2-6 October 2013
60. Reich K, Langley R, Papp K, et al. Treatment with an anti-IL23 p19 humanized monoclonal antibody (MK-3222) provides significant improvement in psoriasis that is maintained for up to 52 weeks. Abstract presented at: 22nd Congress of the European Academy of Dermatology and Venereology; Istanbul, Turkey; 2-6 October 2013
61. Langley R, Thaci D, Papp K, Riedl E, Reich K, Shames R. MK- 3222, an anti-IL-23 p19 humanized monoclonal antibody, provides significant improvement in psoriasis over 52 weeks of treatment that is maintained after discontinuation of dosing. Abstract presented at: 72nd Annual Meeting American Academy of Dermatology; Denver, CO, USA; 21-25 March 2014
62. Pfizer reports positive results from two tofacitinib Phase 3 trials for chronic plaque psoriasis. NewsMedical; 2013. Available at: http://www.news-medical.net/news/20131010/Pfizer-reportspositive- results-from-two-tofacitinib-Phase-3-trials-for-chronic-plaquepsoriasis. aspx(accessed 7 Jan 2014).
63. Reich K, Papp K, Leonardi C, et al. Effects of apremilast on health-related quality of life in patients with moderate to severe plaque psoriasis: results from the ESTEEM 1 study. Abstract presented at: 22nd Congress of the European Academy of Dermatology and Venereology; Istanbul, Turkey; 2-6 October 2013
64. Papp K, Leonardi C, Reich K, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe psoriasis. Abstract presented at: 72nd Annual Meeting American Academy of Dermatology; Denver, CO, USA; 21-25 March 2013
65. Nograles KE, Zaba LC, Guttman-Yassky E, et al. Th17 cytokines interleukin (IL)-17 and IL-22 modulate distinct inflammatory and keratinocyte-response pathways. Br J Dermatol 2008; 159: 1092-102
66. Miossec P, Korn T, Kuchroo VK. Interleukin-17 and type 17 helper T cells. N Engl J Med 2009; 361: 888-98
67. Hueber W, Patel DD, Dryja T, et al. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med 2010; 2: 52-72
68. Papp K, Kaufmann R, Thaçi D, Hu C, Sutherland D, Rohane P. Efficacy and safety of apremilast in subjects with moderate to severe plaque psoriasis: results from a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dosecomparison study. J Eur Acad Dermatol Venereol 2013; 27: e376-83
69. Papp K, Menter A, Strober B, et al. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a phase 2b randomized placebo-controlled dose-ranging study. Br J Dermatol 2012; 167: 668-77
70. Lin AM, Rubin CJ, Khandpur R, et al. Mast cells and neutrophils release IL-17 through extracellular trap formation in psoriasis. J Immunol 2011; 187: 490-500
71. Liang SC, Tan XY, Luxenberg DP, et al. Interleukin (IL)-22 and IL-17 are coexpressed by Th17 cells and cooperatively enhance expression of antimicrobial peptides. J Exp Med 2006; 203: 2271-9
72. Homey B, Dieu-Nosjean MC, Wiesenborn A, et al. Up-regulation of macrophage inflammatory protein-3a/CCL-20 and CC chemokine receptor 6 in psoriasis. J Immunol 2000; 164: 6621-32
73. Fossiez F, Djossou O, Chomarat P, et al. T cell interleukin-17 induces stromal cells to produce proinflammatory and hematopoietic cytokines. J Exp Med 1996; 183: 2593-603
74. Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate to severe plaque psoriasis: a randomised, double-blind, placebo-controlled phase II dose-ranging study. Br J Dermatol 2013; 168: 412-21
75. Rich P, Sigurgeirsson B, Thaçi DP, et al. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomised, double-blind, placebo-controlled, phase II regimenfinding study. Br J Dermatol 2013; 168: 402-11
76. 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
77. Papp K, Leonardi C, Menter A, et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med 2012; 366: 1181-9
78. Iwakura Y, Ishigame H, Saijo S, Nakae S. Functional specialization of interleukin-17 family members. Immunity 2011; 34: 149-62
79. Thaçi D, Papp K, Langley R, et al. MK-3222 (anti-IL-23p19 monoclonal antibody) improves psoriasis in a phase 2b randomized placebo-controlled trial. Abstract presented at: 22nd Congress of the European Academy of Dermatology and Venereology; Istanbul, Turkey; 2-6 October 2013. Abstract P1537
80. U.S. Food and Drug Administration. FDA Approves Otezla to Treat Psoriatic Arthritis. Press release available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm390091.htm. (accessed on 14 April 2014).