How and when to use biologics in psoriasis

Journal of Drugs in Dermatology

Volumn 9, Issue 8, 2010, Pages

  Kircik, Leon H ^a,b   Gonzalez, Mercedes E ^c  

^a MOUNT SINAI MEDICAL CENTER   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ALANINE AMINOTRANSFERASE; ALEFACEPT; ANTIHISTAMINIC AGENT; ASPARTATE AMINOTRANSFERASE; BRIAKINUMAB; CD45RO ANTIGEN; DRUG ANTIBODY; ETANERCEPT; ETRETIN; HEPATITIS B CORE ANTIBODY; IMMUNOGLOBULIN ENHANCER BINDING PROTEIN; INFLIXIMAB; INTERLEUKIN 12; INTERLEUKIN 17; INTERLEUKIN 23; LIVE VACCINE; METHOTREXATE; NEUTRALIZING ANTIBODY; PARACETAMOL; PLACEBO; PROTEIN P55; PROTEIN P75; REMICAIDE; TUMOR NECROSIS FACTOR ALPHA; TUMOR NECROSIS FACTOR ALPHA RECEPTOR; UNCLASSIFIED DRUG; USTEKINUMAB; BIOLOGICAL PRODUCT; DERMATOLOGICAL AGENT; HYBRID PROTEIN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANAPHYLAXIS; ANKYLOSING SPONDYLITIS; ANTIBODY BLOOD LEVEL; ANTIBODY PRODUCTION; ANTIBODY RESPONSE; ANTIBODY TITER; APOPTOSIS; ARTHRALGIA; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BIOLOGICAL THERAPY; BLOOD CELL COUNT; BREAST CANCER; CARDIOVASCULAR DISEASE; CD4 LYMPHOCYTE COUNT; CELL PROLIFERATION; CHEST TIGHTNESS; CHILDHOOD DISEASE; CLINICAL ASSESSMENT; CONFERENCE PAPER; CONGESTIVE HEART FAILURE; CONSULTATION; CROHN DISEASE; CYTOKINE RELEASE; DIABETES MELLITUS; DISABILITY; DISEASE COURSE; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG SAFETY; DYSPNEA; FAMILY HISTORY; FATIGUE; FLUSHING; FOLLOW UP; HEADACHE; HEPATITIS B; HOSPITALIZATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERTENSION; HYPOTENSION; INFECTION; INFECTION RISK; INFUSION; INJECTION SITE PRURITUS; INJECTION SITE REACTION; JOINT SWELLING; LIVER FAILURE; LIVER FUNCTION TEST; LIVER TOXICITY; LOADING DRUG DOSE; LONG TERM CARE; LUPUS ERYTHEMATOSUS; LYMPHOCYTE COUNT; LYMPHOPROLIFERATIVE DISEASE; MORNING STIFFNESS; MORTALITY; MULTIPLE SCLEROSIS; MYCOBACTERIUM TUBERCULOSIS; NAUSEA; NEUROLOGIC DISEASE; NON MELANOMA SKIN CANCER; OPPORTUNISTIC INFECTION; OUTCOME ASSESSMENT; PATHOPHYSIOLOGY; PATIENT MONITORING; PHOTOTHERAPY; PLAQUE TYPE PSORIASIS; POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PREGNANCY; PSORIASIS; PSORIATIC ARTHRITIS; PUVA; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECEPTOR BINDING; RECURRENCE RISK; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SCREENING; SERODIAGNOSIS; SEROLOGY; SIDE EFFECT; SKIN CANCER; SKIN EXAMINATION; SWEATING; T LYMPHOCYTE ACTIVATION; TH1 CELL; TH17 CELL; TREATMENT DURATION; TREATMENT INDICATION; TREATMENT RESPONSE; TUBERCULIN TEST; TUBERCULOSIS; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; VACCINATION; VIRUS REACTIVATION; X RAY; DRUG ANTAGONISM; DRUG MONITORING; REVIEW;

BIOLOGICAL PRODUCTS; DERMATOLOGIC AGENTS; DRUG MONITORING; HUMANS; PSORIASIS; RECOMBINANT FUSION PROTEINS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 77956217069     PISSN: 15459616     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (85)

1. Krueger GG, Feldman SR, Camisa C, et al. Two considerations for patients with psoriasis and their clinicians: What defines mild, moderate, and severe psoriasis? What constitutes a clinically significant improvement when treating psoriasis? J Am Acad Dermatol. 2000;43:281-285. (Pubitemid 30626007)
2. Lebwohl M. A clinician's paradigm in the treatment of psoriasis. J Am Acad Dermatol. 2005;53(1Suppl 1): S59-S69. (Pubitemid 40828182)
3. Feldman SR, Kimball AB, Kreugar GG, et al. Etanercept improves the health-related quality of life of patients with psoriasis: Results of a phase III randomized clinical trial. J Am Acad Dermatol. 2005;53(5):101-107.
4. Finlay AY. Current severe psoriasis and the rule of tens. Br J Dermatol. 2005;152(5):861-867. (Pubitemid 40704922)
5. Sterry W, Barker J, Boehncke WH, et al. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol. 2004;151(Suppl 69):3-17. (Pubitemid 39215184)
6. Callen JP, Krueger GG, Lebwohl M, et al. AAD consensus statement on psoriasis therapies. J Am Acad Dermatol. 2003;49(5):897-899. (Pubitemid 37314880)
7. Sommer DM, Jenisch S, Suchan M, et al. Increased prevalence of the metabolic syndrome in patients with moderate to severe psoriasis. Arch Dermatol Res. 2006;298:321-328.
8. Gelfand JM, Neimann AL, Shin DBet, al. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296(14):1735-1741. (Pubitemid 44547793)
9. Kimball AB, Guerin A, Latremouille-Viau MA, et al. Coronary heart disease and stroke risk in patients with psoriasis: Retrospective analysis. Am J Med. 2010;123(4):350-357.
10. Weiss SC, Kimball AB, Liewehr DJ, et al. Quantifying the harmful effect of psoriasis on health-related quality of life. J Am Acad Dermatol. 2002;47(4):512-518.
11. Kimball AB, Geurin A, Yu AP, et al. 2nd World Psoriasis and Psoriatic Arthritis Conference 2009, International Federation of Psoriasis Stockholm, Sweden. June 25, 2009.
12. Rapp SR, Feldman SR, Exum ML, et al. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41:201-207.
13. Shiraz G, et al. 6th EADV Spring Symposium, Bucharest, Romania.
14. Seidler EM, Kimball AB et al. Br J Dermatol. In press.
15. Seidler EM, et al. 2nd World Psoriasis & Psoriatic arthritis Conference,Stockholm, Sweden. June 25-27, 2009
16. Kreuger G, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: Results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol. 2001;137:280-284. (Pubitemid 32240779)
17. Horn EJ, Fox KM, Patel V, et al. Association of patient-reported psoriasis severity with income and employment. J Am Acad Dermatol. 2007;57(6):963-971. (Pubitemid 350087343)
18. Prodanovich S, Ma F, Taylor JR, et al. Methotrexate reduces incidence of vascular disease in veterans with psoriasis or rheumatoid arthritis. J Am Acad Dermatol. 2005;52:262-267.
19. 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(12):1863-1869.
20. Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: Double-blind placebo-controlled randomised phase III trial. Lancet. 2006;7:367.
21. Gelfand JM, Troxel AB, Lewis JD, et al. The risk of mortality in patients with psoriasis: Results from a population-based study. Arch Dermatol. 2007;143(12):1493-1499. (Pubitemid 350277763)
22. Revicki DA, Menter A, Feldman S, et al. Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: Results from a randomized, controlled Phase III study. Health Qual Life Outcomes. 2008;2;6:75
23. Revicki DA, Willian MK, Menter A, et al. Impact of adalimumab treatment on patient-reported outcomes: Results from a phase III clinical trial in patients with moderate to severe plaque psoriasis. J Dermatolog Treat. 2007;18(6):341-350. (Pubitemid 350223202)
24. Saurat JH, Stringl 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. Br J Dermatol. 2008;158:558-566. (Pubitemid 351239154)
25. Gordon KB, Vaishnaw AK, O'Gorman J, et al. Treatment of psoriasis with alefacept: Correlation of clinical improvement with reductions of memory T-cell counts. Arch Dermatol. 2003;139(12):1563-1570. (Pubitemid 37523074)
26. Ortonne JP, Lebwohl M, Em Griffiths C, et al. Alefacept-induced decreases in circulating blood lymphocyte counts correlate with clinical response in patients with chronic plaque psoriasis. Eur J Dermatol. 2003;13(2):117-123. (Pubitemid 36428354)
27. Krueger GG. Clinical response to alefacept: Results of a phase 3 study of intravenous administration of alefacept in patients with chronic plaque psoriasis. Eur Acad Dermatol Venereol. 2003;17 Suppl 2:17-24. (Pubitemid 36869296)
28. Lebwohl M, Christophers E, Langley R, et al. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol. 2003;139(6):719-727. (Pubitemid 36705938)
29. Gordon KB, Langley RG. Remittive effects of intramuscular alefacept in psoriasis. J Drugs Dermatol. 2003;2(6):624-628.
30. Goffe B, Papp K, Gratton D, et al. An integrated analysis of thirteen trials summarizing the long-term safety of alefacept in psoriasis patients who have received up to nine courses of therapy. Clin Ther. 2005;27(12):1912-1921. (Pubitemid 43293213)
31. Ritchlin CT. The eficacy and safety of alefacept in psoriatic arthritis. Current Rheumatology Reports. 2006;8(5):1638-1645.
32. Zaba LC, Suárez-Fariñas M, Fuentes-Ducula J, et al. Effective treatmentof psoriasis with etanercept is linked to suppression of IL-17 signaling, not immediate response TNF-a genes J Allergy Clin Immunol. 2009;124:1022-1030.
33. Borish LC, Steinke JW. Cytokines and Chemokines. J Allergy Clin Immunol. 2003;111(2 suppl):S460-S475.
34. Papp KA, Tyring M, Laha J, et al. A global phase III randomized controlled trial of etanercept in psoriasis: Safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005;152:1304-1312. (Pubitemid 40933433)
35. Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003;349(21):2014-2022. (Pubitemid 37448924)
36. Driessen RJB, Boezeman JB, Van de Kerkhof PCM, et al. Threeyear registry data on biological treatment for psoriasis: The influence of patient characteristics on treatment outcome. Br J Dermatol. 2009;160:670-675.
37. Tyring S, Gordon KB, Poulin Y, et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007;143(6):719-26. (Pubitemid 46955730)
38. Gordon KB, Richard GL, Craig L, et al. Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: Double-blind, randomized controlled trial and open-label extension study. J Am Acad Dermatol. 2006;55:598-606. (Pubitemid 44436647)
39. 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;58:106-115. (Pubitemid 350298146)
40. Gordon KB, Langley RG, Leonardi C et al. Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: Double-blind, randomized controlled trial and open-label exension study. J Am Acad Dermatol 2006;55(4):598-606. (Pubitemid 44436647)
41. 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(1):106-115. (Pubitemid 350298146)
42. Menter A, et al. Summer AAD 2007. Poster 1808.
43. Lecluse LL, Driessen RJ, Spuls PI, et al. Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol. 2010;146:127-132.
44. West RL, Zelinkova Z, Wolbink GJ, et al. Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn's disease. Aliment Pharmacol Ther. 2008;28:1122-1126.
45. Humira package insert.
46. Croom KF, McCormack PL. Adalimumab in plaque psoriasis. Am J Clin Dermatol. 2009;10(1):43-50.
47. Gottlieb AB, Evans R, Li Shu et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: A randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2004;51:534-542. (Pubitemid 39278071)
48. Reich K, O Nestle F, Papp K et al. Infliximab induction and maintenance therapy for moderate to severe psoriasis: A Phase III, multicentre, double-blind trial. J Am Acad Dermatol. 2004;51:534-542.
49. 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(31):e1-e15.
50. Chandran NS, Chong WS. A dramatic response to a single dose of infliximab as rescue therapy in acute generalized pustular psoriasis of von Zumbusch associated with a neutrophilic cholangitis. Australas J Dermatol. 2010;51(1):29-31.
51. Maini RN, Breedveld FC, Kalden JR, et al. Therapeutic efficacy of multiple intravenous infusions of antitumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. 1998;41:1552-1563. (Pubitemid 28459913)
52. 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(12):1137-1146.
53. Kleyn CE, Griffiths CE. Infliximab for the treatment of psoriasis. Expert Opin Biol Ther. 2006;6:797-805. (Pubitemid 44174212)
54. L.L.A. Lecluse, G. Piskin, J.R. Mekkes, et al. Review and expert opinion on prevention and treatment of infliximab-related infusion reactions. Br J Dermatol. 2008;159(3):527-536.
55. Cheifetz A, Mayer L. Monoclonal antibodies, immunogenicity, and associated infusion reactions. Mt Sinai J Med. 2005; 72:250-256. (Pubitemid 41052052)
56. Wallis RS, Broder MS, Wong JY, et al. Granulomatous infectious diseases associated with tumor necrosis factor antagonists. Clin Infect Dis. 2004;38:1261-1265. (Pubitemid 38608568)
57. Kim YJ, Bae SC, Sung YK, et al. Possible reactivation of potential hepatitis B virus occult infection by tumor necrosis factor-alpha blocker in the treatment of rheumatic diseases. J Rheumatol. 2010;37(2):346-350.
58. Zein NN. Etanercept as an adjuvant to interferon and ribavarin in treatment-naïve patients with chronic hepatitis C virus infection:A phase 2 randomized, double-blind, placebo-controlled study. J Hepatol. 2005;42:315-322. (Pubitemid 40254244)
59. Paradisi A, Caldarola G, Capizzi R, et al. Safety of etanercept in patients with psoriasis and hepatitis C virus assessed by liver histopathology: Preliminary data. J Am Acad Dermatol. 2010;62(6):1067-1069.
60. Sicotte NL, Voskuhl RR. Onset of multiple sclerosis associated with anti-TNF-a therapy. Neurology. 2001;57:1885-1888. (Pubitemid 33096700)
61. Robinson WH, Genovese MC, Moreland LW. Demyelinating and neurologic events reported in association with tumor necrosis factor alpha antagonism: By what mechanisms could tumor necrosis factor alpha antagonists improve rheumatoid arthritis but exacerbate multiple sclerosis? Arthritis Rheum. 2001;44:1977-1983. (Pubitemid 33644038)
62. Brown SL, Green MH, Gershon SK et al. Tumor necrosis factor antagonist therapy and lymphooma development: Twenty-six cases resported to the Food and Drug Administration. Arthritis Rheum. 2002;46:3151-3158. (Pubitemid 35453523)
63. Margolis D, Bilker W, Hennessy S, et al. The risk of malignancy associated with psoriasis. Arch Dermatol. 2001;137(6):778-783. (Pubitemid 32577862)
64. Okada SK, Siegel JN. Risk of serious infections and malignancies with anti-TNF-a antibody therapy in rheumatoid arthritis. J Am Med Assoc. 2006;296(18):2201-2212.
65. Gelfand JM, Dommasch E. Is there truly a risk of lymphoma from biologic therapies? Dermatol Ther. 2009;22(5):418-430.
66. 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;58(5):826-850. (Pubitemid 351509656)
67. Vandenbroeck K, Alloza I, Gadina M, et al. Inhibiting cytokines of the interleukin-12 family: Recent advances and novel challenges. J Pharm Pharmacol. 2004;56:145-160. (Pubitemid 38232744)
68. 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;49:162-175.
69. Krueger GG, Langley RG, Leonardi C, et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. New Engl J Med. 2007;356(6):580-592. (Pubitemid 46220818)
70. 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;371:1665-1674. (Pubitemid 351671883)
71. 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;1675-1684. (Pubitemid 351671884)
72. Gordon K, et al. Poster presented at EADV; Berlin, Germany. Poster P1170. October 7-11, 2009.
73. Gordon K, et al. Poster presented at Winter Clinical Dermatology Conference; Kauai, HI. January 2010.
74. Griffiths CE, Strober BE, Van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med. 2010;362(2):118-128.
75. Lebwohl M, Bagel J, Gelfand JM, et al. From the Medical Board of the National Psoriasis Foundation: Monitoring and vaccinations in patients treated with biologics for psoriasis. J Am Acad Dermatol. 2008 58(1):94.
76. Gelfand JM, Gladman DD, Mease PJ, et al. Epidemimology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol. 2005;53:573.
77. Brock I, Weldingh K, Lillebaek T, et al. Comparison of tuberculin skin test and new specific blood test in tuberculosis contacts. Am J Respir Crit Care Med. 2004;170:65-69. (Pubitemid 38997753)
78. Duchini A, Goss JA, Karpen S, et al. Vaccinations for adult solid-organ transplant recipients: current recommendations and protocols. Clin Microbiol Rev. 2003;16:357-64. (Pubitemid 36871311)
79. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008;58(5):851-64. (Pubitemid 351509657)
80. Kircik L, Bagel J, Korman N, et al. Utilization of narrow-band ultraviolet light B therapy and etanercept for the treatment of psoriasis (UNITE): efficacy, safety, and patient-reported outcomes. J Drugs Dermatol 2008;7(3):245-53.
81. Gisondi P, Del Giglio M, Cotena C, et al. Combining etanercept and acitretin in the therapy of chronic plaque psoriasis: a 24 week, randomized, controlled, investigator-blinded pilot trial. Br J Dermatol 2008;158:1345-1349. (Pubitemid 351692891)
82. Griffiths CEM, Strober BE, Yeilding N, et al. Poster #x 68th Annual AAD Meeting, Miami Beach, FL. March 5-9, 2010.
83. Bissonnette R, Bolduc C, Poulin Y, et al. Efficacy and safety of adalimumab in patients with plaque psoriasis who have shown an unsatisfactory response to etanercept. J Am Acad Dermatol. 2010 [Epub ahead of print].
84. Strober BE, et al. J Am Acad Dermatol. 2010; in press.
85. Paller A, Siegfried EC, Langley RG, et al. Etanercept treatment for children and adolescents with plaque psoriasis. New Engl J Med. 2008;358:241-251.