Off-label biologic regimens in psoriasis: A systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy

PLoS ONE

Volumn 7, Issue 4, 2012, Pages

  Brezinski, Elizabeth A ^a   Armstrong, April W ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ADALIMUMAB ANTIBODY; ALEFACEPT; ETANERCEPT; ETANERCEPT ANTIBODY; INFLIXIMAB; INFLIXIMAB ANTIBODY; INTERLEUKIN 12 ANTIBODY; INTERLEUKIN 23 ANTIBODY; PLACEBO; TUMOR NECROSIS FACTOR ALPHA ANTIBODY; UNCLASSIFIED DRUG; USTEKINUMAB; USTEKINUMAB ANTIBODY;

ABDOMINAL DISEASE; ANTIBODY TITER; CELLULITIS; CEREBROVASCULAR ACCIDENT; COCCIDIOIDOMYCOSIS; CONGESTIVE HEART FAILURE; CONTINUOUS INFUSION; CORONARY ARTERY DISEASE; CUTANEOUS MALIGNANCY; DEMYELINATING DISEASE; DISEASE ACTIVITY; DISEASE CONTROL; DRUG BLOOD LEVEL; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG INTERMITTENT THERAPY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHRODERMA; HELICOBACTER INFECTION; HEPATITIS C; HERPES SIMPLEX; HERPES ZOSTER; HUMAN; HUMERUS FRACTURE; INFECTION; LUPUS LIKE SYNDROME; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MELANOMA; MULTIPLE CYCLE TREATMENT; MYCOPLASMAL TRACHEOBRONCHITIS; NEPHROLITHIASIS; OFF LABEL DRUG USE; OUTCOME ASSESSMENT; PERITONEUM ADHESION; PNEUMONIA; PSORIASIS; PSORIASIS VULGARIS; RELAPSE; RETREATMENT; REVIEW; SIDE EFFECT; SKIN CANCER; SYSTEMATIC REVIEW; THORAX PAIN; TOOTH ABSCESS; TREATMENT DURATION; TREATMENT RESPONSE; TUBERCULOSIS; UMBILICAL HERNIA; DOSE CALCULATION; DRUG APPROVAL; LEGAL ASPECT; SAFETY; STATISTICS; TREATMENT WITHDRAWAL;

DRUG APPROVAL; DRUG DOSAGE CALCULATIONS; HUMANS; OFF-LABEL USE; PSORIASIS; SAFETY; WITHHOLDING TREATMENT;

EID: 84859598341     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0033486     Document Type: Review

References (50)

1. Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, et al. (2001) The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol 137: 280-284.
2. Rapp SR, Feldman SR, Exum ML, Fleischer AB Jr, Reboussin DM, (1999) Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 41: 401-407.
3. Schon MP, Boehncke WH, (2005) Psoriasis. N Engl J Med 352: 1899-1912.
4. Koo J, (1996) Population-based epidemiologic study of psoriasis with emphasis on quality of life assessment. Dermatol Clin 14: 485-496.
5. Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T, (2004) Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. Journal of Investigative Dermatology Symposium Proceedings 9: 136-139.
6. Ferrandiz C, Carrascosa JM, Boada A, (2010) A new era in the management of psoriasis? The biologics: facts and controversies. Clinics in Dermatology 28: 81-87.
7. Ortonne JP, (1999) Recent developments in the understanding of the pathogenesis of psoriasis. Br J Dermatol 140 (Suppl 54): 1-7.
8. Nickoloff BJ, Stevens SR, (2006) What have we learned in dermatology from the biologic therapies? J Am Acad Dermatol 54: S143-151.
9. Krueger GG, Langley RG, Leonardi C, Yeilding N, Guzzo C, et al. (2007) A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med 356: 580-592.
10. Trinchieri G, (2003) Interleukin-12 and the regulation of innate resistance and adaptive immunity. Nature Reviews Immunology 3: 133-146.
11. Prinz JC, (2003) The role of T cells in psoriasis. Journal of the European Academy of Dermatology and Venereology 17: 257-270.
12. Kupper TS, (2003) Immunologic targets in psoriasis. N Engl J Med 349: 1987-1990.
13. Mihatsch MJ, Wolff K, (1992) Consensus conference on cyclosporin A for psoriasis February 1992. Br J Dermatol 126: 621-623.
14. Ho VC, Griffiths CE, Berth-Jones J, Papp KA, Vanaclocha F, et al. (2001) Intermittent short courses of cyclosporine microemulsion for the long-term management of psoriasis: a 2-year cohort study. J Am Acad Dermatol 44: 643-651.
15. Papp KA, Tyring S, Lahfa M, Prinz J, Griffiths CE, et al. (2005) A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol 152: 1304-1312.
16. Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, et al. (2003) Etanercept as monotherapy in patients with psoriasis. N Engl J Med 349: 2014-2022.
17. Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, et al. (2008) Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. J Am Acad Dermatol 58: 106-115.
18. Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM, (2010) Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol 63: 448-456.
19. Reich K, Nestle FO, Papp K, Ortonne JP, Evans R, et al. (2005) Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 366: 1367-1374.
20. Leonardi CL, Kimball AB, Papp KA, Yeilding N, Guzzo C, et al. (2008) 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 371: 1665-1674.
21. Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, et al. (2008) 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 371: 1675-1684.
22. Krueger GG, Papp KA, Stough DB, Loven KH, Gulliver WP, et al. (2002) A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. J Am Acad Dermatol 47: 821-833.
23. Guyatt G, Gutterman D, Baumann MH, Addrizzo-Harris D, Hylek EM, et al. (2006) Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force. Chest 129: 174-181.
24. Enbrel (etanercept) [package insert] Seattle, WA: Immunex Corporation, (2011)
25. Leonardi C, Strober B, Gottlieb AB, Elewski BE, Ortonne JP, et al. (2010) Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. Journal of Drugs in Dermatology 9: 928-937.
26. Cassano N, Loconsole F, Miracapillo A, Travaglini M, Digiuseppe MD, et al. (2010) Treatment of psoriasis with different dosage regimens of etanercept: preliminary results from the Talpharanta Plastic Study Group. Int J Immunopathol Pharmacol 23: 797-802.
27. Gordon KB, Gottlieb AB, Leonardi CL, Elewski BE, Wang A, et al. (2006) Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy. J Dermatolog Treat 17: 9-17.
28. Moore A, Gordon KB, Kang S, Gottlieb A, Freundlich B, et al. (2007) A randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis. J Am Acad Dermatol 56: 598-603.
29. Ortonne JP, Taieb A, Ormerod AD, Robertson D, Foehl J, et al. (2009) Patients with moderate-to-severe psoriasis recapture clinical response during re-treatment with etanercept. Br J Dermatol 161: 1190-1195.
30. Humira (adalimumab) prescribing information [package insert] North Chicago, Abbott Laboratories IL, (2011).
31. Gordon KB, Langley RG, Leonardi C, Toth D, Menter MA, et al. (2006) 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 55: 598-606.
32. Papp K, Crowley J, Ortonne JP, Leu J, Okun M, et al. (2011) Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. British Journal of Dermatology 164: 434-441.
33. Lecluse LL, Driessen RJ, Spuls PI, de Jong EM, Stapel SO, et al. (2010) Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol 146: 127-132.
34. Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, et al. (2011) Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 305: 1460-1468.
35. Remicade (infliximab) [package insert] Malvery, PA: Centocor Inc, (2011).
36. Chaudhari U, Romano P, Mulcahy LD, Dooley LT, Baker DG, et al. (2001) Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet 357: 1842-1847.
37. Menter A, Feldman SR, Weinstein GD, Papp K, Evans R, et al. (2007) 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 56: 31 e31-15.
38. Gottlieb AB, Evans R, Li S, Dooley LT, Guzzo CA, et al. (2004) Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol 51: 534-542.
39. Gottlieb AB, Chaudhari U, Mulcahy LD, Li S, Dooley LT, et al. (2003) Infliximab monotherapy provides rapid and sustained benefit for plaque-type psoriasis. J Am Acad Dermatol 48: 829-835.
40. Stelara (Ustekinumab) [package insert] Horsham, PA: Centocor Ortho Biotech Inc, (2011).
41. Amevive (alefacept) [package insert] Deerfield, IL: Astellas Pharma US Inc, (2011).
42. Gribetz CH, Blum R, Brady C, Cohen S, Lebwohl M, (2005) An extended 16-week course of alefacept in the treatment of chronic plaque psoriasis. J Am Acad Dermatol 53: 73-75.
43. Cafardi JA, Cantrell W, Wang W, Elmets CA, Elewski BE, (2008) The safety and efficacy of high-dose alefacept compared with a loading dose of alefacept in patients with chronic plaque psoriasis. Skinmed 7: 67-72.
44. Ortonne JP, (2003) Clinical response to alefacept: results of a phase 3 study of intramuscular administration of alefacept in patients with chronic plaque psoriasis. Journal of the European Academy of Dermatology and Venereology 17 (Suppl 2): 12-16.
45. Lebwohl M, Christophers E, Langley R, Ortonne JP, Roberts J, et al. (2003) An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol 139: 719-727.
46. Lowe NJ, Gonzalez J, Bagel J, Caro I, Ellis CN, et al. (2003) Repeat courses of intravenous alefacept in patients with chronic plaque psoriasis provide consistent safety and efficacy. International Journal of Dermatology 42: 224-230.
47. Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E, (2010) The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol 62: 968-978.
48. Gordon KB, Langley RG, (2003) Remittive effects of intramuscular alefacept in psoriasis. Journal of Drugs in Dermatology 2: 624-628.
49. Dommasch ED, Abuabara K, Shin DB, Nguyen J, Troxel AB, et al. (2011) The risk of infection and malignancy with tumor necrosis factor antagonists in adults with psoriatic disease: a systematic review and meta-analysis of randomized controlled trials. J Am Acad Dermatol 64: 1035-1050.
50. Ryan C, Leonardi CL, Krueger JG, Kimball AB, Strober BE, et al. (2011) Association between biologic therapies for chronic plaque psoriasis and cardiovascular events: a meta-analysis of randomized controlled trials. JAMA 306: 864-871.