Recommendations for incorporating biologicals into management of moderate to severe plaque psoriasis: individualized patient approaches

  • Richard G. Langley
  • Vincent Ho
  • Charles Lynde
  • Kim A. Papp
  • Yves Poulin
  • Neil Shear
  • Jack Toole
  • Catherine Zip
Article

Abstract

Psoriasis is a T-cell mediated skin disease that affects approximately 2% of the population worldwide. Despite the prevalence of the disease and long-standing efforts to develop strategies to treat it, there is a need for safe and effective therapies to treat psoriasis, particularly the more severe forms. Biological agents such as alefacept, efalizumab, etanercept, and infliximab have been recognized as a class of treatment distinct from other forms of therapy in the treatment algorithm of psoriasis. Recent national and international consensus meetings have developed statements that position biological agents as an important addition to the treatment armamentarium for moderate to severe psoriasis, along with phototherapy and traditional systemic agents. There has been consensus that treatment should be individualized to each patient’s needs and circumstances. Biological agents offer the hope of safe, effective, long-term management of moderate to severe psoriasis. As new agents receive approval from Health Canada, the available range of therapeutic options for treating this chronic disease will broaden. A Canadian Psoriasis Expert Panel recently convened in February 2005 to analyze, based on a series of clinical case scenarios, the indications, contraindications, and considerations for and against each of the four biological agents, derived from product labelling, where available, and from the efficacy and safety data from phase 3 and earlier clinical trials, as well as post-marketing reports. The Panel has formulated a set of recommendations for incorporating these biological agents into the current treatment paradigm of moderate to severe plaque psoriasis and has identified the preferred biological agents for each patient based on individual needs and circumstances.

Keywords

alefacept efalizumab etanercept infliximab contraindications health-related quality of life biological therapeutics 

Notes

Acknowledgement

This work was supported in part by an educational grant from Serono Canada Inc.

References

  1. 1.
    Christophers E. Psoriasis–epidemiology and clinical spectrum. Clin Exp Dermatol Jun 2001; 26(4):314–320PubMedCrossRefGoogle Scholar
  2. 2.
    Naldi L. Epidemiology of psoriasis. Curr Drug Targets Inflamm Allergy Jun 2004; 3(2):121–128PubMedCrossRefGoogle Scholar
  3. 3.
    Nall L, Gulliver W, Charmley P, Farber EM. Search for the psoriasis susceptibility gene: the Newfoundland Study. Cutis Nov 1999; 64(5):323–329. PubMedGoogle Scholar
  4. 4.
    Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. J Investig Dermatol Symp Proc Mar 2004; 9(2):136–139. PubMedCrossRefGoogle Scholar
  5. 5.
    Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol Aug 2003; 49(2 Suppl):S57–61PubMedCrossRefGoogle Scholar
  6. 6.
    Ashcroft DM, Li Wan Po A, Griffiths CE. Therapeutic strategies for psoriasis. J Clin Pharm Ther Feb 2000;25(1):1–10PubMedCrossRefGoogle Scholar
  7. 7.
    O’Neill P, Kelly P. Postal questionnaire study of disability in the community associated with psoriasis. BMJ Oct 12 1996; 313(7062):919–921PubMedGoogle Scholar
  8. 8.
    Krueger G, Koo J, Lebwohl M, Menter A, Stern RS, Rolstad T. The impact of psoriasis on quality of life: results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol; Mar 2001137(3):280–284PubMedGoogle Scholar
  9. 9.
    Tristani-Firouzi P, Krueger GG. Efficacy and safety of treatment modalities for psoriasis. Cutis Feb 1998; 61(2 Suppl):11–21PubMedGoogle Scholar
  10. 10.
    Gordon KB, McCormick TS. Evolution of biologic therapies for the treatment of psoriasis. Skinmed Sep-Oct 2003; 2(5):286–294PubMedGoogle Scholar
  11. 11.
    Greaves MW, Weinstein GD. Treatment of psoriasis. N Engl J Med Mar 2 1995; 332(9):581–588PubMedCrossRefGoogle Scholar
  12. 12.
    Guenther L. Integrating Biologic Agents into Management of Moderate-to-Severe Psoriasis: A Consensus of the Canadian Psoriasis Expert Panel. J Cutan Med Surg 2004; 8(5):321–337PubMedCrossRefGoogle Scholar
  13. 13.
    Callen JP, Krueger GG, Lebwohl M, et al. AAD consensus statement on psoriasis therapies. J Am Acad Dermatol Nov 2003; 49(5):897–899PubMedCrossRefGoogle Scholar
  14. 14.
    Sterry W, Barker J, Boehncke WH, et al. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol 2004; Aug 151 Suppl 69:3–17PubMedCrossRefGoogle Scholar
  15. 15.
    Krueger GG, Papp KA, Stough DB, Loven KH, Gulliver WP, Ellis CN. 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 Dec 2002; 47(6):821–833PubMedCrossRefGoogle Scholar
  16. 16.
    Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med Nov 20 2003; 349(21):2014–2022PubMedCrossRefGoogle Scholar
  17. 17.
    Gottlieb AB, Chaudhari U, Mulcahy LD, Li S, Dooley LT, Baker DG. Infliximab monotherapy provides rapid and sustained benefit for plaque-type psoriasis. J Am Acad Dermatol Jun 2003; 48(6):829–835PubMedCrossRefGoogle Scholar
  18. 18.
    Chaudhari U, Romano P, Mulcahy LD, Dooley LT, Baker DG, Gottlieb AB. Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet Jun 9 2001; 357(9271):1842–1847PubMedCrossRefGoogle Scholar
  19. 19.
    Lebwohl M, Tyring SK, Hamilton TK, et al. A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med Nov 20 2003; 349(21):2004–2013PubMedCrossRefGoogle Scholar
  20. 20.
    Gordon KB, Papp KA, Hamilton TK, et al. Efalizumab for patients with moderate to severe plaque psoriasis: a randomized controlled trial. JAMA Dec 17 2003; 290(23):3073–3080. PubMedCrossRefGoogle Scholar
  21. 21.
    Ortonne JP. Clinical response to alefacept: results of a phase 3 study of intramuscular administration of alefacept in patients with chronic plaque psoriasis. J Eur Acad Dermatol Venereol Jul 2003; 17 Suppl 2:12–16. PubMedCrossRefGoogle Scholar
  22. 22.
    Gottlieb AB, Evans R, Li S, et al. Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol Oct 2004; 51(4):534–542PubMedCrossRefGoogle Scholar
  23. 23.
    Remicade® (infliximab) US Prescribing Information. Centocor, Inc. 2004.Google Scholar
  24. 24.
    Raptiva® (efalizumab) US Prescribing Information. Genentech, Inc. 2004.Google Scholar
  25. 25.
    Enbrel® (etanercept) US Prescribing Information. Marketed by Amgen and Wyeth Pharmaceuticals. 2004.Google Scholar
  26. 26.
    Amevieve® (alefacept) Canadian Prescribing Information. Biogen Idec Canada, Inc. 2004.Google Scholar
  27. 27.
    Amevieve® (alefacept) US Prescribing Information. Biogen, Inc. 2004.Google Scholar
  28. 28.
    Gordon KB, Langley RG. Remittive effects of intramuscular alefacept in psoriasis. J Drugs Dermatol Dec 2003; 2(6):624–628PubMedGoogle Scholar
  29. 29.
    Ellis CN, Krueger GG. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N Engl J Med Jul 26 2001; 345(4):248–255PubMedCrossRefGoogle Scholar
  30. 30.
    Lebwohl M, Christophers E, Langley R, Ortonne JP, Roberts J, Griffiths CE. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol Jun 2003; 139(6):719–727. PubMedCrossRefGoogle Scholar
  31. 31.
    FDA Alefacept Review Briefing Document April 29, 2002.Google Scholar
  32. 32.
    Ellis CN, Mordin MM, Adler EY. Effects of alefacept on health-related quality of life in patients with psoriasis: results from a randomized, placebo-controlled phase II trial. Am J Clin Dermatol 2003; 4(2):131–139PubMedCrossRefGoogle Scholar
  33. 33.
    Feldman SR, Menter A, Koo JY. Improved health-related quality of life following a randomized controlled trial of alefacept treatment in patients with chronic plaque psoriasis. Br J Dermatol Feb 2004; 150(2):317–326PubMedCrossRefGoogle Scholar
  34. 34.
    Finlay AY, Salek MS, Haney J. Intramuscular alefacept improves health-related quality of life in patients with chronic plaque psoriasis. Dermatology 2003; 206(4):307–315PubMedCrossRefGoogle Scholar
  35. 35.
    Raptiva® (efalizumab) Canadian Product Monograph. Serono Canada, Inc. 2005Google Scholar
  36. 36.
    Menter A, Gordon K, Carey W, et al. Efficacy and safety observed during 24 weeks of efalizumab therapy in patients with moderate to severe plaque psoriasis. Arch Dermatol Jan 2005; 141(1):31–38PubMedCrossRefGoogle Scholar
  37. 37.
    Poulin Y, Papp KA, Carey W, Gulliver W. Efalizumab for long-term control of moderate-to-severe psoriasis. (This supplement). 2005Google Scholar
  38. 38.
    Carey W, Toth D, Bissonnette R, Langley R. No evidence for increased risk of infection during efalizumab treatment: A review of the clinical data. 2004Google Scholar
  39. 39.
    Toth D, Carey W, Bissonnette R, Langley R. Risk of malignancy during efalizumab treatment: A review of the clinical data. 2004Google Scholar
  40. 40.
    Papp KA, Ho V, Langley RG, et al. Patient management in psoriasis treatment using efalizumab. (This supplement). 2005Google Scholar
  41. 41.
    Nash P, Clegg DO. Psoriatic arthritis therapy: NSAIDs and traditional DMARDs. Ann Rheum Dis Mar 2005; 64 Suppl 2:ii74–77PubMedCrossRefGoogle Scholar
  42. 42.
    Ricardo RR, Rhoa M, Orenberg EK, Li N, Rundle AC, Caro I. Clinical benefits in patients with psoriasis after efalizumab therapy: clinical trials versus practice. Cutis Sep 2004; 74(3):193–200PubMedGoogle Scholar
  43. 43.
    Ortonne JP, Sterry W, Shear NH, Sumack S, Duru G, Beresniak A. Impact of efalizumab on health-related quality of life outcomes in patients with moderate to severe chronic plaque psoriasis: results of the international randomized controlled experience acquired with Raptiva (Clear) trial. Poster presented at: 34th Annual Meeting of the European Society for Dermatological Research, September 9–11, 2004, Vienna, Austria.Google Scholar
  44. 44.
    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 Jun 2005; 152(6):1304–1312PubMedCrossRefGoogle Scholar
  45. 45.
    Papp K. The Long-term Efficacy of New Biological Therapies for Psoriasis. Presented at the 3rd European Academy of Dermatology and Venereology Spring Symposium. May 19–22, 2005; Sofia, Bulgaria. Poster #32Google Scholar
  46. 46.
    Gottlieb AB, Matheson RT, Lowe N, et al. A randomized trial of etanercept as monotherapy for psoriasis. Arch Dermatol Dec 2003; 139(12):1627–1632; discussion 1632PubMedCrossRefGoogle Scholar
  47. 47.
    Enbrel® (etanercept) Canadian Prescribing Information. Marketed by Amgen and Wyeth Pharmaceuticals. 2005Google Scholar
  48. 48.
    Gottlieb A, Evans R, Li S, Etal. The efficacy of infliximab across a variety of subgroups with plaque psoriasis. Presented at 62nd Annual Meeting of the American Academy of Dermatology, 6–11 February 2004, Washington, DC, Poster 615.Google Scholar
  49. 49.
    Leonardi CL, Papp K, Gordon K. Extended efalizumab therapy improves chronic plaque psoriasis: Results from a randomized phase III trial. J Am Acad Dermatol. In press.Google Scholar

Copyright information

© Canadian Dermatology Association 2006

Authors and Affiliations

  • Richard G. Langley
    • 1
  • Vincent Ho
    • 2
  • Charles Lynde
    • 3
  • Kim A. Papp
    • 4
  • Yves Poulin
    • 5
  • Neil Shear
    • 6
  • Jack Toole
    • 7
  • Catherine Zip
    • 8
  1. 1.Queen Elizabeth II Health Science CentreDalhousie UniversityHalifax
  2. 2.University of British ColumbiaVancouver
  3. 3.University of Toronto, University Health Network, and Lynde Centre for DermatologyMarkham
  4. 4.Probity Medical ResearchWaterloo
  5. 5.Laval University and Centre DermatologiqueSainte Foy
  6. 6.Sunnybrook & Women’s College, University of Toronto Medical School and Ventana Clinical Research Corp.Toronto
  7. 7.University of Manitoba, Dermadvances Research WinnipegWinnipeg
  8. 8.University of Calgary and The Dermatology CentreCalgary

Personalised recommendations