Managing psoriasis: What’s best for your patient?

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Applied Evidence

Managing psoriasis: What’s best for your patient?

J Fam Pract. 2012 July;61(7):402-451

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References

1. Gelfand JM, Weinstein R, Porter SB, et al. Prevalence and treatment of psoriasis in the United Kingdom: a population-based study. Arch Dermatol. 2005;141:1537-1541.

2. Fortune DG, Richards HL, Griffiths CE. Psychologic factors in psoriasis: consequences, mechanisms, and interventions. Dermatol Clin. 2005;23:681-694.

3. Housman TS, Mellen BG, Rapp SR, et al. Patients with psoriasis prefer solution and foam vehicles: a quantitative assessment of vehicle preference. Cutis. 2002;70:327-332.

4. Pettey AA, Balkrishnan R, Rapp SR, et al. Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: implications for clinical practice. J Am Acad Dermatol. 2003;49:271-275.

5. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60:643-659.

6. Kaufmann R, Bibby AJ, Bissonnette R, et al. A new calcipotriol/betamethasone dipropionate formulation (Daivobet) is an effective once-daily treatment for psoriasis vulgaris. Dermatology. 2002;205:389-393.

7. Koo JY, Martin D. Investigator-masked comparison of tazarotene gel q.d. plus mometasone furoate cream q.d. vs. mometasone furoate cream b.i.d. in the treatment of plaque psoriasis. Int J Dermatol. 2001;40:210-212.

8. Berger TG, Duvic M, Van Voorhees AS, et al. The use of topical calcineurin inhibitors in dermatology: safety concerns. Report of the American Academy of Dermatology Association Task Force. J Am Acad Dermatol. 2006;54:818-823.

9. Cornell RC, Stoughton RB. Correlation of the vasoconstriction assay and clinical activity in psoriasis. Arch Dermatol. 1985;121:63-67.

10. Lui H. Phototherapy of psoriasis: update with practical pearls. J Cutan Med Surg. 2002;6(suppl):17-21.

11. Walters IB, Burack LH, Coven TR, et al. Suberythemogenic narrow-band UVB is markedly more effective than conventional UVB in treatment of psoriasis vulgaris. J Am Acad Dermatol. 1999;40:893-900.

12. Stern RS, Laird N. The carcinogenic risk of treatments for severe psoriasis. Photochemotherapy follow-up study. Cancer. 1994;73:2759-2764.

13. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010;62:114-135.

14. Trehan M, Taylor CR. High-dose 308-nm excimer laser for the treatment of psoriasis. J Am Acad Dermatol. 2002;46:732-737.

15. Morison WL, Baughman RD, Day RM, et al. Consensus workshop on the toxic effects of long-term PUVA therapy. Arch Dermatol. 1998;134:595-598.

16. Spuls PI, Witkamp L, Bossuyt PM, et al. A systematic review of five systemic treatments for severe psoriasis. Br J Dermatol. 1997;137:943-949.

17. Murase JE, Lee EE, Koo J. Effect of ethnicity on the risk of developing nonmelanoma skin cancer following long-term PUVA therapy. Int J Dermatol. 2005;44:1016-1021.

18. Lowe NJ, Prystowsky JH, Bourget T, et al. Acitretin plus UVB therapy for psoriasis. Comparisons with placebo plus UVB and acitretin alone. J Am Acad Dermatol. 1991;24:591-594.

19. Torras H, Aliaga A, Lopez-Estebaranz JL, et al. A combination therapy of calcipotriol cream and PUVA reduces the UVA dose and improves the response of psoriasis vulgaris. J Dermatolog Treat. 2004;15:98-103.

20. Tanew A, Guggenbichler A, Honigsmann H, et al. Photochemotherapy for severe psoriasis without or in combination with acitretin: a randomized, double-blind comparison study. J Am Acad Dermatol. 1991;25:682-684.

21. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61:451-485.

22. Strober BE, Menon K. Folate supplementation during methotrexate therapy for patients with psoriasis. J Am Acad Dermatol. 2005;53:652-659.

23. Taler SJ, Textor SC, Canzanello VJ, et al. Cyclosporine-induced hypertension: incidence, pathogenesis and management. Drug Saf. 1999;20:437-449.

24. 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;58:826-850.

25. Heydendael VM, Spuls PI, Opmeer BC, et al. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med. 2003;349:658-665.

26. Lloyd ME, Carr M, McElhatton P, et al. The effects of methotrexate on pregnancy, fertility and lactation. QJM. 1999;92:551-563.

27. Ellis CN, Fradin MS, Messana JM, et al. Cyclosporine for plaque-type psoriasis. Results of a multidose, double-blind trial. N Engl J Med. 1991;324:277-284.

28. Buccheri L, Katchen BR, Karter AJ, et al. Acitretin therapy is effective for psoriasis associated with human immunodeficiency virus infection. Arch Dermatol. 1997;133:711-715.

29. 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;58:94-105.

30. 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;139:1563-1570.

31. Brown SL, Greene MH, Gershon SK, et al. Tumor necrosis factor antagonist therapy and lymphoma development: twenty-six cases reported to the Food and Drug Administration. Arthritis Rheum. 2002;46:3151-3158.

32. Fulchiero GJ, Jr, Salvaggio H, Drabick JJ, et al. Eruptive latent metastatic melanomas after initiation of antitumor necrosis factor therapies. J Am Acad Dermatol. 2007;56(suppl):S65-S67.

33. 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;371:1665-1674.

34. US Food and Drug Administration. FDA approves new drug to treat psoriasis. Sept. 25, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183851.htm. Accessed June 15, 2012.

35. Duchini A, Goss JA, Karpen S, et al. Vaccinations for adult solid-organ transplant recipients: current recommendations and protocols. Clin Microbiol Rev. 2003;16:357-364.

36. Mann DL, McMurray JJ, Packer M, et al. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL). Circulation. 2004;109:1594-1602.

37. 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;362:118-128.

38. 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;371:1675-1684.

TABLE 3
Is your patient a candidate for biologics?^24,30-33

Agent (Drug class)	Alefacept (T-cell inhibitor)	Adalimumab (TNF-inhibitor)	Etanercept (TNF-inhibitor)	Infliximab (TNF-inhibitor)	Ustekinumab (IL-12/23 inhibitor)
Dosing	15 mg IM/wk for 12 wk, then 12-wk nontreatment period	80 mg SC the first wk, 40 mg the 2nd wk, followed by 40 mg every other wk	50 mg SC twice/wk for 3 mo, then 50 mg/wk	5 mg/kg IV infusion to start, repeat at 2 and 6 wk, then q6-8 wk	45 mg SC (for patients <100 kg); 90 mg (for patients >100 kg) to start, repeat at 4 wk, followed by q12 wk for maintenance
Contra-indications	HIV	First-degree relative with MS or personal history of MS or other demyelinating disease Hepatitis B Active TB	First-degree relative with MS or personal history of MS or other demyelinating disease Hepatitis B Active TB Sepsis	First-degree relative with MS or personal history of MS or other demyelinating disease Hepatitis B Active TB Doses >5 mg/kg should not be given to patients with NYHA Class III or IV CHF*	Active TB
Baseline monitoring	CD4 count	PPD LFT, CBC Hepatitis profile	PPD LFT, CBC	PPD LFT, CBC Hepatitis profile	PPD
Ongoing monitoring	Biweekly CD4 count; hold dose for counts <250	Periodic H&P Consider a yearly PPD and periodic CBC & LFT	Periodic H&P Consider a yearly PPD and periodic CBC & LFT	Periodic H&P Consider a yearly PPD and periodic CBC & LFT	Consider a yearly PPD
CBC, complete blood cell count; CHF, congestive heart failure; HIV, human immunodeficiency virus; H&P, history and physical; IL-12/23, interleukin-12, interleukin-23; LFTs, liver function test; MS, multiple sclerosis; NYHA, New York Heart Association; PPD, purified protein derivative; TB, tuberculosis; TNF, tumor necrosis factor. *For this patient population, adalimumab and etanercept have a (theoretical) risk.

Biologic therapy is contraindicated in patients with active serious infection. If patients develop infections requiring antibiotics while being treated, holding the biologic until infection resolution is advised.³⁴ Standard vaccinations (eg, pneumococcal, hepatitis A and B, influenza, diphtheria, tetanus) are recommended before initiation of immunosuppressive therapy. After therapy starts, patients should avoid live and live-attenuated vaccines (varicella, mumps, measles, and rubella, oral typhoid, yellow fever, herpes zoster, intranasal influenza).³⁵

FAST TRACK

Advise patients who are candidates for biologic therapy to get any standard vaccinations they need before treatment begins.

Currently, none of the biologics are indicated for use in children or adolescents with psoriasis, despite epidemiologic data suggesting that one-third of adults with psoriasis developed it during childhood, in a form severe enough to warrant the use of systemic medications.³⁴ The FDA is currently reviewing the possibility of indicating etanercept for pediatric psoriasis patients. All biologics are category B for pregnancy as there is no evidence that they negatively affect pregnancy.²⁴

T-cell inhibitor. Alefacept binds CD2 on memory-effector T lymphocytes, inhibiting activation. Weekly intramuscular injections of alefacept for 12 weeks can clear lesions with long remissions.³⁰

TNF-inhibitors. The TNF-inhibitors have been available for more than 10 years, predominantly for inflammatory bowel disease (IBD) and rheumatoid arthritis (RA), and more than 1.5 million patients have used adalimumab, etanercept, and infliximab for these disorders. Safety data, especially long term, are mostly derived from patients with IBD or RA, who have often combined TNF-inhibitors with additional immunosuppressive therapies. Thus, for psoriasis patients, who typically use biologics as monotherapy, the risk may be overestimated.²⁴

TNF-inhibitors increase the risk for infection, most commonly of the upper respiratory tract, and, rarely, have been associated with opportunistic infections. Numerous cases of TB reactivation and an increased incidence of disseminated cases have been associated with TNF-inhibitors, so screening is recommended.²⁴

The impact of TNF inhibition on congestive heart failure (CHF) is not well understood. Studies have variously shown that TNF-inhibitors have no effect on CHF morbidity or mortality, increase CHF mortality, or improve left ventricular function. TNF-inhibitors should be avoided in patients with severe CHF (New York Heart Association class III or IV). In milder CHF patients with worsening of symptoms, treatment should be discontinued.³⁶

The increased risk of malignancy, especially lymphoma, is a concern, as there have been numerous case reports of lymphoma occurring with TNF-inhibitors. Psoriasis patients in general have an increased risk of lymphoma that confounds data interpretation.³¹ A number of case reports and a large observational study have shown patients receiving TNF-inhibitors may be at a greater risk for developing melanoma and nonmelanoma skin cancer.³²

Ustekinumab, an interleukin 12/23 inhibitor, is a human monoclonal antibody that is absorbed and eliminated slowly, making dosing injections every 12 weeks convenient with efficacy maintained for at least one year.³³ Because of its relative novelty, few studies are published regarding long-term safety. A recent head-to-head trial compared the efficacy and safety of ustekinumab with etanercept and found superior efficacy with ustekinumab, with comparable adverse events.^37,38 Similar concerns exist with ustekinumab as with TNF-inhibitors, including infection, malignancy, CHF, and TB.³³