An attempt to formulate an evidence-based strategy in the management of moderate-to-severe psoriasis: A review of the efficacy and safety of biologics and prebiologic options

Expert Opinion on Pharmacotherapy

Volumn 8, Issue 5, 2007, Pages 617-632

  Leon, Argentina ^a   Nguyen, Alain ^b   Letsinger, Julie ^c,d   Koo, John ^c,d  

^a UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Adalimumab; Alefacept; Ciclosporin; D PUVA; Efalizumab; Etanercept; Goeckerman; Infliximab; Methotrexate; NB UVB; PASI 75; Psoriasis; RePUVA; Retinoids

Indexed keywords

ADALIMUMAB; ALEFACEPT; CALCIPOTRIOL; COAL TAR; CYCLOSPORIN A; EFALIZUMAB; ETANERCEPT; ETRETIN; ETRETINATE; INFLIXIMAB; LACTIC ACID; MAGNESIUM; METHOTREXATE; PLACEBO; POTASSIUM; PSORALEN; RETINOID; SALICYLIC ACID; TAZAROTENE; URIC ACID; BIOLOGICAL PRODUCT; DERMATOLOGICAL AGENT; HYBRID PROTEIN; MONOCLONAL ANTIBODY;

BONE MARROW SUPPRESSION; CD4 LYMPHOCYTE COUNT; CELL DIFFERENTIATION; CELL PROLIFERATION; CLINICAL TRIAL; COCHRANE LIBRARY; COMORBIDITY; CYTOKINE PRODUCTION; DIGESTIVE SYSTEM ULCER; DISEASE ASSOCIATION; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHEMA; EVIDENCE BASED MEDICINE; FATIGUE; FOLLICULITIS; HAIR LOSS; HUMAN; HYPERLIPIDEMIA; HYPEROSTOSIS; HYPERTENSION; INJECTION SITE REACTION; LIVER CIRRHOSIS; LIVER FIBROSIS; LOADING DRUG DOSE; LOW DRUG DOSE; MEDLINE; MELANOMA; META ANALYSIS; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NEPHROTOXICITY; PHOTOAGING; PHOTOTHERAPY; PHOTOTOXICITY; PROTEIN SYNTHESIS INHIBITION; PSORIASIS; PSORIASIS SEVERITY INDEX; PSORIASIS VULGARIS; PUVA; REBOUND; RECOMMENDED DRUG DOSE; REVIEW; SIDE EFFECT; SKIN IRRITATION; SQUAMOUS CELL CARCINOMA; SYSTEMATIC REVIEW; TERATOGENICITY; ULTRAVIOLET B RADIATION; BIOLOGICAL THERAPY; CLASSIFICATION; CONTROLLED CLINICAL TRIAL; EXPERT WITNESS; METHODOLOGY; RANDOMIZED CONTROLLED TRIAL;

ACITRETIN; ANTIBODIES, MONOCLONAL; BIOLOGICAL PRODUCTS; BIOLOGICAL THERAPY; DERMATOLOGIC AGENTS; EVIDENCE-BASED MEDICINE; EXPERT TESTIMONY; HUMANS; METHOTREXATE; PSORIASIS; PUVA THERAPY; RANDOMIZED CONTROLLED TRIALS; RECOMBINANT FUSION PROTEINS;

EID: 34047203806     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.8.5.617     Document Type: Review

References (87)

1. CHRISTOPHERS E: Psoriasis: epidemiology and clinical spectrum. Clin. Exp. Dermatol. (2001) 26:314-320.
2. FELDMAN SR, FLEISCHER AB Jr, REBOUSSIN DM et al.: The economic impact of psoriasis increases with psoriasis severity. J. Am. Acad. Dermatol. (1997) 37:564-569.
3. RAPP SR, FELDMAN SR, EXUM ML, FLEISCHER AB JR, REBOUSSIN DM: Psoriasis causes as much disability as other major medical diseases. J. Am. Acad. Dermatol. (1999) 41:401-207.
4. KRUEGER G, KOO J, LEBWOHL M, MENTER A, STERN RS, ROLSTAD T: The impact of psoriasis on quality of life. Arch. Dermatol. (2001) 137:280-284.
5. NALDI L, GRIFFITHS CE: Traditional therapies in the management of moderate to severe chronic plaque psoriasis: an assessment of the benefits and risks. J. Dermatol. (2005) 152:597-615.
6. KOO J, KHERA P: Update on the mechanisms and efficacy of biological therapies for psoriasis. J. Dermatol. Sci. (2005) 38:75-87.
7. FREDRIKSSON T, PETTERSSON U: Severe psoriasis oral therapy with a new retinoid. Dermatologica (1978) 157:238-244.
8. 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.
9. DUBERTRET L, STERRY W, BOS JD et al.: Clinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: results from a Phase II international randomized, placebo-controlled trial. Br. J. Dermatol. (2006) 155:170-181.
10. LEBWOHL M, TYRING S, HAMILTON T et al.: A novel targeted T -cell modulater, efalizumab, for plaque psoriasis. New Engl. J. Med. (2003) 349:2004-2013.
11. LEONARDI CL, PAPP KA, GORDON KB et al.: Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized Phase III trial. J. Am. Acad. Dermatol. (2004) 52:425-433.
12. 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. Lancet (2005) 366:1367-1374.
13. 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.
14. 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.
15. LEONARDI C, JEROLD LP, ROBERT TM et al.: Etanercept as monotherapy in patients with psoriasis. New Engl. J. Med. (2003) 349:2014-2022.
16. LEBWOHL M, CHRISTOPHERS E, LANGLEY R et al.: An international, randomized, double-blind, placebo-controlled Phase III trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch. Dermatol. (2003) 139:719-727.
17. KRUEGER GG, PAPP KA, STOUGH DB et al.: 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. (2002) 47:821-833.
18. DAWE RS: A quantitative review of studies comparing the efficacy of narrow-band and broad-band ultraviolet B for psoriasis. Br. J. Dermatol. (2003) 149:669-672.
19. HOFER A, FINK-PUCHES R, KERL H, WOLF P: Comparison of phototherapy with near versus far erythemogenic doses of narrow-band ultraviolet B in patients with psoriasis. Br. J. Dermatol. (1998) 138:96-100.
20. CAMERON H, DAWE RS, YULE S, MURPHY J, IBBOTSON SH, FERGUSON J: A randomized, observer-blinded trial of twice versus three times weekly narrowband ultraviolet B phototherapy for chronic plaque psoriasis. Br. J. Dermatol. (2002) 147:973-978.
21. BEHRENS S, GRUNDMANN-KOLLMANN M, SCHIENER R, RALF-UWE P, KERSCHER M: Combination phototherapy of psoriasis with narrow-band UVB irradiation and topical tazarotene gel. J. Am. Acad. Dermatol. (2000) 42:493-495.
22. 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. Dermatol. Treat. (2004) 15:98-103.
23. FRAPPAZ A, THIVOLET J: Calcipotriol in combination with PUVA: a randomized double blind placebo study in severe psoriasis. Eur. J. Dermatol. (1993) 3:351-354.
24. TANEW A, GUGGENBLICHER A, HONIGSMANN H, GEIGER JM, FRITSCH P: Photochemotherapy for severe psoriasis without or in combination with acitretin: a randomized, double-blind comparison study. J. Am. Acad. Dermatol. (1991) 25:682-684.
25. LAUHARANTA J, GEIGER JM: A double-blind comparison of acitretin and etretinate in combination with bath PUVA in the treatment of extensive psoriasis. Br. J. Dermatol. (1989) 121:107-112.
26. LEE E, KOO J: Modern modified 'ultra' Goeckerman therapy: a PASI assessment of a very effective therapy for psoriasis resistant to both prebiologic and biologic therapies. J. Dermatol. Treat. (2005) 000:1-6.
27. MENTER A, CRAM DL: The Goeckerman regimen in two psoriasis day care centers. J. Am. Acad. Dermatol. (1983) 9:59-65.
28. PERRY HO, SODERSTROM CW, SCHULZE RW: The Goeckerman treatment of psoriasis. Arch. Dermatol. (1968) 98:178-182.
29. KRAGBALLE K, JANSEN CT, GEIGER JM et al.: A double-blind comparison of acitretin and etretinate in the treatment of severe psoriasis. Acta Derm. Venereol. (1989) 69:35-40.
30. GEIGER JM: Efficacy of acitretin in severe psoriasis. Skin Therapy Lett. (2003) 8:1-3, 7.
31. MURRAY HE, ANHALT AW, LESSARD R et al.: A 12-month treatment of severe psoriasis with acitretin: results of a Canadian open multicenter study. J. Am. Acad. Dermatol. (1991) 24:598-602.
32. HEYDENDAEL VMR, PHYLLIS IS, OPMEER BC et al.: Methotrexate versus ciclosporin in moderate to severe chronic plaque psoriasis. New Engl. J. Med. (2003) 349:658-665.
33. SANDU K, KAUR I, KUMAR B, SARASWAT A: Efficacy and safety of ciclosporin versus methotrexate in severe psoriasis: a study from north India. J. Dermatol. (2003) 30:458-463.
34. KOO J: A randomized, double-blind study comparing the efficacy, safety and optimal dose of two formulations of ciclosporin, Neoral and Sandimmun, in patients with severe psoriasis. Br. J. Dermatol. (1998) 139:88-95.
35. MAHRLE G, SCHULZE HJ, FARBER L, WEIDINGER G, STEIGLEDER GK: Low-dose short-term ciclosporin versus etretinate in psoriasis: improvement of skin, nail, and joint involvement. J. Am. Acad. Dermatol. (1995) 32:78-88.
36. DAS S, LLOYD JJ, FARR PM: Similar dose-response and persistence of erythema with broad-band and narrow-band ultraviolet B lamps. J. Invest. Dermatol. (2001) 117:1318-1321.
37. IBBOTSON SH, BILSLAND D, COX NH et al.: An update and guidance on narrowband UVB phototherapy: a British Photodermatology Group Workshop Report. Br. J. Dermatol. (2004) 151:283-297.
38. FELDMAN SR, KOO JYM, LEBWOHL MG, MENTER A, VAN VOORHEES A: The Psoriasis and Psoriatic Arthritis Pocket Guide. Treatment Algorithms and Management Options. National Psoriasis Foundation (2005).
39. COX NH, JONES SK, DOWNEY DJ et al.: Cutaneous and ocular side effects of oral photochemotherapy: results of an 8-year follow-up study. Br. J. Dermatol. (1987) 116:145-152.
40. FLINDT-HANSEN H, MCFADDEN N, EEG-LARSEN et al.: Effect of a new narrow-band UVB lamp on photocarcinogenesis in mice. Photodermatol. Photoimmunol. Photomed. (1994) 10:192-197.
41. WULF HC, HANSEN AB, BECH-THOMSEN N: Differences in narrow-band ultraviolet B and broad-spectrum ultraviolet photo-carcinogenesis in lightly pigmented hairless mice. Photodermatol. Photoimmunol. Photomed. (1994) 10:1192-1197.
42. GIBBS NK, TRAYNOR NJ, MACKIE RM et al.: The phototumorigenic potential of broad-band (270-350 nm) and narrow-band (311-313 nm) phototherapy sources cannot be predicted by their edematogenic potential in hairless mouse skin. J. Invest. Dermatol. (1995) 104:359-363.
43. MAN I, CROMBIE IK, DAWE RS, FERGUSON J: The photocarcinogenic risk of narrowband TL-01 ultraviolet B phototherapy; early follow-up data. Br. J. Dermatol. (2003) 149(Suppl. 64):12 (Abstr.).
44. STERN RS, LAIRD N: Photochemotherapy follow-up study. The carcinogenic risks of treatments for severe psoriasis. Cancer (1994) 73:2759-2764.
45. STERN RS et al.: Risk of squamous cell carcinoma and methoxsalen (psoralen) and UV-A radiation (PUVA): a meta-analysis. Arch. Dermatol. (1998) 134:1582-1585.
46. STERN RS, NICHOLS KT, VAKEVA LH: Malignant melanoma in patients treated for psoriasis with methoxsalen (psoralen) and ultraviolet A radiation (PUVA). N. Engl. J. Med. (1997) 336:1041-1045.
47. KOO J, FITZPATRICK TB, KRUEGER G et al.: PUVA phototherapy: assessing and optimizing the risk/benefit ratio. Skin & Allergy News (a supplement).
48. LINDELOF B, SIGURGEIRSSON B, TEGNER E et al.: PUVA and cancer risk: the Swedish follow-up study. Br. J. Dermatol. (1999) 141:108-112.
49. HANNUKSELA-SVAHN A, SIGURGEIRSSON B, PUKKALA E et al.: Trioxsalen bath PUVA did not increase the risk of squamous cell skin carcinoma and cutaneous malignant melanoma in a joint analysis of 944 Swedish and Finnish patients with psoriasis. Br. J. Dermatol. (1999) 141:497-501.
50. HANNUKSELA M, STENBACK F, LAHTI A: The carcinogenic properties of topical PUVA. A lifelong study in mice. Arch. Dermatol. Res. (1986) 278:347-351.
51. HANNUKSELA-SVAHN A, PUKKALA E, KOULU L et al.: Cancer incidence among Finnish psoriasis patients treated with 8-methoxypsoralen bath PUVA. J. Am. Acad. Dermatol. (1999) 40:694-696.
52. LEBWOHL M, DRAKE L, MENTER A et al.: Consensus conference: acitretin in combination with UVB or PUVA in the treatment of psoriasis. J. Am. Acad. Dermatol. (2001) 45:544-553.
53. CHAKRAVARTY EF, MICHAUD K, WOLFE F: Skin cancer, rheumatoid arthritis, and tumor necrosis factor inhibitors. J. Rheumatol. (2005) 32:2130-2135.
54. BEUPARLANT P, PAPP K, HARAOUI B: The incidence of cancer associated with treatment of rheumatoid arthritis. Semin. Arthritis Rheum. (1999) 29:148-158.
55. ABBOTT CORP.: HUMIRA® (adalimumab) prescribing information. Abbott Corp., Abbot Park (IL) USA (2005)
56. BONGARTZ T, SUTTON AJ, SWEETING MJ et al.: Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies systemic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA (2006) 295:2275-2284.
57. LEBWOHL M, ALI S: Treatment of psoriasis. Part 2. Systemic therapies. J. Am. Acad. Dermatol. (2001) 45:649-661.
58. WOLLINA U, STANDER K, BARTA U: Toxicity of methotrexate treatment in psoriasis and psoriatic arthritis short-and long-term toxicity in 104 patients. Clin. Rheumatol. (2001) 20:406-410.
59. MYLAN PHARMACEUTICALS INC.: Methotrexate prescribing information. Mylan Pharmaceuticals Inc., Morgantown (WV) USA (2004).
60. WHITING-O'KEEFE QE, SACK KD: Methotrexate and histologic hepatic abnormalities; a meta-analysis. Am. J. Med. (1991) 90:711-716.
61. ORTIZ Z, SHEA B, SAUREZ A et al.: Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis. Cochrane Database Syst. Rev. (2001) 2:CD000951
62. VAN EDE AE, LAAN RF, ROOD MJ et al.: Effect of folic or folinic acid supplementation on the toxicity and efficacy of methotrexate in rheumatoid arthritis: a forty-eight week, multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. (2001) 44:1515-1524.
63. CENTOCOR INC.: Remicade® (infliximab) prescribing information. Centocor, Inc., Malvern (PA) USA (2004).
64. GOLDA N, BENHAM S, KOO J: Rebound of psoriasis during treatment with efalizumab. J. Drugs Dermatol. (2006) 5:63-65.
65. MENTER A, KARDATZKE D, RUNDLE AC et al.: Incidence and prevention of rebound upon efalizumab discontinuation. Poster presented at The 10th International Psoriasis Symposium. Toronto, Canada (10-13 June 2004).
66. CAREY W, RUNDLE AC, KWON P et al.: Taper Regimens in the management of patients discontinuing efalizumab therapy. Poster presented at The 10th International Psoriasis Symposium. Toronto, Canada (10-13 June 2004).
67. NOVARTIS PHARMACEUTICAL CORP: Neoral® (cyclosporine) prescribing information. Novartis Pharmaceutical Corp., East Hanover (NJ) USA (2005).
68. ELLIS CN, FRADIN MS, MESSANA JM et al.: Ciclosporin for plaque-type psoriasis. Results of a multidose, double-blind trial. New Engl. J. Med. (1991) 324:277-284.
69. GRIFFITHS CEM, DUBERTRET L, ELLIS CN et al.: Ciclosporin in psoriasis clinical practice: an intern consensus statement. Br. J. Dermatol. (2004) 150(Suppl. 67):11-23.
70. MYCEK MJ, HARVEY RA, CHAMPE PC: Lippincott's Illustrated Reviews: Pharmacology, 2nd edn. Hampton, New Jersey, Lippincott Williams & Wilkins (2000).
71. GOLLNICK HP, DUMMLER U: Retinoids. Clin. Dermatol. (1997) 15:799-810.
72. KOO J: Systemic sequential therapy of psoriasis: a new paradigm for improved therapeutic results. J. Am. Acad. Dermatol. (1999) 41:S25-S28.
73. SPULS PI, HADI S, RIVERA L, LBEBWOHL M: Retrospective study of the efficacy of narrowband UVB and acitretin. J. Dermatol. Treat. (2003) 14(Suppl. 2):17-20.
74. NIJSTEN TE, STERN RS: Oral retinoid use reduces cutaneous squamous cell carcinoma risk in patients with psoriasis treated with psoralen-UVA: a nested cohort study. J. Am. Acad. Dermatol. (2003) 49:644-650.
75. YONES SS, PALMER RA, GARIBALDINOS TT et al.: Randomized double-blind trial of the treatment of chronic plaque psoriasis. Arch. Dermatol. (2006) 142:836-842.
76. GORDON PM, DIFFREY BL, MATTHEWS JNS et al.: A randomized comparison of narrow-band TL-01 phototherapy and PUVA photochemotherapy for psoriasis. J. Am. Acad. Dermatol. (1999) 41:728-732.
77. KOO J, LEBWOHL M: Duration of remission of psoriasis therapies. J. Am. Acad. Dermatol. (1999) 41:51-59.
78. RUZICKA TT, SOMMERBURG C, BRAUN-FALCO O et al.: Efficiency of acitretin in combination with UVB in the treatment of severe psoriasis. Arch. Dermatol. (1990) 126:482-486.
79. LOWE N PRYSTOWSKY JH, BOURGET T, EDELSTEIN J, NYCHAY S, ARMSTRONG R: Acitretin plus UVB therapy for psoriasis: comparisons with placebo plus UVB and acitretin alone. J. Am. Acad. Dermatol. (1991) 24:591-594.
80. IEST J, BOER J: Combined treatment of psoriasis with acitretin and UVB phototherapy compared with acitretin alone and UVB alone. Br. J. Dermatol. (1989) 120:665-670.
81. MARKS R, BARTON SP, SHUTTLEWORTH D, FINLAY AY: Assessment of disease progress in psoriasis. Arch. Dermatol. (1989) 125:235-240.
82. KHERA P, KOO J: A review of the chemopreventive and chemotherapeutic effects of topical and oral retinoids for both cutaneous and internal neoplasms. J. Drugs Dermatol. (2005) 4:432-434.
83. HONIGSMANN H: Phototherapy for psoriasis. Clin. Dermatol. (2001) 26:343-350.
84. IMMUNEX CORE: Enbrel® (etanercept) prescribing information. Immunex Corp., Thousand Oaks (CA) USA (2005).
85. CONNETICS CORE: Soriatane® (acitretin) prescribing information. Connetics Corp., Palo Alto (CA) USA (2004).
86. GENENTECH INC.: Raptiva® (efalizumab) prescribing information. Genentech Inc., San Francisco (CA) USA (2005).
87. ASTELLAS CORP.: Amevive® (alefacept) prescribing information. Astellas Corp., Cambridge (MA) USA (2005).