A need for improved psoriasis management drove the development of four biologicals now approved for use in moderate to severe psoriasis: alefacept, efalizumab, etanercept, and infliximab.
Objective:
This review compares the recommended and practical use of biologicals in “difficult-to-treat” psoriasis. Difficult-to-treat patients, a subpopulation of particular interest to caregivers and regulators, are those for whom conventional options are unavailable, contraindicated, intolerable, or ineffective.
Conclusions:
Despite guidance recommending that biologicals be considered among first-line antipsoriasis treatments, formulary inclusion may be influenced by the biologicals' success in controlling difficult-to-treat psoriasis. Findings from the Clinical Experience Acquired with Raptiva (CLEAR) randomized controlled trial (RCT) established efalizumab's equal efficacy in difficult-to-treat and moderate to severe psoriasis. The CLEAR data were cited in support of a regulatory recommendation to include efalizumab in Canadian provincial formularies. For some other biologicals, evidence regarding efficacy in difficult-to-treat psoriasis remains equivocal. Additional RCTs are needed to define appropriate roles for specific biologicals in difficult-to-treat patients.
Get full access to this article
View all access options for this article.
References
1.
KruegerGKooJLebwohlM. The impact of psoriasis on quality of life: Results of a 1998 National Psoriasis Foundation patient-membership survey. Arch Dermatol2001;137:280–4.
2.
RoenigkHHJrAuerbachRMaibachH. Methotrexate in psoriasis: Consensus conference. J Am Acad Dermatol1998;38:478–85.
3.
McClureSLValentineJGordonKB. Comparative tolerability of systemic treatments for plaque-type psoriasis. Drug Saf2002;25:913–27.
4.
GuentherLLangleyRGShearNH. Integrating biologic agents into management of moderate-to-severe psoriasis: A consensus of the Canadian Psoriasis Expert Panel. February 27, 2004. J Cutan Med Surg2004;8:321–37.
5.
Tristani-FirouziPKruegerGG. Efficacy and safety of treatment modalities for psoriasis. Cutis1998;61(2 Suppl):11–21.
6.
British Photodermatology Group. British Photodermatology Group guidelines for PUVA. Br J Dermatol1994;130:246–55.
7.
FriedrichMKrammigSHenzeM. Flow cytometric characterization of lesional T cells in psoriasis: Intracellular cytokine and surface antigen expression indicates an activated, memory/effector type 1 immunophenotype. Arch Dermatol Res2000;292:519–21.
8.
ShearNHLangleyRGHoV. Efalizumab, a reversible T-cell modulator for psoriasis. J Cutan Med Surg2006;9Suppl 1:4–9.
9.
BoehnckeWHPrinzJGottliebAB. Biologic therapies for psoriasis. A systematic review. J Rheumatol2006;33:1447–51.
10.
PappKA. The long-term efficacy and safety of new biological therapies for psoriasis. Arch Dermatol Res2006;298:7–15.
11.
WoolacottNHawkinsNMasonA. Etanercept and efalizumab for the treatment of psoriasis: A systematic review. Health Technol Assess2006;10:1–252.
12.
SterryWBarkerJBoehnckeWH. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol2004;151Suppl 69:3–17.
13.
SmithCHAnsteyAVBarkerJN. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005. Br J Dermatol2005;153:486–97.
Health Canada Drug Safety and Medical Services. Health Canada endorsed important safety information on Remicade (infliximab). Available at: http://napra.ca/pdfs/advisories/remicade_hpc_2_e.pdf (accessed April 2007).
16.
StroberBEYamauchiPKormanN. Efficacy of etanercept in psoriatic patients previously treated with systemic therapy or phototherapy [abstract]. J Am Acad Dermatol2004;50:147.
17.
KalbREGurskeJ. Infliximab for the treatment of psoriasis: Clinical experience at the State University of New York at Buffalo. J Am Acad Dermatol2005;53:616–22.
18.
DubertretLSterryWBosJD. Clinical experience acquired with the efalizumab (Raptiva) (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: Results from a phase III international randomized, placebo-controlled trial. Br J Dermatol2006;155:170–81.
19.
van de KerkhofPGriffithsCEChristophersE. Alefacept in the treatment of psoriasis in patients for whom conventional therapies are inadequate. Dermatology2005;211:256–63.
20.
DubertretLBerth-JonesJYamauchiP. Etanercept is an effective treatment for psoriasis regardless of previous psoriasis systemic treatment. Presented at the European Academy of Dermatology and Venerology 3rd Spring Symposium; 2005 May 19–22; Sofia, Bulgaria.
21.
de GrootMAppelmanMSpulsPI. Initial experience with routine administration of etanercept in psoriasis. Br J Dermatol2006;155:808–14.
22.
PappKATyringSLahfaM. A global phase III randomized controlled trial of etanercept in psoriasis: Safety, efficacy, and effect of dose reduction. Br J Dermatol2005;152:1304–12.
23.
LeonardiCLPowersJLMathesonRT. Etanercept as monotherapy in patients with psoriasis. N Engl J Med2003;349:2014–22.
24.
AhmadKRogersS. Two years of experience with etanercept in recalcitrant psoriasis. Br J Dermatol2007 Apr 4. [Epub ahead of print].
25.
CassanoNLoconsoleFAmorusoA. Infliximab monotherapy for refractory psoriasis: Preliminary results. Int J Immunopathol Pharmacol2004;17:373–80.
26.
AhmadKRogersS. Three years' experience with infliximab in recalcitrant psoriasis. Clin Exp Dermatol2006;31:630–3.
27.
SmithCHJacksonKBashirSJ. Infliximab for severe, treatment-resistant psoriasis: A prospective, open-label study. Br J Dermatol2006;155:160–9.
28.
MenterAFeldmanSRWeinsteinGD. 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 Dermatol2007;56:31.
29.
ReichKNestleFOPappK. Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: A phase III, multicentre, double-blind trial. Lancet2005;366:1367–74.
30.
LebwohlMChristophersELangleyR. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol2003;139:719–27.
31.
KruegerGGPappKAStoughDB. A randomized, doubleblind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. J Am Acad Dermatol2002;47:821–33.
SchlessingerJPariserRParkSWierzG. Evaluation of the efficacy and safety of alefacept in patients for whom conventional psoriasis therapies are ineffective or inappropriate. Presented at the 65th Annual Meeting of the American Academy of Dermatology; 2007 Feb 2–6; Washington, DC.
34.
OrtonneJP. 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 Venereol2003;17Suppl:12–6.
35.
GottliebAGordonKHamiltonT. Maintenance of efficacy and safety with continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: final phase IIIb study results. Presented at the 63rd Annual Meeting of the American Academy of Dermatology; 2005 Feb 18–22; New Orleans, LA.
36.
GottliebABHamiltonTCaroI. Long-term continuous efalizumab therapy in patients with moderate to severe chronic plaque psoriasis: Updated results from an ongoing trial. J Am Acad Dermatol2006;54 (4 Suppl 1):S154–63.
37.
PrinzJCHenningerE. Patient characteristics and drug exposure in high-need patients: the CLEAR experience. Presented at the European Academy of Dermatology and Venerology 3rd Spring Symposium; 2005 May 19–22; Sofia, Bulgaria.
38.
LeonardiCLPappKAGordonKB. Extended efalizumab therapy improves chronic plaque psoriasis: Results from a randomized phase III trial. J Am Acad Dermatol2005;52:425–33.
39.
GordonKBPappKAHamiltonTK. Efalizumab for patients with moderate to severe plaque psoriasis: A randomized controlled trial. JAMA2003;290:3073–80.
40.
LebwohlMTyringSKHamiltonTK. A novel targeted T-cell modulator, efalizumab, for plaque psoriasis. N Engl J Med2003;349:2004–13.
41.
OrtonneJPShearNShumackS. Impact of efalizumab on patient-reported outcomes in high-need psoriasis patients: Results of the international, randomized, placebo-controlled phase III Clinical Experience Acquired with Raptiva (CLEAR) trial [NCT00256139]. BMC Dermatol2005;5:13.
42.
SterryWStinglGLangleyRG. Clinical Experience Acquired with Raptiva (CLEAR) trial in patients with moderate-to-severe plaque psoriasis: Results from extended treatment in an international, phase III, placebo-controlled trial. J Dtsch Dermatol Ges2006;4:947–56.
43.
FretzinSCrowleyJJonesL. Successful treatment of hand and foot psoriasis with efalizumab therapy. J Drugs Dermatol2006;5:838–46.
44.
LeonardiCSofenHKrellJ. Phase IV study to evaluate the safety and efficacy of efalizumab for treatment of hand and foot plaque psoriasis. Presented at the 65th Annual Meeting of the American Academy of Dermatology; 2007 Feb 2–6; Washington, DC.
45.
GottliebABLeonardiCLGoffeBS. Etanercept monotherapy in patients with psoriasis: A summary of safety, based on an integrated multistudy database. J Am Acad Dermatol2006;54 (3 Suppl 2):S92–100.
46.
TyringSGottliebAPappA. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: Double-blind placebo-controlled randomised phase III trial. Lancet2006;367:29–35.
PappKACamisaCStoneSP. Safety of efalizumab in patients with moderate to severe chronic plaque psoriasis: Review of clinical data. Part II. J Cutan Med Surg2005;9:313–23.
49.
KruegerGGElewskiBPappK. Patients with psoriasis respond to continuous open-label etanercept treatment after initial incomplete response in a randomized, placebo-controlled trial. J Am Acad Dermatol2006;54 (3 Suppl 2):S112.
GodwinMChapmanJMowatD. Delisting of drugs in Ontario. How attitudes and prescribing strategies of family physicians in the Kingston area changed. Can Fam Physician1996;42:1309–16.
52.
MarraFPatrickDMWhiteR. Effect of formulary policy decisions on antimicrobial drug utilization in British Columbia. J Antimicrob Chemother2005;55:95–101.
