QUICK REFERENCE

Biologics in psoriasis: A quick reference guide

Valencia D. Thomas, MD, F. Clarissa Yang, MD, and Joseph C. Kvedar, MD
Boston, Massachusetts

M ore than 4.5 million Americans are affected
by psoriasis. Of them, 35% have moderate
to severe disease, affecting between 2% and
[10% total body surface area. Recent advances in
therapeutics have introduced a variety of antibody
and fusion proteinebased biologic therapies whose
direct immune targeting can be utilized to treat this
chronic disease. The field of biologics is rapidly
changing, however, and it can become difficult for a
practitioner to remain abreast of the updates in
clinical efficacy, required patient monitoring, and
side effects. This study card was developed as a basic,
quick reference guide for practitioners that serves to
summarize common biologics used in the treatment
of psoriasis.
We thank Dr Charles R. Taylor, Dr Robert Stern, and
Dr Alexa B. Kimball for their editorial input.

From the Department of Dermatology, Harvard Medical School.

Funding sources: None.
Conflicts of interest: None identified.
Reprint requests: Valencia D. Thomas, MD, Resident in
Dermatology, Harvard Medical School, 55 Fruit St, Bartlett
616, Boston, MA 02114. E-mail: vthomas1@partners.org.
J Am Acad Dermatol 2005;53:346-51.
0190-9622/$30.00
ª 2005 by the American Academy of Dermatology, Inc.
doi:10.1016/j.jaad.2005.04.011

346
Table I. Biologics in psoriasis: A quick reference guide
Alefacept
(Amevive

)
Description Fusion protein of human LFA-3
and the Fc portion of IgG1
Mechanism Inhibits T cell activation/prolif-
eration by blocking the LFA-3/
CD2 interaction, resulting in
selective apoptosis of T
cells
FDA Mod to severe plaque
indication psoriasis in adults
Dosing 15 mg IM qwk 3 12 wks, wait
12 wks, then consider a
second course 3 12 wks
FDA CD4 at baseline and weekly
monitoring (hold dose if \250 cells/L)
Optional PPD and/or CXR, and b-HCG at
monitoring baseline
Efalizumab

)
(Raptiva

Humanized form of a
murine antibody
directed against CD11a
Inhibits T cell activation, cuta-
neous trafficking, and adhe-
sion to keratinocytes through
the blockade of LFA-1/
ICAM-1 binding
Mod to severe plaque
psoriasis in adults
Begin 0.7 mg/kg SC then hold
at 1 mg/kg (max 200 mg) QW
(maintenance therapy)
Platelet count on initiation and
monthly, then
every 3 months
PPD and/or CXR, and b-HCG at
baseline
Etanercept

)
(Enbrel

Fusion protein of the Fc of
human IgG1 and the ex-
tracellular TNF receptor
Binds soluble TNF and
blocks its interaction
with cell surface receptors
Mod to severe plaque pso-
riasis in adults; psoriatic,
rheumatoid, and juvenile
rheumatoid arthritis;
ankylosing spondylitis
50 mg SC BIW 3 12 weeks
then 50 mg SC QWK
None
PPD and/or CXR, BUN, Cr,
SGOT, SGPT, Hep C serol-
ogy and/or b-HCG at
baseline
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Infliximab Adalimumab
(Remicade

)
)
(Humira

Chimeric antibody Recombinant human
against TNFa com- IgG1 monoclonal anti-
posed of a human body against TNFa
IgG1 constant
domain and murine
variable regions
Binds soluble and bound Binds TNF and blocks its
TNFa interaction with cell
surface TNF receptors
Crohn’s disease, RA Mod to severe RA in
adults
3 mg/kg IV over 2 hours 40 mg SC over
at weeks 0, 2, 6, then 3-5 minutes Q2 WKS 3
3 mg/kg q8 WKS (pre- 12 weeks; can increase
ferred RA dose) to QW doses if not on
methotrexate
Screen for latent TB (PPD Screen for latent TB (PPD
and/or CXR) at base- and/or CXR), routine
line CBC/chemistries at
baseline; anti-dsDNA
Ab if lupus-like sx
Thomas, Yang, and Kvedar 347
present
BUN, Cr, SGOT, PPD and/or CXR, and
SGPT, Hep C b-HCG at baseline
serology and/
or b-HCG at
baseline Con-
sider periodic
CBC and clinical
follow-up
Q 3-months
Table I. Cont’d
Alefacept
(Amevive

)
Optional monitoring (Continued)
Side effects Common:
Cough, dizziness, nausea,
pharyngitis, pruritus,
myalgias, chills, injection site
reactions, transaminitis
Serious:
Lymphopenia (10% IM, 22%
IV), malignancies (1.3%),
serious infections (0.9%), hy-
persensitivity (\1%), trans-
aminase elevations (rare),
cardiovascular events (1.2%)
Contraindications d Hypersensitivity to alefacept
d Discontinue use if CD4 \250
cells/L 3 1 mo
Efalizumab Etanercept

)
(Raptiva

)
(Enbrel

Consider periodic CBC, ESR
and clinical follow-up Q
3-months
Common: Common:
Headache (32%), flu-like symp- Injection site reactions
toms with first (37%), cough and respira-
dose (13%: tory sx (45%),
fever, headache, myalgias, infections (35%),
nausea), headaches (17%), positive
infection (29%), ANA (11%)
elevated Alk
Phos (4%)
Serious: Serious:
Infection Allergic
(0.4%), malignancy (1.8/100 reactions (\2%); leukope-
patient years), thrombocytope- nia, pancytopenia; new
nia (0.3%), and worsening of onset or exacerbation of
psoriasis/ CNS demylinating disor-
variants (0.7%) ders (rare), increased
incidence of lymphoma
(two-fold the general risk),
infections
d Hypersensitivity d Hypersensitivity to etaner-
to efalizumab or cept or its components,
any murine or humanized mono- active infections or sepsis
clonal antibody
d Avoid combination with natali- d Live vaccines
zumab
d CHF, poorly controlled
diabetes, or immunosup-
pression
348 Thomas, Yang, and Kvedar
Infliximab Adalimumab
(Remicade

)
)
(Humira

Common: Common:
Nausea, Injection site reaction
abdominal pain, back (8%), positive ANA
pain, (12%)
arthralgia,
fatigue,
headache
Serious: Serious:
Hypersensitivity reac- Hypersensitivity reac-
tions (10%), infusion tions (\1%), confu-
reactions (20%), wors- sion, multiple sclerosis,
ening of CHF (14%), paresthesia, subdural
infections (same as hematoma, tremor, in-
placebo at [41 fections/sepsis, malig-
weeks) tuberculosis nancy (standardized
(post-marketing data, incidence ratio of 5.4
rate unavailable), inva- for lymphoma), TB
sive fungal infections,
a lupus-like syndrome
(17%)
Hypersensitivity to inflix- d Hypersensitivity to in-
imab or murine fliximab or murine
products, CHF (NYHA products, chronic or
Class III/IV) recurrent infections,
latent TB, immuno-
suppression
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d Avoid concomitant
therapy with anakinra
and TNF-blocking
AUGUST 2005
agents

Precautions Infection, history of malig-
nancy, live vaccines
Relative d PASI 75: 21% at week 14 (2
efficacy weeks postdosing)
PASI 50: 42% at week 14 (2 weeks
postdosing)
d PGA ‘‘almost clear’’ or ‘‘clear’’:
14% at week 14 (2 weeks post-
dosing)
d PASI 50 began 60 days after
start
d Most patients maintained a at
least a PASI 50 through the 3-
month observation period
Pregnancy/ d Pregnancy category B
nursing
d Lactation safety unknown
Thrombocytopenia, live vaccines Concurrent treatment with High risk of infection,
immunosuppression, infection,
elderly or history of malignancy TNF-blocking agents or
d PASI 75: 22%-
39% at 12 weeks
d PASI 50: 52%-61% at 12 weeks
d sPGA ‘‘almost clear’’ or ‘‘clear’’:
19%-32% at 12 weeks
d PASI 50 began 4 weeks after start
d 77% of patients achieving PASI
75 maintained their improve-
ment through
a second 12-week treatment
period
d Pregnancy category C
d Unsafe in lactation
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d Mild CHF (NYHA Class
anakinra, natalizumab, with pre-existing or I/II)
recent onset of CNS pts require close car-
use in pts with pregnancy, demyelinating disease diac monitoring
renal impairment, asthma, or seizure disorders, or
CNS demyeliating disease, who have received live
or blood virus vaccines
dyscrasias
d Discontinue if a lupus-
like syndrome develops
d Exercise caution when
treating the elderly, pts
with pre-existing or re-
cent onset of CNS de-
myelinating disease
d PASI 75: 47% at 3 months, d PASI 75: 82% at week d PASI 50: achieved by
54% at 6 months 10 and 33% at week 26 week 12 and week 16
(on a dose of 5 mg/kg)2 in 2 out of 2 patients3
d PASI 50: 71% at 3 months d PASI 50: 40% d PASI 75: achieved by
at week 26 (on a dose week 20 in 1 out of 2
of 5 mg/kg)2 patients (maintained
through week 40)3
d sPGA ‘‘almost clear’’ or d Statistically significant
‘‘clear’’: 47% at 3 months reduction in PASI with
respect to placebo by 2
weeks after start2
d Median time to PASI 50
and PASI 75 was 1 and 2
months, respectively,
after start
Thomas, Yang, and Kvedar 349
d 77% of patients achieving
a PASI 75 at 3 months with
50 mg SC BIW 3 3 mo
maintained their improve-
ment at month 6 with 25
mg SC QW
d Pregnancy category B d Pregnancy category B d Pregnancy category B
d Lactation safety unknown d Lactation safety un- d Lactation safety
(secreted in breast milk) known unknown
Table I. Cont’d

350 Thomas, Yang, and Kvedar

Alefacept Efalizumab Etanercept Infliximab Adalimumab
(Amevive

)
)
(Raptiva

)
(Enbrel
(Remicade

)
)
(Humira

Manufacturer Biogen Genentech, Inc; Xoma Ltd Amgen, Wyeth Pharmaceu- Centocor, Inc Abbott Pharmaceutical
ticals
Other d Can use concurrently with d Improvement as early as 2 d Can use with methotrexate d Can use with metho- Can use with methotrex-
phototherapy weeks trexate ate, steroids, salicy-
lates, NSAIDs
d Max reduction in psoriasis at 8 d Maintained PASI improve- d Improvement after first
weeks after the last dose ment during extended treat- few weeks
ment with QW or every-other-
week dosing
d 16-week cycles are under in- d Rebound effect with d/c in
vestigation nearly 14%; median time to
relapse:
60-80 days

Ab, Antibody; Alk Phos, alkaline phosphatase; ANA, anti-nuclear antibody; b-HCG, beta human chorionic gonadotropin; BUN, blood urea nitrogen; CBC, complete blood count; CHF, congestive heart
failure; CNS, central nervous system; Cr, creatine; CXR, chest radiograph; d/c, discontinuation; FDA, US Food and Drug Administration; Hep C, hepatitis C; IM, intramuscular; IV, intravenous; Max,
maximum; Mod, moderate; NYHA, New York Heart Association; PA, psoriatic arthritis; PASI 75, 75% or greater reduction in the Psoriasis Severity and Area Index; PASI 50, 50% or greater reduction in
the Psoriasis Severity and Area Index; PGA, physician global assessment; PPD, purified protein derivative; qwk, weekly; RA, rheumatoid arthritis; SGOT, serum glutamic oxaloacetic transaminase; SGPT,
serum glutamic pyruvic transaminase; sPGA, static physician global assessment; sx, symptoms; TB, tuberculosis; TNFa, tumor necrosis factor alfa.

J AM ACAD DERMATOL
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J AM ACAD DERMATOL
VOLUME 53, NUMBER 2
BIBLIOGRAPHY
Chaudhari U, Romano P, Mulcahy L, Dooley L, Baker D, Gottlieb A.
Efficacy and safety of infliximab monotherapy for plaque-type
psoriasis: a randomized trial. Lancet 2001;357:1842-7.
Chew AL, Bennett A, Smith CH, Barker J, Kirkham B. Successful
treatment of severe psoriasis and psoriatic arthritis with
adalimumab. Br J Dermatol 2004;151:492-6.
Ellis CN, Krueger GG, Alefacept Clinical Study Group. Treatment of
chronic plaque psoriasis by selective targeting of memory
effector T lymphocytes. N Engl J Med 2001;345:248-55.
Facts—psoriasis. National Psoriasis Foundation; 2002. Available at
www.psoriasis.org/facts/psoriasis/. Accessed December 15, 2004.
Gardam MA, Keystone EC, Menzies R, Manners S, Skamene E,
Long R, et al. Anti-tumour necrosis factor agents and tuber-
culosis risk: mechanisms of action and clinical management.
Lancet Infect Dis 2003;3:148-55.
Gordon KB, Papp KA, Hamilton TK, Walicke PA, Dummer W, Li N,
et al. Efalizumab for patients with moderate to severe
plaque psoriasis: a randomized controlled trial. JAMA 2003;
290:3073-80. Erratum in: JAMA 2004;291:1070.
Gordon KB, Vaishnaw AK, O’Gorman J, Haney J, Menter A. Treat-
ment of psoriasis with alefacept: correlation of clinical im-
provement with reductions of memory T-cell counts. Arch
Dermatol 2003;139:1563-70.
Gottlieb AB, Krueger JG, Bright R, Ling M, Lebwohl M, Kang S, et al.
Effects of administration of a single dose of a humanized
monoclonal antibody to CD11a on the immunobiology and
clinical activity of psoriasis. J Am Acad Dermatol 2000;42:
428-35.
Gottlieb AB, Casale TB, Frankel E, Goffe B, Lowe N, Ochs HD, et al.
CD41 T-celledirected antibody responses are maintained in
patients with psoriasis receiving alefacept: results of a ran-
domized study. J Am Acad Dermatol 2003;49:816-25.
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 2003;48:
829-35.
Jablonska S, Majewski S. On the immunopathogenesis of psoriasis.
Arch Dermatol 2001;137:229-30.
Kirby B, Griffiths CEM. Novel immune-based therapies for psoriasis.
Br J Dermatol 2002;146:546-51.
Krueger GG, Callis KP. Development and use of alefacept to treat
psoriasis. J Am Acad Dermatol 2003;49(suppl 2):S87-97.
Thomas, Yang, and Kvedar 351
Krueger JG. The immunologic basis for the treatment of psoriasis
with new biologic agents. J Am Acad Dermatol 2002;46:1-23.
Lebwohl M. Combining the new biologic agents with our current
psoriasis armamentarium. J Am Acad Dermatol 2003;49(suppl
2):S118-24.
Lebwohl M, Christophers E, Langley R, Ortonne JP, Roberts J,
Griffiths CE. An international, randomized, double-blind, pla-
cebo-controlled phase 3 trial of intramuscular alefacept in
patients with chronic plaque psoriasis. Arch Dermatol
2003;139:719-27.
Lebwohl M, Tyring SK, Hamilton TK, Toth D, Glazer S, Tawfik NH,
et al. A novel targeted T-cell modulator, efalizumab, for plaque
psoriasis. N Engl J Med 2003;349:2004-13.
Leonardi CL. Efalizumab: an overview. J Am Acad Dermatol
2003;49(suppl 2):S98-104.
Mohan N, Edwards ET, Cupps TR, Oliverio PJ, Sandberg G,
Crayton H, et al. Demyelination occurring during anti-tumor
necrosis factor alpha therapy for inflammatory arthritides.
Arthritis Rheum 2001;44:2862-9.
Patel T, Gordon KB. Adalimumab: efficacy and safety in psoriasis and
rheumatoid arthritis. Dermatol Ther 2004;17:427-31.
Raptiva (efalizumab) package insert. San Francisco, CA: Genentech,
Inc; 2003.
Scheinfeld N. Adalimumab (HUMIRA): a review. J Drugs Dermatol
2003;2:375-7.
Singri P, West DP, Gordon KB. Biologic therapy for psoriasis. Arch
Dermatol 2002;183:657-63.
US Food and Drug Administration Web site. Amevive (alefacept)
package insert. Cambridge, MA: Biogen, Inc; 2003. Available
at: http://www.fda.gov/cder/foi/label/2003/alefbio013003LB.
htm.
US Food and Drug Administration Web site. Enbrel (etanercept)
package insert. Seattle, WA: Immunex Corp; 2004. Available at:
www.fda.gov/cder/foi/label/2002/etanimm091202LB.pdf. Ac-
cessed April 13, 2005.
US Food and Drug Administration Web site. Remicade (inflix-
imab) package insert. Malvern, PA: Centocor Inc; 2002. Avail-
able at: www.fda.gov/cder/foi/label/2002/inflcen022702LB.pdf.
Accessed April 13, 2005.
US Food and Drug Administration Web site. Humira (adali-
mumab) package insert. North Chicago, IL: Abbott Laboratories;
2002. Available at: www.fda.gov/cder/foi/label/2002/ada
labb123102LB.pdf. Accessed April 13, 2005.