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## Complete Summary

#### GUIDELINE TITLE

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.

#### BIBLIOGRAPHIC SOURCE(S)

Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon
KB, Lebwohl M, Koo JY, Elmets CA, Korman NJ, Beutner KR, Bhushan R.
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
May;58(5):826-50. \[177 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18423260)

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references drug(s) for which important revised regulatory and/or warning
information has been released.

-   [October 17, 2008, Raptiva
    (efalizumab)](http://www.fda.gov/medwatch/safety/2008/safety08.htm#Raptiva):
    The U.S. Food and Drug Administration (FDA) notified healthcare
    professionals of extensive labeling changes, including a Boxed
    Warning, to highlight the risks of life-threatening infections,
    including bacterial sepsis, viral meningitis, invasive fungal
    disease, progressive multifocal leukoencephalopathy and other
    opportunistic infections with the use of Raptiva. In addition, the
    prescribing information will be updated to describe a potential risk
    for the permanent suppression of the immune system with repeat
    administration of Raptiva in children. Raptiva is not approved for
    children under 18 years of age.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Psoriasis (adult and childhood)

-   Psoriatic arthritis (PsA)

**Note**: Guideline developers did not include less common subtypes of
psoriasis, such as guttate, pustular, inverse, and erythrodermic.

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Dermatology\
Family Practice\
Internal Medicine\
Pediatrics\
Rheumatology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

-   To present guidelines on the management and treatment of adult and
    childhood psoriasis and psoriatic arthritis

-   To present an overview of classification, comorbidities, and
    assessment tools and cover biologic treatments for psoriasis

#### TARGET POPULATION

Children and adults with psoriasis and psoriatic arthritis

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Evaluation/Management/Treatment**

1.  Classification of psoriasis

2.  Evaluation of comorbidities

3.  Evaluation of psoriasis treatment using assessment tools (The
    Psoriasis Area and Severity Index \[PASI\]; the Physicians Global
    Assessment \[PGA\] and target plaque scores together with percent of
    body surface area \[BSA\] involvement)

4.  Topical therapies

5.  Ultraviolet (UV) light therapies, including narrowband (NB) and
    broadband UVB, psoralen plus ultraviolet A (PUVA), and sunlight

6.  Systemic agents, including methotrexate, cyclosporine (CyA), oral
    retinoids

7.  Biologic therapies

    -   Therapies that target pathogenic T cells, including alefacept
        and efalizumab

    -   Tumor necrosis factor (TNF) inhibitors, including adalimumab,
        etanercept, infliximab

#### MAJOR OUTCOMES CONSIDERED

-   Sensitivity, specificity and utility of assessment tools

-   Safety and efficacy of treatments

-   Adverse effects of treatment

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A work group of recognized psoriasis experts was convened to determine
the audience and scope of the guideline, and identify clinical questions
to structure the primary issues in diagnosis and management. Work group
members completed a disclosure of commercial support.

An evidence-based model was used and evidence was obtained using a
search of the MEDLINE database spanning the years 1990 through 2007.
Only English-language publications were reviewed.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)\
Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Evidence was graded using a 3-point scale based on the quality of
methodology as follows:

I.  Good-quality patient-oriented evidence.

II. Limited-quality patient-oriented evidence.

III. Other evidence including consensus guidelines, opinion, or case
     studies.

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The available evidence was evaluated using a unified system called the
Strength of Recommendation Taxonomy developed by editors of the US
family medicine and primary care journals (i.e., *American Family
Physician, Family Medicine, Journal of Family Practice*, and *British
Medical Journal USA*). This strategy was supported by a decision of the
Clinical Guidelines Task Force in 2005 with some minor modifications for
a consistent approach to rating the strength of the evidence of
scientific studies.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Clinical recommendations were developed on the best available evidence
tabled in the guideline.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

A.  Recommendation based on consistent and good quality patient-oriented
    evidence.

B.  Recommendation based on inconsistent or limited quality
    patient-oriented evidence.

C.  Recommendation based on consensus, opinion, or case studies.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

These guidelines have been developed in accordance with the American
Academy of Dermatology (AAD)/American Academy of Dermatology Association
\"Administrative Regulations for Evidence-Based Clinical Practice
Guidelines,\" which include the opportunity for review and comment by
the entire AAD membership and final review and approval by the AAD Board
of Directors.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Level of evidence grades (I-III) and strength of recommendations (A-C)
are defined at the end of the \"Major Recommendations\" field.

**[General Recommendations for the Treatment of Psoriasis]{.underline}**

Topical treatments are appropriate for patients who are candidates for
localized therapy but may not be practical as monotherapy for most
patients who are candidates for systemic and/or phototherapy (Pariser et
al., 2007), where traditional systemic treatments, including
methotrexate, cyclosporine (CyA), narrowband (NB) and broadband
ultraviolet light B (UVB), psoralen plus ultraviolet A (PUVA), oral
retinoids, and the newer biologic agents are prescribed.

1.  UVB is safe, effective, and cost-effective. NB UVB is more effective
    than broadband UVB. Up to 20 to 25 NB UVB treatments, given 2 to 3
    times a week, are usually required for significant improvement.
    Treatment can be offered in the office or at home; home UVB reduces
    the inconvenience of patients having to travel a long distance for
    treatment. Other forms of UV exposure, including sun exposure, may
    offer benefit in select patients.

2.  PUVA therapy is very effective in the majority of patients, with
    potential for long remissions. However, long-term PUVA treatment in
    Caucasians is associated with an increased risk of squamous cell
    carcinoma and possibly malignant melanoma. PUVA induces photoaging
    and other skin changes including lentigines. Ingestion of psoralen
    may also produce nausea. Oral psoralen is contraindicated in
    pregnancy. NB-UVB therapy avoids some of the adverse side effects of
    PUVA, while being slightly less effective than PUVA.

3.  Methotrexate, although effective in the majority of patients, has
    the potential for hepatotoxicity and is contraindicated in the
    following clinical scenarios: pregnancy; individuals with renal
    impairment, hepatitis, or cirrhosis; alcoholics; unreliable
    patients; and patients with leukemia or thrombocytopenia. In
    addition, drug interactions are common. Methotrexate is an
    immunosuppressive agent. In patients treated with methotrexate, drug
    interactions are common with resultant bone-marrow suppression a
    concern. Methotrexate may induce pneumonitis. Methotrexate is a
    teratogen, an abortifacient, and decreases sperm count. Prior
    guidelines suggest a liver biopsy after 1.5-g cumulative dose
    (Roenigk et al., 1988).

4.  CyA, another immunosuppressive medication, works rapidly and is
    effective in the majority of patients. However, impaired renal
    function, hypertension, concerns about lymphoma, and a potential
    increase in cutaneous malignancies are known adverse effects after
    long-term treatment with CyA. CyA is thus best used interventionally
    in short-term courses of 3 to 4 months. There are also numerous
    potential drug interactions with CyA. Guidelines exist for reducing
    the CyA dose in patients who develop hypertension or elevations in
    creatinine.

5.  Acitretin is an effective systemic agent for the treatment of
    psoriasis that is not immunosuppressive. Because it is teratogenic
    and should not be used in women who are pregnant, breast-feeding, or
    may become pregnant within 3 years of discontinuing acitretin, its
    use is substantially limited in female patients of childbearing
    potential. Mucocutaneous side effects are frequent. Dyslipidemia may
    also ensue and require dose reduction or treatment with
    lipid-lowering agents. Hepatotoxicity rarely arises during therapy.
    Acitretin is frequently used in combination therapy with UVB or
    PUVA.

6.  Biologic agents are proteins that can be extracted from animal
    tissue or produced by recombinant deoxyribonucleic acid (DNA)
    technology and possess pharmacologic activity. Five biologic agents
    are currently Food and Drug Administration (FDA) approved for
    psoriasis. Their safety and efficacy are discussed in detail in the
    original guideline document.

**[Treatment of Psoriasis with Biologics]{.underline}**

Refer to the original guideline document for general recommendations for
all patients who will be treated with biologics including T-cell
inhibitors and tumor necrosis factor (TNF) inhibitors.

**[Biologics that Target Pathogenic T Cells]{.underline}**

**Recommendations for Alefacept**

-   **Indication**: moderate to severe psoriasis

-   **Dosing**: 15 mg every week given as an intramuscular injection for
    12 weeks, with a 12-week follow-up nontreatment period

-   **Short-term Results**: 21% of patients achieved a 75% improvement
    in the Psoriasis Area and Severity Index (PASI-75) at week 14

-   **Long-term Results**:

    -   Associated with long remissions in a subset of responders

    -   Prior response to alefacept is a likely marker of future
        treatment response; thus, patients responding to the first
        course of therapy may be treated long-term with repeated 12-week
        courses of alefacept \-- at a minimum of 24-week intervals

-   **Toxicity**: excellent safety profile in clinical trials

-   **Baseline Monitoring**: CD4 count

-   **Ongoing Monitoring**: biweekly CD4 count required; hold dose for
    counts \<250

-   **Pregnancy Category**: B

-   **Contraindications**: human immunodeficiency virus (HIV) infection

**Recommendations for Efalizumab**

-   **Indication**: moderate to severe psoriasis

-   **Dosing**: 0.7 mg/kg first dose followed by 1.0 mg/kg/week
    subcutaneously

-   **Short-term Response**: 27% of patients achieve a 75% improvement
    in the Psoriasis Area and Severity Index score (PASI-75) at 3
    months)

-   **Long-term Response**: 44% to 50% of patients achieved and
    maintained a PASI-75 response in a 3-year open-label study that only
    enrolled responders

-   **Toxicities**:

    -   Flu-like symptoms frequently occur initially and generally
        disappear after the third week of treatment

    -   Thrombocytopenia, hemolytic anemia, pancytopenia, and peripheral
        demyelination have all been reported

-   **Other Issues**:

    -   Small percentage of patients may develop rebound or flare

    -   Do not discontinue treatment abruptly unless essential

    -   Not effective in psoriatic arthritis; flares and new-onset
        psoriatic arthritis have been reported in a subset of patients

-   **Baseline Monitoring**: complete blood count (CBC)

-   **Ongoing Monitoring**:

    -   CBCs monthly for the first 3 months and at periodic intervals
        thereafter

    -   Liver function test (LFT) and a periodic history and physical
        examination are recommended while on treatment

-   **Pregnancy Category**: C

**Table: The Strength of Recommendations for the Treatment of Psoriasis
Using Biologics That Target Pathogenic T Cells**

  ------------------------------------------------------------------------------
  **Recommendation**   **Strength of      **Level of   **References**
                       Recommendation**   Evidence**   
  -------------------- ------------------ ------------ -------------------------
  Alefacept            A                  I            Gordon et al.,
                                                       \"Treatment of
                                                       psoriasis,\" 2003;
                                                       Krueger & Ellis, 2003;
                                                       Ellis & Krueger, 2001;
                                                       Finlay, Salek, & Haney,
                                                       2003; Gottlieb, Boehncke,
                                                       & Darif, 2005; Krueger,
                                                       2003; Krueger et al.,
                                                       2002; Lebwohl et al.,
                                                       \"An international,\"
                                                       2003; Menter et al., 2006

  Efalizumab           A                  I            Ortonne et al., 2005;
                                                       Dubertret et al., 2006;
                                                       Lebwohl et al., \"A
                                                       novel,\" 2003; Leonardi
                                                       et al., 2005; Gordon et
                                                       al., Efalizumab for
                                                       patients,\" 2003;
                                                       Gottlieb et al.,
                                                       \"Extended efalizumab
                                                       therapy,\" 2004; Gottlieb
                                                       et al., \"Long-term
                                                       continuous efalizumab
                                                       therapy,\" 2006; Menter
                                                       et al., 2005; Menter et
                                                       al., 2006; Papp et al.,
                                                       \"Safety of efalizumab in
                                                       adults,\" 2006; Papp et
                                                       al., 2005; Papp et al.,
                                                       \"Efalizumab
                                                       retreatment,\" 2006;
                                                       Pariser et al., 2005;
                                                       Leonardi et al., 2007
  ------------------------------------------------------------------------------

**General Recommendations for Tumor Necrosis Factor (TNF) Inhibitors**

-   Anti-TNF agents are contraindicated in patients with active, serious
    infections

-   Tuberculosis testing (purified protein derivation \[PPD\]) should be
    performed on all patients who will be treated with TNF inhibitors as
    there are reports of tuberculosis reactivation in patients treated
    with this class of drug. (Desai & Furst, 2006)

-   Do not use with live vaccines; biologically inactive or recombinant
    vaccines may be considered, although the immune response of these
    vaccines could be compromised

-   Because there is an association between anti-TNF therapy and
    demyelinating diseases (i.e., multiple sclerosis \[MS\]), TNF
    inhibitors should not be used in patients with MS or other
    demyelinating diseases; first-degree relatives of patients with MS
    have an increased risk of developing MS, with a sibling relative
    risk of between 18 and 36, evidence strongly suggesting that TNF
    inhibitors should not be used in first-degree relatives of patients
    with MS.

-   Because there have been reports of new onset and worsening of
    congestive heart failure (CHF) in patients treated with TNF
    inhibitors, caution should be used when considering TNF inhibitor
    use in patients with CHF; it is recommended that patients with New
    York Heart Association class III or IV CHF avoid all use of TNF
    inhibitors and patients with class I or II CHF undergo
    echocardiogram testing; if the ejection fraction of these patients
    is \<50%, then TNF inhibitor treatment should potentially be
    avoided. (Desai & Furst, 2006)

-   Hepatitis B reactivation after treatment with TNF inhibitors has
    been reported; in the appropriate clinical setting, patients should
    be screened for hepatitis B infection.

**Recommendations for Adalimumab**

-   **Indications**: moderate to severe psoriatic arthritis, moderate to
    severe psoriasis, adult and juvenile rheumatoid arthritis (as young
    as age 4 years), ankylosing spondylitis, and Crohn\'s disease

-   **Dosing for Psoriasis**: 80 mg the first week, 40 mg the second
    week, followed by 40 mg every other week given subcutaneously

-   **Short-term Results**: 80% of patients achieve PASI-75 at 12 week

-   **Long-term Results**: 68% of patients achieve 75% improvement in
    the Psoriasis Area and Severity Index score (PASI-75) at 60 weeks

    -   Small percentage of patients lose efficacy with continued use

-   **Toxicities**:

    -   Moderately painful injection site reactions are noted

    -   Rare reports of serious infections (i.e., tuberculosis and
        opportunistic infections) and malignancies

    -   There are rare reports of drug-induced, reversible side effects
        including lupus without renal or central nervous system (CNS)
        complications, cytopenia, multiple sclerosis (MS), and
        exacerbation of and new onset of congestive heart failure (CHF)

-   **Baseline Monitoring**:

    -   Purified protein derivation (PPD) is required

    -   Liver function test (LFT), complete blood count (CBC), and
        hepatitis profile

-   **Ongoing Monitoring**:

> Periodic history and physical examination are recommended while on
> treatment
>
> Consider a yearly PPD, and periodic CBC and LFT

-   **Pregnancy Category**: B

**Recommendations for Etanercept**

-   **Indications**: moderate to severe psoriasis, moderate to severe
    psoriatic arthritis, adult and juvenile rheumatoid arthritis (as
    young as 4 years), and ankylosing spondylitis

-   **Dosing**: 50 mg twice/week given subcutaneously for 3 months
    followed by 50 mg once/week

-   **Short-term Results**: 49% of patients given 50 mg twice/week
    achieved a PASI-75 at 12 weeks; 34% of patients given 25 mg
    twice/week achieved a PASI-75 at 12 weeks

-   **Step-down Results**: 54% of patients whose dose was decreased from
    50 mg twice/week to 25 mg twice/week achieved a PASI-75 at 24 weeks;
    45% of patients whose dose remained at 25 mg twice/week achieved a
    PASI-75 at 24 weeks

-   **Toxicities**:

    -   Mildly pruritic injection site reactions may occur

    -   Rare cases of serious infections (i.e., tuberculosis) and
        malignancies

    -   There are also rare cases of drug-induced, reversible side
        effects including lupus without renal or central nervous system
        (CNS) complications, cytopenia, multiple sclerosis (MS), and
        exacerbation and new onset of congestive heart failure (CHF)

-   **Baseline Monitoring**:

    -   Purified Protein Derivation (PPD) is required

    -   Liver function test (LFT) and complete blood count (CBC)

-   **Ongoing Monitoring**:

    -   Periodic history and physical examination are recommended while
        on treatment

    -   Consider yearly PPD, and periodic CBC and LFT

-   **Pregnancy Category***:* B

-   **Contraindications**: sepsis

**Recommendations for Infliximab**

-   **Indications**: severe psoriasis, moderate to severe psoriatic
    arthritis, adult rheumatoid arthritis, ankylosing spondylitis,
    ulcerative colitis, and Crohn\'s disease

-   **Dosing**: 5 mg/kg dose infusion schedule at week 0, 2, and 6 and
    then every 6 to 8 weeks; dose and interval of infusions may be
    adjusted as needed

-   **Short-term Response**: 80% of patients achieved a PASI-75 at week
    10, 50% PASI improvement noted by week 2

-   **Long-term Response**: 61% of patients achieved a PASI-75 at week
    50

-   **Toxicities**:

    -   Infusion reactions and serum sickness can occur \-- more
        commonly in patients who have developed antibodies

    -   The incidence of infusion reactions may be reduced by concurrent
        administration of methotrexate

    -   Rare cases of serious infections (i.e., tuberculosis) and
        malignancies including hepatosplenic T-cell lymphoma (in
        children); there are rare reports of drug-induced, reversible
        side effects including lupus without renal or central nervous
        system (CNS) complications, cytopenia, multiple sclerosis (MS),
        and exacerbation of and new onset of congestive heart failure
        (CHF)

-   **Baseline Monitoring**:

    -   Purified Protein Derivation (PPD) is required

    -   Liver function test (LFT), complete blood count (CBC), and
        hepatitis profile

-   **Ongoing Monitoring**:

    -   Periodic history and physical examination are recommended while
        on treatment

    -   Consider a yearly PPD, and periodic CBC and LFT

-   **Pregnancy Category**: B

-   **Contraindications**: infliximab at doses \>5 mg/kg should not be
    given to patients with New York Heart Association functional class
    III or IV CHF

**Table: The Strength of Recommendations for the Treatment of Psoriasis
Using Tumor Necrosis Factor Inhibitors**

  ------------------------------------------------------------------------------
  **Recommendation**   **Strength of      **Level of   **References**
                       Recommendation**   Evidence**   
  -------------------- ------------------ ------------ -------------------------
  Adalimumab           A                  I            Gordon et al., \"Clinical
                                                       response,\" 2006; Menter
                                                       et al., 2008; Patel &
                                                       Gordon, 2004; Gordon,
                                                       2007

  Etanercept           A                  I            Tyring et al., 2006;
                                                       Gottlieb et al., \"A
                                                       randomized trial of
                                                       etanercept,\" 2003;
                                                       Gordon et al., \"Efficacy
                                                       of etanercept, \" 2006;
                                                       Gottlieb et al.,
                                                       \"Etanercept
                                                       monotherapy,\' 2006;
                                                       Krueger et al., 2005;
                                                       Moore et al., 2007;
                                                       Leonardi et al., 2003;
                                                       Papp et al., 2005; Paller
                                                       et al., 2008

  Infliximab           A                  I            Menter et al., 2007;
                                                       Gottlieb et al.,
                                                       \"Pharmacodynamic and
                                                       pharmacokinetic
                                                       response,\" 2003;
                                                       Chaudhari et al., 2001;
                                                       Feldman et al., 2005;
                                                       Gottlieb et al.,
                                                       \"Infliximab
                                                       monotherapy,\" 2003;
                                                       Gottlieb et al.,
                                                       \"Infliximab induction,
                                                       \" 2004; Antoni et al.,
                                                       2005; Reich et al., 2005
  ------------------------------------------------------------------------------

**[Definitions]{.underline}**:

**Levels of Evidence**

I.  Good-quality patient-oriented evidence.

II. Limited-quality patient-oriented evidence.

III. Other evidence including consensus guidelines, opinion, or case
     studies.

**Strength of Recommendations**

A.  Recommendation based on consistent and good quality patient-oriented
    evidence.

B.  Recommendation based on inconsistent or limited quality
    patient-oriented evidence.

C.  Recommendation based on consensus, opinion, or case studies.

#### CLINICAL ALGORITHM(S)

A decision tree for the treatment of psoriasis with or without psoriatic
arthritis is provided in the original guideline document.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=12505)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for selected
recommendations (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate management of psoriasis and psoriatic arthritis

#### POTENTIAL HARMS

**Adverse Effects of Treatment**

-   *Psoralen Plus Ultraviolet A (PUVA)*. Long-term PUVA treatment in
    Caucasians is associated with an increased risk of squamous cell
    carcinoma and possibly malignant melanoma. PUVA induces photoaging
    and other skin changes including lentigines. Ingestion of psoralen
    may also produce nausea.

-   *Methotrexate* has the potential for hepatotoxicity. In addition,
    drug interactions are common. Methotrexate is an immunosuppressive
    agent. In patients treated with methotrexate, drug interactions are
    common with resultant bone-marrow suppression a concern.
    Methotrexate may induce pneumonitis. Methotrexate is a teratogen, an
    abortifacient, and decreases sperm count.

-   *Cyclosporine (CyA)*. Known adverse effects after long-term
    treatment include impaired renal function, hypertension, concerns
    about lymphoma, and a potential increase in cutaneous malignancies.
    There are also numerous potential drug interactions with CyA.

-   *Acitretin* is a teratogenic. Mucocutaneous side effects are
    frequent. Dyslipidemia may also ensue and require dose reduction or
    treatment with lipid-lowering agents. Hepatotoxicity rarely arises
    during therapy.

-   *Adalimumab*: Moderately painful injection site reactions are noted.
    There are rare reports of serious infections (i.e., tuberculosis and
    opportunistic infections) and malignancies, drug-induced, reversible
    side effects including lupus without renal or central nervous system
    (CNS) complications, cytopenia, multiple sclerosis (MS), and
    exacerbation of and new onset of congestive heart failure (CHF).

-   *Etanercept*. Mildly pruritic injection site reactions may occur.
    There have been rare cases of serious infections (i.e.,
    tuberculosis) and malignancies, and cases of drug-induced,
    reversible side effects including lupus without renal or CNS
    complications, cytopenia, MS, and exacerbation and new onset of CHF.

-   *Infliximab*. Infusion reactions and serum sickness can occur more
    commonly in patients who have developed antibodies. There have been
    rare cases of serious infections (i.e., tuberculosis) and
    malignancies including hepatosplenic T-cell lymphoma (in children).
    There have also been rare reports of drug-induced, reversible side
    effects including lupus without renal or CNS complications,
    cytopenia, MS, and exacerbation of and new onset of CHF.

See the original guideline document for detailed discussions concerning
general and specific safety issues of the tumor necrosis factor (TNF)
inhibitors.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

-   *Oral psoralen* is contraindicated in pregnancy.

-   *Methotrexate* is contraindicated in the following clinical
    scenarios: pregnancy; individuals with renal impairment, hepatitis,
    or cirrhosis; alcoholics; unreliable patients; and patients with
    leukemia or thrombocytopenia.

-   Treatment with biologics (e.g., anti-TNF agents) is contraindicated
    in patients with active, serious infections. If patients develop
    serious infections (usually defined as an infection that requires
    antibiotic therapy) while being treated with a biologic agent, it is
    prudent to hold the biologic until the infection has resolved.

-   *Acitretin* is contraindicated in women who are pregnant,
    breast-feeding, or may become pregnant within 3 years of
    discontinuing acitretin.

-   *Alefacept* therapy is not indicated for patients with a CD4
    T-lymphocyte count below normal or in those who are infected with
    human immunodeficiency virus (HIV) because of the potential for
    acceleration of disease progression as a result of CD4 T-lymphocyte
    count reduction induced by alefacept. Caution should be exercised in
    patients who are at risk for or have a history of malignancy or
    infection, especially clinically significant infections.

-   *Etanercept* is contraindicated in sepsis.

-   *Infliximab* at doses \>5 mg/kg should not be given to patients with
    New York Heart Association functional class III or IV CHF.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

Adherence to these guidelines will not ensure successful treatment in
every situation. Furthermore, these guidelines do not purport to
establish a legal standard of care and should not be deemed inclusive of
all proper methods of care nor exclusive of other methods of care
reasonably directed to obtaining the same results. The ultimate judgment
regarding the propriety of any specific therapy must be made by the
physician and the patient in light of all the circumstances presented by
the individual patient.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Clinical Algorithm

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness\
Safety

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon
KB, Lebwohl M, Koo JY, Elmets CA, Korman NJ, Beutner KR, Bhushan R.
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
May;58(5):826-50. \[177 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18423260)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2008 May

#### GUIDELINE DEVELOPER(S)

American Academy of Dermatology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Academy of Dermatology operational funds and member volunteer
time supported the development of this guideline.

#### GUIDELINE COMMITTEE

American Academy of Dermatology Work Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Work Group Members*: Alan Menter, MD, *Chair*, Baylor University
Medical Center, Dallas; Alice Gottlieb, MD, PhD, Department of
Dermatology, Tufts-New England Medical Center, Tufts University School
of Medicine, Boston; Steven R. Feldman, MD, PhD, Department of
Dermatology, Wake Forest University School of Medicine, Winston-Salem;
Abby S. Van Voorhees, MD, Department of Dermatology, University of
Pennsylvania; Craig L. Leonardi, MD, Saint Louis University; Kenneth B.
Gordon, MD, Division of Dermatology, Evanston Northwestern Healthcare
and Department of Dermatology, Northwestern University, Fienberg School
of Medicine, Chicago; Mark Lebwohl, MD, Department of Dermatology, Mount
Sinai School of Medicine, New York; John Y. M. Koo, MD, Department of
Dermatology, University of California - San Francisco; Craig A. Elmets,
MD, Department of Dermatology, University of Alabama at Birmingham; Neil
J. Korman, MD, PhD, Murdough Family Center For Psoriasis, Department of
Dermatology, University Hospitals Case Medical Center, Cleveland; Karl
R. Beutner, MD, PhD, Anacor Pharmaceuticals Inc, Palo Alto; Reva
Bhushan, PhD, American Academy of Dermatology, Schaumburg

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Alan Menter: MD, Chair, Psoriasis Work Group. Dr Menter served on the
Advisory Board and was a consultant, investigator and speaker for Abbott
Labs, Amgen, and Centocor, receiving grants and honoraria; served on the
Advisory Board and was an investigator and consultant for Cephalon and
UCB, receiving grants and honoraria; was a consultant, investigator, and
speaker for Warner Chilcott and Wyeth, receiving honoraria; served on
the Advisory Board and was an investigator for Galderma and Genentech,
receiving grants and honoraria; was a consultant and investigator for
Allergan and Astellas, receiving grants and honoraria; as an
investigator for Collagenex, CombinatoRx, Dow, Ferndale, Leo, Medicis,
Photocure, Pierre Fabre, 3M Pharmaceuticals and XOMA, receiving grants;
and was an investigator for Connetics, receiving grants and honorarium.

Alice Gottlieb, MD, PhD: Dr Gottlieb served as a speaker for Amgen Inc
and Wyeth Pharmaceuticals; has current consulting/advisory board
agreements with Amgen Inc, Centocor, Inc, Wyeth Pharmaceuticals, Celgene
Corp, Bristol Myers Squibb Co, Beiersdorf, Inc, Warner Chilcott, Abbott
Labs, Roche, Sankyo, Medarex, Kemia, Celera, TEVA, Actelion, UCB, Novo
Nordisk, Almirall, Immune Control, RxClinical, Dermipsor Ltd, Medacorp,
DermiPsor, Can-Fite, Incyte; and has received research/educational
grants from Centocor, Amgen, Wyeth, Immune Control, Celgene, Pharmacare,
Incyte. All income has been paid to her employer directly.

Steven R. Feldman, MD, PhD: Dr Feldman served on the Advisory Board and
was investigator and speaker for Galderma, Stiefel, Warner Chilcott,
Abbott Labs and Astellas, receiving grants and honoraria; served on the
Advisory Board for Photomedex, receiving stock options; served on the
advisory board and was speaker for National Psoriasis Foundation,
receiving honoraria; and was an investigator and speaker for Amgen,
Centocor and Genentech, receiving grants and honoraria.

Abby S. Van Voorhees, MD: Dr Van Voorhees served on the Advisory Board,
was an investigator and speaker for Amgen and Genentech, receiving
grants and honoraria; investigator for Astellas, IDEC and Roche,
receiving grants; Advisory Board and investigator for Birstol Myers
Squibb and Warner Chilcott, receiving grants and honoraria; Advisory
Board and was speaker for Abbott Labs and Centocor, receiving honoraria;
served on the Advisory Board for Connetics, receiving honoraria; was
consultant for Incyte and Xtrac and VGX and has received honoraria from
Synta for another function. Dr. Van Voorhees\' spouse is an employee
with Merck receiving a salary, stock and stock options.

Craig L. Leonardi, MD: Dr Leonardi served on the Advisory Board and was
consultant, investigator, and speaker for Abbott Labs, Amgen, Centocor,
Genentech, receiving honoraria, other financial benefit, and grants for
Amgen and Genentech; was speaker for Warner Chillcott receiving
honoraria; was on the Advisory Board and was investigator for Serano
receiving honoraria and other financial benefit; was investigator for
Astellas, Biogen, Bristol Myers, Allergun, Fujisawa, CombinatorRx, and
Vitae receiving other financial benefit.

Kenneth B. Gordon, MD: Dr Gordon served on the Advisory Board and was
consultant, investigator, and speaker for Abbott Labs, Amgen, and a
consultant and investigator for Centocor, receiving grants and
honoraria; and was investigator for Genentech, receiving grants.

Mark Lebwohl, MD: Dr Lebwohl served on the Advisory Board and was
consultant, investigator, and speaker for Abbott Labs, Amgen, Centocor,
Galderma, Genentech, and Warner Chilcott, receiving honoraria and
grants; served on the Advisory Board and was consultant, investigator,
and speaker for Stiefel, receiving honoraria; was consultant and
investigator for Astellas, receiving grants and honoraria; was
consultant for Biogen, UCB and Isotechnika, receiving honoraria; was on
the Advisory Board and was consultant and investigator for Novartis,
receiving grants and honoraria; and had an \"other\" relationship with
PharmaDerm receiving grants and honoraria.

John Y. M. Koo, MD: Dr Koo served on the Advisory Board, was speaker,
consultant, and investigator for Amgen, Abbott Labs, Astellas, Warner
Chilcott, and Galderma, receiving grants and honoraria; was investigator
for Genentech, receiving grants; and was an Advisory Board consultant
and investigator for Teikokio, receiving compensation.

Craig A. Elmets, MD: Dr Elmets has served on the Advisory Board and was
investigator for Amgen and Abbott Labs, receiving grants and honoraria;
was consultant for Astellas, receiving honoraria; and was an
investigator for Genentech and Connetics, receiving grants.

Neil J. Korman, MD, PhD: Dr Korman has served on the Advisory Board and
was investigator and speaker for Abbott Labs, Genentech and Astellas,
receiving grants and honoraria; served on the Advisory Board and was
investigator for Centocor, receiving grants and residency/fellowship
program funding; and was investigator and speaker for Amgen, receiving
grants and honoraria.

Karl R. Beutner, MD, PhD: Chair, Clinical Research Committee. Dr Beutner
was an employee of Anacor, receiving salary, stock and stock options and
had other relationships and received stock from Dow Pharmaceutical
Sciences.

Reva Bhushan, PhD: Dr. Bhushan had no relevant conflicts of interest to
disclose.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from
[American Academy of Dermatology Web
site](http://www.aad.org/education/grants/_doc/Psosection1.pdf).

Print copies: Available from the AAD, PO Box 4014, Schaumburg, IL
60168-4014, Phone: (847) 330-0230 ext. 333; Fax: (847) 330-1120; Web
site: [www.aad.org](http://www.aad.org/).

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on June 30, 2008. The
information was verified by the guideline developer on July 16, 2008.
This summary was updated by ECRI Institute on October 30, 2008 following
the U.S. Food and Drug Administration advisory on Raptiva (efalizumab).

#### COPYRIGHT STATEMENT

The American Academy of Dermatology Association places no restriction on
the downloading, use, or reproduction of its guidelines.

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008