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• As guidelines evolve, individual patient preferences, history of nonmelanoma skin cancer (NMSC), pregnancy
disease severity, and comorbid conditions remain and lactation, and specific contraindications to therapy
important considerations when selecting treatment (eg, renal failure, liver disease, active malignancy) should be
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agents for psoriasis. considered. In this article, we summarize common themes
• More frequent updates to psoriasis treatment guide- across existing guidelines and consensus statements for the
lines are becoming increasingly important given the treatment of psoriasis and highlight areas where there is
rapid changes in the field. consistent agreement or lack of sufficient information.
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Disease Severity and Treatment Outcomes
Psoriasis is a complex chronic autoimmune skin disease with mul- There currently are no consensus definitions for mild,
tiple comorbidities that can have a considerable impact on quality of moderate, and severe psoriasis, but several consensus state-
life (QoL). As therapeutic options evolve, physicians should look to
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soriasis is a chronic autoinflammatory disorder affect- aged with local and topical therapy, and moderate to severe
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ing approximately 2% to 4% of the Western popula- psoriasis typically warrants consideration for escalated treat-
tion.1 While there is no absolute cure for psoriasis, ment with phototherapy or systemic agents.
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novel therapies allow for substantial reduction in symptoms Most definitions of disease severity in psoriasis refer-
and considerable improvement in quality of life (QoL). In ence 5% to 10% BSA involvement as a cutoff that should
the past few years, multiple treatment guidelines (recom- trigger consideration of systemic treatment; however,
mendations based on evidence-based literature reviews) these criteria could result in undertreatment of patients
and consensus statements (a set of declarations determined with substantial disease. For example, patients who
and voted on by a panel of experts in the field) have been have limited BSA involvement but whose disease has a
developed to guide physicians worldwide in treating psoria- considerable impact on QoL, as well as those who have
sis in the clinical setting (eTable).2-10 debilitating disease in localized areas (eg, palms, soles,
Because psoriasis is a complex disease with multiple scalp, nails) or substantial joint involvement may also be
comorbidities, applicability of these guidelines may be appropriate candidates for systemic treatment.5,8
Ms. Golbari is from the School of Medicine, Stony Brook University, New York. Drs. Porter and Kimball are from the Clinical Laboratory for
Epidemiology and Applied Research in Skin, Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Ms. Golbari reports no conflict of interest. Dr. Porter has received fellowship funding from the National Psoriasis Foundation. Dr. Kimball is a
consultant for Abbvie Inc; Eli Lilly and Company; Janssen Pharmaceuticals, Inc; Novartis; and UCB, Inc and is an investigator for AbbVie Inc, and
UCB, Inc. She also has received fellowship funding from AbbVie Inc and Janssen Pharmaceuticals, Inc.
The eTable is available in the Appendix online at www.mdedge.com/cutis.
Correspondence: Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center, 375 Longwood Ave, Boston, MA 02215
(clears@bidmc.harvard.edu).
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PSORIASIS TREATMENT GUIDELINES
Once therapy is initiated, patients should be evaluated of serum biomarkers for liver function also can be used to
for appropriate treatment response at dedicated intervals. monitor noninvasively for hepatotoxicity before biopsy is
While the time to maximum therapeutic benefit depends considered; these recommendations are likely to be incorpo-
on the agent of choice, European guidelines recommend rated into newer guidelines in development.12 Methotrexate
that patients be evaluated after an induction phase (typically has demonstrated safety and increased efficacy when used
16–24 weeks) and define treatment success as either (1) at least in combination with biologic agents such as adalimumab,
75% improvement in PASI or (2) at least 50% improvement etanercept, infliximab, and secukinumab7 and has been stud-
in PASI and a Dermatology Quality of Life Index (DLQI) score ied in combination with many biologics indicated for PsA.13
of 5 or lower.6 Due to a considerable risk of glomerulosclerosis,
Alternatively, the National Psoriasis Foundation (NPF) cyclosporine is approved for a maximum of 1 year of con-
recommended BSA as the preferred outcome measure in a tinuous treatment of psoriasis in the United States and
recent consensus statement and concluded that an outcome 2 years in Europe.5,7 Cyclosporine is best used as induc-
of 3% or less BSA involvement or improvement in BSA of tion therapy in psoriasis patients with severe disease who
75% or more is considered a desirable treatment response.9 are seeking faster abatement of symptoms.
Additionally, the Medicare Merit-based Incentive Payment Acitretin is another systemic treatment option,
System (MIPS) guidelines for successful systemic treatment although efficacy of this agent is dose dependent. Higher
response include at least 1 of the following: (1) physician dosing often is limited due to lower tolerability.5
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global assessment score of 2 or lower, (2) BSA involvement Given that many insurance formularies primarily cover
of less than 3%, (3) PASI score lower than 3, or (4) DLQI traditional systemic therapies and that MTX and pho-
score of 5 or lower.10 totherapy are generally well tolerated and cost effective,
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Although an array of outcome measures have been uti- patients may need to be treated with traditional agents
lized in clinical trials and proposed in psoriasis guidelines before escalating to biologics. Prior to starting treatment
and consensus statements, BSA is typically a manageable with any biologic, patients should typically be screened for
measure of treatment response in a clinical setting; how- tuberculosis (TB), human immunodeficiency virus infec-
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ever, DLQI should also be assessed if possible, particularly tion, and immunization for, exposure to, and/or infection
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in patients with debilitating localized disease.9 with hepatitis B and C virus, and any other active infec-
tions. In patients who do not demonstrate hepatitis immu-
Treatment Options nity, the hepatitis B vaccine should be administered prior
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Because topical treatment regimens can be arduous and to starting treatment with a biologic.14 In psoriasis patients
typically do not result in sustained clearance, patient expec- with latent TB, 2 months of treatment should be completed
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tations should be ascertained prior to initiation of therapy. before initiating biologic therapy8; once a biologic has been
Topical corticosteroids often can be used as monotherapy in initiated, all patients should be screened annually for TB.
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patients with mild psoriasis.3 Topical vitamin D analogues European guidelines for biologic treatment recom-
and retinoids also can be effective; however, combined use mend that complete blood count and liver and renal
of these agents with topical steroids should be considered function be evaluated at baseline, at months 1 and 3 of
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to increase efficacy, and combination formulations can be treatment, and then every 3 to 6 months thereafter while
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prescribed to simplify application and improve adherence. on the biologic agent.7 These recommendations are more
Treatment with UVB or psoralen plus UVA photo- stringent than those indicated in regulatory labeling and,
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therapy is recommended for patients with moderate to based on the continual accumulation of data regarding
severe psoriasis as well as in those who have had minimal the safety of these agents, some investigators have argued
response to topical therapy.4 Targeted phototherapy with that laboratory testing might not be necessary at all.15
an excimer laser can be used in patients with BSA involve-
ment of less than 10%. Treatment in Special Populations
Methotrexate (MTX), cyclosporine, and acitretin are the Psoriasis patients often present with comorbidities or a com-
most commonly prescribed systemic medications for severe plicated medical history, which can make it challenging to
psoriasis in the United States.5 Despite the risk for hepato- decide which therapy is most suitable. Patients with comorbid
toxicity, MTX appears to have the best combined safety and diseases (eg, PsA, risk of major cardiac event, IBD) or a history
efficacy profile in terms of serious adverse events compared of NMSC and those who are pregnant or are lactating require
to other systemic agents.11 Guidelines for MTX monitoring, special considerations to ensure treatment safety and efficacy.
especially with regard to when to do a liver biopsy, have been Tumor necrosis factor α (TNF-α) and IL-17 inhibitors
substantially liberalized over time, and the recommended are used in the treatment of joint disorders and should
interval for biopsy has been extended by years; biopsy was be considered in patients with PsA. IL-23/IL-12 inhibi-
previously recommended after a cumulative MTX dose of tion appears to have less benefit in patients with PsA,
1 to 1.5 g, but guidelines now suggest biopsy after 3.5 to but studies on IL-23 inhibition (p19 antibodies) alone
4 g in low-risk patients.5 While abnormally elevated liver are ongoing.16 It has been reported that TNF-α inhibi-
function tests during treatment with MTX may necessitate tion may be beneficial in patients at risk for major cardiac
liver biopsy, the use of transient elastography and a panel events.8,17 In patients with IBD, IL-17 inhibitors should be
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Recommendations for biologic treatment in psoriasis patients
2011;303:1-10.
who are pregnant or lactating also are limited. European guide- 7. Nast A, Gisondi P, Ormerod AD, et al. European S3-guidelines on the sys-
lines have noted pregnancy as an absolute contraindication temic treatment of psoriasis vulgaris—update 2015—short version—EDF
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to treatment with biologics,7 but the regulatory guidance has in cooperation with EADV and IPC [published online October 9, 2015].
recently changed for some agents, so this recommendation J Eur Acad Dermatol Venereol. 2015;29:2277-2294.
8. Smith CH, Jabbar-Lopez ZK, Yiu ZZ, et al. British Association of
also may evolve.21 British8 and US5 guidelines do not consider
Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J
pregnancy a contraindication for treatment with biologics.
t Dermatol. 2017;177:628-636.
Information on the safety of TNF-α antagonists during
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9. Armstrong AW, Siegel MP, Bagel J, et al. From the medical board of the
pregnancy comes primarily from use in patients with IBD National Psoriasis Foundation: treatment targets for plaque psoriasis. J Am
and rheumatologic disease. To date, reports on the incidence Acad Dermatol. 2017;76:290-298.
of congenital malformations have been generally reassuring. 10. Quality ID #410: psoriasis: clinical response to oral systemic or biologic
medications—national quality strategy domain: person and caregiver-
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Because IgG antibodies are actively transferred across the centered experience and outcomes. Centers for Medicare and Medicaid
placenta in the late-second or the third trimesters, neonates
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should be avoided in neonates whose mothers were treated treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane
Database of Syst Rev. 2017;12:CD011535.
with IgG-based biologics. 12. Lynch M, Higgins E, McCormick PA, et al. The use of transient elastography
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Patients may need to stop and change treatment agents 13. Behrens F, Canete J, Olivieri I, et al. Tumor necrosis factor inhibitor mono-
due to ineffectiveness, personal preference, or worsening therapy versus combination with MTX in the treatment of PsA: a systemic
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PSORIASIS TREATMENT GUIDELINES
APPENDIX
eTABLE. Current Guidelines and Consensus Statements for the Treatment of Psoriasis
Treatment Algorithm
and Laboratory
Outcome Measure(s) For Monitoring
Type of Proposed Classification of Evaluation After Treatment Recommendations
Group (Year) Document Disease Severity Initiation Provided?
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American Guidelines Candidates for topical Improvement in PASI of Yes
Academy of therapy: BSA<5%; ≥75% from baseline
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Dermatology3-5 candidates for phototherapy
(2009) and systemic therapy:
BSA>10%
European Consensus Mild: BSA≤10 + PASI≤10 Treatment success: No
consensus statement + DLQI≤10; moderate
t Improvement in PASI of
no
program6 to severe: BSA>10 ≥75% from baseline;
(2011) + DLQI>10 or PASI>10 treatment failure:
+ DLQI>10 improvement in PASI
<50%; for patients in whom
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treatment response is
between PASI 50%-75%, a
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British Association Guidelines Candidates for biologic ≥50% improvement in PASI Yes
of Dermatologists8 therapy: DLQI>10 or BSA from baseline, DLQI
(2017) + PASI≥10, or BSA>10 improvement of ≥4 points
National Psoriasis Consensus None Acceptable: improvement No
Foundation9 statement in BSA≥75% from baseline
(2017) or ≥3% BSA; target:
≥1% BSA
MIPS Quality None One of the following: No
(2018)10 Measure PGA≤2 (clear to mild skin
disease), BSA<3%,
PASI<3, DLQI≤5
Abbreviations: BSA, body surface area; N/A, not available; PASI, psoriasis area and severity index; DLQI, Dermatology Quality of Life Index;
PGA, physician global assessment; MIPS, Merit-based Incentive Payment System.