Box 1.

Recommendations for Currently Approved TNF Inhibitors*

Box 2.

General Safety Recommendations for TNF Inhibitors⁶²

Table 1.

Definition of Subtypes of PsA

Table 2.

Comparative Primary End Point Data for Currently Approved TNF Inhibitors

Gottlieb, A. et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J. Am. Acad. Dermatol. 58, 851-864 (2008).
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Gladman, D. D., Farewell, V. T., Wong, K. & Husted, J. Mortality studies in psoriatic arthritis: results from a single outpatient center. II. Prognostic indicators for death. Arthritis Rheum. 41, 1103-1110 (1998).
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Kavanaugh, A. F. & Ritchlin, C. T. Systematic review of treatments for psoriatic arthritis: an evidence based approach and basis for treatment guidelines. J. Rheumatol. 33, 1417-1421 (2006).
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Menter, A. et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J. Am. Acad. Dermatol. 62, 114-135 (2010).
Laine, L. Nonsteroidal anti-inflammatory drug gastropathy. Gastrointest. Endosc. Clin. N. Am. 6, 489-504 (1996).
Gislason, G. H. et al. Increased mortality and cardiovascular morbidity associated with use of nonsteroidal anti-inflammatory drugs in chronic heart failure. Arch. Intern. Med. 169, 141-149 (2009).
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Dore, R. K. How to prevent glucocorticoid-induced osteoporosis. Cleve. Clin. J. Med. 77, 529-536 (2010).
[No authors listed] Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis: 2001 update. American College of Rheumatology Ad Hoc Committee on Glucocorticoid-Induced Osteoporosis. ArthritisRheum. 44, 1496-1503 (2001).
Black, R. L. et al. Methotrexate therapy in psoriatic arthritis; double-blind study on 21 patients. JAMA 189, 743-747 (1964).
Willkens, R. F. et al. Randomized, double-blind, placebo controlled trial of low-dose pulse methotrexate in psoriatic arthritis. ArthritisRheum. 27, 376-381 (1984).
Chandran, V., Schentag, C. T. & Gladman, D. D. Reappraisal of the effectiveness of methotrexate in psoriatic arthritis: results from a longitudinal observational cohort. J. Rheumatol. 35, 469-471 (2008).
Lie, E. et al. Effectiveness and retention rates of methotrexate in psoriatic arthritis in comparison with methotrexate-treated patients with rheumatoid arthritis. Ann. Rheum. Dis. 69, 671-676 (2010).
Menter, A. et al. 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. 58, 826-850 (2008) .
Kalb, R. E., Strober, B., Weinstein, G. & Lebwohl, M. Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference. J.Am. Acad. Dermatol. 60, 824-837 (2009).
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Nash, P., Thagi, D., Behrens, F., Falk, F. & Kaltwasser, J. P. Leflunomide improves psoriasis in patients with psoriatic arthritis: an in-depth analysis of data from the TOPAS study. Dermatology 212, 238-249 (2006).
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Gottlieb, A. et al. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet 373, 633-640 (2009).
Menter, A. et al. 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. Dermatol. 56, 31.e1-31.e15 (2007).
Pitarch, G., Sanchez-Carazo, J. L., Mahiques, L. & Oliver, V. Efficacy of etanercept in psoriatic patients previously treated with infliximab. Dermatology 216, 312-316 (2008).
Haberhauer, G., Strehblow, C. & Fasching, P. Observational study of switching anti-TNF agents in ankylosing spondylitis and psoriatic arthritis versus rheumatoid arthritis. Wien. Med. Wochenschr. 160, 220-224 (2010).
Haraoui, B. et al. Clinical outcomes of patients with rheumatoid arthritis after switching from infliximab to etanercept. J. Rheumatol. 31, 2356-2359 (2004).
Sandborn, W. J. et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann. Intern.Med. 146, 829-838 (2007).
Maini, R. N. et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. 41, 1552-1563 (1998).
Atzeni, F. & Sarzi-Puttini, P. Autoantibody production in patients treated with anti-TNF-alpha. Expert Rev. Clin. Immunol. 4, 275-280 (2008).
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Mease, P. J. et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. ArthritisRheum. 52, 3279-3289 (2005).
Gladman, D. D. et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum. 56, 476-488 (2007).
Mease, P. J. et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann. Rheum. Dis. 68, 702-709 (2009).
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Mease, P. J. et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 50, 2264-2272 (2004).
Sterry, W. et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ 340, c147 (2010).
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Author(s)

Caroline A. Chang, MD

Department of Dermatology, Tufts Medical Center, Boston, Massachusetts

Disclosures

Disclosure: Caroline A. Chang, MD, has disclosed no relevant financial relationships.

Alice B. Gottlieb, MD, PhD

Department of Dermatology, Tufts Medical Center, Boston, Massachusetts

Disclosures

Disclosure: Alice B. Gottlieb, MD, PhD, has disclosed the following relevant financial relationships:
Served on the advisory board for and is a recipient of honoraria from: Abbott Laboratories; Actelion, Pharmaceuticals, Ltd; Amgen Inc.; Astellas Beiersdorf; Bristol-Myers Squibb Company; Celgene Corporation; Centocor Ortho Biotech Inc.; Cytokine PharmaSciences; Novo Nordisk; UCB Pharma, Inc.
Served as a consultant for and is a recipient of honoraria from: Alnylam Pharmaceuticals; Amgen Inc.; BIND Biosciences; Can-Fite BioPharma; Celgene Corporation; Incyte Corporation; Merck & Co., Inc.; Ono Pharmaceutical Co., Ltd.; Pharmaceutical Product Development, Inc.; Puretech, Schering-Plough Corporation
Served as investigator for and recipient of research grants and/or honoraria from: Abbott Laboratories; Amgen Inc.; Centocor Ortho Biotech, Inc.; Immune Control; Novo Nordisk; UCB Pharma, Inc.
Received unspecified grants from: Amgen Inc.; Centocor Ortho Biotech, Inc.
Received unspecified honoraria from: DermiPsor

Paul F. Lizzul, MD, PhD, MPH, MBA

Department of Dermatology, Tufts Medical Center, Boston, Massachusetts

Disclosures

Disclosure: Paul F. Lizzul, MD, PhD, MPH, MBA, has disclosed the following relevant financial relationships:
Served as investigator and grant recipient for: Centocor Ortho Biotech, Inc.
Served as investigator for and received grants from: Abbott Laboratories; Amgen Inc.; Immune Control; Novo Nordisk

Editor(s)

Jenny Buckland

Chief Editor, Nature Reviews Rheumatology

Disclosures

Disclosure: Jenny Buckland has disclosed no relevant financial relationships.

CME Author(s)

Charles P. Vega, MD

Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine

Disclosures

Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Sarah Fleischman

CME Program Manager, Medscape, LLC

Disclosures

Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.

CME

Management of Psoriatic Arthritis From the View of the Dermatologist

Authors: Caroline A. Chang, MD; Alice B. Gottlieb, MD, PhD; Paul F. Lizzul, MD, PhD, MPH, MBA
CME Released: 9/13/2011
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 9/13/2012, 11:59 PM EST

Start Activity

Target Audience and Goal Statement

This activity is intended for primary care physicians, dermatologists, rheumatologists, and other physicians who care for patients with psoriasis.

The goal of this activity is to analyze the evaluation and management of PsA.

Upon completion of this activity, participants will be able to:

Assess the epidemiology and clinical presentation of PsA
Evaluate the prognosis of patients with PsA
Distinguish first-line treatment for mild PsA
Analyze the use of disease-modifying drugs for PsA

Disclosures

Author(s)

Caroline A. Chang, MD

Department of Dermatology, Tufts Medical Center, Boston, Massachusetts

Disclosures

Disclosure: Caroline A. Chang, MD, has disclosed no relevant financial relationships.

Alice B. Gottlieb, MD, PhD

Department of Dermatology, Tufts Medical Center, Boston, Massachusetts

Disclosures

Disclosure: Alice B. Gottlieb, MD, PhD, has disclosed the following relevant financial relationships:
Served on the advisory board for and is a recipient of honoraria from: Abbott Laboratories; Actelion, Pharmaceuticals, Ltd; Amgen Inc.; Astellas Beiersdorf; Bristol-Myers Squibb Company; Celgene Corporation; Centocor Ortho Biotech Inc.; Cytokine PharmaSciences; Novo Nordisk; UCB Pharma, Inc.
Served as a consultant for and is a recipient of honoraria from: Alnylam Pharmaceuticals; Amgen Inc.; BIND Biosciences; Can-Fite BioPharma; Celgene Corporation; Incyte Corporation; Merck & Co., Inc.; Ono Pharmaceutical Co., Ltd.; Pharmaceutical Product Development, Inc.; Puretech, Schering-Plough Corporation
Served as investigator for and recipient of research grants and/or honoraria from: Abbott Laboratories; Amgen Inc.; Centocor Ortho Biotech, Inc.; Immune Control; Novo Nordisk; UCB Pharma, Inc.
Received unspecified grants from: Amgen Inc.; Centocor Ortho Biotech, Inc.
Received unspecified honoraria from: DermiPsor

Paul F. Lizzul, MD, PhD, MPH, MBA

Department of Dermatology, Tufts Medical Center, Boston, Massachusetts

Disclosures

Disclosure: Paul F. Lizzul, MD, PhD, MPH, MBA, has disclosed the following relevant financial relationships:
Served as investigator and grant recipient for: Centocor Ortho Biotech, Inc.
Served as investigator for and received grants from: Abbott Laboratories; Amgen Inc.; Immune Control; Novo Nordisk

Editor(s)

Jenny Buckland

Chief Editor, Nature Reviews Rheumatology

Disclosures

Disclosure: Jenny Buckland has disclosed no relevant financial relationships.

CME Author(s)

Charles P. Vega, MD

Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine

Disclosures

Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

Nafeez Zawahir, MD

CME Clinical Director, Medscape, LLC

Disclosures

Disclosure: Nafeez Zawahir, MD, has disclosed no relevant financial relationships.

Sarah Fleischman

CME Program Manager, Medscape, LLC

Disclosures

Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.

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Assessment of PsA

The Outcome Measures in Rheumatology (OMERACT) initiative and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) consortium developed a set of six core domains that should be included in all clinical trials for PsA. The fields assessed are peripheral joint activity, skin activity, patient global assessment, pain assessment, physical function and health-related quality of life.^[17]

Quality of Life Tools

The Stanford Health Assessment Questionnaire (HAQ) is easily administered and widely used to predict productivity, morbidity, healthcare utilization, healthcare costs and death associated with rheumatic diseases;^[18] however, this questionnaire has limited relevance for patients with PsA as it does not assess the dermatologic effect of psoriasis. As a consequence, the HAQ-Skin (HAQ-SK) was developed as a PsA-specific tool. HAQ-SK is a short questionnaire that addresses the functional, but not the social or psychological, aspects of psoriasis.^[19]The Psoriatic Arthritis Quality of Life (PsAQoL) tool was later developed to determine the impact of PsA on functional, social, psychological and vocational needs.^[17,20]PsAQoL is an easily administered test in which patients provide 'true' or 'false' answers to a set of 20 questions. Although PsAQoL has demonstrated good reliability, more studies are needed to determine its correlation with treatment effects.^[21]

Treatment Efficacy Tools

Tools to assess treatment efficacy in PsA rely heavily on the standard criteria used to assess rheumatoid arthritis (RA).

ACR20. According to the American College of Rheumatology (ACR) criteria for 20% improvement (ACR20), an improvement of at least 20% in swollen and tender joint count and in three of five other measures (erythrocyte sedimentation rate or C-reactive protein level; physician global assessment of disease activity; patient global assessment of disease activity; patient pain assessment; disability) is indicative of treatment efficacy in patients with PsA.^[22]

DAS28. The Disease Activity Score (DAS)-28 includes the assessment of 28 joints and was originally developed for patients with RA.^[23] DAS28 comprises the following measures: tender joint count; swollen joint count; patient's assessment of pain; patient's and physician's global assessments of disease activity; patient's assessment of physical function; and laboratory evaluation of one acute-phase reactant. However, the joints usually involved in PsA, such as the distal interphalangeal joints of the hands, are not included in the DAS28 assessment. As a consequence, disease activity might be missed with these criteria. In addition, the inclusion of a square root in the DAS28 formula necessitates the use of a calculator in the clinic. Whereas most rheumatologists have access to a hand-held tool that easily calculates the DAS28 score, dermatologists do not have access to or use such a device.

PsARC. The Psoriatic Arthritis Response Criteria (PsARC) were created for a study of sulfasalazine in patients with PsA.^[24]PsARC response is defined by improvement in joint swelling or tenderness in association with improvement in any of four other measures (patient global assessment of articular disease; physician global assessment of articular disease; joint pain or tenderness; joint swelling).^[24,25]Nonetheless, PsARC determines only relative changes from baseline, overestimates the number of responders, has not been formally validated, and is not widely used.

EULAR. The European League Against Rheumatism (EULAR) criteria defines a good response to treatment based on DAS or DAS28 score. Response is measured as improvement in DAS or DAS28 >1.2 and reaching DAS <2.4 or DAS28 <3.2. A study that compared the efficacy of response criteria found that the EULAR criteria were better than ACR20 or PsARC for distinguishing the effects of a TNF inhibitor from placebo in patients with PsA.^[26] However, all three criteria showed improvement in the treatment group and are probably most relevant for PsA patients with active polyarticular disease.

DAPSA. The Disease Activity Index for Psoriatic Arthritis (DAPSA) is derived from the Disease Activity Index for Reactive Arthritis (DAREA) assessment tool; it measures the number of swollen and tender joints, the patient's pain and global assessment, and levels of C-reactive protein. This tool is a useful measure of disease activity for PsA.^[27]

PsAJAI. The PsA Joint Activity Index (PsAJAI) is a simplified score based on ACR30, which involves the weighted sum of 30% improvement in several core measures. This tool is useful as an outcome measure for assessing the response of joint disease in PsA clinical trials.^[28]

CPDAI. The Composite Psoriatic Disease Activity Index (CPDAI) assesses five domains (peripheral arthritis; skin disease; enthesitis; dactylitis; and spinal disease) on a scale of mild (1 point), moderate (2 points) or severe (3 points) in an attempt to create a single composite score for both skin and joint disease. Definitions of what constitutes mild, moderate and severe disease have been defined by the authors and are not universally accepted. CPDAI can distinguish between patients who require a change in treatment regimen and those who do not.^[29]

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Page 2 of 8

Long-term Consequences of PsA

CME Information

References

Box 1.

Box 2.

Table 1.

Table 2.

CME

Management of Psoriatic Arthritis From the View of the Dermatologist

Target Audience and Goal Statement

Disclosures

Author(s)

Caroline A. Chang, MD

Alice B. Gottlieb, MD, PhD

Paul F. Lizzul, MD, PhD, MPH, MBA

Editor(s)

Jenny Buckland

CME Author(s)

Charles P. Vega, MD

CME Reviewer(s)

Nafeez Zawahir, MD

Sarah Fleischman

Accreditation Statements

For Physicians

Instructions for Participation and Credit

Management of Psoriatic Arthritis From the View of the Dermatologist: Assessment of PsA

Assessment of PsA

Quality of Life Tools

Treatment Efficacy Tools

Table of Contents

Box 1.

Box 2.

Table 1.

Table 2.

References

Faculty and Disclosures

Author(s)

Caroline A. Chang, MD

Alice B. Gottlieb, MD, PhD

Paul F. Lizzul, MD, PhD, MPH, MBA

Editor(s)

Jenny Buckland

CME Author(s)

Charles P. Vega, MD

CME Reviewer(s)

Nafeez Zawahir, MD

Sarah Fleischman

CME

Management of Psoriatic Arthritis From the View of the Dermatologist

Target Audience and Goal Statement

Disclosures

Author(s)

Caroline A. Chang, MD

Alice B. Gottlieb, MD, PhD

Paul F. Lizzul, MD, PhD, MPH, MBA

Editor(s)

Jenny Buckland

CME Author(s)

Charles P. Vega, MD

CME Reviewer(s)

Nafeez Zawahir, MD

Sarah Fleischman

Accreditation Statements

For Physicians

Instructions for Participation and Credit

Management of Psoriatic Arthritis From the View of the Dermatologist: Assessment of PsA

Assessment of PsA

Quality of Life Tools

Treatment Efficacy Tools

Table of Contents