Standards of Care

Selection of an appropriate treatment regimen is tailored to individual patients based on disease severity, measured by body surface area, disease location, presence of psoriatic arthritis, impact on quality of life, and previous responses or contraindications to psoriatic therapies. Specific psoriasis treatment algorithms have been developed by leaders in the field and are previously published. Topical therapies are selected as a monotherapy for localized disease but are not appropriate for more widespread cutaneous lesions, severe involvement of the palmoplantar surfaces, genitalia, scalp, or nails, and psoriatic arthritis. In these cases systemic treatments are required, such as cyclosporine, oral retinoids (in the absence of psoriatic arthritis), methotrexate, apremilast or biologic agents. Currently biologic agents are the gold standard for the systemic treatment of psoriasis and psoriatic arthritis with more rapid and complete control of disease signs and symptoms and a more favorable side effect profile.

Current Practice

Despite the increasing number of highly efficacious and safe treatments for psoriasis, surveys demonstrate overall low treatment satisfaction and high noncompliance among psoriatic patients. In a survey of 5604 patients with psoriasis or psoriatic arthritis, approximately 50% are reportedly dissatisfied with their current treatment. Among patients with mild, moderate, and severe disease, one-half, one-third, and one-fifth remain untreated, respectively. Additionally, topical treatments alone were prescribed to 30% of patients with moderate disease and 21% of patients with severe disease.

Three hundred ninety-one dermatologists in North America and Europe surveyed in the Multinational Assessment of Psoriasis and Psoriatic Arthritis program demonstrated similar results. Among patients with moderate to severe disease, topical monotherapy was prescribed to 54.0%, systemic therapy to 39.1%, and biologic therapy to 19.6%. Despite the US Food and Drug Administration approval of biologic agents for the treatment of psoriasis since 2003, a retrospective review of the US National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey demonstrated no increase in the use of systemic therapy for moderate to severe psoriasis between 1993 and 2010. Similarly among private practitioners in Germany, systemic treatments for psoriasis were prescribed to 31% of patients with moderate to severe psoriasis and only 58% of patients with psoriatic arthritis.

Gaps

Despite a growing number of systemic agents and increasing long-term safety data for these therapies, a large number of psoriatic patients remain undertreated. Additional considerations, such as the association between psoriasis and cardiovascular (CV) disease and the cardioprotective effects of several systemic therapies, add further importance to appropriate treatment selection. Provider- and patient-centered, clinically relevant, and adaptable outcome measures in psoriasis incorporating key domains comorbidities including CV risk and psoriatic arthritis are lacking. These measures would provide more defined end points to assess treatment efficacy in clinical practice.

Barriers

In a survey conducted by dermatologists from both academic and private practice settings in Germany, self-reported confidence in prescribing systemic psoriasis treatments is low, with 76% of those polled noting that their own confidence in prescribing systemic agents limited their use. Among physicians asked about the prescription of anti–tumor necrosis factor (TNF) agents, none were very confident, 9% were confident, 27% were relatively confident, 48% were uncertain, and 16% were very uncertain. Fewer than half of dermatologists reported that they were aware of the most recent guidelines 6 months after publication. Additional concerns over long-term safety, tolerability, and efficacy of systemic agents also influence prescription practices.

Moreover, prescribing is influenced by the considerable time and overhead costs required for the prescription and management of systemic therapies. An example is the inefficient system of verbal and written interactions with insurance companies and pharmacies in order to obtain prior authorizations. Further economic disincentives, including physician tiering, also negatively impact treatment patterns in psoriasis and other chronic conditions. The cost and quality measures used to assign provider tiers fail to integrate important variables, such as disease severity, case complexity, and clearance of disease. Therefore, physicians receiving difficult referrals and treating refractory, chronic diseases that require expensive interventions are assigned worse tiers because of the higher costs of their practice. One consequence of receiving a worse tier is that patients require higher copays to see the doctor and the physician may be excluded from their tight networks. Finally, the lack of outcome measures useful in clinical practice that evaluate disease co-morbidities based on the input of both patient and provider prevents meaningful assessment of treatment effectiveness.

Recommendations for Improvement

The steps taken to address the treatment gaps in psoriasis are among the most important initiatives facing patients with psoriasis and the providers who deliver care. A group of academic and private practice German dermatologists participated in a 2-hour educational initiative focused on assisting physicians to optimize the selection of psoriasis treatments based on the most recent guidelines. Among participants, 42% reported that they would change their daily practice based on this single training session. Both educational initiatives and greater incentives for the appropriate use of systemic agents are necessary. A combined educational initiative involving multiple dermatologic societies would provide the most global visibility, both for practitioners and their patients. Thoughtfully developed measures that limit disincentives for prescribing systemic therapies should be developed, for example, a code specific for the prescription of biologic agents that factors time required by ancillary staff to navigate the process from the initial prior authorization to the delivery of a medication to patients (see section Access to Biologics later). Medical practice models that integrate dermatologists, primary care physicians, physician assistants, and nurse practitioners into psoriasis management have also shown promise in improving the care that psoriatic patients receive.

Finally, clinically practical, patient-centered treatment outcome measures that assess clearance of psoriasis and important psoriasis comorbidities, including CV risk and psoriatic arthritis, are needed. These measures will ultimately provide meaningful feedback to providers and other stakeholders, such as payers to help achieve the standard of care in the treatment of psoriatic disease. This process is currently underway through the International Dermatology Outcome Measures (IDEOM) initiative. The IDEOM has adapted principles defined by the Outcome Measure for Rheumatoid Arthritis Clinical Trials initiative in rheumatology that has accomplished a similar goal. IDEOM outcome initiatives involve not only patients and health care providers but also regulatory agencies, pharmaceutical health economists, and payers. The two diseases currently under study are psoriasis and hidradenitis suppurativa.

Standards

Psoriatic patients, particularly those with severe disease and those with psoriatic arthritis, have a higher prevalence of CV risk factors, including hypertension, diabetes, obesity, dyslipidemia, and insulin resistance, increasing the risk for adverse outcomes, such as coronary artery disease, myocardial infarction, stroke, and CV death. The association between psoriasis and the proinflammatory cascade may have a systemic effect leading to an increased risk of CV disease. Treatment with anti-TNF agents and other therapies, such as methotrexate, reduce both the inflammatory burden and the risk of CV disease. Current practice guidelines include counseling all patients with psoriasis about lifestyle modifications, smoking cessation, and monitoring for comorbidities, such as hypertension, obesity, and diabetes mellitus. The National Psoriasis Foundation and American Heart Association also recommend screening psoriatic patients for CV risk factors beginning at 20 years of age. Consensus guidelines from a European-led panel include yearly CV risk factor screening with measurements of blood pressure, body mass index, waist circumference, lipid profile, fasting glucose, glycosylated hemoglobin, and smoking status with aggressive risk factor management for patients with moderate to severe psoriasis. Targets for risk factor interventions may also need to be adjusted, as psoriasis is a known independent risk factor for CV disease. However, no such recommendations currently exist. At routine follow-up visits for psoriasis, dermatologists should provide encouragement about lifestyle modifications and regular appointments with primary care providers. The positive effects of counseling by dermatologists was demonstrated in one study, showing 79.1% of psoriatic patients who were educated on their increased CV risk made subsequent lifestyle changes. The dermatologist should also communicate the patients’ increased CV risk to the primary care physician directly. However, when treatment of CV risk or adverse events becomes necessary, patients should seek further care and referrals from their primary care physician.

Current Practices

Psoriatic patients are screened for CV risk factors and treated for comorbid conditions, such as hypertension, less frequently than the general population. Similarly, counseling on lifestyle modifications, such as smoking and alcohol cessation, is not a routine practice. In data collected from 251 primary care physicians and cardiologists, only 45% of those surveyed were aware of the increased prevalence of CV disease risk factors and adverse outcomes among psoriatic patients. In another recent study, 92% of dermatologists polled were aware of the increased risk for CV risk factors, of whom 72% were well aware of the increased risk and 20% had heard of the increased risk in limited detail. However, only 13.9% of these dermatologists’ patients were screened for dyslipidemia, 47.2% for obesity, 30.6% for hypertension, and 27.8% for diabetes. Additionally, just 26.9% of patients were educated about their increased CV disease risk, with the majority receiving this information from the mass media.

Gaps

Despite the established increased risk of CV risk factors and adverse CV outcomes among patients with psoriasis, both dermatologists and nondermatologists are not routinely screening for or counseling patients on CV risk factors. The specific role of dermatologists and primary care physicians in the counseling and screening process of psoriatic patients is not well defined, and providers are not all aware of the CV risk associated with psoriasis.

Barriers

Among dermatologists’ limitations in screening facilities and time, lack of integration of screening into the electronic medical record as well as ambivalence about the need for screening prevent the evaluation of psoriatic patients for CV risk factors.

Recommendation for Improvement

The first step in increasing adherence to recommended screening for CV risk among psoriatic patients is creating an organized, collaborative approach between dermatologists, primary care physicians, cardiologists, and endocrinologists. Presentations and publications on CV risk and psoriasis should achieve a broad audience across multiple medical specialties. Electronic medical records can incorporate specific screening questions and measurements for psoriatic patients to improve the adherence to practice guidelines for both counseling and routine testing. Self-assessment programs for physicians to emphasize the importance of CV risk screening among psoriatic patients would also improve screening rates. Finally a systematic protocol for screening and management of CV risk factors should be established to clarify the specific role of each health care provider in the process.

Standards

Up to 40% of patients with psoriasis have an associated inflammatory, destructive arthritis, which can lead to permanent joint deformities when left untreated. Psoriatic arthritis is characterized by enthesitis, dactylitis, spondylitis, and nail dystrophy and is associated with significant morbidity and impact on quality of life. Among patients with psoriatic arthritis, approximately 15% initially develop joint involvement only and 15% exhibit concurrent joint and skin findings, whereas in 70% skin manifestations are found before joint signs and symptoms. Therefore, all patients diagnosed with psoriasis should be routinely screened for arthritis. Dermatologists play an important role in the diagnosis of psoriatic arthritis as cutaneous involvement typically presents before joint manifestations.

Early diagnosis and treatment of psoriatic arthritis improves clinical outcomes, limits pain, and prevents irreversible joint disease through suppression of pathogenic inflammatory signaling. Patients with psoriasis should be questioned about symptoms, such as prolonged morning stiffness, joint swelling, erythema, or pain. The physical examination includes an investigation for signs of active synovitis and other associated findings, such as nail pitting.

Patients should be screened for arthritis at the time of psoriasis diagnosis and at least annually thereafter. Multiple psoriatic arthritis screening algorithms have been proposed, although the Classification of Psoriatic Arthritis (CASPAR) is the most widely used. CASPAR has a specificity of 99.1% and sensitivity of 87.0% and was developed as a tool for clinical research studies. The Psoriasis Epidemiology Screening Tool was validated in the adult psoriatic population with a sensitivity of 94% and specificity of 78%. Additional screening tools include Psoriatic Arthritis Screening and Evaluation with 82% sensitivity and 73% specificity and Toronto Psoriatic Arthritis Screening Questionnaire with 86.8% sensitivity and 93.1% specificity.

Current Practices

Psoriatic arthritis is underdiagnosed because of limited frequency of screening, improper use of screening tools, and limitations in the currently available screening tools particularly in the general clinic setting. It is also possible that economic disincentives decrease detection, as diagnosis of psoriatic arthritis increases overhead and puts the physician at increased risk for an unfavorable tier rating and elimination from tight networks.

Gaps

Although the importance of early diagnosis of psoriatic arthritis is known, rates of detection remain well less than the predicted incidence rates. Up to one-third of psoriatic arthritis cases are undiagnosed leading to significant increases in morbidity and decreases in health-related quality of life.

Barriers

The absence of a time-efficient, validated, sensitive, and specific screening tool for psoriatic arthritis limits the frequency of early diagnosis and treatment. Additional barriers include limited patient awareness of the significance and prevalence of psoriatic arthritis, lack of confidence among dermatologists in evaluating and detecting joint disease, the broad range of psoriatic arthritis manifestations, and the overlap between psoriatic arthritis and other rheumatologic conditions.

Recommendations for Improvement

The creation of a time-effective, validated screening tool with high sensitivity and specificity for the detection of psoriatic arthritis is needed to improve the care provided to the psoriatic population. Educational initiatives emphasizing to patients the importance of annual screening, early diagnosis, and intervention as well as workshops to instruct dermatologists on recommended screening practices and techniques are needed. Routine questions on psoriatic arthritis that appear in the electronic medical record for all psoriatic patients would also promote screening. Limiting economic disincentives for the diagnosis and treatment of psoriatic arthritis may also improve detection and treatment patterns. Finally, an interdisciplinary approach, for example, with combined rheumatology-dermatology clinics, would lead to higher detection rates of psoriatic arthritis.