New Advances, New Guidelines

A few highlights of the biologics, systemic non-biological, and topical therapies treatment guidelines include:

• Discusses the use of topical corticosteroids for longer than 12 weeks as well as the alternate use of steroids and steroid-sparing agents for the management of chronic disease
• Revised monitoring guidance to methotrexate associated hepatoxicity, which now recommends new non-invasive tests to evaluate for hepatic fibrosis
• Oral apremilast is recommended for the treatment of moderate to severe psoriasis in adults
• Discusses the dermatologist’s role in monitoring patients and educating them about the risks and benefits associated with the use of biologic agents

Additionally, the Guidelines of Care for the Management and Treatment of Psoriasis with Biologics have been updated to include 11 biologic treatments available at the time of publication, an update from 3 approved when the previous guidelines were published. These guidelines are also based on an increased amount of published research specifically related to psoriasis, where prior guidelines used the more comprehensive research available, which also included research related to psoriatic arthritis and other conditions.

More than just providing updated information and recommendations to providers, these new guidelines assist in justifying patient access to new treatments. “There have been so many advances in the treatment of psoriasis since the last guidelines were published in 2008, that there was a clear need to signal insurers that new treatments were available and patients needed to get access to those new therapies. NPF and the AAD have jointly issued these guidelines which justify patient access to the many new treatments available,” says Dr. Mark Lebwohl, M.D., Waldman Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City and chairman emeritus of the NPF Medical Board.

Phototherapy is recognized as an effective treatment option for many patients and can include options such as narrowband and broadband UVB, UVA in conjunction with photosensitizing agents, and targeted UVB treatments. While there were guidelines published in 2009 related to phototherapy, these new guidelines are an important update. “There has been so much progress in psoriasis in the last decade that this update was long overdue. The most important change is that we completely reworked the standard narrowband phototherapy dosing protocol. The new dosing in the guidelines was tested in the Vascular Inflammation in Psoriasis trial and demonstrated efficacy comparable to adalimumab both in terms of objective response (PASI75) and improvement in patient-reported quality of life. In fact, patients randomized to phototherapy tended to do better on patient-reported outcomes compared to adalimumab,” says Dr. Joel Gelfand, M.D., Professor of Dermatology and Epidemiology at the University of Pennsylvania Perelman School of Medicine.

Highlights from the Guidelines of Care for the Management and Treatment of Psoriasis with Phototherapy:

• Recommended dosing regimen, efficacy, and adverse effects of the various phototherapy modalities
• Discusses evidence-based use of phototherapy in different types of psoriasis and in combination with other treatment modalities
• Shares safety data such as adverse events and contraindications

“Phototherapy is highly effective and safe for the treatment of psoriasis. However, it is not backed by a major pharmaceutical company, and therefore there is virtually no direct to consumer advertising to build awareness,” adds Dr. Gelfand.

Even though research has shown that comorbidities commonly occur in patients with psoriasis, the joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities are the first from the American Academy of Dermatology to address comorbidities in this patient group. “Comorbidities are extremely common in patients with psoriasis. The most common ones are psoriatic arthritis, high blood pressure, diabetes, obesity and cardiovascular disease,” shares Dr. Gelfand. “Some of our therapies are particularly helpful for psoriatic arthritis, while others may induce or aggravate co-morbidities such as inflammatory bowel disease, depression or multiple sclerosis. It is critical that the provider has a complete understanding of the patient’s underlying health issues.”

Highlights from the Joint AAD-NPF Guidelines of Care for the Management and Treatment of Psoriasis with Awareness and Attention to Comorbidities include:

• Identifying the most common comorbidities among patients with psoriasis
• Addressing how to assess and manage major comorbid conditions associated with psoriasis
• The importance of collaborative care between dermatologists and patients’ primary care doctors

“These guidelines were the first from the AAD to address comorbidities in patients with psoriasis. They are critically important. Patients with psoriasis are at increased risk for a number of serious, life-threatening comorbidities and those with more severe disease die about 5 years younger than expected. The new guidelines especially emphasize the importance of screening for and managing increased cholesterol levels in patients with moderate to severe psoriasis (those who are candidates for phototherapy, pills, or biologics or whose body surface area affected is 10% or greater),” says Dr. Gelfand.

Adults are not the only people affected by psoriasis; this chronic inflammatory condition affects approximately 1 percent of pediatric patients. The Joint AAD–NPF Guidelines of Care for the Management and Treatment of Psoriasis in Pediatric Patients discusses the unique physiology, how treatments are processed by the body (pharmacokinetics), and the importance of interactions between pediatric patients, their caregivers, and the providers.

“The publication of the first guideline specifically addressing the management of pediatric psoriasis is monumental,” wrote Dr. Kelly M. Cordoro, M.D., professor of dermatology and pediatrics and chief of the Division of Pediatric Dermatology at the University of California, San Francisco in a commentary article regarding the new AAD-NPF pediatric guidelines, published in the Journal of Psoriasis and Psoriatic Arthritis® [1]. She continues, writing “Pediatric patients are being enrolled in clinical trials earlier, without the long waiting period of the past when efficacy and safety had to be proven and sustained in adult patients before pediatric studies could ensue.”

Highlights from the Joint AAD-NPF guidelines of care for the management and treatment of psoriasis in pediatric patients include:

• Pediatric psoriasis can be associated with emotional stress, increased body mass index, second-hand cigarette smoke, pharyngeal and perianal Group A beta-hemolytic strep infection, Kawasaki disease, withdrawal of systemic corticosteroids
• Anthralin is effective as a long-term treatment of mild to moderate disease, but should not be used for face or genitalia
• Phototherapy is effective for moderate to severe plaque psoriasis and guttate psoriasis in this population
• Methotrexate is the most commonly used non-biologic systemic treatment used for moderate to severe psoriasis and should be supplemented with folic acid

“Comprehensive care of children with psoriasis requires attention to the overall physical, mental, and emotional health of the patient,” adds Dr. Cordoro. “It marks an end of the era of borrowing data from adult studies and applying it to management decisions for pediatric patients.”

These new guidelines are an important step forward for patients and providers. The NPF has some fantastic resources available on the website for providers looking to learn more about the guidelines.