Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, Dallas, TX.
Within the last decade, advances in the understanding of psoriasis and new therapeutic options have transformed the treatment landscape for this chronic disease. Discovery of the inflammatory mechanisms of psoriasis led to the development of biologics, which has altered treatment for those with moderate to severe disease. Additionally, research shows that psoriasis is strongly associated with various noncutaneous conditions, from mental health comorbidities, such as depression, to cardiovascular disease and metabolic syndrome.
The two new guidelines from the American Academy of Dermatology (AAD) and the National Psoriasis Foundation (NPF), which were last updated in 2008, cover more recent evidence on biologics and screening for comorbid conditions among this patient population.1,2 “The guidelines provide practicing physicians with the latest evidence-based information,” said Craig A. Elmets, MD, professor of dermatology at the University of Alabama in Birmingham and co-chair of the guideline workgroup, in an interview with The Dermatologist. These recommendations outline some of the best practices for treating patients with this debilitating skin disease. In part 1, we review recommendations for the use of biologics.
Creating the Guidelines
Experts in the field of psoriasis, as well as a rheumatologist, cardiologist, and representatives from a patient advocacy organization, were included in the workgroup. One of the challenges was “putting together a guideline committee group where 51% of members could not have any industry relationship, such as talks,” said Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center in Dallas, TX, and co-chair of the workgroup, in an interview with The Dermatologist. Data published from January 1, 2008 through December 31, 2017 was evaluated using the Strength of Recommendation Taxonomy and graded using a 3-point scale and ranked. “It was important to get a consensus,” said Dr Elmets, “which was challenging because everyone had their own opinion.” Standards for developing guidelines from the AAD, NPF, National Academy of Medicine, and Council of Medical Specialty Societies were used to develop the new psoriasis guidelines.1,2
Recommendations for Biologics
Several biologics are approved for the treatment of psoriasis and psoriatic arthritis (PsA), with a few new promising therapies still awaiting approval. The guidelines “allow dermatologists to better understand all biologic agents, especially the new IL-17 and IL-23 therapies, and prescribe them more effectively,” said Dr Menter.
Recommended dosing for biologics, based on FDA approvals for each agent, whether the therapy can be administered alone or in combination with other modalities, and immunogenicity, among other information, is included in the Table.1
The guidelines recommend considering dose escalation and/or the addition of other therapies for patients experiencing partial response to treatment for tumor necrosis factor (TNF)-α inhibitors, IL-12/IL-23 inhibitors, and IL-17 inhibitors. While certain inhibitors, such as IL-17 agents, lack data on efficacy and safety in combination with other modalities, the authors of the guidelines noted that there was no reason to consider combination therapy unsafe.1
Switching to a different biologic should be determined on a case-by-case basis and depends on discontinuation of treatment, prior response to treatment, and disease severity, along with expert opinion. Restarting or resuming a biologic with the loading dose depends on whether the patient is experiencing a flare and/or if more than 3 to 4 half-lives of the agent have passed since the previous dose. The guidelines also include considerations based on patients’ weight, such as the lack of efficacy associated with obesity, and precautions for patients with concomitant infectious diseases, such as HIV. Other aspects covered in the guidelines are vaccinations while receiving biologics, surgery, and considerations for children.1
These recommendations ensure providers have “the ability to fully discuss all the positive aspects of each biologic prescribed, as well as need for routine screening and laboratory evaluations,” said Dr Menter. Certain biologics also treat comorbid conditions, such as inflammatory bowel disease (IBD) and multiple sclerosis. “Full evaluation of all comorbidities in each and every patient, including PsA, is needed to select the best treatment,” added Dr Menter.
In addition, the guidelines emphasize collaboration between the doctor and patient on selecting the best biologic based on patients’ quality of life, disease severity, and/or comorbid conditions, as well as preferences for route of administration, cost, and dosing scheduling.1
Research on the long-term adverse events, impact on comorbidities, pregnancy and lactation, and the safety and efficacy of combination treatment with newer agents is still needed. “Future research on biomarkers is essential to enable dermatologists to prescribe the appropriate biologic agent for each individual patient,” said Dr Menter.
While more research is needed on the long-term safety and efficacy of biologics, the guidelines offer physicians evidence-based recommendations to guide treatment decisions.
Four other guidelines for psoriasis are expected to be updated this year on the treatment of pediatric patients, nonbiologic systemic agents, topical therapy, and phototherapy. Part II will cover the guidelines on managing comorbidities.
1. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072. doi:10.1016/j.jaad.2018.11.057
2. Elmets CA, Leonardi CL, Davis DMR, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities. J Am Acad Dermatol. 2019;80(4):1073-1113. doi:10.1016/j.jaad.2018.11.058