During the past decade, since the American Academy of Dermatology and National Psoriasis Foundation last published a joint guideline on the management of psoriasis, “there’s been an incredible amount of progress in this area,” explains Joel M. Gelfand, MD, MSCE. “For example, two new systemic non-biologic treatments have been approved since our last guidelines: apremilast for psoriasis and psoriatic arthritis, and tofacitinib for psoriatic arthritis. Also, there have been major advancements in the non-invasive monitoring of liver damage from methotrexate.”
Better & Safer Outcomes
To provide clinicians and other stakeholders with comprehensive, evidence based recommendations for the use of systemic non-biologic treatments for psoriasis so that patients can achieve better and safer outcomes, Dr. Gelfand and colleagues developed updated guidelines of care, published in the Journal of the American Academy of Dermatology, for the management of psoriasis with systemic nonbiologic therapies (Figure).
“The biggest change with the new guidelines is that they deemphasize the use of liver biopsy and emphasize the use of new non-invasive blood tests and imaging (specialized ultrasound or MRI) to detect signs of liver damage from methotrexate,” says Dr. Gelfand. “With advances in testing that can detect liver fibrosis at an early stage, most patients can be treated safely with methotrexate—a treatment used for over 50 years for psoriasis—without the need for a liver biopsy, as was recommended in the past. This advance will come as a great relief to our patients and clinicians and demonstrates that progress is made not only with new treatments, but also in improving older therapies.”
Although less focus is given to the other FDA-approved medications for psoriasis, the guidelines do recommend apremilast for the treatment of moderate to severe psoriasis in adults, with benefits that include oral administration and the lack of a requirement for laboratory monitoring and disadvantages that include slower onset of skin clearance and lower likelihood of clearing when compared with injectable agents. The guidelines also recommend cyclosporine for patients with severe, recalcitrant psoriasis, adding that the drug can be recommended for the treatment of erythrodermic, generalized pustular, and/or palmoplantar psoriasis as well as for short-term interventional therapy in patients who flare up while on a pre-existing systemic therapy. Lastly, the guidelines state that acitretin can be recommended as monotherapy for plaque psoriasis; treatment of erythrodermic, pustular, and palmarplantar psoriasis; combination therapy with psoralens with ultraviolet A for psoriasis; and combined with broadband ultraviolet B for plaque psoriasis.
In regard to why several non-FDA-approved medications are covered in the guidelines, Dr. Gelfand notes that while tofacitinib, for example, is not approved by the FDA as a treatment of psoriasis, large randomized, placebo-controlled trials indicate that it is efficacious in the treatment of skin disease. “It is FDA-approved for psoriatic arthritis, so it is important that dermatologists are aware of the role this drug has to play in the management of psoriatic disease,” he adds. “We also touch on the use of fumarates, which are used for psoriasis in Europe. While they are not approved for psoriasis in the US, they are approved for the treatment of multiple sclerosis (MS) and thus may have a role to play in patients living with both diseases. For example, we cannot use TNF alpha inhibitors in patients with MS, as it can make MS worse, so a treatment that can improve both conditions may be a good option for some patients.”
Dr. Gelfand notes that advances in oral medications have lagged behind those in injectable biologic medicines for the common and incurable condition that is psoriasis. “Many patients prefer a pill over an injection, and therefore, we have a significant unmet need for oral medications for psoriasis that are highly effective and well tolerated,” he adds. “There is also a need for ‘personalized medicine,’ in which we can advise patients on the best drug for them based on their genetics, health status, and preferences.”
In the meantime, Dr. Gelfand stresses the transformative changes in recommendations for monitoring liver damage from methotrexate in the guidelines. “Physicians should rapidly adopt these new recommendations so patients can be spared the pain, anxiety, cost, and inconvenience that comes with a liver biopsy and instead have monitoring with simple blood tests and imaging techniques that can detect liver damage long before it becomes clinically significant,” he says.
JOINT AAD-NPF GUIDELINES OF CARE FOR THE MANAGEMENT OF PSORIASIS WITH SYSTEMIC NON-BIOLOGICAL THERAPIES