In a session at AMCP Nexus 2021, speakers provided an overview of the psoriasis treatment landscape, including disease burden, changing standards in pharmacology research, and drugs currently in the pipeline.

Steven Kheloussi, PharmD, MBA, assistant professor of Pharmacy Practice, Wilkes University, and senior pharmacist, Clinical Pharmacy Strategies, Highmark, Inc, highlighted key aspects of psoriasis treatment and patient outcomes during the presentation. Additionally, Carly Rodriguez, PharmD, FAMCP, vice president and chief pharmacy officer, Moda Health, zeroed in on the finances surrounding patient access to therapies.

Disease and Economic Burden Associated With Psoriasis

Psoriasis is a chronic immune-mediated disorder of which there are several types, moderate-to-severe plaque psoriasis being the most common. Physical manifestations of the disease—itchy and painful red patches and scales—typically present on the scalp, knees, elbows, and lower back, Dr Kheloussi said.

Approximately 8 million Americans, and between 2% and 3% of the world’s population, are affected by psoriasis. Most patients experience disease onset before reaching 40 years of age, and a third will go on to develop comorbid psoriatic arthritis.

The disease is associated with decreased quality of life, decreased life expectancy, and increased mortality.

“Most of the time, the problems with psoriasis are not really going to be the skin manifestations,” Dr Kheloussi said, noting extracutaneous outcomes such as depression and increased risk of developing pulmonary disorders and diabetes, among others.

Current treatments include phototherapy, topical therapies such as corticosteroids and tazarotene, and oral therapies such as apremilast, cyclosporine, and methotrexate. Dr Kheloussi described some of the guidelines for selecting a therapy, which included the following:

• effective against widespread disease;
• comparatively low cost;
• increased availability; and
• improved ease of administration.

From an economic standpoint, psoriasis costs the health care system approximately $35 billion annually, with total incremental costs ranging from about $2000 to $10,000 per patient per year depending on disease severity. Dr Kheloussi also noted that spending on psoriasis drugs accounts for over half of all dermatology spending in Medicare.

“Not every patient is going to be treated with biologics, and not every patient is going to adhere to those biologics during treatment,” both of which impact the average incremental cost, Dr Kheloussi said.

Evolving Endpoints and Drugs in the Pipeline

Dr Kheloussi also noted that one of the standard primary endpoints, a Psoriasis Area and Severity Index (PASI) score of 75 or more, is increasing to PASI90. The shift is due to recent clinical trials in which the novel agent bimekizumab achieved PASI90 and PASI100 scores—90% and 100% skin clearance, respectively.

Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17A and IL-17F. The drug was superior to three other agents and placebo in four studies involving adults with moderate-to-severe psoriasis over six months. Dr Kheloussi showed the following findings supporting bimekizumab’s efficacy in a chart during the session:

• BE RADIANT: Superior to secukinumab at week 16 for PASI100 (61.7% vs 48.9%, respectively). Results maintained to 48 weeks.
• BE SURE: Superior to adalimumab at week 16 for PASI90 (86.2% vs 47.2%, respectively). Results maintained to 56 weeks.
• BE VIVID: Superior to ustekinumab at week 16 for PASI90 (85% vs 50%, respectively). Results maintained to 52 weeks.
• BE READY: Superior to placebo at week 16 for PASI90 (91% vs 1%, respectively). Results maintained to 56 weeks.

Bimekizumab is slated to become the new standard of care if the US Food and Drug Administration approves it for market, Dr Kheloussi said, likely at a dosage of 320 mg subcutaneously every 4 to 8 weeks and indicated for moderate-to-severe psoriasis in adults who are candidates for systemic or phototherapy.

“The results look promising at this point,” Dr Rodriguez said. “There is a lot of excitement in the provider community about bimekizumab due to the high proportion of patients” achieving high skin clearance.

Other drugs in the pipeline are two topicals, including roflumilast cream (PDE-4 inhibitor) and tapinarof (AhR agonist); three oral agents, including deucravacitinib (TYK2 selective inhibitor), piclidenoson (A3 adenosine receptor agonist), and dimethyl fumarate (Nrf2 transcriptional pathway enhancer); and two originator injectables, including netakimab (IL-17A inhibitor) and mirikizumab (IL-23 inhibitor).

“A therapy that once worked for a patient can stop working for that patient over time depending on how severity progresses,” Dr Rodriguez said. “So we need treatments for psoriasis that have multiple mechanisms of action, multiple routes of administration, in order to be sure that all patient types can be covered.”