Psoriasis is a common, chronic autoimmune disease affecting more than 8 million Americans with painful, thick, red patches that often itch and bleed. Despite advances in treatments, psoriasis remains widely undertreated, and patients often are dissatisfied with their level of disease control. Psoriasis has profound effects on health-related quality of life, and in moderate to severe cases, it carries an increased risk of heart attack, stroke, and premature death.
African Americans are more likely to experience severe psoriasis compared to whites, but also are less likely to receive effective treatments. Ultraviolet B phototherapy is a preferred treatment, because systemic medications can have serious side effects. Phototherapy requires treatment in an office three times per week for 12 weeks, which is a substantial burden for patients, pulling time away from work and family obligations, and adding to transportation costs.
A more patient-centered approach is home-based phototherapy; however, a lack of data comparing the effectiveness of home-based versus office-based phototherapy has led to decisional uncertainty by patients, dermatologists, and payers. The Institute of Medicine has prioritized comparative effectiveness research of psoriasis treatments. Our engagement studies of 1,000 dermatologists and more than 3,000 patients, in addition to psoriasis experts, the National Psoriasis Foundation, payers, and our patient research partners prioritized comparative studies of home-based versus office-based phototherapy, and 82 percent of patients said they would prefer home-based phototherapy if the treatments were equally effective.
We will conduct a randomized, controlled study in 1,050 patients age 6 and older to compare the effectiveness and safety of 12 weeks of home-based versus office-based phototherapy for the treatment of psoriasis. The study will be conducted under real world conditions at 20-40 sites across the US. We will also study whether patients with fairer skin are more prone to problems with tolerability, such as burns from increased light penetration, and whether those with darker skin are more prone to problems with effectiveness due to decreased UV light penetration. Therefore, three subgroups based on the anticipated sensitivity to UV light (fair white skin, olive to light brown skin, and dark brown to black skin) will be identified with 350 patients in each subgroup.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.