More than seven million Americans suffer from psoriasis, and it’s estimated that up to 30 percent of them also have psoriatic arthritis (PsA)—a complex disease that manifests in various ways. However, PsA clinical trials have tended to focus exclusively on the subset who have peripheral arthritis and, per FDA standards, have measured the same primary outcome used for rheumatoid arthritis. Alexis Ogdie-Beatty, MD, MSCE, of our Epidemiology Division and Alisa Stephens Shields, PhD, of our Biostatistics Division are exploring how we can revolutionize the design of clinical trials in PsA, so that our research proposes appropriate solutions for the diverse PsA population.
The traditional study design has led to approval of therapies that suit only some PsA sufferers, Dr. Ogdie-Beatty says. “Researchers tailor the types of people they enroll in the study in order to match the study design. The way to get your drug to win has been to get a patient population that looks like rheumatoid arthritis.”
Dr. Stephens-Shields’ expertise is essential to creating complex simulations that picture the full array of PsA patients. “Since randomized trials involving the treatments, endpoint and patient population we’re investigating have never been conducted before, we’re using data from other studies to predict—accounting for uncertainty—the metrics we need to put in place in order to come out with a rigorous clinical trial design, ” she says.