Puja Khanna, MD, MPH is an Associate Professor in the Department of Internal Medicine whose research interests include designing novel clinical trials and assessing quality of life in patients with gout, a form of inflammatory arthritis. Dr. Khanna's long-term goals are to create patient and physician interventions that improve patient-reported outcomes in patients with arthritides.
Dr. Khanna is currently conducting an NIH-funded study that is evaluating the feasibility and preliminary efficacy and safety of a short course of immunosuppressive therapy to prevent immunogenicity conferred by Pegloticase in patients with gout.
Gout is on the rise
Gout affects approximately 4% of the U.S. population. It is the most common form of inflammatory arthritis in men and is associated with a decreased quality of life.
The frequency of gout is increasing worldwide, with prevalence rates estimated to be as high as 7% in older men. It is estimated that up to 400,000 people in the U.S. (up to 5% of the estimated 8 million suffering from gout) experience chronic refractory gout, characterized by ongoing symptoms of active disease and a failure to control/maintain serum urate < 6 mg/dL with conventional xanthine oxidase inhibitors (i.e. Allopurinol and Febuxostat) and uricosuric agents (i.e. Probenecid).
Current treatment is limited by immunogenicity
These patients often have significant, disabling urate deposits in soft tissues and bone known as tophi. Pegloticase, a recombinant modified mammalian urate oxidase (uricase), is approved by the Food and Drug Administration (FDA) and is highly efficacious in reducing serum urate, thereby improving clinical signs and symptoms of gout, such as tophi size. However, Pegloticase has been associated with a high rate of infusion reactions including anaphylaxis.
The ability of Pegloticase to induce antibody production (leading to the need to stop therapy) raised the question of whether the loss of response to the drug could be prevented or delayed if the anti-Pegloticase antibodies were reduced via an immune modifying drug.
REduCing Immunogenicity to PegloticasE (RECIPE) study
This possibility led Dr. Khanna and her team to conduct a Phase II, double-blind, placebo-controlled multi-site proof-of-concept study in participants initiating Pegloticase for treatment of chronic refractory gout. This trial will help answer the question of whether a short course of immune modulating therapy with Mycophenolate Mofetil (MMF) can significantly and safely attenuate immunogenicity to Pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life.
Learn more about the REduCing Immunogenicity to PegloticasE (RECIPE) study.
