Higher Response Rates in RECIPE Randomized Controlled Trial of KRYSTEXXA (pegloticase injection) Concomitantly Used with the Immunomodulator Mycophenolate Mofetil
Horizon Therapeutics plc (Nasdaq: HZNP) today announced data from the first randomized controlled clinical trial (RCT) of KRYSTEXXA (pegloticase injection) concomitantly used with an immunomodulator showed improved response rates as compared to KRYSTEXXA monotherapy. Reducing Immunogenicity of Pegloticase (RECIPE) demonstrated that 86.4 percent of patients (19 of 22) receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL through Month 3, the primary study endpoint, compared to 40.0 percent of patients (4 of 10) receiving KRYSTEXXA monotherapy. The data are being presented as part of the American College of Rheumatology (ACR) Convergence 2020, Nov. 5 – 9, 2020.
While KRYSTEXXA has been traditionally used as a biologic monotherapy with a clinically demonstrated impact on chronic gout refractory to conventional therapies (uncontrolled gout), recent literature suggests that adding an immunomodulator has the potential to increase the durability of response to KRYSTEXXA.1 The safety and efficacy of KRYSTEXXA co-prescribed with an immunomodulator has not been established by any health authorities.
“Given the significant physical disability and risks associated with gout, reducing the burden of urate is critical to improving overall patient outcomes and quality of life,” said Kenneth Saag, M.D., M.Sc., co-principal investigator for the RECIPE trial, Jane Knight Lowe Professor of Medicine and Director of the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham. “Working with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Horizon, the University of Michigan and leading clinical centers across the United States we were able to conduct the RECIPE randomized controlled trial and demonstrate that the co-treatment approach appears to deliver clinically meaningful results for people living with uncontrolled gout.”
Data from the double-blind, placebo-controlled RECIPE trial illustrate the effect of a co-treatment regimen of KRYSTEXXA with mycophenolate mofetil. In the study, 35 adult patients with uncontrolled gout were randomized (3:1) to receive either mycophenolate mofetil or placebo for two weeks prior to starting KRYSTEXXA (12 infusions of 8 mg every 2 weeks). Thirty-two patients participated in the trial, with three patients discontinuing prior to the first KRYSTEXXA infusion. During the trial, patients continued to receive either mycophenolate mofetil (1g) twice daily or placebo with KRYSTEXXA for 12 weeks. After Month 3, all patients received only KRYSTEXXA 8 mg IV every two weeks for 12 weeks, providing a full course of KRYSTEXXA therapy (through Month 6). The study evaluated the proportion of patients who reached and maintained response to therapy (defined as sUA levels less than 6 mg/dL over 12 weeks), as well as the safety of the regimen.