Phase II trial data for Krystexxa in gout published in Arthritis & Rheumatology journal.- Horizon Therapeutics

Horizon Therapeutics announced the publication of data from the first randomized controlled phase II clinical trial (RCT) of Krystexxa (pegloticase injection) in gout concomitantly used with an immunomodulator, mycophenolate mofetil, in Arthritis & Rheumatology [doi.org/10.1002/art.41731]. The Reducing Immunogenicity of Pegloticase (RECIPE) trial demonstrated that 86 percent of patients (19 of 22) receiving co-therapy of Krystexxa with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) of up to 6 mg/dL at 12 weeks, the primary study endpoint, compared to 40 percent of patients (4 of 10) receiving Krystexxa monotherapy. The safety and efficacy of Krystexxa co-prescribed with mycophenolate mofetil has not been established by any health authorities. In total, 86 percent (19 of 22) of patients receiving co-therapy of Krystexxa and mycophenolate mofetil achieved serum uric acid up to 6 mg/dL at Week 12 versus 40 percent (4 of 10) of patients in the Krystexxa and placebo arm, with a sustained response at Week 24 in 68 percent (15 of 22) of patients versus 30 percent (3 of 10) of patients, respectively. In the Krystexxa with mycophenolate mofetil arm, no (0 of 22 patients) infusion reactions were reported compared to 30 percent (3 of 10) of patients reporting infusion reactions in the Krystexxa with placebo arm. The most commonly reported adverse events for the Krystexxa with mycophenolate mofetil arm versus the Krystexxa with placebo arm included musculoskeletal (41 percent versus 10 percent), gastrointestinal disorders (18 percent versus 10 percent), respiratory (18 percent versus 0 percent) and infections (9 percent versus 0 percent). See: "Reducing Immunogenicity of Pegloticase (RECIPE) with Concomitant Use of Mycophenolate Mofetil in Patients with Refractory Gout— a Phase II Double Blind Placebo Controlled Randomized Trial." Puja P. Khanna et al. Arthritis & Rheumatology 22 March 2021 [doi.org/10.1002/art.41731].