MIRROR Randomized Controlled Trial Meets Primary Endpoint and Shows 71% of Patients Achieved a Complete Response Rate Using KRYSTEXXA (pegloticase injection) with Methotrexate - Seite 2

“The impact of uncontrolled gout cannot be overstated; in addition to its effect on the patient’s quality of life, research underscores the systemic burden and increased risk of morbidity and mortality,” said John K. Botson M.D., R.Ph., C.C.D., president, Alaska Rheumatology Alliance and rheumatologist, Orthopedic Physicians Alaska. “Effectively attenuating the development of anti-drug antibodies often seen in biologics, like KRYSTEXXA, has been central in our approach to reduce the burden of urate and address the long-term consequences of systemic uric acid deposition.”

The MIRROR randomized controlled trial follows the MIRROR open-label trial (NCT03635957), which showed a 79% (11 of 14 patients) response rate (sUA <6 mg/dL) at Month 6 when KRYSTEXXA was used with methotrexate.⁴ Separately, two independent, in-practice case series showed 80⁵ and 100%⁶ of patients (8 of 10 patients and 10 of 10 patients, respectively) were able to receive a full course of treatment with the concomitant use of KRYSTEXXA and methotrexate. No new safety concerns were identified in these studies, but the findings are limited by the small sample sizes.

“These results reinforce trends seen in clinical practice and illustrate that the use of an immunomodulator, such as methotrexate, with KRYSTEXXA can help more uncontrolled gout patients complete a full course of therapy,” said Jeff R. Peterson, M.D., president, Washington Rheumatology Alliance and a director at Northwest Rheumatism Society and Western Washington Medical Group Arthritis Clinic's clinical research department. “Taken together with the open-label trial and published literature, the MIRROR randomized controlled trial results highlight an evolution of care for people living with uncontrolled gout and shift in approach to addressing the underlying burden of disease.”

Data from the trial are expected to be presented at an upcoming medical congress. Horizon plans to submit a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2022.

About KRYSTEXXA

INDICATIONS AND USAGE

KRYSTEXXA (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.

Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.