{"id":685087,"date":"2022-09-14T08:03:25","date_gmt":"2022-09-14T12:03:25","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/data-from-the-mirror-randomized-controlled-trial-of-krystexxa-pegloticase-injection-with-methotrexate-published-in-arthritis-rheumatology\/"},"modified":"2022-09-14T08:03:25","modified_gmt":"2022-09-14T12:03:25","slug":"data-from-the-mirror-randomized-controlled-trial-of-krystexxa-pegloticase-injection-with-methotrexate-published-in-arthritis-rheumatology","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/data-from-the-mirror-randomized-controlled-trial-of-krystexxa-pegloticase-injection-with-methotrexate-published-in-arthritis-rheumatology\/","title":{"rendered":"Data from the MIRROR Randomized Controlled Trial of KRYSTEXXA\u00ae (pegloticase) Injection with Methotrexate Published in Arthritis & Rheumatology"},"content":{"rendered":"

<\/p>\n

Data from the MIRROR Randomized Controlled Trial of KRYSTEXXA\u00ae<\/sup> (pegloticase) Injection with Methotrexate Published in Arthritis & Rheumatology<\/i><\/b><\/p>\n

— Month 6 data showed a greater than 30 percentage-point increase in efficacy, and a significant reduction in infusion reactions from 31% to 4% —<\/i><\/p>\n

— Publication of data follows U.S. Food and Drug Administration (FDA) approval of expanded labeling of KRYSTEXXA co-administered with methotrexate on July 7, 2022 —<\/i><\/p>\n

DUBLIN–(BUSINESS WIRE<\/a>)–
\nHorizon Therapeutics plc (Nasdaq: HZNP) today announced the publication of data from the MIRROR randomized controlled clinical trial of KRYSTEXXA (pegloticase) injection with methotrexate, a commonly used immunomodulator, in Arthritis & Rheumatology<\/i> [https:\/\/doi.org\/10.1002\/art.42335<\/a>].\n<\/p>\n

\n\u201cThe publication of this data coupled with the recently expanded labeling provides clinicians the opportunity to evolve how we care for patients with uncontrolled gout,\u201d said Suneet Grewal, M.D., co-author and rheumatologist at East Bay Rheumatology Medical Group, Inc. \u201cOur patients often live with the impact of uncontrolled gout for 10 to 15 years before seeing a specialist. They have significant comorbidities like hypertension and chronic kidney disease, as well as inflammation and damage from urate crystals formed because of chronically elevated uric acid levels. These insights should encourage more clinicians to focus on care that rapidly reduces the urate burden and will change the course of disease for more patients.\u201d\n<\/p>\n

\nThe co-administration of KRYSTEXXA with an immunomodulator like methotrexate has increasingly been employed for patients with uncontrolled gout (chronic gout refractory to oral therapies) to help reduce the development of anti-drug antibodies, which can affect treatment efficacy.1,2 <\/sup>Following a series of case studies and an open-label study, the MIRROR randomized controlled trial (Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving KRYSTEXX<\/i>A trial, NCT03994731<\/a>) was conducted3-5<\/sup> and evaluated differences in treatment response for KRYSTEXXA with methotrexate compared to KRYSTEXXA with placebo.\n<\/p>\n

\nThe primary endpoint was the proportion of serum uric acid (sUA) responders defined as sUA <6 mg\/dL for at least 80% of the time during Month 6 (Weeks 20-24). The study\u2019s secondary endpoints included the proportion of sUA responders during Month 12 (Weeks 48-52), defined as sUA <6 mg\/dL for at least 80% of the time, and the proportion of participants with complete resolution of at least one tophus with no new tophus and no single tophus showing progression (using digital photography) at Week 52 in subjects with tophi at baseline.6<\/sup><\/p>\n

\nThe Month 6 MIRROR randomized controlled trial results included:\n<\/p>\n