[{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Horizon Therapeutics To Present Data on Multiple Immunomodulation Approaches with KRYSTEXXA at the EULAR 2020","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase IV"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Data Presented on KRYSTEXXA Co-Prescribed with an Immunomodulator Adds to Growing Body of Evidence for this Treatment Approach","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase IV","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"June 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Find Clinical Drug Pipeline Developments & Deals for Pegloticase
The co-administration of KRYSTEXXA (pegloticase) with an immunomodulator like methotrexate has increasingly been employed in patients with uncontrolled gout to help reduce the development of antidrug antibodies, which can affect treatment efficacy with biologics.
The MIRROR randomized controlled trial outcomes provided a clear view of improvements in patient response and reductions in infusion reactions for KRYSTEXXA plus low-dose (15 mg/week) methotrexate compared to KRYSTEXXA plus placebo.
KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Application based on recent MIRROR randomized controlled trial results, which showed 71% of patients randomized to receive KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme plus methotrexate achieved a complete response.
sBLA Submission based on recent results from the MIRROR randomized clinical trial, which showed a 71% response rate for patients randomized to receive KRYSTEXXA (Pegloticase) PEGylated uric acid specific enzyme, plus methotrexate for people living with uncontrolled Gout.
The results from the completed PROTECT trial (NCT04087720) demonstrated that Krystexxa (Pegloticase & Methotrexate) provide a substantial and sustained decrease in serum uric acid (sUA) for patients with uncontrolled gout who had received a kidney transplant.
The findings indicated that the use of KRYSTEXXA with an immunomodulator may improve persistence to therapy. Approx 90% of the evaluated population met the sUA treatment target and those who received immunomodulation after starting on KRYSTEXXA were less likely to discontinue.
Results show that 71% (71 of 100) of patients who were randomized to receive KRYSTEXXA with methotrexate compared to 40% (21 of 52) of patients who were randomized to receive KRYSTEXXA with placebo achieved the primary endpoint (p<0.001).
The Prospective Study of Pegloticase in Transplant patients trial is an ongoing Phase 4, open-label trial evaluating the safety and efficacy of KRYSTEXXA in adults with uncontrolled gout who have received a kidney transplant and are on stable immunosuppressive therapy.
PROTECT trial evaluating the use of KRYSTEXXA (pegloticase injection) in people with chronic gout refractory to conventional therapies who have received a kidney transplant, as well as pharmacokinetic data regarding the concomitant use of KRYSTEXXA and methotrexate.
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