Amgen Presents Positive Data for UPLIZNA in IgG4-Related Disease and KRYSTEXXA Infusion Time Reduction
核心洞察
UPLIZNA demonstrated an 87% reduction in IgG4-RD flare risk compared to placebo in the Phase 3 MITIGATE study, showcasing its potential as a novel treatment.
A significant 57.4% of UPLIZNA-treated participants achieved flare-free, treatment-free, complete remission at Week 52 versus 22.4% on placebo.
AGILE trial data support the safety and efficacy of shortening KRYSTEXXA infusion time to 60 minutes when co-administered with methotrexate for uncontrolled gout (搜索).
Amgen presented new data at the American College of Rheumatology (ACR) Convergence 2024, highlighting advancements in treatments for rare inflammatory diseases. The data reinforce the potential of UPLIZNA in Immunoglobulin G4-Related Disease (IgG4-RD) and support shorter infusion times for KRYSTEXXA in uncontrolled gout (搜索).
UPLIZNA Shows Promise in IgG4-Related Disease
The Phase 3 MITIGATE study, the first randomized, double-blind, placebo-controlled trial in IgG4-RD, evaluated the efficacy and safety of UPLIZNA, a CD19 (搜索)+ B-cell depleter. Results indicated a clinically meaningful and statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo (Hazard Ratio 0.13, p<0.001) over a 52-week period. Specifically, 7 out of 68 participants on UPLIZNA experienced a flare, compared to 40 out of 67 on placebo.
"These data add to the growing body of evidence for UPLIZNA and KRYSTEXXA and strengthen our commitment to developing new treatment options for rare diseases like IgG4-RD and uncontrolled gout (搜索)," said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen.
The study also revealed a reduction in the annualized flare rate, with 0.10 for UPLIZNA versus 0.71 for placebo (p<0.001). Furthermore, 57.4% of UPLIZNA recipients achieved flare-free, treatment-free, complete remission at Week 52, compared to only 22.4% in the placebo group (p<0.001). A similar percentage, 58.8%, achieved flare-free, corticosteroid-free, complete remission with UPLIZNA, versus 22.4% with placebo (p<0.001).
Notably, 89.7% of UPLIZNA-treated patients did not require glucocorticoid treatment for disease control during the placebo-controlled period, compared to 37.3% of placebo patients. After Week 8, UPLIZNA-treated patients experienced a ten-fold reduction in total glucocorticoid use relative to placebo.
The safety profile of UPLIZNA in the placebo-controlled period was consistent with previous findings. Common adverse events included COVID-19, lymphopenia, urinary tract infection, and headache. The findings were simultaneously published in the New England Journal of Medicine. The FDA previously granted Breakthrough Therapy Designation for UPLIZNA in IgG4-RD based on the MITIGATE study data, and regulatory filings are underway.
Shorter KRYSTEXXA Infusion Time Supported by AGILE Trial
The AGILE trial assessed the safety, tolerability, and efficacy of KRYSTEXXA when administered with a shorter, 60-minute infusion duration in patients with uncontrolled gout (搜索) also receiving methotrexate. The data showed that a 60-minute infusion duration of KRYSTEXXA with methotrexate yielded similar safety and efficacy results to the longer infusion times used with the current administration of KRYSTEXXA with methotrexate.
Key findings include that 67.2% of participants receiving the 60-minute infusion achieved and maintained a response during Month 6, defined as a urate level of < 6mg/dL for ≥80% of the time. Infusion reactions, including anaphylaxis, occurred in 6.0% of participants receiving the shorter infusion. Regulatory filings for the AGILE study findings are currently underway.
KRYSTEXXA is a biologic treatment approved for adults with uncontrolled gout (搜索) who have failed conventional therapies. In 2022, its label was expanded to include co-administration with methotrexate, which has shown improved efficacy and safety, including a reduction in infusion reactions.