THOUSAND
OAKS, Calif., Nov. 2, 2023
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data for
KRYSTEXXA® (pegloticase) showing a decrease in blood
pressure during treatment of adults living with chronic gout
refractory to oral urate-lowering treatment − uncontrolled gout −
both with and without chronic kidney disease (CKD). The data will
be presented at the American Society of Nephrology Kidney Week,
taking place Nov. 2-5, in
Philadelphia.
"As we seek to address the overall burden of uncontrolled gout,
especially in those with coexisting chronic kidney disease, it is
critical to further understand the benefits of treatment," said
Brad Marder, M.D., medical director,
nephrology at Amgen. "Recognizing the high prevalence of
hypertension among these patients, we're excited to present data
that offers new insight into the potential role of urate reduction
with KRYSTEXXA with methotrexate in regulating blood pressure."
In the MIRROR randomized controlled trial, 152 adults were
randomized 2:1 to receive KRYSTEXXA with methotrexate (n=100) or
KRYSTEXXA with placebo (n=52) for 52 weeks. Treatment groups had
similar blood pressure prior to treatment. The decrease in systolic
blood pressure during treatment was greater at Week 24 of treatment
(-6±16 vs. -1±18 mmHg) and more sustained over the full 52-week
treatment period in patients receiving KRYSTEXXA with methotrexate
than in those receiving KRYSTEXXA with placebo. Compared to those
with pre-treatment CKD (eGFR less than 60 ml/min/1.73 m2), patients without
pre-treatment CKD had a more pronounced decrease in blood pressure
after Week 24 of treatment, with differences persisting through
Week 52 of treatment.
"Given the myriad of comorbidities uncontrolled gout patients
live with, it is critical that clinicians understand the systemic
connections and potential benefits of urate reduction," said
Richard J. Johnson, M.D., professor,
Division of Renal Diseases and Hypertension, University of Colorado Denver - Anschutz Medical
Campus. "These new data add to prior studies and further support
the potential role that both KRYSTEXXA urate-lowering and
methotrexate administration played in the blood pressure changes
observed."
Additional presentations include data from a validated
microsimulation model used to project the potential health and
economic benefits of effective serum urate reduction in those with
both CKD and gout. In patients projected to have oral
urate-lowering therapy inefficacy, treatment with KRYSTEXXA was
projected to prevent 300,000 cases of uncontrolled gout by 2035 in
this vulnerable CKD population.
About KRYSTEXXA®
(pegloticase)
KRYSTEXXA® (pegloticase) is the
first and only biologic approved by the FDA to treat adults living
with uncontrolled gout, a painful and debilitating inflammatory
condition with which people continue to have abnormally high levels
of uric acid and symptoms despite the use of conventional
therapies.
In 2022, the FDA approved expanded labeling to include
co-administration with the immunomodulator methotrexate, based on
results from the MIRROR randomized controlled trial, which showed
significant improvements in efficacy and safety, including a
reduction in infusion reactions.
About Uncontrolled Gout
Gout is a chronic, progressive
inflammatory form of arthritis that is caused by high urate levels
in the body. Tiny needle-like crystals can form and build up almost
anywhere in the body. Patients with uncontrolled gout continue to
have high levels of uric acid and ongoing symptoms of gout despite
the use of oral urate-lowering therapies. Uncontrolled gout is a
chronic, systemic disease, and if not addressed can have
significant clinical consequences.
INDICATION
KRYSTEXXA® (pegloticase) is
indicated for the treatment of chronic gout in adult 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.
Limitations of Use: KRYSTEXXA is not recommended for the
treatment of asymptomatic hyperuricemia.
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS
AND INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS AND
METHEMOGLOBINEMIA
- Anaphylaxis and infusion reactions have been reported to
occur during and after administration of KRYSTEXXA.
- Anaphylaxis may occur with any infusion, including a first
infusion and generally manifests within 2 hours of the infusion.
Delayed hypersensitivity reactions have also been
reported.
- KRYSTEXXA should be administered in healthcare settings and
by healthcare providers prepared to manage anaphylaxis and infusion
reactions.
- Patients should be premedicated with antihistamines and
corticosteroids and closely monitored for anaphylaxis for an
appropriate period after administration of KRYSTEXXA.
- Serum uric acid levels should be monitored prior to each
infusion and treatment discontinued if levels increase to above 6
mg/dL, particularly when 2 consecutive levels above 6 mg/dL are
observed.
- Patients at risk for glucose-6-phosphate dehydrogenase
(G6PD) deficiency should be screened prior to starting KRYSTEXXA.
Hemolysis and methemoglobinemia have been reported with KRYSTEXXA
in patients with G6PD deficiency. KRYSTEXXA is contraindicated in
patients with G6PD deficiency.
CONTRAINDICATIONS:
- In patients with G6PD deficiency.
- In patients with history of serious hypersensitivity reactions,
including anaphylaxis, to KRYSTEXXA or any of its
components.
WARNINGS AND PRECAUTIONS
Gout Flares: An
increase in gout flares is frequently observed upon initiation of
anti-hyperuricemic therapy, including KRYSTEXXA. Gout flare
prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or
colchicine is recommended starting at least 1 week before
initiation of KRYSTEXXA therapy and lasting at least 6 months,
unless medically contraindicated or not tolerated.
Congestive Heart Failure: KRYSTEXXA has not been
formally studied in patients with congestive heart failure, but
some patients in the pre-marketing placebo-controlled clinical
trials experienced exacerbation. Caution should be exercised in
patients who have congestive heart failure and patients should be
closely monitored following infusion.
ADVERSE REACTIONS
The most commonly reported adverse
reactions (≥5%) are:
- KRYSTEXXA co-administration with methotrexate trial:
gout flares, arthralgia, COVID-19, nausea and fatigue; KRYSTEXXA
alone: gout flares, arthralgia, COVID-19, nausea, fatigue,
infusion reactions, pain in extremity, hypertension and
vomiting.
- KRYSTEXXA pre-marketing placebo-controlled trials: gout
flares, infusion reactions, nausea, contusion or ecchymosis,
nasopharyngitis, constipation, chest pain, anaphylaxis and
vomiting.
Please see Full Prescribing
Information, including Boxed Warning.
About Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one
of the world's leading independent biotechnology
companies, has reached millions of patients around the world and is
developing a pipeline of medicines with breakaway
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