-- New insights on the factors associated with
tophi formation and total body disease burden of gout --
Horizon Pharma plc (NASDAQ:HZNP) presents multiple analyses of
KRYSTEXXA® (pegloticase injection) clinical trial data underscoring
the complex nature of chronic gout refractory to conventional
therapies, also known as uncontrolled gout. The data are
being presented in oral and poster sessions at the Annual European
Congress of Rheumatology (EULAR 2018), June 13 -16, 2018.
“These data presented at EULAR demonstrate how elevated serum
uric acid levels may have systemic effects across multiple organ
systems and the need to manage uncontrolled gout aggressively,”
said Jeffrey Kent, M.D., senior vice president, medical affairs and
outcomes research, Horizon Pharma plc. “As a leader in
uncontrolled gout, Horizon Pharma is driven to provide research and
analysis which reflects an expansive view about what chronically
elevated serum uric acid means for those living with the disease
and the long-term consequences of inadequate management.
Through an increased understanding of the complex nature of
uncontrolled gout, we are able to further educate on the safety and
efficacy profile of KRYSTEXXA while applying learnings to the
development of next-generation opportunities.”
Analysis of the KRYSTEXXA clinical trials in Association of
Renal Dysfunction and Development of Tophi in Subjects with Chronic
Refractory Gout and Reponses to Treatment with Pegloticase
(abstract SAT0370) offers insights on how tophi may serve as
manifestation of the total body disease burden of uncontrolled
gout. In the KRYSTEXXA clinical trials, 73 percent of
patients with uncontrolled gout had clinically apparent tophi at
baseline. Patients with tophi had a significantly lower
estimated glomerular filtration rate (eGFR) (85.2 mL/min) than
those without tophi (116.5 mL/min) (p=0.001). Low eGFR levels
mean that patients have renal (kidney) disease. This new
post-hoc analysis demonstrates a significant association between
the frequency with which those living with uncontrolled gout
manifested tophi and the presence of renal dysfunction.
Data presented in Pegloticase Treatment Significantly Decreases
Mean Arterial Blood Pressure in Patients with Chronic Gout
(FRI0237) shows that 62.1 percent of patients who received
KRYSTEXXA every two weeks, and were characterized as serum uric
acid (sUA) responders by the prespecified primary endpoint,
experienced meaningful reductions in mean arterial blood pressure
throughout the trials. In addition, these reductions were
independent of changes in renal function. People living with
uncontrolled gout often have kidney disease, hypertension or other
comorbidities in which lowering blood pressure is essential.
This data offers meaningful insights on connections between sUA
levels and blood pressure for people living with uncontrolled gout
treated with KRYSTEXXA.
“Gout is a serious medical condition but remains an undermanaged
disease for which too often only the acute symptoms are being
addressed,” said N. Lawrence Edwards, M.D., professor of medicine,
division of clinical immunology at the University of Florida in
Gainesville and chairman of the Gout & Uric Acid Education
Society. “Mounting evidence suggests the serious impact of
gout across multiple organ systems and emphasizes the importance of
aggressively managing the underlying accumulation of uric acid to
mitigate joint damage as well as significant tissue damage.”
All KRYSTEXXA abstracts can be accessed here.
These studies are investigational and the information included
has not been approved by health authorities. Safety and
efficacy within the context of these studies have not been
established.
About Uncontrolled GoutGout is a chronic,
progressive inflammatory form of arthritis that is caused by excess
uric acid in the body and needs to be managed aggressively.i
Patients with uncontrolled gout continue to have abnormally
high levels of uric acid and continued symptoms of gout despite the
use of conventional therapies. KRYSTEXXA is the only biologic
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of uncontrolled gout in adult patients. For more
information, please visit www.KRYSTEXXAHCP.com.
About KRYSTEXXAINDICATIONS AND
USAGEKRYSTEXXA® (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.
Important Limitations of Use: KRYSTEXXA is not
recommended for the treatment of asymptomatic
hyperuricemia.
IMPORTANT SAFETY INFORMATIONWARNING:
ANAPHYLAXIS AND INFUSION REACTIONS
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. However,
delayed-type 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. Patients should be
closely monitored for an appropriate period of time for anaphylaxis
after administration of KRYSTEXXA. Serum uric acid levels
should be monitored prior to infusions, and healthcare providers
should consider discontinuing treatment if levels increase to above
6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are
observed.
The risk of anaphylaxis and infusion reactions is higher in
patients who have lost therapeutic response.
Concomitant use of KRYSTEXXA and oral urate-lowering agents may
blunt the rise of sUA levels. Patients should discontinue
oral urate-lowering agents and not institute therapy with oral
urate-lowering agents while taking KRYSTEXXA.
In the event of anaphylaxis or infusion reaction, the infusion
should be slowed, or stopped and restarted at a slower rate.
Patients should be informed of the symptoms and signs of
anaphylaxis and instructed to seek immediate medical care should
anaphylaxis occur after discharge from the healthcare setting.
CONTRAINDICATIONS: G6PD DEFICIENCY ASSOCIATED
HEMOLYSIS AND METHEMOGLOBINEMIAPatients should be screened
patients for G6PD deficiency prior to starting KRYSTEXXA.
Hemolysis and methemoglobinemia have been reported with KRYSTEXXA
in patients with G6PD deficiency. KRYSTEXXA should not be
administered to these patients.
GOUT FLARESAn increase in gout flares is
frequently observed upon initiation of anti-hyperuricemic therapy,
including treatment with KRYSTEXXA. If a gout flare occurs
during treatment, KRYSTEXXA need not be discontinued. 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 FAILUREKRYSTEXXA has not been
studied in patients with congestive heart failure, but some
patients in the clinical trials experienced exacerbation.
Caution should be exercised when using KRYSTEXXA in patients who
have congestive heart failure, and patients should be monitored
closely following infusion.
ADVERSE REACTIONSThe most commonly reported
adverse reactions in clinical trials with KRYSTEXXA were gout
flares, infusion reactions, nausea, contusion or ecchymosis,
nasopharyngitis, constipation, chest pain, anaphylaxis and
vomiting.
Please see Full Prescribing
Information and Medication
Guide for more information.
About Horizon Pharma plc Horizon
Pharma plc is focused on researching, developing and
commercializing innovative medicines that address unmet treatment
needs for rare and rheumatic diseases. By fostering a growing
pipeline of medicines in development and exploring all potential
uses for currently marketed medicines, we strive to make a powerful
difference for patients, their caregivers and physicians. For
us, it’s personal: by living up to our own potential, we are
helping others live up to theirs. For more information,
please visit www.horizonpharma.com.
Follow @HZNPplc on Twitter, like us
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on LinkedIn.
Contacts:Tina VenturaSenior Vice President,
Investor RelationsInvestor-relations@horizonpharma.com
Ruth VenningExecutive Director, Investor
RelationsInvestor-relations@horizonpharma.com
U.S. Media Contact:Amanda PhranerSenior
Manager, Public Relations and Social
Mediamedia@horizonpharma.com
Ireland Media Contact: Ray Gordon Gordon
MRM ray@gordonmrm.ie
Source: Horizon Pharma plc
i Keuhn, B. Chronic Disease Approaches Needed to Curb Gout’s
Growing Burden. Journal of the American Medical Association. 2018;
319(13):1308-1309.
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