-- The AGILE trial is designed based on patient
and clinician input and part of Horizon’s continued investment to
impact the KRYSTEXXA patient experience --
Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the
first patient has been enrolled in the Infusion Duration Study to
Assess Tolerability of Pegloticase Administered with a Shorter
Infusion Duration in Subjects with Uncontrolled Gout Receiving
Methotrexate, or AGILE, clinical trial to evaluate a shorter
infusion duration for KRYSTEXXA® (pegloticase injection)
co-prescribed with methotrexate to treat people with chronic gout
refractory to conventional therapies, also known as uncontrolled
gout.
Biologic therapies, like KRYSTEXXA, are often administered
through infusions that deliver the therapeutic into the body over a
period of time. Currently, KRYSTEXXA is infused for at least two
hours. Based on input from the patient community, Horizon has
designed this Phase 4, multicenter, open-label study to assess the
safety and efficacy of KRYSTEXXA co-prescribed with methotrexate
when administered over a shorter period of time.
“As clinicians, we understand the urgency to treat uncontrolled
gout and address its effects on joints, tissues and organ systems,”
said John K. Botson M.D., R.Ph., C.C.D., president, Alaska
Rheumatology Alliance and rheumatologist, Orthopedic Physicians
Alaska. “A shorter infusion duration for KRYSTEXXA could
meaningfully impact the experience for patients, clinicians and
sites of care.”
AGILE will enroll from 30 to 50 adult participants with
uncontrolled gout.1 After four weeks of treatment with
methotrexate, participants will receive up to 24 weeks of weekly
oral methotrexate and biweekly KRYSTEXXA infusions (8 mg) in one of
three sequential assigned infusion durations: 60-minute infusion,
45-minute infusion and 30-minute infusion. Each study segment will
include a minimum of 10 participants. This trial will primarily
focus on safety and tolerability of each infusion duration.
This trial initiation follows the recent announcement that data
from the Methotrexate to Increase Response Rates in Patients With
Uncontrolled Gout Receiving KRYSTEXXA, or MIRROR, open-label trial
was published in the Journal of Rheumatology2 and that the
company’s MIRROR randomized controlled trial3 evaluating the
concomitant use of KRYSTEXXA with methotrexate to improve response
rates reached target enrollment. The safety and efficacy of
KRYSTEXXA co-prescribed with methotrexate has not been established
by any health authorities.
“AGILE reflects our efforts to innovate and improve experiences
based on the input from patients, their families and clinicians,”
said Paul Peloso, M.D., M.Sc., vice president and therapeutic area
head, rheumatology, Horizon. “Through trials like this and our
MIRROR clinical program, Horizon continues to advance understanding
of uncontrolled gout and treatment approaches that help to improve
patient outcomes.”
More information about the trial can be found on
clinicaltrials.gov (NCT 04511702).
About KRYSTEXXA
INDICATIONS AND USAGE
KRYSTEXXA® (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 INFORMATION
WARNING: 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
METHEMOGLOBINEMIA
Patients should be screened 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 FLARES
An 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 FAILURE
KRYSTEXXA 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 REACTIONS
The 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
Horizon is focused on researching, developing and
commercializing medicines that address critical needs for people
impacted by rare and rheumatic diseases. Our pipeline is
purposeful: we apply scientific expertise and courage to bring
clinically meaningful therapies to patients. We believe science and
compassion must work together to transform lives. For more
information on how we go to incredible lengths to impact lives,
please visit www.horizontherapeutics.com and follow us on Twitter,
LinkedIn, Instagram and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the potential benefits of a shorter
infusion duration of KRYSTEXXA, expectations regarding the AGILE
clinical trial, and Horizon’s product development strategy and
plans. These forward-looking statements are based on management's
expectations and assumptions as of the date of this press release
and actual results may differ materially from those in these
forward-looking statements as a result of various factors. These
factors include, but are not limited to, risks regarding whether
results of the AGILE clinical trial will be consistent with results
of prior trials or other data or Horizon’s expectations and the
risks associated with clinical development. For a further
description of these and other risks facing Horizon, please see the
risk factors described in Horizon’s filings with the United States
Securities and Exchange Commission, including those factors
discussed under the caption “Risk Factors” in those filings.
Forward-looking statements speak only as of the date of this press
release and Horizon undertakes no obligation to update or revise
these statements, except as may be required by law.
References
- National Institute of Health. Infusion Duration Study To Assess
Tolerability of Pegloticase Administered With a Shorter Infusion
Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
(AGILE). https://clinicaltrials.gov/ct2/show/NCT04511702. Accessed
Oct. 16, 2020.
- Botson JK, Tesser JRP, Bennett R, et al. Pegloticase in
combination with methotrexate in patients with uncontrolled gout: A
multicenter, open-label study (MIRROR). J Rheumatol. 2020 Sep
15:jrheum.200460.
- National Institute of Health. Study of KRYSTEXXA® (pegloticase)
plus methotrexate in patients with uncontrolled gout (MIRROR RCT).
https://www.clinicaltrials.gov/ct2/show/NCT03994731. Accessed
October 26, 2020.
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version on businesswire.com: https://www.businesswire.com/news/home/20201029005178/en/
Tina Ventura Senior Vice President, Investor Relations
Investor-relations@horizontherapeutics.com
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Investor-relations@horizontherapeutics.com
U.S. Media Contact: Amanda Phraner Director,
Public Relations and Social Media media@horizontherapeutics.com
Ireland Media Contact: Gordon MRM Ray Gordon
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