Horizon Therapeutics plc Highlights the Systemic Implications of Gout and the Need for Improved Patient Care Strategies with a Series of Presentations at EULAR 2019

– Poster presentations raise critical systemic correlations
central to optimizing patient care –

– Oral presentation illustrates novel monitoring tool designed to
track response to treatment –

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) is elevating the dialogue on
gout within the medical and scientific community during the Annual
European Congress of Rheumatology (EULAR 2019) with a series of data
presentations on gout and its systemic implications. Oral and poster
presentations reinforce the increasingly robust evidence linking gout to
renal and cardiovascular health risks and raise important clinical
considerations in monitoring and tracking patient status beyond joint
health over time.

Across a number of independent evaluations, we’re finding important
links between gout and other organ system diseases,” said Jeffrey Kent,
M.D., senior vice president, medical affairs and outcomes research,
Horizon. “Gout is a complex, multi-system disease that should be treated
with rigor to manage both the arthritis components as well as other
important comorbidities over time. Our work represents a growing
dialogue that calls for a more focused approach to managing this chronic
disease, including improved monitoring efforts that can inform the use
of novel therapeutic solutions to better manage the disease.”

Evidence reinforces correlation of gout to
kidney and cardiovascular disease

A series of poster presentations illustrate the true burden of gout in
the U.S. population, with recent statistics linking gout to a heightened
risk of both cardiovascular and renal disease. The body of evidence
reinforces the need for greater consideration of gout diagnosis and
management, particularly among patients with kidney disease, to optimize
treatment strategies for both diseases.

  • Significantly higher rates of hospitalizations among gout patients
    for cardiac or acute renal events

    Previous research indicated
    a significant increase in all-cause hospitalizations among patients
    with gout, far exceeding trends in hospitalization rates among the
    general population. Now, a broad hospital database analysis found
    significant differences in the events requiring hospitalization among
    this population as compared with the general population, including
    “hypertensive complications and secondary hypertension” (4.0% vs.
    1.7%, respectively) and acute renal failure (4.5% vs. 2.1%,
    respectively). Gout in the US: Significant Associations with
    Cardiovascular and Renal Disease Hospitalizations (
    SAT0446)
  • Diagnosis of gout prior to and following kidney transplantation may
    be linked to mortality

    A retrospective review of data from
    more than 6,000 people who have had a kidney transplant showed an
    important connection about the onset of gout before and after
    transplantation. The analysis found that in total, one-fourth of the
    renal transplant population had a diagnosis of gout: 15 percent prior
    to the transplant and another 10percent who developed gout
    following the transplant. Analysis of the Prevalence and Timing of
    Gout Co-Morbidity in Patients Undergoing Kidney Transplant (
    SAT0428)

    Evidence
    linking kidney transplantation and gout diagnosis thus raises the
    question of whether gout may contribute to increased mortality among
    renal transplant patients. A retrospective study among Medicare
    patients with a history of kidney transplant found that gout may serve
    as an early indicator of declining health, warranting additional
    research to improve identification and intervention strategies. Impact
    of Gout on All-Cause Mortality Among Medicare Beneficiaries with a
    History of Kidney Transplantation: A Retrospective Cohort Study (
    SAT0430)

  • Marked increase in comorbidities among uncontrolled gout patients
    compared with controlled patients

    A large analysis of more
    than 6,500 gout patients finds important differences between gout
    patients who are well controlled and those whose disease remains
    uncontrolled as defined by sUA levels above 6 mg/dL. This analysis
    compared gout patients with sUA levels <6 mg/dL to those with sUA levels >8 mg/dL. Specifically, patients who have not achieved their
    treatment goals with respect to lowering uric acid have:

    • A higher prevalence of chronic kidney disease (49.4% vs. 32.4%
      respectively)
    • Higher rates of hospitalizations for congestive heart failure
      (20.0% vs. 7.0%, respectively)
    • More frequent hospitalizations due to acute kidney failure (20.0%
      vs. 8.0%, respectively)
      Comorbidities in an Early
      Diagnosed Cohort of Uncontrolled versus Controlled Gout: Analysis
      of a Large Payer Database (
      SAT0429)

Composite measure captures multi-variable
changes in disease status

The complex pathology of gout, with its wide range of signs and
symptoms, complicates physicians’ ability to assess effectiveness of
therapy. Most assessments evaluate change in serum urate and rates of
flares, but composite measures may more accurately reflect a patient’s
status, particularly among those with uncontrolled gout. Now, a newly
designed gout composite measure, the multivariable improvement measure
(GMIM) captures a broader spectrum of gout manifestations and trends
over the course of treatment, focusing on those that best correlate with
time to maximum treatment benefit. This includes not only serum urate,
absence of tophi and flares, and level of pain, but also swollen or
tender joints. This measurement approach assesses the degree of
improvement associated with treatment, scoring based on a 20, 50, or 70
percent improvement in at least four of the six clinical evaluations.
Evaluation of the GMIM indicates sensitivity to changes in disease
severity and an ability to distinguish persistent versus transient
response to therapy. As such, the GMIM may serve as a compelling,
evidence-based tool to assess response to therapy either during clinical
trials or in the course of medical practice. Development of a
Multivariable Improvement Measure for Gout (
OP0051,
June 12, 16:15)

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,
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Contacts

Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizontherapeutics.com

Ruth Venning
Executive Director, Investor Relations
Investor-relations@horizontherapeutics.com

U.S. Media Contact:
Amanda Phraner
Associate
Director, Public Relations and Social Media
media@horizontherapeutics.com

Ireland Media Contact:
Gordon MRM
Ray Gordon
ray@gordonmrm.ie