Horizon Pharma Presents Clinical Data Demonstrating RAYOS(R)
(prednisone) Delayed-Release Tablets Reduce Morning Stiffness in
Patients With Active Rheumatoid Arthritis
Reduction in Morning Stiffness Correlates With ACR20, DAS28 and
DEERFIELD, IL -- (Marketwire) -- 11/12/12 -- Horizon Pharma, Inc.
(NASDAQ: HZNP) today announced an additional analysis of data from
the pivotal Circadian Administration of Prednisone in Rheumatoid
Arthritis-2 (CAPRA- 2) trial demonstrating that patients with active
rheumatoid arthritis (RA) treated with its recently approved RAYOS(R)
5 mg (prednisone) delayed-release tablets who met ACR20, DAS28 and
HAQ-DI response criteria had a significantly greater reduction in
morning stiffness than patients who didn't meet these criteria. Data
were presented during the American College of Rheumatology
(ACR)/Association of Rheumatology Health Professionals (ARHP) Annual
Scientific Meeting in Washington, D.C.
"Morning pain and stiffness severity, in addition to duration of
morning stiffness, are key patient reported outcomes for both
treatment response and disease progression in RA patients," said Dr.
Frank Buttgereit, principal investigator of the study, senior
consultant and deputy head of the Department of Rheumatology and
Clinical Immunology, Charite Hospital, Berlin, Germany. "In addition
to a reduction in morning stiffness of RA, patients treated with
RAYOS also experience a significant ACR20 response and a significant
reduction in DAS28 compared to immediate-release prednisone. Based on
these analyses, we now better understand the strong correlation
between patient response and the reduction in morning stiffness."
The efficacy of RAYOS in the treatment of RA was assessed in the
CAPRA-2 trial, a double-blind, placebo-controlled, randomized,
12-week trial in patients with active rheumatoid arthritis diagnosed
according to American College of Rheumatology (ACR) criteria.
Enrolled patients were not currently being treated with
corticosteroids and received non-biologic disease-modifying
antirheumatic drug (DMARD) therapy for at least 6 months prior to
receipt of study medication. Patients were randomized in a 2:1 ratio
to treatment with RAYOS 5 mg (n=231) or placebo (n=119) administered
at 10 p.m. in addition to their DMARD therapy. Patients ranged in age
from 27 to 80 years (median age 57 years) old, were predominantly
Caucasian and were predominately (84%) female.
The primary endpoint was the proportion of patients achieving ACR20
response after 12 weeks. A key secondary endpoint was the reduction
of morning stiffness duration at week 12, as captured in patient
daily diaries. Pearson Correlations were conducted to evaluate the
relationships between change from baseline in morning stiffness
duration (minutes), morning stiffness severity or pain intensity upon
awakening with measures of disease DAS28 and HAQ-DI collected at
patient visits. Additionally, a Wilcoxon rank sum analysis was
completed between patients who responded and those that didn't
respond based on ACR20, DAS28 (score < 2.6) and HAQ-DI (percent
change from baseline < -0.22) and morning stiffness duration.
Results from these analyses demonstrated that morning stiffness
duration, morning stiffness severity and pain intensity upon
awakening correlated with DAS28 and HAQ-DI in all treatment group
analyses (p < 0.0001). There were stronger absolute correlations seen
with morning stiffness severity and pain intensity upon awakening
than with morning stiffness duration, whether the treatment groups
were analyzed separately or together. Specifically, a moderately
strong correlation (≥ 0.5) was seen between DAS28 and morning
stiffness severity and pain intensity in the treatment and placebo
groups. The ranges of correlations found are similar to previous
studies showing joint impairment is moderately correlated with
disability (0.42-0.50) as measured by self-report questionnaires
(Yazici, J Rheumatol 2004). Patients who met ACR20, DAS28 and HAQ-DI
response criteria had a greater relative reduction in morning
stiffness than patients who didn't meet these criteria.
There were no safety concerns for RAYOS 5 mg shown in the study
beyond those already established for immediate-release prednisone.
RAYOS, known as LODOTRA(R) in Europe, is a proprietary
delayed-release formulation of low-dose prednisone. The
pharmacokinetic profile of RAYOS is different with an approximately
four-hour lag time from that of immediate-release prednisone
formulations. In clinical trials studying use of RAYOS in RA,
patients were administered RAYOS at 10 p.m. with food. The
delayed-release profile of RAYOS helps to achieve therapeutic
prednisone blood levels at a time point when cytokine levels start
rising during the middle of the night. While the pharmacokinetic
profile of RAYOS differs in terms of lag time from immediate-release
prednisone, its absorption, distribution and elimination processes
RAYOS utilizes SkyePharma's proprietary Geoclock(TM) technology.
Outside the United States, LODOTRA is approved for the treatment of
moderate to severe active RA when accompanied by morning stiffness in
19 countries. Horizon has granted commercialization rights for
LODOTRA in Europe, Asia (excluding Japan) and Latin America to its
distribution partner Mundipharma International Corporation Limited.
Horizon has an exclusive license from SkyePharma for RAYOS.
Important Safety Information
RAYOS(R) (prednisone) delayed-release tablets
Approved uses of RAYOS
RAYOS, a delayed-release form of prednisone,
prevents the release of substances in the body that cause
inflammation. RAYOS is approved to treat a broad range of diseases
including RA, polymyalgia rheumatica (PMR), psoriatic arthritis
(PsA), ankylosing spondylitis (AS), asthma and chronic obstructive
pulmonary disease (COPD). For a full list of RAYOS indications,
please see full prescribing information at www.RAYOSrx.com.
RAYOS is contraindicated in patients who have known hypersensitivity
to prednisone or to any of the excipients. Rare instances of
anaphylaxis have occurred in patients receiving corticosteroids.
Important information about RAYOS
Do not use RAYOS if you are
allergic to prednisone.
Long-term use of RAYOS can affect how your body responds to stress.
Symptoms can include weight gain, severe fatigue, weak muscles and
high blood sugar.
RAYOS can weaken your immune system, making it easier for you to get
an infection or worsening an infection you already have or have
RAYOS can cause high blood pressure, salt and water retention and low
There is an increased risk of developing holes in the stomach or
intestines if you have certain stomach and intestinal disorders.
Behavior and mood changes can occur, including intense excitement or
happiness, sleeplessness, mood swings, personality changes or severe
Long-term use of RAYOS can cause decreases in bone density.
RAYOS can cause cataracts, eye infections and glaucoma.
Do not receive a "live" vaccine while taking RAYOS. The vaccine may
not work as well during this time and may not fully protect you from
Taking RAYOS during the first trimester of pregnancy can harm an
Long-term use of RAYOS can slow growth and development in children.
The most common side effects with RAYOS are water retention, high
blood sugar, high blood pressure, unusual behavior and mood changes,
increased appetite and weight gain.
Please see full prescribing information for RAYOS at www.RAYOSrx.com.
About Horizon Pharma
Horizon Pharma, Inc. is a biopharmaceutical
company that is developing and commercializing innovative medicines
to target unmet therapeutic needs in arthritis, pain and inflammatory
diseases. For more information, please visit www.horizonpharma.com.
This press release contains
forward-looking statements, including statements regarding the
potential for RAYOS to treat and improve RA symptoms such as morning
stiffness and understanding of the correlation between patient
response and the reduction in morning stiffness. 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, including, but not limited to, risks
regarding the company's ability to commercialize products
successfully, whether physicians will prescribe and patients will use
RAYOS, once available, and competition in the market for RAYOS. 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.
Burns McClellan, Inc.
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