SPROUT 52-Week Data Demonstrate Durable
Response and Consistent Safety Profile of Oral Otezla in Children
with Moderate to Severe Plaque Psoriasis
Late-Breaking Phase 3 Study of Otezla in
Palmoplantar Pustulosis Achieves Primary and Secondary Endpoints at
16 Weeks
THOUSAND OAKS,
Calif., March 9, 2024 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced new, 52-week results from the
Phase 3 SPROUT study examining the use of Otezla®
(apremilast) in children and adolescents aged 6 to 17 years with
moderate to severe plaque psoriasis. These data, along with
findings from a Phase 3 late-breaking study on Otezla in
palmoplantar pustulosis, will be presented at the 2024 American
Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San
Diego.
"These data reflect Amgen's commitment to
exploring new ways to treat inflammatory skin disease," said Ponda
Motsepe-Ditshego, vice president, Global Medical, at Amgen. "A
decade after the launch of Otezla, we continue to study how this
oral therapy can help improve care and reduce disease burden in
underserved patient populations."
SPROUT Phase 3 Study
Results from
SPROUT, a multicenter, randomized, placebo-controlled, double-blind
study, demonstrated the efficacy and safety of Otezla in pediatric
patients aged 6 to 17 years with moderate to severe plaque
psoriasis inadequately controlled by or intolerant to topical
therapy. Continued Otezla use resulted in sustained improvements in
psoriasis severity and skin involvement in patients for up to one
year. The safety profile was consistent with previous Otezla
studies. These findings add to the published 16-week
results.1
"For the first time, we have a full year of data
on a potential oral treatment for children and adolescents with
moderate to severe plaque psoriasis, who currently lack any
approved oral treatment options," said Loretta Fiorillo, M.D., FRCPC, clinical
professor of pediatrics, University of
Alberta. "At 52 weeks, more than half of patients achieved
clear or almost clear skin. Otezla showed increased efficacy beyond
that seen at the week 16 primary endpoint, with a durable
maintenance of response – an important finding for families living
with this chronic inflammatory disease."
All patients in the study received Otezla for a
36-week extended active treatment period following the 16-week
randomized placebo-controlled treatment period, providing up to 52
weeks of data. There were 186 patients who completed the 36-week
extension: 125 who continued to receive Otezla, and 61 patients
switched from placebo to Otezla.
Study findings include:2
- 56.3% of patients who received Otezla through week 52 achieved
static Physician Global Assessment (sPGA) response (score of ≥3),
an investigator assessment of overall disease severity of plaque
psoriasis, the study's primary endpoint.
- 52.5% of patients who switched from placebo to Otezla achieved
sPGA response at week 52.
- 71.4% of patients who received Otezla through week 52 achieved
Psoriasis Area and Severity Index (PASI)-75, an investigator
assessment of disease severity and skin involvement, a secondary
endpoint.
- 75.4% of patients who switched from placebo to Otezla achieved
PASI-75 at week 52.
- Treatment-emergent adverse events (AEs) were consistent with
the known safety profile of Otezla in adults. The most common AEs
(>10%) throughout the study were nausea, diarrhea, abdominal
pain, vomiting and headache.
Findings will be presented as an e-poster with an
oral presentation on Saturday, March
9 at 4:50 p.m. PST.
Phase 3 Late-Breaking Palmoplantar Pustulosis
Findings
Amgen also will present late-breaking findings from
a Phase 3 study evaluating the efficacy and safety of Otezla in
patients with moderate to severe palmoplantar pustulosis in
Japan following inadequate
response to topical therapy. Palmoplantar pustulosis is a chronic
inflammatory condition characterized by pustules on the palms and
soles. The condition can be difficult to treat, with limited
available treatment options.3,4
"Palmoplantar pustulosis can severely impact
daily functioning due to its painful effects on the hands and feet,
necessitating new therapeutic options for this impactful
inflammatory skin condition," said Melinda
Gooderham, M.D., FRCPC, dermatologist and clinical
investigator at SKiN Centre for Dermatology and assistant
professor, Queen's University, Ontario,
Canada. "The study presented at AAD highlighted significant
improvement in disease severity, symptoms such as itch, pain,
discomfort, and patient-reported quality of life among those
treated with Otezla compared to placebo."
The randomized, placebo-controlled, double-blind
study included 176 patients who received Otezla (n=88) or placebo
(n=88) for 16 weeks. All primary and secondary endpoints were
met.
Study findings include:5
- 67.8% of patients who received Otezla achieved the primary
endpoint of PPPASI 50 (>50% improvement in the Palmoplantar
Pustulosis Area and Severity Index); this was a significantly
greater response as compared to placebo (35.3%; P<0.0001).
- Statistically significant improvements in all secondary
endpoints were observed with Otezla relative to placebo, including
changes from baseline to week 16 in PPPASI, PPSI (Palmoplantar
Pustulosis Severity Index), Patient Visual Analogue Scale of
palmoplantar pruritus and pain/discomfort and DLQI (Dermatology
Life Quality Index).
- Treatment-emergent AEs were consistent with the known safety
profile of Otezla. The most common AEs (>10%) throughout the
study were diarrhea, soft feces, headache and nausea.
Findings will be presented as a late-breaking
oral presentation on Saturday, March
9 at 9:20 a.m. PST.
Additional Amgen data to be presented at AAD
include:
Otezla Abstracts
- Long-term Impact of Apremilast on Cardiometabolic Parameters
and the Relationship of Cardiometabolic Changes with Psoriasis
Efficacy
Abstract #50668, E-Poster and Oral Presentation of Poster on
Saturday, March 9 at 3:55 p.m. PST
- Beyond Race-Ethnicity: Fitzpatrick Skin Type Analysis
Highlights Unmet Needs and Differing Treatment Patterns in
Psoriasis Among the Conventional Systemics Cohort of British
Association of Dermatologists Biologic and Immunomodulators
Register (BADBIR)
Abstract #51067, E-Poster and Oral Presentation of Poster on
Saturday, March 9 at 4:15 p.m. PST
- Apremilast Improves Clinical Outcomes and Pain in Patients
with Oligoarticular Psoriatic Arthritis
Abstract #51246, E-Poster
- Efficacy of Apremilast in Adults with Mild-to-Moderate
Plaque Psoriasis with Scalp Involvement: Pooled Data from
PROMINENT, ADVANCE, and EMBRACE Trials
Abstract #51480, E-Poster
- Proportion of the US Psoriasis Population Impacted by Common
Warnings for Moderate-to-Severe Plaque Psoriasis Treatment
Abstract #52846, E-Poster
Rocatinlimab (AMG 451/KHK4083)
Abstract
- Rocatinlimab Significantly Improves Clinical Responses in
Patients with Moderate-to-Severe Atopic Dermatitis by Week 2 in a
Randomized Double-Blind Placebo-Controlled Phase 2b Study
Abstract #50233, E-Poster
About
Psoriasis
Psoriasis is a chronic disease where skin cells build up quickly,
typically causing red or discolored, scaly, and itchy patches on
the skin.6 Approximately 125 million people worldwide
have psoriasis, including around 14 million people in Europe and more than 8 million people in
the United States.7,8
About 80% of those patients have plaque psoriasis.9
About Otezla®
(apremilast)
Otezla® (apremilast) is an oral small-molecule inhibitor
of phosphodiesterase 4 (PDE4) specific for cyclic adenosine
monophosphate (cAMP). PDE4 inhibition results in increased
intracellular cAMP levels, which is thought to indirectly modulate
the production of inflammatory mediators. The specific mechanism(s)
by which Otezla exerts its therapeutic action in patients is not
well defined.
Since its initial FDA approval in 2014, Otezla
has been prescribed to more than 920,000 patients
worldwide.10
Otezla® (apremilast) U.S.
INDICATIONS
INDICATIONS
Otezla® (apremilast) is indicated for
the treatment of adult patients with plaque psoriasis who are
candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult
patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult
patients with oral ulcers associated with Behçet's Disease.
Otezla® (apremilast) U.S. IMPORTANT
SAFETY INFORMATION
Contraindications
- Otezla® is contraindicated in patients with a known
hypersensitivity to apremilast or to any of the excipients in the
formulation
Warnings and Precautions
- Hypersensitivity: Hypersensitivity reactions, including
angioedema and anaphylaxis, have been reported during postmarketing
surveillance. If signs or symptoms of serious hypersensitivity
reactions occur, discontinue Otezla and institute appropriate
therapy
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea,
nausea, and vomiting were associated with the use of Otezla. Most
events occurred within the first few weeks of treatment. In some
cases, patients were hospitalized. Patients 65 years of age or
older and patients taking medications that can lead to volume
depletion or hypotension may be at a higher risk of complications
from severe diarrhea, nausea, or vomiting. Monitor patients who are
more susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider Otezla dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
- Depression: Carefully weigh the risks and benefits of treatment
with Otezla for patients with a history of depression and/or
suicidal thoughts/behavior, or in patients who develop such
symptoms while on Otezla. Patients, caregivers, and families should
be advised of the need to be alert for the emergence or worsening
of depression, suicidal thoughts or other mood changes, and they
should contact their healthcare provider if such changes occur
-
- Plaque Psoriasis: Treatment with Otezla is associated with an
increase in depression. During clinical trials in patients with
moderate to severe plaque psoriasis, 1.3% (12/920) of patients
reported depression compared to 0.4% (2/506) on placebo. Depression
was reported as serious in 0.1% (1/1308) of patients exposed to
Otezla, compared to none in placebo-treated patients (0/506).
Suicidal behavior was observed in 0.1% (1/1308) of patients on
Otezla, compared to 0.2% (1/506) on placebo. One patient treated
with Otezla attempted suicide; one patient on placebo committed
suicide
- Psoriatic Arthritis: Treatment with Otezla is associated with
an increase in depression. During clinical trials, 1.0% (10/998)
reported depression or depressed mood compared to 0.8% (4/495)
treated with placebo. Suicidal ideation and behavior was observed
in 0.2% (3/1441) of patients on Otezla, compared to none in
placebo-treated patients. Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in
placebo-treated patients (0/495). Two patients who received placebo
committed suicide compared to none on Otezla
- Behçet's Disease: Treatment with Otezla is associated with an
increase in depression. During the clinical trial, 1% (1/104)
reported depression or depressed mood compared to 1% (1/103)
treated with placebo. No instances of suicidal ideation or behavior
were reported in patients treated with Otezla or treated with
placebo
- Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla
-
- Plaque Psoriasis: Body weight loss of 5-10% occurred in 12%
(96/784) of patients with moderate to severe plaque psoriasis
treated with Otezla and in 5% (19/382) of patients treated with
placebo. Body weight loss of ≥10% occurred in 2% (16/784) of
patients treated with Otezla compared to 1% (3/382) of patients
treated with placebo
- Psoriatic Arthritis: Body weight loss of 5-10% was reported in
10% (49/497) of patients taking Otezla and in 3.3% (16/495) of
patients taking placebo
- Behçet's Disease: Body weight loss of >5% was reported in
4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of
patients taking placebo
- Drug Interactions: Apremilast exposure was decreased when
Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy
may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin,
phenobarbital, carbamazepine, phenytoin) is not recommended
Adverse Reactions
- Plaque Psoriasis: The most common adverse reactions (≥ 5%) are
diarrhea, nausea, upper respiratory tract infection, and headache,
including tension headache. Overall, the safety profile of Otezla
in patients with mild to moderate plaque psoriasis was consistent
with the safety profile previously established in adult patients
with moderate to severe plaque psoriasis
- Psoriatic Arthritis: The most common adverse reactions (≥ 5%)
are diarrhea, nausea, and headache
- Behçet's Disease: The most common adverse reactions (≥ 10%) are
diarrhea, nausea, headache, and upper respiratory tract
infection
Use in Specific Populations
- Otezla has not been studied in pregnant women. Advise pregnant
women of the potential risk of fetal loss.
Please click here for Otezla® Full Prescribing
Information.
About Atopic Dermatitis
Atopic dermatitis is a chronic inflammatory disease that causes
excessively dry, itchy skin that can be painful. Repeated
scratching can cause the skin to thicken, harden or become
vulnerable to infection. Atopic dermatitis is the most common form
of eczema – affecting 1-3% of adults worldwide – and the prevalence
is increasing. The disease typically manifests in childhood
followed by other allergy symptoms.
About rocatinlimab
Rocatinlimab (AMG 451/KHK4083), an investigational product, is
a potential first-in-class anti-OX40 monoclonal antibody that is
being studied for its ability to inhibit and reduce the number of
OX40+ pathogenic T cells responsible for driving systemic and local
AD inflammatory responses.
It has been reported that effector T cells expressing OX40 are
present in the lesions of patients with atopic dermatitis and are
critical in the disease pathophysiology. The initial antibody was
discovered in collaboration between Kyowa Kirin US Research and La
Jolla Institute for Immunology.
Amgen and Kyowa Kirin Collaboration
On June 1, 2021, Kyowa Kirin and
Amgen entered into an agreement to jointly develop and
commercialize rocatinlimab. Under the terms of the agreement, Amgen
will lead the development, manufacturing, and commercialization for
KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all
rights. If approved, the companies will co-promote the asset in
the United States and Kyowa Kirin
has opt-in rights to co-promote in certain other markets including
Europe and Asia.
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 potential.
Amgen is one of the 30 companies that comprise the Dow Jones
Industrial Average and is also part of the Nasdaq-100 index. In
2023, Amgen was named one of "America's Greatest Workplaces" by
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Companies" by TIME.
For more information, visit Amgen.com and follow us on X
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Amgen Forward-Looking
Statements
This news release contains forward-looking statements that are
based on the current expectations and beliefs of Amgen. All
statements, other than statements of historical fact, are
statements that could be deemed forward-looking statements,
including any statements on the outcome, benefits and synergies of
collaborations, or potential collaborations, with any other company
(including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance
of Otezla® (apremilast) (including anticipated Otezla
sales growth and the timing of non-GAAP EPS accretion), our
acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon
Therapeutics plc (including the prospective performance and outlook
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