FOREMOST Study Finds Oral
Otezla® (apremilast) Significantly
Improved Disease Control vs. Placebo
THOUSAND
OAKS, Calif., Nov. 7, 2023
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from
the global Phase 4 FOREMOST study evaluating
Otezla® (apremilast) in patients with early
oligoarticular psoriatic arthritis. FOREMOST is the
first placebo-controlled study designed
to specifically assess people with oligoarticular
psoriatic arthritis with early disease duration of five or
fewer years. Results will be presented at the American College of
Rheumatology (ACR) Convergence 2023, Nov.
10-15 in San Diego.
"Patients with early oligoarticular psoriatic arthritis who
received Otezla were twice as likely as patients receiving placebo
to achieve MDA-Joints, a composite endpoint representing minimal
disease activity at 16 weeks," said Philip
Mease, M.D., MACR, director, Rheumatology Research,
Providence Swedish Medical Center, clinical professor, University of Washington School of Medicine,
Seattle, and FOREMOST presenting
author at ACR. "These patients experienced a significant reduction
in psoriatic disease activity, a crucial finding for those in the
early stages of the condition."
"Psoriatic arthritis patients with a smaller number of affected
joints have been underrepresented in clinical trials, even though
oligoarticular psoriatic arthritis is very common and can cause
patients significant pain and functional impairment," said Laure
Gossec, M.D., Ph.D., professor of rheumatology, Sorbonne Université
and Pitié Salpêtrière Hospital, Rheumatology, Paris. "FOREMOST found that people with
oligoarticular disease experienced significant improvements with
Otezla. This is a key trial, which will help clinicians and
patients with this disease type to discuss treatment choices in a
data-driven manner."
"Otezla has been studied in numerous trials and prescribed to
840,000 patients, yet we continue to identify unmet needs and
opportunity to benefit patients," said Ponda Motsepe-Ditshego, vice
president, Global Medical at Amgen. "This research builds on our
ongoing goal to reduce the burden of psoriatic disease and improve
outcomes for patients."
The multicenter, randomized, double-blind, placebo-controlled,
parallel-group Phase 4 FOREMOST study met the primary endpoint
of modified minimal disease activity (MDA-Joints) and key secondary
endpoints at week 16. In patients with early psoriatic arthritis
disease duration (≤5 years) and ≤4 tender and ≤4 swollen joints
affected, Otezla plus standard of care doubled the modified minimal
disease activity (MDA-Joints) response compared to placebo plus
standard of care. In the study, standard of care was defined as
nonsteroidal anti-inflammatory drugs (NSAIDs), oral
glucocorticosteroids or ≤1 conventional synthetic disease-modifying
antirheumatic drugs (csDMARDs).
Detailed study findings include:
- 33.9% of patients treated with Otezla achieved MDA-Joints
response versus 16.0% with placebo, (p=0.0008), the primary
endpoint.
- 70.2% of patients treated with Otezla achieved Clinical Disease
Activity in psoriatic arthritis (cDAPSA) remission (REM ≤4) or low
disease activity (LDA >4 to ≤13) versus 51.8% with placebo, as
measured by patient global assessment score (p=0.0017), the key
secondary endpoint.
- Common treatment-emergent adverse events (TEAEs) that occurred
in more than 5% of Otezla patients were diarrhea (23.0%), nausea
(10.8%) and headache (7.8%). TEAEs were consistent with the known
safety profile of Otezla.
The study randomized 308 patients with a mean disease duration
of 9.9 months, of whom 39.9% were using a csDMARD. MDA-Joints was a
composite endpoint consisting of tender joint count ≤1 and swollen
joint count ≤1 plus achieving 3 of the following: psoriasis Body
Surface Area (BSA) ≤3%, patient assessment of pain visual analog
scale (VAS) on a 100-mm scale ≤15, Patient Global Assessment (PtGA)
of disease activity on a 100-mm scale ≤20, physical function
[HAQ-DI] ≤0.5, and enthesitis count ≤1 based on the Leeds
Enthesitis Index.
The FOREMOST oral presentation is one of more than 20
Amgen-sponsored abstracts at ACR highlighting new scientific and
clinical research across its expanded rheumatology pipeline.
About Psoriatic Arthritis
Psoriatic arthritis is a chronic, inflammatory form of arthritis,
which can cause swelling, stiffness and pain in and around the
joints that worsens over time and can decrease physical function.
It is estimated that nearly 38 million people worldwide have
psoriatic arthritis.1 Around a third of people living
with psoriasis may go on to develop psoriatic
arthritis.1 If left untreated, psoriatic arthritis can
cause disability.
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 840,000 patients worldwide.2
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 Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
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References
1 National Psoriasis Foundation. Psoriasis
Statistics. Available at:
https://www.psoriasis.org/psoriasis-statistics/. Accessed
October 16, 2023.
2 Amgen Data on File. March
2023.
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