POETYK PsA-1 and POETYK PsA-2 trials met
primary endpoint, with significantly greater proportion of
Sotyktu-treated patients achieving ACR20 response compared with
placebo at Week 16
Sotyktu was well-tolerated and demonstrated
safety consistent with established profile
Bristol Myers Squibb (NYSE: BMY) today announced results from
POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal
Phase 3 trials evaluating the efficacy and safety of Sotyktu
(deucravacitinib) in adults with active psoriatic arthritis (PsA).
Both trials met their primary endpoint, with a significantly
greater proportion of Sotyktu-treated patients achieving ACR20
response (at least a 20 percent improvement in signs and symptoms
of disease) after 16 weeks of treatment compared with placebo.
Additionally, the POETYK PsA-1 and POETYK PsA-2 trials met
important secondary endpoints across PsA disease activity at Week
16. The overall safety profile of Sotyktu through 16 weeks of
treatment in the POETYK PsA-1 and POETYK PsA-2 trials was
consistent with the established safety profile of Sotyktu observed
in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe
plaque psoriasis clinical trials.
"Psoriatic arthritis is a heterogenous disease that causes a
range of different symptoms, including joint pain and swelling, as
well as psoriatic skin lesions. Despite available therapies,
rheumatologists continue to express a need for a safe and effective
oral treatment," said Roland Chen, MD, senior vice president and
head, Immunology, Cardiovascular and Neuroscience development,
Bristol Myers Squibb. "These POETYK PsA-1 and POETYK PsA-2 findings
demonstrate that oral Sotyktu has the potential to be the first
TYK2 inhibitor for people living with psoriatic arthritis and
reinforce the established efficacy and safety profile of Sotyktu.
We are encouraged by the positive data across both Phase 3 trials
and look forward to discussing the results with health
authorities."
Bristol Myers Squibb will work with key investigators to present
detailed results at upcoming medical congresses.
These topline results represent the first Phase 3 clinical
trials for Sotyktu in a rheumatic condition. Sotyktu is approved in
numerous countries around the world for the treatment of adults
with moderate-to-severe plaque psoriasis.
Bristol Myers Squibb thanks the patients, investigators and
clinical trial sites who participated in these clinical trials.
About the Sotyktu Phase 3 Psoriatic Arthritis Trial
Program
The Phase 3 Sotyktu psoriatic arthritis (PsA) program includes
two Phase 3, multicenter, randomized, double-blind,
placebo-controlled trials evaluating the efficacy and safety in
adults 18 years of age and older with active PsA: POETYK PsA-1
(IM011-054; NCT04908202) and POETYK PsA-2 (IM011-055;
NCT04908189).
POETYK PsA-1 enrolled approximately 670 patients with active PsA
who were not previously treated with a biologic disease-modifying
antirheumatic drug (bDMARD naïve). POETYK PsA-2 enrolled
approximately 730 patients with active PsA who were bDMARD naïve or
had previously received TNFα inhibitor treatment. Both trials
include a 52-week treatment period comprised of a
placebo-controlled treatment period through Week 16, followed by a
reallocation and continued active treatment period from Week 16 to
Week 52. POETYK PsA-2 also included an apremilast safety reference
arm.
The primary endpoint of both trials was the proportion of
participants achieving an ACR20 response at Week 16. Important
secondary endpoints were also assessed at Week 16 across measures
of PsA disease activity.
Patients in both trials completing 52 weeks of treatment are
potentially eligible to enroll in the open-label extension
study.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, immune-mediated,
heterogenous disease with multiple musculoskeletal and skin
manifestations, including inflammatory arthritis, enthesitis
(inflammation where tendon or ligament attaches to the bone),
dactylitis (swelling of finger and toe joints) and psoriatic skin
and nail lesions. Up to 30 percent of patients with psoriasis will
develop PsA. In addition to the loss of physical function, pain and
fatigue caused by PsA, the disease can significantly impact the
mental and emotional well-being of patients. Patients with PsA are
also at increased risk of serious comorbidities, including
cardiovascular disease, metabolic syndrome, depression and
anxiety.
About Sotyktu (deucravacitinib)
Sotyktu (deucravacitinib) is an oral, selective, allosteric
tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of
action, representing a new class of small molecules. It is the
first selective TYK2 inhibitor in clinical studies across multiple
immune-mediated diseases. Bristol Myers Squibb scientists designed
Sotyktu to selectively target TYK2, thereby inhibiting signaling of
interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key
cytokines involved in the pathogenesis of multiple immune-mediated
diseases. Sotyktu achieves a high degree of selectivity by binding
to the regulatory domain of TYK2, resulting in allosteric
inhibition of TYK2 and its downstream functions. Sotyktu
selectively inhibits TYK2 at physiologically relevant
concentrations. At therapeutic doses, Sotyktu does not inhibit
JAK1, JAK2 or JAK3.
Sotyktu is approved in numerous countries around the world for
the treatment of adults with moderate-to-severe plaque
psoriasis.
Bristol Myers Squibb: Pursuing Bold Science in Immunology to
Transform Patients’ Lives
Bristol Myers Squibb is inspired by a single vision –
transforming patients’ lives through science. For people living
with immune-mediated diseases, the debilitating reality of enduring
chronic symptoms and disease progression can make simple tasks and
daily life a challenge. Driven by our deep understanding of the
immune system that spans over 20 years of experience, we continue
to pursue bold science as we work to deliver life-changing
medicines that elevate new standards of care across rheumatology,
dermatology and pulmonology. Our sequential immunotherapy research
framework aims to address the root cause of disease by controlling
inflammation, resetting the immune system and promoting immune
homeostasis with the goal of achieving transformational efficacy.
By continuously pushing the boundaries of scientific knowledge, we
strive to bring forward tailored approaches, treatments and
combinations that may lead to durable remissions, improved quality
of life and functional cures. Our collaborations with patients,
caregivers, healthcare providers and researchers inform our
patient-centric approach as we aim to break efficacy ceilings and
deliver what matters most – the promise of living a better
life.
SOTYKTU U.S. INDICATION
SOTYKTU® (deucravacitinib) is indicated for the treatment of
moderate-to-severe plaque psoriasis in adults who are candidates
for systemic therapy or phototherapy.
Limitations of Use:
SOTYKTU is not recommended for use in combination with other
potent immunosuppressants.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
SOTYKTU is contraindicated in patients with a history of
hypersensitivity reaction to deucravacitinib or to any of the
excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as
angioedema have been reported. If a clinically significant
hypersensitivity reaction occurs, institute appropriate therapy and
discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections.
Serious infections have been reported in patients with psoriasis
who received SOTYKTU. The most common serious infections reported
with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU
in patients with an active or serious infection. Consider the risks
and benefits of treatment prior to initiating SOTYKTU in
patients:
- with chronic or recurrent infection
- who have been exposed to tuberculosis
- with a history of a serious or an opportunistic infection
- with underlying conditions that may predispose them to
infection.
Closely monitor patients for the development of signs and
symptoms of infection during and after treatment. A patient who
develops a new infection during treatment should undergo prompt and
complete diagnostic testing, have appropriate antimicrobial therapy
initiated and be closely monitored. Interrupt SOTYKTU if a patient
develops a serious infection. Do not resume SOTYKTU until the
infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (e.g., herpes zoster, herpes simplex)
was reported in clinical trials with SOTYKTU. Through Week 16,
herpes simplex infections were reported in 17 patients (6.8 per 100
patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100
patient-years) treated with placebo. Multidermatomal herpes zoster
was reported in an immunocompetent patient. During PSO-1, PSO-2,
and the open-label extension trial, the majority of patients who
reported events of herpes zoster while receiving SOTYKTU were under
50 years of age. The impact of SOTYKTU on chronic viral hepatitis
reactivation is unknown. Consider viral hepatitis screening and
monitoring for reactivation in accordance with clinical guidelines
before starting and during therapy with SOTYKTU. If signs of
reactivation occur, consult a hepatitis specialist. SOTYKTU is not
recommended for use in patients with active hepatitis B or
hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with
latent TB who were treated with SOTYKTU and received appropriate TB
prophylaxis, no patients developed active TB (during the mean
follow-up of 34 weeks). One patient, who did not have latent TB,
developed active TB after receiving 54 weeks of SOTYKTU. Evaluate
patients for latent and active TB infection prior to initiating
treatment with SOTYKTU. Do not administer SOTYKTU to patients with
active TB. Initiate treatment of latent TB prior to administering
SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in
patients with a past history of latent or active TB in whom an
adequate course of treatment cannot be confirmed. Monitor patients
for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including
lymphomas, were observed in clinical trials with SOTYKTU. Consider
the benefits and risks for the individual patient prior to
initiating or continuing therapy with SOTYKTU, particularly in
patients with a known malignancy (other than a successfully treated
non-melanoma skin cancer) and patients who develop a malignancy
when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU
was associated with an increased incidence of asymptomatic creatine
phosphokinase (CPK) elevation and rhabdomyolysis compared to
placebo.
Discontinue SOTYKTU if markedly elevated CPK levels occur or
myopathy is diagnosed or suspected. Instruct patients to promptly
report unexplained muscle pain, tenderness or weakness,
particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was
associated with increases in triglyceride levels. Periodically
evaluate serum triglycerides according to clinical guidelines
during treatment. SOTYKTU treatment was associated with an increase
in the incidence of liver enzyme elevation compared to placebo.
Evaluate liver enzymes at baseline and thereafter in patients with
known or suspected liver disease according to routine management.
If treatment-related increases in liver enzymes occur and
drug-induced liver injury is suspected, interrupt SOTYKTU until a
diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU,
consider completion of all age-appropriate immunizations according
to current immunization guidelines including prophylactic herpes
zoster vaccination. Avoid use of live vaccines in patients treated
with SOTYKTU. The response to live or non-live vaccines has not
been evaluated.
Potential Risks Related to JAK Inhibition: It is not
known whether tyrosine kinase 2 (TYK2) inhibition may be associated
with the observed or potential adverse reactions of Janus Kinase
(JAK) inhibition. In a large, randomized, postmarketing safety
trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50
years of age and older with at least one cardiovascular risk
factor, higher rates of all-cause mortality, including sudden
cardiovascular death, major adverse cardiovascular events, overall
thrombosis, deep venous thrombosis, pulmonary embolism, and
malignancies (excluding non-melanoma skin cancer) were observed in
patients treated with the JAK inhibitor compared to those treated
with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS
Most common adverse reactions (≥1% of patients on SOTYKTU and
more frequently than with placebo) include upper respiratory
infections, blood creatine phosphokinase increased, herpes simplex,
mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU
use during pregnancy are insufficient to evaluate a drug-associated
risk of major birth defects, miscarriage, or adverse maternal or
fetal outcomes. Report pregnancies to the Bristol Myers Squibb
Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU
in human milk, the effects on the breastfed infant, or the effects
on milk production. SOTYKTU is present in rat milk. When a drug is
present in animal milk, it is likely that the drug will be present
in human milk. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical
need for SOTYKTU and any potential adverse effects on the breastfed
infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in
patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including
Medication Guide, for SOTYKTU.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, that future study results may not be consistent with
the results to date, that Sotyktu (deucravacitinib) may not receive
regulatory approval for the additional indication described in this
release in the currently anticipated timeline or at all, any
marketing approvals, if granted, may have significant limitations
on their use, and, if approved, whether Sotyktu for such additional
indication will be commercially successful. No forward-looking
statement can be guaranteed. Forward-looking statements in this
press release should be evaluated together with the many risks and
uncertainties that affect Bristol Myers Squibb’s business and
market, particularly those identified in the cautionary statement
and risk factors discussion in Bristol Myers Squibb’s Annual Report
on Form 10-K for the year ended December 31, 2023, as updated by
our subsequent Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and other filings with the Securities and Exchange
Commission. The forward-looking statements included in this
document are made only as of the date of this document and except
as otherwise required by applicable law, Bristol Myers Squibb
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
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