Following four years of continuous Sotyktu
treatment, clinical response was maintained in more than seven out
of 10 patients for Psoriasis Area and Severity Index (PASI) 75 in
the POETYK PSO long-term extension trial
No new safety signals observed at Year 4 in
the POETYK PSO long-term extension trial, consistent with the
established Sotyktu safety profile
Bristol Myers Squibb (NYSE:BMY) today announced new four-year
results from the POETYK PSO long-term extension (LTE) trial of
Sotyktu (deucravacitinib) treatment in adult patients with
moderate-to-severe plaque psoriasis. After four years of continuous
treatment, Week 208 responses for Psoriasis Area and Severity Index
(PASI) 75 and 90 were 71.7% and 47.5%, respectively, and 57.2% for
static Physician’s Global Assessment (sPGA) 0/1 (clear/almost
clear), using modified nonresponder imputation (mNRI). The safety
profile of Sotyktu at Year 4 remained consistent with the
established safety profile, with no new safety signals
identified.
These data were presented at the European Academy of Dermatology
and Venereology (EADV) Spring Symposium in St. Julian’s, Malta
taking place May 16-18, 2024.
“These four-year results further validate the safety profile,
efficacy and key role of once-daily Sotyktu, the first and only
TYK2 inhibitor available, for adults with moderate-to-severe plaque
psoriasis,” said April Armstrong, MD, MPH, clinical investigator in
the POETYK PSO clinical trial program and professor and chief of
dermatology at the University of California, Los Angeles. “Many
patients and their healthcare providers are looking for an
efficacious, convenient oral treatment option that provides
sustained relief from this chronic disease, allowing patients to
prioritize other aspects of their daily lives. These findings
further reinforce that we are able to offer a potential oral
standard of care to meet patients’ needs.”
The efficacy analysis included 513 patients who received
continuous Sotyktu treatment from Day 1 in the pivotal POETYK PSO-1
and POETYK PSO-2 trials and transitioned to the POETYK PSO-LTE
trial. Clinical efficacy outcomes were maintained in patients who
were continuously treated with Sotyktu from baseline through Year
4, with sustained response rates for PASI 75 of 71.7% at Year 4
(Year 1, 72.0%; Year 3, 73.8%), PASI 90 of 47.5% (Year 1, 45.6%;
Year 3, 49.0%) and sPGA 0/1 of 57.2% (Year 1, 57.7%; Year 3,
55.2%).
The safety analysis included 1,519 patients who received at
least one dose of Sotyktu across POETYK PSO-1, POETYK PSO-2 and
POETYK PSO-LTE. Cumulative exposure from parent trial randomization
was 4,392.8 patient-years (PYs) for the safety analyses. With
increased exposure to Sotyktu, the exposure-adjusted incidence
rates (EAIRs)/100 PYs at Year 4 decreased or remained the same as
those at Year 1 for adverse events (AEs) (Year 1, 229.2; Year 4,
131.7), serious AEs (Year 1, 5.7; Year 4, 5.0), discontinuation due
to AEs (Year 1, 4.4; Year 4, 2.2), herpes zoster (Year 1, 0.8; Year
4, 0.6), malignancies (Year 1, 1.0; Year 4, 0.9), major adverse
cardiovascular events (Year 1, 0.3; Year 4, 0.3), venous
thromboembolism (Year 1, 0.2; Year 4, 0.1) and deaths (Year 1, 0.2;
Year 4, 0.3). EAIRs/100 PYs were calculated as the number of
patients with an AE over the total exposure time for all patients
at risk (time to an initial AE occurrence for patients with an AE
and time of total exposure for patients without an AE).
“The data from our robust POETYK PSO clinical program continue
to reinforce the potential of the first-in-class Sotyktu as an oral
standard of care for individuals living with moderate-to-severe
plaque psoriasis,” said Alyssa Johnsen, MD, PhD, senior vice
president and head of clinical development, Immunology,
Cardiovascular and Neuroscience, Bristol Myers Squibb. “Our
leadership in TYK2 innovation highlights our transformational
science that is advancing care for immune-mediated diseases.”
Bristol Myers Squibb thanks the patients and investigators
involved in the POETYK PSO clinical trial program.
About the POETYK PSO Clinical Trial Program
PrOgram to Evaluate the efficacy and safety
of Sotyktu (deucravacitinib), a selective TYK2 inhibitor
(POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) were
global Phase 3 studies designed to evaluate the efficacy of Sotyktu
compared to placebo and Otezla® (apremilast), and the safety of
Sotyktu, in patients with moderate-to-severe plaque psoriasis. Both
POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which
enrolled 1,020 patients, were multicenter, randomized, double-blind
trials that evaluated Sotyktu (6 mg once daily) compared to placebo
and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized
withdrawal and retreatment period after Week 24.
The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2
were the percentage of patients who achieved Psoriasis Area and
Severity Index (PASI) 75 response and those who achieved static
Physician's Global Assessment (sPGA) score of 0 or 1 (clear/almost
clear) at Week 16 versus placebo. Key secondary endpoints of the
trials included the percentage of patients who achieved PASI 75 and
sPGA 0/1 compared to Otezla at Week 16 and other measures
evaluating Sotyktu versus placebo and Otezla.
Across both clinical trials and timepoints, significantly more
Sotyktu-treated patients achieved a sPGA score of 0/1, PASI 75
response and PASI 90 response. Responses persisted through Week 52,
as 82% (187/228) of patients who achieved PASI 75 with Sotyktu at
Week 24 maintained their response at Week 52 in POETYK PSO-1. In
POETYK PSO-2, 80% (119/148) of patients who continued Sotyktu
maintained PASI 75 response compared to 31% (47/150) of patients
who were withdrawn from Sotyktu.
Following the 52-week POETYK PSO-1 and POETYK PSO-2 trials,
patients could enroll in the ongoing POETYK PSO long-term extension
(LTE) trial (NCT04036435) and receive open-label Sotyktu 6 mg
once-daily. In the LTE trial, 1,221 patients were enrolled and
received at least one dose of Sotyktu. Efficacy was analyzed
utilizing treatment failure rules (TFR) method of imputation, along
with sensitivity analyses using modified non-responder imputation
and as-observed analysis, which have been used in similar analyses
with other agents.
In addition to POETYK PSO-1, POETYK PSO-2 and POETYK PSO-LTE,
Bristol Myers Squibb has evaluated Sotyktu in two other Phase 3
studies in psoriasis: POETYK PSO-3 (NCT04167462) and POETYK PSO-4
(NCT03924427).
About Psoriasis
Psoriasis is a widely prevalent, chronic, systemic
immune-mediated disease that substantially impairs patients’
physical health, quality of life and work productivity. Psoriasis
is a serious global problem, with at least 100 million people
worldwide impacted by some form of the disease, including around 14
million people in Europe and approximately 7.5 million people in
the United States. Nearly one-quarter of people with psoriasis have
cases that are considered moderate-to-severe. Up to 90 percent of
patients with psoriasis have psoriasis vulgaris, or plaque
psoriasis, which is characterized by distinct round or oval plaques
typically covered by silvery-white scales. Despite the availability
of effective systemic therapy, many patients with
moderate-to-severe plaque psoriasis remain undertreated or even
untreated and are dissatisfied with current treatments. People with
psoriasis report an impact on their emotional well-being, straining
both personal and professional relationships and causing a reduced
quality of life. Psoriasis is associated with multiple
comorbidities that may impact patients’ well-being, including
psoriatic arthritis, cardiovascular disease, metabolic syndrome,
obesity, diabetes, inflammatory bowel disease and depression.
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.
Bristol Myers Squibb: Pioneering Paths Forward 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 take a toll on their
physical, emotional and social well-being, making simple tasks and
daily life a challenge. Driven by our deep understanding of the
immune system that spans over 20 years of experience, and our
passion to help patients, the company continues to pursue
pathbreaking science with the goal of delivering meaningful
solutions that address unmet needs in rheumatology,
gastroenterology, dermatology and pulmonology. We follow the
science, aiming to tailor therapies to individual needs, improve
outcomes and expand treatment options by working to identify
mechanisms with the potential to achieve long-term remission – and
perhaps even cures – in the future. By building partnerships with
researchers, patients and caregivers to deliver innovative
treatments, Bristol Myers Squibb strives to elevate patient care to
new standards 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, Twitter, YouTube, Facebook and
Instagram.
Otezla® (apremilast) is a registered trademark of Amgen Inc.
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 and whether Sotyktu (deucravacitinib) for the
indication described in this release 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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