In the Phase 3b/4 PSORIATYK SCALP trial
Sotyktu was superior to placebo across all primary and secondary
endpoints at Week 16, with patients reporting significantly greater
improvement in symptoms
Safety profile in PSORIATYK SCALP was
consistent with the established safety profile of Sotyktu
In the real-world RePhlect registry of
patients, six months of Sotyktu treatment was consistent with the
efficacy outcomes observed in the POETYK clinical studies for
psoriasis
Bristol Myers Squibb (NYSE:BMY) today announced positive results
from the Phase 3b/4 PSORIATYK SCALP trial evaluating Sotyktu
(deucravacitinib) for the treatment of patients with
moderate-to-severe scalp psoriasis, including those with less
extensive overall psoriasis. The primary endpoint was met, with a
statistically significant improvement in the scalp-specific
Physician’s Global Assessment (ss-PGA) response of 0 or 1
(clear/almost clear) at 16 weeks, with more than three times as
many patients achieving ss-PGA 0/1 with Sotyktu treatment compared
to those on placebo (48.5% versus 13.7%, respectively;
p<0.0001).
The new PSORIATYK SCALP efficacy and safety results (oral
presentation FC04.07, abstract #5627), patient-reported outcomes
(oral presentation FC06.06, abstract #5390) and 23 additional
abstracts are being presented at the European Academy of
Dermatology and Venereology (EADV) Congress in Amsterdam,
Netherlands taking place September 25-28, 2024.
“Approximately 80% of people living with plaque psoriasis have
scalp involvement and typically experience itching, flaking, pain
and bleeding, which greatly diminish their quality of life,” said
Mark Lebwohl, MD, dean of Clinical Therapeutics at the Kimberly and
Eric J. Waldman Department of Dermatology at the Icahn School of
Medicine at Mount Sinai and an investigator and paid consultant for
Bristol Myers Squibb. “These new results reinforce that oral
Sotyktu is a safe and effective once-daily treatment for people
living with moderate-to-severe psoriasis, with involvement of high
impact areas such as the scalp.”
The trial also met key secondary endpoints at Week 16, with a
significantly higher percentage of patients achieving at least a
90% improvement in Psoriasis Scalp Severity Index (PSSI) response
and a change from baseline (CFB) in scalp-specific itch with
Sotyktu treatment compared with placebo (PSSI 90: 38.8% versus
2.0%, respectively, p<0.0001; mean CFB in scalp-specific itch
-3.2 versus -0.7, respectively, p<0.0001). In patients with
Static Physician’s Global Assessment (sPGA) ≥3, a greater
proportion achieved sPGA 0/1 with Sotyktu treatment versus placebo
(51.0% versus 4.3%; p<0.0001).
Greater improvements were also reported by patients receiving
Sotyktu versus placebo, respectively, in achieving the minimum
clinically important difference (MCID) for scalp-specific itch
(41.7% versus 9.8%; p<0.0001), pain (26.2% versus 11.8%;
p=0.0372) and flaking (53.4% versus 19.6%; p<0.0001), as well as
whole-body itch (39.8% versus 13.7%; p=0.0009) numeric rating scale
(NRS) scores.
The safety profile of Sotyktu in PSORIATYK SCALP was consistent
with findings in previously conducted clinical trials of Sotyktu in
psoriasis. The most common adverse events associated with Sotyktu
treatment in the PSORIATYK SCALP trial were nasopharyngitis
(14.6%), upper respiratory tract infection (11.7%), acne (9.7%),
headache (7.8%), COVID-19 (5.8%) and pustular acne (5.8%).
Real-world analysis demonstrates consistent effectiveness
with Sotyktu
An interim analysis (poster #P3311, abstract #5500) of the
Registry of Psoriasis Health Outcomes: A Longitudinal Real-World
Collaboration Study (RePhlect) evaluated 118 patients, 108 of whom
had moderate-to-severe plaque psoriasis. This analysis found that
the effectiveness after six months of continuous Sotyktu treatment
in real-world registry patients was consistent with efficacy
outcomes observed in the POETYK PSO clinical studies in patients
living with moderate-to-severe plaque psoriasis.
Findings showed that patients in the overall group achieved
statistically significant mean decreases in measures of disease
severity (67.9% achieved Psoriasis Area and Severity Index (PASI)
scores ≤3; PASI mean baseline score 6.3, change from baseline -4.1,
p<0.001), percentage of affected Body Surface Area (BSA) scores
(64.1% of patients achieved a BSA ≤3%; BSA mean baseline score 9.3,
change from baseline -5.8, p<0.001) and Investigator’s Global
Assessment (IGA) scores (46.8% achieved IGA scores of 0/1; IGA mean
baseline score 2.7, change from baseline -1.2, p<0.001) from
baseline to follow-up. Similar results were observed in the subset
of patients with moderate-to-severe plaque psoriasis.
“These data further demonstrate the safety and efficacy of
Sotyktu for the treatment of psoriasis in high-impact areas, such
as the scalp, and include the first analysis from our RePhlect
registry providing evidence highlighting the real-world benefit of
Sotyktu for the treatment of moderate-to-severe plaque psoriasis,”
said Daniel Quirk, MD, MPH, MBA, senior vice president, worldwide
Immunology and Neuroscience medical affairs, Bristol Myers Squibb.
“We believe Sotyktu has the potential to be the systemic therapy
that healthcare providers turn to when treating adult patients with
moderate-to-severe psoriasis, especially those with scalp
involvement. Overall, these promising results reinforce once-daily
Sotyktu as a potential oral standard of care as we continue to lead
in TYK2 innovation.”
Sotyktu is also being studied in clinical trials across multiple
immune-mediated diseases.
Bristol Myers Squibb thanks the patients and investigators
involved in the ongoing PSORIATYK SCALP trial and RePhlect
study.
About the PSORIATYK SCALP Trial
PSORIATYK SCALP (NCT05478499) is an ongoing, 52-week, Phase 3b/4
multicenter, randomized, double-blind, placebo-controlled trial
evaluating the efficacy and safety of Sotyktu in patients with
moderate-to-severe scalp psoriasis, as defined by scalp-specific
Physician’s Global Assessment (ss-PGA) ≥3, Psoriasis Scalp Severity
Index (PSSI) ≥12 and Scalp Surface Area (SSA) ≥20%, who also had
body surface area involvement ≥3%.
The Week 16 efficacy and safety analysis included 154 patients
(Sotyktu, n=103; placebo, n=51).
The primary endpoint was the percentage of patients who achieved
a ss-PGA score of 0 or 1 (clear/almost clear) at Week 16. Key
secondary endpoints were the percentage of patients who achieved a
PSSI response 90, defined as at least a 90% improvement in PSSI,
change from baseline in scalp-specific itch and static Physician’s
Global Assessment (sPGA) 0/1 at Week 16. Endpoints were evaluated
for the overall population and the subpopulation with global sPGA
score ≥3.
About the Registry of Psoriasis Health Outcomes: A
Longitudinal Real-World Collaboration Study (RePhlect)
RePhlect (NCT05744466) is a prospective, observational,
real-world study of adult patients with dermatologist-diagnosed
psoriasis, with a targeted sample size of 2,500 Sotyktu patients in
six countries (United States, Canada, United Kingdom, Germany,
Japan and France). The enrollment of the study began in September
2023.
RePhlect North American cohort (United States and Canada) data
are collected through the CorEvitas Psoriasis Registry, currently
enrolling patients across 263 private and academic clinical sites
from 596 physicians in 40 states in the United States and seven
Canadian provinces.
The design and conduct of the RePhlect North American cohort
study was a collaborative effort between CorEvitas and Bristol
Myers Squibb, with financial support for the research provided by
Bristol Myers Squibb. The CorEvitas Psoriasis Registry was
developed in collaboration with the National Psoriasis
Foundation.
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.
Scalp psoriasis, which occurs in approximately 80% of patients
with plaque psoriasis, is associated with itching, flaking, pain
and bleeding and disproportionately reduces health-related quality
of life. Scalp psoriasis can be challenging to treat with topical
agents and there are limited available published data about the
efficacy of systemic agents in the treatment of moderate-to-severe
scalp disease.
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.
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 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 results of future post-marketing studies will be consistent
with the results of these studies, that Sotyktu (deucravacitinib)
for the indication described in this release may not be
commercially successful, any marketing approvals, if granted, may
have significant limitations on their use, and that continued
approval of Sotyktu for such indication may be contingent upon
verification and description of clinical benefit in additional
confirmatory trials. 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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