Nearly two million people are living with
moderate to severe plaque psoriasis in the U.S., but patients often
face stigma and feel misunderstood by those around them
Bristol Myers Squibb (NYSE: BMY) has launched Clear
Understanding, a campaign featuring patients living with moderate
to severe plaque psoriasis who are sharing what it’s really like
for them to live with the disease — from dealing with symptoms to
navigating relationships with friends, family or co-workers to
dispelling misconceptions about the condition. These powerful
personal stories aim to inspire others to reflect upon their own
experiences, recognize the frequent compromises made because of
their disease and feel empowered to talk to their doctor about
treatment options available.
This press release features multimedia. View
the full release here:
Nitika, living with moderate to severe
plaque psoriasis. Nitika is not taking Sotyktu. (Photo: Bristol
“I was young when I was diagnosed with moderate to severe plaque
psoriasis, and it felt like my whole life revolved around my
condition. After coping with symptoms for years, I began to
recognize the compromises I was making in my daily life, like
avoiding seeing my friends, quitting hobbies that I loved or
missing new work opportunities, because of the severity of my
symptoms,” said Nitika Chopra, founder of Chronicon, an
organization dedicated to elevating the visibility of those living
with chronic illness, and person living with plaque psoriasis.
“This led me to feel empowered to face the stigma I’ve experienced,
speak up about my own health and advocate for others to do the
Psoriasis is a widely prevalent, chronic, systemic
immune-mediated disease that affects approximately 7.5 million
people in the U.S.1 Up to 90 percent of patients with psoriasis
have plaque psoriasis, which is characterized by distinct, round or
oval plaques typically covered by silvery white scales.1 Nearly
one-quarter of people with plaque psoriasis, or around two million
in the U.S., have cases that are considered moderate to severe.1
According to the UPLIFT survey, many patients with moderate to
severe plaque psoriasis remain untreated or undertreated, with over
40% of patients not treated with systemic therapy as recommended by
the joint American Academy of Dermatology (AAD)-National Psoriasis
Foundation (NPF) guidelines.2
"We know from the psoriasis community that many patients can
experience stigma due to their disease and as a result may make
compromises in their daily lives,” said Michael Braun, senior vice
president, U.S. Immunology, Bristol Myers Squibb. “This insight
drove us to launch the Clear Understanding campaign to recognize
those concessions and encourage people living with moderate to
severe plaque psoriasis to talk to their dermatologist about
available treatment options."
To learn more about Clear Understanding and take an interactive
quiz to uncover which relationships may be most impacted by
moderate to severe plaque psoriasis visit
Moderate to severe plaque psoriasis does not just happen on the
surface of the skin — it starts in the body’s immune system.1
Normally, the immune system works to protect the body from
infections and illness, but in psoriasis, the immune system becomes
overactive and sends too many inflammatory signals.3 TYK2 is one of
many molecules in the immune system that plays a key role in
passing these signals throughout the body.4 In psoriasis, TYK2
passes on too many signals, which can lead to inflammation and
cause the skin to build up and form plaques.4 Sotyktu™
(deucravacitinib) is a selective inhibitor of TYK2. It is not
currently known how blocking TYK2 signals works to reduce psoriasis
“Many individuals living with moderate to severe plaque
psoriasis are untreated or undertreated, with persistent,
disruptive symptoms,” said Bruce Strober, M.D., Ph.D.,
board-certified dermatologist and clinical professor of dermatology
at Yale University School of Medicine. “Being prepared to talk
about your condition with your dermatologist can help inform a path
forward, which may include exploring an oral treatment option, like
Sotyktu, the only FDA-approved once-daily pill that selectively
targets and blocks TYK2 signals.”
Sotyktu is the only once-daily pill of its kind, a selective
inhibitor of TYK2. It is a prescription medicine used to treat
adults with moderate-to-severe plaque psoriasis who may benefit
from taking pills or injections (systemic therapy) or treatment
using ultraviolet or UV light (phototherapy). It is not known if
Sotyktu is safe and effective in children under 18 years of age. In
two studies of moderate to severe plaque psoriasis, Sotyktu was
compared to placebo and Otezla® (apremilast). Of the 1684 adults in
the studies, 841 received Sotyktu, 421 received placebo, and 422
received Otezla. Patients were assessed at 16, 24, and 52 weeks
after starting treatment. The co-primary endpoints were the
percentage of patients who achieved Psoriasis Area and Severity
Index (PASI) 75 and the percentage of patients who achieved static
Physician's Global Assessment (sPGA) score of 0 or 1 at Week 16
versus placebo. Key secondary endpoints included the percentage of
patients who achieved PASI 75, PASI 90 and sPGA 0/1 compared to
Otezla at Week 16 and Week 24. Once-daily Sotyktu demonstrated
superior efficacy compared to placebo and twice-daily Otezla. In
one study, POETYK PSO-2, 50% of people taking Sotyktu saw clear or
almost clear skin at 16 weeks versus 9% of people taking placebo,
and 53% of people saw 75% clearer skin at 16 weeks versus 9% of
people taking placebo. At 24 weeks, 32% of people taking Sotyktu
saw 90% clearer skin versus 20% taking Otezla.5
Sotyktu may cause serious side effects, including serious
allergic reactions. Stop taking Sotyktu and get emergency medical
help right away if you develop any of the following symptoms of a
serious allergic reaction: feel faint; swelling of your face,
eyelids, lips, mouth, tongue or throat; trouble breathing or throat
tightness; chest tightness; skin rash, hives. The most common side
effects of Sotyktu include common cold, sore throat and sinus
infection, cold sores, canker sores on inner lips, gums, tongue, or
roof of the mouth, inflamed hair pores and acne. These are not all
of the possible side effects of Sotyktu. See additional Important
Safety Information below.
About Psoriasis Psoriasis is a widely prevalent, chronic,
systemic immune-mediated disease that substantially impairs
patients’ physical health, quality of life and work productivity.6
Psoriasis is a serious global problem, with at least 100 million
people worldwide impacted by some form of the disease,7 including
approximately 7.5 million people in the U.S.1 Nearly one-quarter of
people with psoriasis have cases that are considered
moderate-to-severe.1 Up to 90 percent of patients with psoriasis
have psoriasis vulgaris, or plaque psoriasis,8 which is
characterized by distinct round or oval plaques typically covered
by silvery-white scales.1
About Sotyktu™ (deucravacitinib) Sotyktu™
(deucravacitinib) is a selective, allosteric inhibitor of tyrosine
kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family.
Sotyktu binds to the regulatory domain of TYK2, stabilizing an
inhibitory interaction between the regulatory and the catalytic
domains of the enzyme. This results in allosteric inhibition of
receptor-mediated activation of TYK2 and its downstream activation
of Signal Transducers and Activators of Transcription (STATs) as
shown in cell-based assays. Janus kinases function as pairs of
homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with
JAK1 to mediate multiple cytokine pathways and also pairs with JAK2
to transmit signals as shown in cell-based assays. The precise
mechanism linking inhibition of TYK2 enzyme to therapeutic
effectiveness in the treatment of adults with moderate-to-severe
plaque psoriasis is not currently known.
IMPORTANT SAFETY INFORMATION
INDICATION SOTYKTU™ (deucravacitinib) is a
prescription medicine used to treat adults with moderate-to-severe
plaque psoriasis who may benefit from taking injections or pills
(systemic therapy) or treatment using ultraviolet or UV light
It is not known if SOTYKTU is safe and effective in children
under 18 years of age.
IMPORTANT SAFETY INFORMATION about
SOTYKTU (deucravacitinib) SOTYKTU may cause serious side
Serious allergic reactions. Stop taking SOTYKTU and get
emergency medical help right away if you develop any of the
following symptoms of a serious allergic reaction:
- feel faint
- swelling of your face, eyelids, lips, mouth, tongue, or
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
Infections. SOTYKTU is a medicine that affects your
immune system. SOTYKTU can lower the ability of your immune system
to fight infections and can increase your risk of infections. Some
people have had serious infections while taking SOTYKTU, such as
infections of the lungs, including pneumonia and tuberculosis (TB),
- Your healthcare provider should check you for infections and TB
before starting treatment with SOTYKTU and watch you closely for
signs and symptoms of TB during SOTYKTU treatment.
- You may be treated for TB before you begin SOTYKTU treatment if
you have a history of TB or have active TB.
- If you get a serious infection, your healthcare provider may
tell you to stop taking SOTYKTU until your infection is
SOTYKTU should not be used in people with an active, serious
infection, including localized infections. You should not start
taking SOTYKTU if you have any kind of infection unless your
healthcare provider tells you it is okay.
You may be at a higher risk of developing shingles (herpes
Before starting SOTYKTU, tell your healthcare provider if
- are being treated for an infection, or have had an infection
that does not go away or keeps coming back
- have TB or have been in close contact with someone with TB
- have or have had hepatitis B or C
- think you have an infection or have symptoms of an infection
- fever, sweats, or chills
- muscle aches
- weight loss
- shortness of breath
- blood in your phlegm (mucus)
- warm, red, or painful skin or sores on your body different from
- diarrhea or stomach pain
- burning when you urinate or urinating more often than
- feeling very tired
After you start taking SOTYKTU, call your healthcare provider
right away if you have an infection or have symptoms of an
SOTYKTU can make you more likely to get infections or make any
infections you have worse.
Cancer. Certain kinds of cancer including lymphoma have
been reported in people taking SOTYKTU. Tell your healthcare
provider if you have ever had any type of cancer.
Muscle problems (rhabdomyolysis). SOTYKTU can cause
muscle problems that can be severe. Treatment with SOTYKTU may
increase the level of an enzyme in your blood called creatine
phosphokinase (CPK) and can be a sign of muscle damage. Increased
CPK is common in people taking SOTYKTU. Your healthcare provider
may tell you to stop taking SOTYKTU if the amount of CPK in your
blood gets too high or if you have signs and symptoms of severe
muscle problems. Tell your healthcare provider right away if you
have any of these signs or symptoms of severe muscle problems:
unexplained muscle pain, tenderness, or weakness, feeling very
tired, fever, or dark- colored urine.
Do not take SOTYKTU if you are allergic to
deucravacitinib or any of the ingredients in SOTYKTU.
Before taking SOTYKTU, tell your healthcare provider about
all of your medical conditions, including if you: have liver
problems or kidney problems, have high levels of fat in your blood
(triglycerides), or have recently received or are scheduled to
receive an immunization (vaccine), as you should avoid receiving
live vaccines during treatment with SOTYKTU.
Tell your healthcare provider if you are pregnant, plan to
become pregnant, or if you are breastfeeding or plan to
breastfeed. It is not known if SOTYKTU can harm your unborn
baby or if SOTYKTU passes into your breast milk.
- Report pregnancies to the Bristol-Myers Squibb Company’s
Adverse Event reporting line at 1-800-721-5072
Tell your healthcare provider about all the medicines you
take, including prescription medicines, over-the-counter
medicines, vitamins, and herbal supplements. Keep a list of them to
show your healthcare provider and pharmacist when you get a new
Take SOTYKTU exactly as your healthcare provider tells you to
take it. Take SOTYKTU 1 time every day, with or without food.
Do not crush, cut, or chew the SOTYKTU tablets.
SOTYKTU may cause serious side effects, including:
- Changes in certain laboratory test results. Changes in
laboratory tests have happened in some people taking SOTYKTU. Your
healthcare provider may do blood tests before you start taking
SOTYKTU and during treatment with SOTYKTU to check for the
- Increased triglycerides. Too much fat in your blood can
cause problems with your heart.
- Increased liver enzymes. If your liver enzymes increase
too much, your healthcare provider may need to do additional tests
on your liver and may tell you to stop taking SOTYKTU if they think
that SOTYKTU is harming your liver.
- Potential risks from Janus kinase (JAK) inhibition.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor. TYK2 is in the JAK
family. It is not known whether taking SOTYKTU has the same risks
as taking JAK inhibitors. Increased risk of death (all causes) has
happened in people who were 50 years of age and older with at least
1 heart disease (cardiovascular) risk factor who were taking a JAK
inhibitor used to treat rheumatoid arthritis (RA) compared to
people taking another medicine in a class of medicines called TNF
blockers. SOTYKTU is not for use in people with RA.
The most common side effects of SOTYKTU include: common
cold, sore throat and sinus infection (upper respiratory
infections), cold sores (herpes simplex), sores on inner lips,
gums, tongue, or roof of the mouth (canker sores), inflamed hair
pores (folliculitis) and acne.
These are not all of the possible side effects of SOTYKTU.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Please see the U.S. Full Prescribing Information and 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.
____________________________ 1 Armstrong AW, Mehta MD, Schupp
CW, et al. Psoriasis prevalence in adults in the United States.
JAMA Dermatol. Published online June 30, 2021.
doi:10.1001/jamadermatol.2021.2007. 2 Lebwohl, M., Langley, R.G.,
Paul, C. et al. Evolution of Patient Perceptions of Psoriatic
Disease: Results from the Understanding Psoriatic Disease
Leveraging Insights for Treatment (UPLIFT) Survey. Dermatol Ther
(Heidelb) 12, 61–78 (2022).
https://doi.org/10.1007/s13555-021-00635-4 3 National Psoriasis
Foundation. (2022, December 12). Psoriatic disease and the immune
system. The National Psoriasis Foundation: National Psoriasis
4 Muromoto, R., Oritani, K., & Matsuda, T. (2022). Current
understanding of the role of tyrosine kinase 2 signaling in immune
responses. World journal of biological chemistry, 13(1), 1–14.
https://doi.org/10.4331/wjbc.v13.i1.1 5 SOTYKTU Prescribing
Information. SOTYKTU U.S. Product Information. September 2022.
Princeton, N.J.: Bristol-Myers Squibb Company. 6 Armstrong AW,
Schupp C, Wu J, Bebo B. Quality of life and work productivity
impairment among psoriasis patients: findings from the National
Psoriasis Foundation survey data 2003–2011. PloS One.
2012;7(12):e52935. 7 World Health Organization. Global report on
psoriasis. 2016. Accessed May 12, 2022.
8 Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al.
Guidelines of care for the management of psoriasis and psoriatic
arthritis: Section 1. Overview of psoriasis and guidelines of care
for the treatment of psoriasis with biologics. J Am Acad Dermatol.
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