• 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

PRINCETON, N.J. / Aug 08, 2023 / Business Wire / 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.

“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 same.”

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 www.Clear-Understanding.com.

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 symptoms.

“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 (phototherapy).

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 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

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), and COVID-19.

• 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 controlled.

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 zoster).

Before starting SOTYKTU, tell your healthcare provider if you:

• 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 such as:
  • fever, sweats, or chills
  • muscle aches
  • weight loss
  • cough
  • shortness of breath
  • blood in your phlegm (mucus)
  • warm, red, or painful skin or sores on your body different from your psoriasis
  • diarrhea or stomach pain
  • burning when you urinate or urinating more often than normal
  • feeling very tired

After you start taking SOTYKTU, call your healthcare provider right away if you have an infection or have symptoms of an infection.

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 medicine.

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 following:
  • 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 Foundation. https://www.psoriasis.org/psoriatic-disease-and-the-immune-system/
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. https://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf.psoriasis?sequence=1
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. 2008 May;58(5):826-50.