Living with Psoriasis? This New Treatment Option Might Be the Remedy You’ve Been Looking For

 

 

People living with Psoriasis – particularly those with the skin condition known as moderate-to-severe Plaque Psoriasis – now have a new prescription treatment option as the FDA recently approved a new oral treatment.

 

Dry air and low levels of exposure to sunlight’s ultraviolet rays likely cause skin dehydration and worsening psoriasis symptoms during fall and winter.

 

 

And that’s only one of the challenges people with psoriasis face. There is also a problem with treatment — despite the availability of therapies, many people living with plaque psoriasis in the United States are untreated or undertreated.

 

There is now a new treatment option for the estimated 2 million people in the United States living with moderate-to-severe plaque psoriasis^1,2,3 whose symptoms may make day-to-day life more challenging. For those that aren’t familiar with psoriasis, it is a widely prevalent, chronic, systemic immune-mediated disease.⁴

 

And up to 90% of patients with psoriasis have psoriasis vulgaris, also known as plaque psoriasis,⁵ which is characterized by distinct round or oval plaques typically covered by silvery-white scales.

 

One of the challenges that both doctors and patients face is that despite the availability of therapies, many people living with plaque psoriasis in the United States are untreated or undertreated.^5,6

 

 

But good news has arrived. The U.S. Food and Drug Administration (FDA) has officially approved a new treatment for adults with moderate-to-severe plaque psoriasis in adults who may benefit from systemic therapy (pills or injections that work inside the body) or phototherapy (treatment using specialized ultraviolet or UV light).

 

SOTYKTU is an oral prescription medication for adults, and it is not yet known if SOTYKTU is safe and effective in children under 18 years of age.

 

 

 

 

Dr. April Armstrong, Dermatologist and clinical investigator in one of the treatment’s trials and Associate Dean and Professor of Dermatology at the University of Southern California, alongside Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation, joined me to discuss more about skin health, the impact of Psoriasis and its challenges, plus more details about the new, FDA-approved oral treatment for moderate-to-severe plaque psoriasis.

 

 

 

ABOUT OUR GUESTS

 

 

Leah M. Howard, J.D.

President and CEO

National Psoriasis Foundation

Leah M. Howard, J.D., is the President and CEO of the National Psoriasis Foundation (NPF). She is a lawyer and patient rights advocate leading the largest psoriatic disease support and research nonprofit organization in the world. NPF represents more than 8 million individuals in the U.S. who live with psoriasis and psoriatic arthritis with the shared vision of creating a world free from the burdens of psoriatic disease.

 

Howard has lived with psoriasis for 21 years and has more than two decades of experience working with national health and disability organizations, local governments, and leading health care and research institutions. She believes that solving today’s health care challenges begins with talking individuals living with chronic diseases, like psoriasis and psoriatic arthritis. Over the last decade, Howard has empowered people with psoriatic disease to share their challenges with policymakers at the state and federal level, as well as with regulators, and health agency management. This led to a number of improvements for the community including more than 40 new state laws improving access to treatment.

 

Howard has positioned NPF as a leading voice in efforts to measure value and reflect patient preferences in health outcomes. She has also piloted efforts to engage non-traditional patient advocacy partners including health insurers, pharmacy benefit managers, and employers – beginning with the launch of the NPF Payer Roundtable series in 2016. Under Howard’s leadership, NPF has prioritized serving all segments of the community. Today, NPF connects with over 2.75 million individuals each year through its highly accessible website.

 

Howard has a Bachelor of Arts degree in government and international relations from the University of Notre Dame and a law degree from George Mason University School of Law. Howard is based at NPF headquarters in Alexandria, VA.

 

 

 

 

 

 

Dr. April Armstrong is Professor of Dermatology and Associate Dean at the University of Southern California. She also serves as Vice Chair in the dermatology department at USC. She leads the psoriasis program at USC.

 

Dr. Armstrong obtained her Medical Degree from Harvard Medical School and completed dermatology residency at Harvard. She also obtained a Master of Public Health degree from Harvard School of Public Health. Prior to joining faculty at the University of Southern California, Dr. Armstrong was Vice Chair at the University of California Davis and later at the University of Colorado.

 

Dr. Armstrong’s clinical expertise lies in inflammatory skin diseases, especially psoriasis and atopic dermatitis. She has conducted over 150 clinical trials and published over 350 high-impact articles in scientific journals. She holds multiple leadership positions at professional societies, serving as the Chair of the Medical Board of the National Psoriasis Foundation, Co-President for the Group in Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), a Counselor for the International Eczema Council (IEC) and the International Psoriasis Council (IPC), and board director for the American Academy of Dermatology. Dr. Armstrong has also served on the editorial boards for the journals JAMA Dermatology and JAAD.

 

 

 

 

 

 

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:

• feeling 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. Your dermatologist should check you for infections before starting SOTYKTU. Some people have had serious infections while taking SOTYKTU, such as infections of the lungs, including pneumonia and tuberculosis (TB), and COVID-19.

Before starting SOTYKTU, your dermatologist should check you for TB. If you have active TB or a history of TB, you may be treated for TB before beginning treatment with SOTYKTU. Your dermatologist should watch you closely for signs and symptoms of TB during treatment with SOTYKTU.

If you get a serious infection, your dermatologist may tell you to stop taking SOTYKTU until your infection is controlled.

• Call or see a dermatologist if you notice any symptoms of TB.
• Call or see a dermatologist right away if you have an infection or develop any new or worsening symptoms of an infection, including:

○    Fever, sweats, or chills

○    Muscle aches

○    Weight loss

○    Cough

○    Shortness of breath

○    Blood in your phlegm (mucus you cough up)

○    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

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 dermatologist tells you it is okay.

You may be at higher risk of developing shingles (herpes zoster).

Before starting SOTYKTU, tell your dermatologist if you:

• Have any kind of infection or symptoms of an infection (see symptoms listed in “What is the most important information I should know about SOTYKTU?”), as SOTYKTU may lower the ability of your immune system to fight infections and may increase your risk of infections. Infections include:
  • Any infection for which you are currently being treated.
  • Any infection that will not go away or a history of infections that keep coming back.
  • Tuberculosis (TB), a type of lung infection. Tell your dermatologist if you have TB or have been in close contact with someone with TB.
  • Hepatitis B or C. Tell your dermatologist if you have or have had hepatitis B or C

After you start taking SOTYKTU, call your dermatologist right away if you have an infection or 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 dermatologist 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 dermatologist 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
• Dark-colored urine

A serious side effect is a side effect that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal.

Talk to your dermatologist about all of your medical conditions, including if:

• You have liver or kidney problems.
• You have high levels of fat in your blood (triglycerides).

Talk to your dermatologist if you have recently received or are scheduled to receive a vaccine (immunization).

During treatment with SOTYKTU, you should avoid receiving live vaccines (vaccines that use a small

amount of the weakened virus). Common live vaccines (among others) include:

• Measles, mumps, and rubella (MMR)
• Rotavirus
• Smallpox
• Chickenpox
• Yellow fever

 

Talk to your dermatologist if:

• You are pregnant or plan to become pregnant. It is not known if SOTYKTU can harm your unborn baby.
• You are breastfeeding or plan to breastfeed. It is not known if SOTYKTU passes
• into your breast milk.

Tell your dermatologist if you become pregnant or think you are pregnant during treatment with SOTYKTU. Report pregnancies to Bristol-Myers Squibb by calling 1-800-721-5072.

Talk to your dermatologist about all of the medications you are taking, including:

• Prescription medicines
• Over-the-counter medicines
• Vitamins
• Herbal supplements

Keep a list of them to show your dermatologist and pharmacist when you get a new medicine.

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 dermatologist 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 dermatologist 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.

Talk to your dermatologist, pharmacist, or other members of your healthcare team for more information about side effects. If you experience any side effects and would like to report them to the FDA, you can visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Take SOTYKTU exactly as your dermatologist tells you. Take 1 time every day, can be taken with or without food. Do not crush, cut, or chew the SOTYKTU tablets.

SOTYKTU is available as a 6 milligram (mg) pink, round pill. Each pill is marked with “BMS 895” and “6 mg.”

Do not take SOTYKTU if you are allergic to deucravacitinib or any of the ingredients in SOTYKTU.

Inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicon dioxide

Pill coating inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red and yellow

Store SOTYKTU at room temperature between 68°F to 77°F (20°C to 25°C).

Keep SOTYKTU and all medicines out of reach of children.

For more information, please see the U.S. Full Prescribing Information and Medication Guide for SOTYKTU. Talk to your healthcare team for more information about this medication.

 

 

References 

1. Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis prevalence in adults in the United States. JAMA Dermatol.2021;157(8):940-946. doi:10.1001/jamadermatol.2021.2007

2 Armstrong AW, Read C. Pathophysiology, clinical presentation, and treatment of psoriasis: a review. JAMA. 2020;323(19):1945-1960. doi:10.1001/jama.2020.4006

3 Armstrong et al. Undertreatment, Treatment Trends, and Treatment Dissatisfaction Among Patients With Psoriasis and Psoriatic Arthritis in the United States: Findings From the National Psoriasis Foundation Surveys, 2003-2011. JAMA Dermatol. 2013;149(10):1180–1185.

4. 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.

5. 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.

6. Lebwohl M, Langley RG, 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).2022;12(1):61-78. doi:10.1007/s13555-021-00635-4