What Is Sotyktu, and Why Does It Matter?
Sotyktu (deucravacitinib) is an oral selective tyrosine kinase 2 (TYK2) inhibitor used to treat autoimmune inflammatory diseases such as plaque psoriasis in adults. The FDA has approved Sotyktu as the only TYK2 inhibitor for adults with active psoriatic arthritis.
Psoriatic arthritis is a long-term condition where the immune system causes inflammation in the joints, tendons, and skin. It can lead to swollen fingers or toes (dactylitis), pain in areas where tendons attach to bone (enthesitis), inflammation in joints, and psoriasis on the skin and nails. About 1 in 3 people with psoriasis develop psoriatic arthritis, which causes pain, fatigue, and trouble moving. This condition can significantly affect daily activities and increase the risk for other serious health problems.
Sotyktu works by blocking TYK2, a protein that regulates immune signals (such as interleukin (IL)-23, IL-12, and type 1 interferons), which are responsible for driving inflammation in psoriasis and psoriatic arthritis. By selectively attaching to a specific region in TYK2, Sotyktu reduces the activity of these immune signals without affecting similar proteins (JAK1, JAK2, or JAK3). The exact mechanism by which blocking TYK2 leads to symptomatic relief is not fully understood.
This approval matters because it is the first oral TYK2 inhibitor for psoriatic arthritis with a novel way of working, and it may provide an effective and convenient treatment option for managing daily activities and long-term care.
Sotyktu was first approved in 2022 for adults with moderate-to-severe plaque psoriasis who are candidates for whole-body (systemic) therapy or light therapy (phototherapy).
Why Was It Approved?
The FDA’s decision was based on positive results from clinical studies that showed that a 6-milligram once-daily dose of Sotyktu was safe and effective in providing symptomatic relief and improving joint and skin health in adults with active psoriatic arthritis.
The FDA approval of Sotyktu was supported by two phase 3 trials, which together enrolled 1,294 adults with active psoriatic arthritis. Participants had active joint inflammation and a history of plaque psoriasis and were either new to biologic treatments or had received prior therapies. Both 52-week studies included a 16-week placebo-controlled period followed by continued active treatment.
At week 16, about 54% of patients taking Sotyktu achieved at least 20% improvement in joint symptoms (ACR20) compared with 34% to 39% taking the placebo. More people on this medicine also achieved deeper responses (ACR50 and ACR70), minimal disease activity, and quality-of-life measures related to pain and physical function. People who finished one year could enter longer open-label extensions.
The safety profile of Sotyktu was found to be generally consistent with previous psoriasis studies, with common side effects including upper respiratory infections, cold sores (herpes simplex), elevated blood creatine phosphokinase (CPK) levels, mouth ulcers, inflamed hair pores (folliculitis), and acne. This medicine is also associated with serious side effects, including intense allergic reactions, certain kinds of cancer such as lymphoma, abnormal laboratory test results, elevated liver enzymes, and severe muscle problems (rhabdomyolysis).
The FDA noted that continued approval of Sotyktu for psoriatic arthritis may depend on further trials confirming its clinical benefits.
What Do I Need to Know?
Sotyktu is a once-daily oral tablet that can be taken with or without food. Swallow the tablet whole; do not crush, split, or chew it.
Inform your health care provider if you have an infection or are getting treated for it, or have an infection that doesn’t go away or keeps coming back; you have tuberculosis (TB) or have been in close contact with someone with TB; have or have had hepatitis B or C, liver or kidney problems or high levels of fat in your blood (triglycerides); or if you have ever had any type of cancer.
Before starting treatment, your health care provider will test you for TB and ensure your routine vaccines, including shingles prevention, are up to date. Do not receive live vaccines while taking Sotyktu. Patients with a history of hepatitis or herpes virus reactivation should discuss risks with their health care provider.
Be sure to share a list of all the medicines, vitamins, and supplements you take with your health care provider to avoid drug interactions. Avoid combining it with other strong immune-suppressing medicines. You must not take Sotyktu if you have had a serious allergic reaction to deucravacitinib.
Your health care provider will monitor you during and after treatment for any signs and symptoms of infections, reactivation of shingles, active TB, allergic reactions, or muscle problems. They will also do certain tests to check for CPK and triglyceride levels in your blood.
Because Sotyktu can make you more likely to get infections or worsen an existing infection, watch for any signs of infection during treatment and after stopping; your provider may pause therapy until the infection is cleared or treated.
It is not known if Sotyktu can harm a fetus or pass into breast milk. Be sure to tell your health care provider if you are pregnant, planning pregnancy, or breastfeeding.
Inform your health care provider immediately if you have fever, sweating, chills, flu-like symptoms, cough, or trouble breathing, or if you notice any other signs of infection, such as pain while urinating or warm, red, or painful areas of skin or sores on your body.
Contact your health care provider immediately if you experience new muscle pain, soreness, or weakness, especially if you also have a fever, are feeling unwell, or notice dark-colored urine. Also seek medical help if you have symptoms of an allergic reaction, including breathing problems; swelling of the face, lips, mouth, tongue, or throat; dizziness; lightheadedness; itching; hives; or skin rash.