SOTYKTU: Uses, Dosage & Side Effects

What Is SOTYKTU and What Is It Used For?

SOTYKTU contains the active substance deucravacitinib, which belongs to a class of medications known as tyrosine kinase 2 (TYK2) inhibitors. TYK2 is a member of the Janus kinase (JAK) family of intracellular enzymes, which also includes JAK1, JAK2, and JAK3. These enzymes play important roles in transmitting signals from cell surface receptors to the cell nucleus, regulating the expression of genes involved in immune function, inflammation, and blood cell production. While all four JAK family members share a similar catalytic domain structure, they have distinct roles in different signaling pathways.

What makes deucravacitinib fundamentally different from earlier JAK inhibitors (such as tofacitinib, baricitinib, or upadacitinib) is its unique binding mechanism. Traditional JAK inhibitors bind to the catalytic (kinase) domain of JAK enzymes – the active site where the enzyme performs its signaling function. Because the catalytic domains of all four JAK family members are structurally similar, these inhibitors tend to block multiple JAK enzymes simultaneously, which can lead to off-target effects including changes in blood counts, increased cholesterol levels, and other immune-related complications.

Deucravacitinib, by contrast, binds to the regulatory (pseudokinase or JH2) domain of TYK2 rather than its catalytic domain. This regulatory domain is unique to TYK2 and is structurally distinct from the corresponding domains in JAK1, JAK2, and JAK3. By targeting this allosteric site, deucravacitinib locks TYK2 in an inactive conformation, preventing it from signaling without directly interfering with the catalytic activity of other JAK family members. This provides a level of selectivity that is approximately 100-fold greater for TYK2 over JAK1, JAK2, and JAK3 in cellular assays. The clinical significance of this selectivity is reflected in the safety profile of SOTYKTU, which has not shown the same types of safety signals (such as increased rates of serious infections, major adverse cardiovascular events, venous thromboembolism, or malignancies) that have been associated with some non-selective JAK inhibitors.

TYK2 mediates signaling downstream of several key cytokine receptors that are centrally involved in the pathogenesis of plaque psoriasis. Specifically, TYK2 is required for signaling through the receptors for interleukin-23 (IL-23), interleukin-12 (IL-12), and type I interferons (IFN-α/β). IL-23 is widely recognized as a master cytokine in psoriasis, driving the differentiation and maintenance of pathogenic Th17 cells that produce the pro-inflammatory cytokines IL-17A, IL-17F, and IL-22 – the primary effectors of keratinocyte hyperproliferation, epidermal thickening, and neutrophil recruitment that characterize psoriatic plaques. IL-12 contributes to Th1 cell differentiation and IFN-γ production, while type I interferons play roles in innate immune activation that can initiate or exacerbate psoriasis. By selectively inhibiting TYK2, deucravacitinib reduces the activity of all three of these pathways, leading to a comprehensive reduction in the inflammatory processes that drive psoriasis.

SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Plaque psoriasis is the most common form of psoriasis, affecting approximately 80–90% of people with the condition. It is characterized by well-defined, raised, red or pink patches of skin covered with silvery-white scales (plaques) that can appear anywhere on the body but most commonly affect the scalp, elbows, knees, and lower back. Moderate-to-severe plaque psoriasis typically involves more than 3–10% of the body surface area (BSA) or affects areas that have a significant impact on quality of life, such as the face, hands, feet, or genitals. The condition can cause substantial physical symptoms including itching, pain, burning, stinging, and skin tightness, as well as significant psychological burden including depression, anxiety, social isolation, and reduced quality of life.

The efficacy of SOTYKTU was established in two pivotal, randomized, double-blind, placebo-controlled phase III clinical trials:

• POETYK PSO-1: This trial enrolled 666 adults with moderate-to-severe plaque psoriasis. At week 16, 58.4% of patients treated with deucravacitinib 6 mg once daily achieved a PASI 75 response (at least 75% improvement in the Psoriasis Area and Severity Index) compared with 12.7% of patients receiving placebo. Additionally, 53.6% of deucravacitinib-treated patients achieved a static Physician Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) compared with 7.2% of patients receiving placebo. SOTYKTU was also compared with apremilast (the only other oral systemic therapy specifically approved for psoriasis at the time), and demonstrated statistically significant superiority, with 58.4% of deucravacitinib-treated patients achieving PASI 75 versus 35.5% for apremilast.
• POETYK PSO-2: This trial enrolled 1,020 adults with moderate-to-severe plaque psoriasis. Results were consistent with POETYK PSO-1, with 53.0% of deucravacitinib-treated patients achieving PASI 75 at week 16 compared with 9.4% for placebo. Superiority over apremilast was also confirmed (53.0% vs 40.2% for PASI 75). In the randomized withdrawal phase of this trial, patients who had responded to deucravacitinib and were re-randomized to placebo experienced a gradual loss of response, confirming the need for continued therapy.

Across both trials, SOTYKTU demonstrated improvements not only in objective measures of psoriasis severity (PASI, sPGA) but also in patient-reported outcomes including itch severity, skin pain, and quality of life as measured by the Dermatology Life Quality Index (DLQI). A significant proportion of patients achieved PASI 90 (75% or greater skin clearance) and PASI 100 (complete skin clearance) responses, reflecting the potential for deep disease control with continued therapy.

SOTYKTU was first approved by the U.S. Food and Drug Administration (FDA) in September 2022 and by the European Medicines Agency (EMA) in 2023. It is marketed globally by Bristol-Myers Squibb and represents the first approved medication in the TYK2 inhibitor class, opening a new therapeutic avenue for patients with moderate-to-severe plaque psoriasis who seek an effective oral treatment with a differentiated safety profile.

What Should You Know Before Taking SOTYKTU?

Contraindications

SOTYKTU must not be used in the following situations:

• Hypersensitivity: Do not take SOTYKTU if you are allergic to deucravacitinib or to any of the other ingredients in the tablet (listed in the contents section). Signs of an allergic reaction may include rash, itching, swelling of the face, lips, tongue, or throat, and difficulty breathing.
• Active serious infections: Do not take SOTYKTU if you have a clinically significant active infection that your doctor considers important. This includes active tuberculosis (TB). Your doctor will assess whether your infection has been adequately treated before you can start SOTYKTU.

Warnings and Precautions

Before starting SOTYKTU, tell your doctor or pharmacist if any of the following apply to you:

• Infections that are not healing or keep recurring: SOTYKTU works by modulating the immune system, which can affect the body’s ability to fight certain infections. If you have a chronic infection or a pattern of recurrent infections, your doctor will carefully assess whether SOTYKTU is appropriate for you and will monitor you closely during treatment. If you develop a serious infection during treatment, your doctor may temporarily stop SOTYKTU until the infection is controlled.
• Tuberculosis (TB): If you have ever had TB or have been in close contact with someone who has TB, tell your doctor. You will be screened for TB before starting SOTYKTU, as the medication could potentially reactivate latent TB. If latent TB is detected, you will need to receive treatment for TB before starting SOTYKTU.
• Cancer: If you have cancer, your doctor will need to assess whether you should still receive SOTYKTU. Some immunomodulatory medications have been associated with an increased risk of certain cancers. While the clinical trial data for SOTYKTU have not shown an increased malignancy risk, long-term surveillance data are still being collected.
• Heart problems or cardiovascular risk factors: Tell your doctor if you have heart disease or conditions that increase your risk of cardiovascular disease. It is not yet established whether SOTYKTU increases the risk of cardiovascular events. Your doctor will consider your overall cardiovascular risk when deciding whether SOTYKTU is appropriate for you.
• History of or risk for blood clots: Inform your doctor if you have ever had blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE), or if you have risk factors for these conditions. Seek immediate medical attention if you develop leg swelling and pain, or chest pain and shortness of breath, as these could be signs of blood clots. It is not yet established whether SOTYKTU increases the risk of blood clots.
• Vaccinations: If you have recently received a vaccine or plan to receive one, tell your doctor. You should not receive certain types of vaccines (live vaccines) while using SOTYKTU, as the immunomodulatory effects of the medication could reduce the effectiveness of the vaccine or potentially cause the live vaccine organism to cause infection. Examples of live vaccines include the MMR (measles, mumps, rubella) vaccine, the live varicella vaccine, the live influenza (nasal spray) vaccine, and the BCG vaccine. Non-live (inactivated) vaccines can generally be given during SOTYKTU treatment, although the immune response may be somewhat reduced.

Children and Adolescents

SOTYKTU is not recommended for use in children or adolescents under 18 years of age. The safety and efficacy of deucravacitinib have not been evaluated in this age group. Psoriasis in children and adolescents may require different treatment approaches, and healthcare providers should consider age-appropriate treatment options. Clinical trials in pediatric populations may be conducted in the future to establish the safety and efficacy of SOTYKTU in younger patients.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking SOTYKTU. The effects of deucravacitinib on human pregnancy are not known. As a precaution, SOTYKTU should preferably be avoided during pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus. Animal reproductive toxicology studies are available in the prescribing information, but animal data are not always predictive of human response. Women of childbearing potential should discuss effective contraception with their healthcare provider.

It is not known whether deucravacitinib or its metabolites pass into human breast milk. A risk to the breastfed infant cannot be excluded. The decision to breastfeed during SOTYKTU treatment should be made in consultation with your doctor, weighing the benefits of breastfeeding for the infant against the benefits of SOTYKTU treatment for the mother.

Driving and Operating Machinery

SOTYKTU is not expected to affect your ability to drive or operate machinery. Based on its pharmacological properties and the adverse reaction profile observed in clinical trials, there is no reason to expect that deucravacitinib would impair psychomotor performance. However, if you experience any side effects that could affect your ability to drive or operate machinery safely, refrain from these activities until you feel well.

Important Information About Ingredients

SOTYKTU tablets contain lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The amount of lactose in each tablet is small but may be clinically relevant for patients with severe lactose intolerance.

SOTYKTU contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.

How Does SOTYKTU Interact with Other Drugs?

Understanding potential drug interactions is important for the safe and effective use of SOTYKTU. Deucravacitinib is primarily metabolized by cytochrome P450 1A2 (CYP1A2), with a minor contribution from CYP2B6. This metabolic pathway determines how deucravacitinib is cleared from the body and which medications may affect its blood levels.

Unlike many biologic therapies used for psoriasis (such as monoclonal antibodies), which are degraded through general protein catabolic pathways and have minimal drug interaction potential, SOTYKTU is a small molecule that undergoes hepatic metabolism. This means that medications affecting CYP1A2 enzyme activity can potentially alter deucravacitinib levels in the body.

It is important to note that smoking (tobacco use) is a known inducer of CYP1A2 and could potentially reduce the blood levels of deucravacitinib, which may affect the efficacy of SOTYKTU. If you smoke or recently stopped smoking, inform your doctor, as this may be relevant to your treatment response.

The combination of SOTYKTU with other potent immunosuppressive medications (such as cyclosporine, methotrexate, azathioprine, or biologic therapies) has not been studied. Combining multiple immunosuppressive agents could theoretically increase the risk of infections or other immune-related adverse effects. Your doctor will advise you on whether it is appropriate to use SOTYKTU in combination with other psoriasis therapies.

Always inform your doctor, pharmacist, or nurse about all medications you are taking, have recently taken, or plan to take, including over-the-counter medicines, herbal supplements, and dietary supplements. This information will help your healthcare team identify any potential interactions and adjust your treatment plan accordingly.

What Is the Correct Dosage of SOTYKTU?

Always take SOTYKTU exactly as your doctor or pharmacist has instructed. The dosing regimen is straightforward: one 6 mg film-coated tablet taken by mouth once every day. There is no titration period – you start on the full 6 mg dose from day one. The tablet can be taken at any time of day, with or without food, although taking it at the same time each day can help you remember to take it consistently.

Adults

No dose adjustment is required based on body weight, age (in adults), sex, or ethnicity. The 6 mg once-daily dose was selected based on comprehensive dose-ranging studies and confirmed in the pivotal POETYK PSO-1 and PSO-2 trials as providing the optimal balance of efficacy and safety. In these trials, the 6 mg dose consistently demonstrated clinically meaningful improvements in psoriasis severity compared with placebo, and was statistically superior to apremilast 30 mg twice daily.

Your doctor will assess the effectiveness of SOTYKTU after approximately 24 weeks (6 months) of treatment. If there has been no clinical benefit after this period, your doctor may consider discontinuing SOTYKTU and exploring alternative treatment options. Some patients may begin to see improvements within the first few weeks, but full efficacy may require several months of continued therapy.

Children and Adolescents

SOTYKTU is not recommended for use in patients under 18 years of age. Safety and efficacy have not been established in this age group. Pediatric dosing recommendations are not currently available.

Elderly Patients

No dose adjustment is required for elderly patients. Clinical trials included patients aged 65 years and older. Although limited data are available for patients over 75 years, no overall differences in safety or efficacy were observed between older and younger adult patients. As with any medication in elderly patients, careful clinical monitoring is advisable, particularly given the potential for a higher prevalence of comorbidities and concomitant medications in this population.

Renal and Hepatic Impairment

No dose adjustment is required for patients with mild, moderate, or severe renal (kidney) impairment. SOTYKTU has not been studied in patients on dialysis. For patients with mild or moderate hepatic (liver) impairment, no dose adjustment is required. SOTYKTU has not been studied in patients with severe hepatic impairment, and use in this population is not recommended. Since deucravacitinib is metabolized in the liver, severe hepatic impairment could significantly alter drug exposure.

Missed Dose

If you forget to take SOTYKTU, take your regular dose the next day as usual. Do not take a double dose to make up for a missed tablet. Missing an occasional dose is unlikely to significantly affect your treatment outcome, but consistent daily dosing is important for maintaining therapeutic drug levels. Using a pillbox, phone alarm, or daily routine association (such as taking the tablet with breakfast) can help you remember to take SOTYKTU every day.

Overdose

If you have taken more SOTYKTU than you should, contact your doctor as soon as possible. In the event of an overdose, monitor for signs and symptoms of adverse effects and provide appropriate supportive care as needed. There is no specific antidote for deucravacitinib overdose. In clinical studies, doses higher than 6 mg daily were associated with a higher incidence of some side effects. You may experience some of the side effects described in the side effects section of this article.

Stopping Treatment

Do not stop taking SOTYKTU without first talking to your doctor. If you discontinue treatment, your psoriasis symptoms may return. In the POETYK PSO-2 trial, patients who were responding well to SOTYKTU and were then re-randomized to placebo experienced a gradual loss of response, confirming that continued therapy is necessary to maintain the benefits. Your doctor will advise you on the appropriate duration of treatment and any necessary monitoring if treatment is to be discontinued.

What Are the Side Effects of SOTYKTU?

Like all medicines, SOTYKTU can cause side effects, although not everybody gets them. The safety profile of SOTYKTU has been characterized in the POETYK PSO-1 and PSO-2 pivotal trials, as well as in long-term extension studies. Overall, SOTYKTU has been well tolerated, with a safety profile that is distinct from non-selective JAK inhibitors. The majority of adverse events reported during clinical trials were mild to moderate in severity.

Understanding the frequency and nature of potential side effects can help you and your doctor make informed decisions about treatment and know what to watch for during therapy. The side effects are categorized below by their frequency of occurrence, based on clinical trial data and post-marketing experience.

Upper respiratory tract infections were the most frequently reported side effect in clinical trials. These were predominantly mild in severity and included common colds, pharyngitis (sore throat), sinusitis, and rhinitis (nasal congestion). Most cases resolved without specific treatment or with standard over-the-counter remedies. The rate of upper respiratory tract infections was moderately higher in the SOTYKTU group compared with placebo, which is consistent with the immunomodulatory mechanism of action.

Oral herpes (herpes simplex virus type 1) occurred more frequently in patients taking SOTYKTU compared with placebo. These episodes typically presented as cold sores on or around the lips and were generally mild. Patients with a known history of recurrent cold sores may experience more frequent episodes during SOTYKTU treatment. If you experience frequent or severe oral herpes outbreaks, discuss antiviral prophylaxis options with your doctor.

Elevated creatine phosphokinase (CPK) levels were observed in some patients during clinical trials. CPK is an enzyme found in the heart, brain, and skeletal muscle, and elevated levels can indicate muscle damage or stress. In most cases, CPK elevations were mild, asymptomatic, and transient. Your doctor may monitor your CPK levels through routine blood tests, particularly if you engage in vigorous physical exercise or experience unexplained muscle pain, tenderness, or weakness.

Herpes zoster (shingles) was reported as an uncommon side effect. Shingles is caused by reactivation of the varicella-zoster virus (the virus that causes chickenpox) and typically presents as a painful, blistering rash in a band-like distribution on one side of the body. If you develop symptoms suggestive of shingles, contact your doctor promptly for evaluation and treatment. Patients who have not had chickenpox or have not been vaccinated against varicella may wish to discuss vaccination with their doctor before starting SOTYKTU (using a non-live recombinant vaccine such as Shingrix).

In the pivotal clinical trials, the overall rate of serious adverse events was comparable between the SOTYKTU and placebo groups. There were no signals of increased rates of serious infections requiring hospitalization, major adverse cardiovascular events (MACE), venous thromboembolism (DVT or PE), or malignancies in the SOTYKTU treatment groups compared with placebo. This safety profile is noteworthy and distinguishes SOTYKTU from some non-selective JAK inhibitors that have been associated with these risks.

Long-term safety data from extension studies have been consistent with the safety profile observed during the controlled trial periods. No new safety signals have emerged with continued use, and the incidence and types of adverse events have remained stable over time.

How Should You Store SOTYKTU?

Proper storage of SOTYKTU helps ensure the quality, safety, and efficacy of your medication. Unlike many biologic therapies that require refrigeration, SOTYKTU tablets do not have any special temperature or humidity storage requirements, making them convenient to store at home or carry while traveling.

Follow these storage guidelines carefully:

• Room temperature storage: No special storage conditions are required. Store SOTYKTU at standard room temperature. Avoid extreme heat or cold, but the tablets are stable under normal household conditions.
• Keep in original packaging: Keep the tablets in their original blister pack or carton until you are ready to take them. The packaging helps protect the tablets from moisture and light degradation.
• Keep out of reach of children: Store SOTYKTU in a secure location where children cannot access it. The tablets should never be left within sight or reach of young children.
• Check expiration date: Do not use SOTYKTU after the expiration date printed on the blister pack and carton after “EXP.” The expiration date refers to the last day of the stated month.
• Inspect tablets: Do not use this medicine if the tablets appear damaged or if there are signs that the packaging has been tampered with.
• Proper disposal: Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. These measures help protect the environment.

When traveling with SOTYKTU, keep the tablets in their original packaging and carry them in your hand luggage for easy access and to avoid exposure to extreme temperatures in checked baggage. No special travel precautions (such as insulated bags or cold packs) are needed, which is a practical advantage of this oral medication compared with injectable therapies that require temperature-controlled storage.

What Does SOTYKTU Contain?

Understanding the complete composition of your medication is important, particularly if you have known allergies or intolerances to specific pharmaceutical ingredients. Below is a detailed breakdown of what SOTYKTU contains.

Active Ingredient

The active substance is deucravacitinib, a selective allosteric inhibitor of tyrosine kinase 2 (TYK2). Each film-coated tablet contains 6 mg of deucravacitinib.

Inactive Ingredients (Excipients)

Appearance and Pack Sizes

SOTYKTU tablets are pink, round, biconvex film-coated tablets, imprinted with “BMS 895” and “6 mg” on two lines on one side, with no marking on the other side. The tablets are supplied in calendar or non-calendar blister packs containing 7 or 14 tablets. Available carton sizes include 7, 14, 28, or 84 film-coated tablets. Not all pack sizes may be marketed in every country.

Marketing Authorization Holder and Manufacturer

SOTYKTU is manufactured by Bristol-Myers Squibb. The marketing authorization holder for the European Union is Bristol-Myers Squibb Pharma EEIG, Dublin, Ireland. Manufacturing is carried out at Swords Laboratories Unlimited Company (trading as Bristol-Myers Squibb Pharmaceutical Operations), Dublin, Ireland. In the United States, SOTYKTU is marketed by Bristol-Myers Squibb Company. SOTYKTU is approved and available in multiple countries across North America, Europe, and other regions worldwide.