For your moderate-to-severe plaque psoriasis patients

THE EVERY DAY PILL FOR EVERYDAY PSORIASIS

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When topicals aren’t enough, start with SOTYKTU

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SUPERIOR EFFICACY

UP TO 2x THE EFFICACY
VS OTEZLA® (APREMILAST)1*†

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SAFETY
PROFILE

THROUGH 5 YEARS
IN CLINICAL TRIALS2,3‡

SOTYKTU® has once-daily dosing

SIMPLE

ONCE-DAILY
DOSING1§

5 year data

DURABLE

RESPONSE RATES
THROUGH 5 YEARS3||

* POETYK PSO-1 (N=664) and POETYK PSO-2 (N=1,020) were two 52-week, multicenter, randomized, double-blind, placebo- and active (Otezla 30 mg twice daily)-controlled, Phase 3 studies to evaluate the safety and efficacy of SOTYKTU (6 mg once daily) in adult patients with moderate-to-severe plaque psoriasis. See additional study design details.1
† Co-primary endpoints: percentage of patients achieving PASI 75 at Week 16 vs placebo and percentage of patients achieving sPGA 0/1 vs placebo at Week 16. The results were achieved for PASI 75 (POETYK PSO-1: 58% vs 13%; POETYK PSO-2: 53% vs 9%); and sPGA 0/1 (POETYK PSO-1: 54% vs 7%; POETYK PSO-2: 50% vs 9%). Statistical significance was achieved for secondary endpoint PASI 90 vs Otezla at Week 24 (POETYK PSO-1: 42% vs 22%; POETYK PSO-2: 32% vs 20%).1
‡ Patients had varying lengths of treatment exposure. 2,3
§ Evaluate patients for active and latent tuberculosis prior to initiating treatment. Update immunizations according to current immunization guidelines. Monitor for laboratory abnormalities. SOTYKTU is not recommended for patients with severe hepatic impairment. Tablets should be taken whole.1
|| In POETYK PSO-LTE, PASI 75 response rates in patients treated with continuous SOTYKTU (n=485) were 72% at Week 52 and 67% at Week 256.

Data derived from a post hoc sub-analysis and were analyzed descriptively.3 In open-label LTEs, patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may raise the proportion of responders in the overall population.
  SOTYKTU tablet is not actual size. Shown for illustrative purposes only.
  LTE=long-term extension; PASI=Psoriasis Area and Severity Index; PASI 75=≥75% improvement from baseline in PASI; PASI 90=≥90% improvement from baseline in PASI; sPGA 0/1=static Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin.
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SOTYKTU RESOURCES
Check here for information about patient support, program details, enrollment information, and downloadable resources.

References:
  1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  2. Lebwohl M, Warren RB, Sofen H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase III POETYK trials. Br J Dermatol. 2024;190:668-679. doi:10.1093/bjd/ljae014
  3. Armstrong AW, Warren RB, Strober B, et al. Deucravacitinib in moderate to severe plaque psoriasis: 5-year, long-term safety and efficacy results from the phase 3 POETYK PSO-1, PSO-2, and LTE trials. Presented at: Winter Clinical Dermatology Conference; February 14-19, 2025; Waikoloa, Hawaii.
References

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.

Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of SOTYKTU prior to initiating treatment in patients:

  • with chronic or recurrent infection
  • who have been exposed to tuberculosis
  • with a history of a serious or an opportunistic infection
  • with underlying conditions that may predispose them to infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy be initiated, and be closely monitored. Interrupt SOTYKTU if a serious infection occurs. Do not resume SOTYKTU until the infection resolves or is adequately treated.

Viral Reactivation

Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. In the 16-week placebo-controlled period of Trials PSO-1 and PSO-2, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. The clinical implications of SOTYKTU on viral hepatitis reactivation are unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.

Tuberculosis (TB): In trials of PSO-1 and PSO-2, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.

Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy during treatment with SOTYKTU.

Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to treatment with placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. Treatment with SOTYKTU has been associated with liver enzyme elevation. Evaluate liver enzymes at baseline and during treatment with SOTYKTU in patients with known or suspected liver disease according to routine management. If increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.

Immunizations: Prior to initiating therapy with SOTYKTU, complete all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.

Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.

ADVERSE REACTIONS

Most common adverse reactions in patients with plaque psoriasis (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.

The overall safety profile of SOTYKTU observed in patients with active psoriatic arthritis was generally consistent with the safety profile observed in patients with plaque psoriasis.

SPECIFIC POPULATIONS

Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.

Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.

Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.

SOTYKTU is available in 6 mg tablets.

INDICATIONS

SOTYKTU® (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use:
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

SOTYKTU® (deucravacitinib) is indicated for the treatment of active psoriatic arthritis in adults.

Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.

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SOTYKTU and SOTYKTU logo are registered trademarks and SOTYKTU 360 SUPPORT is a trademark of Bristol-Myers Squibb Company.
This site is intended for U.S. Healthcare Professionals only.

Otezla is a registered trademark of Amgen Inc.

© 2026 Bristol-Myers Squibb Company.

1787-US-2500554 03/26

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