SOTYKTU WAS STUDIED IN TWO HEAD-TO-HEAD TRIALS TO ESTABLISH ITS EFFICACY AND SAFETY

Actor portrayal of SOTYKTU® patient with moderate-to-severe plaque psoriasis going surfing

POETYK PSO-1 AND PSO-2 STUDY DESIGNS1-3

SOTYKTU® POETYK PSO-1 Clinical Trial Design and SOTYKTU® POETYK PSO-2 Clinical Trial Design

STUDY DESIGN1

Key eligibility criteria

  • Adults with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy
  • PASI ≥12, sPGA ≥3, BSA involvement ≥10%

Co-primary endpoints

  • Proportion of patients who achieved the following responses vs placebo at Week 16:
    • At least a 75% improvement in PASI scores from baseline (PASI 75)
    • sPGA score of 0 (clear) or 1 (almost clear)

Select key secondary endpoints

  • Proportion of patients who achieved the following responses vs Otezla:
    • At Week 16 and Week 24: PASI 75, PASI 90
    • At Week 16: ss-PGA score of 0 (clear) or 1 (almost clear)
  • Proportion of patients who achieved the following responses vs placebo
    • At Week 16: ss-PGA score of 0 (clear) or 1 (almost clear)
  • Statistical significance was not met for the following key secondary endpoints1,4,5
    • PGA-F 0/1 (PGA-F score of clear or minimal disease) vs placebo (BL ≥3) at Week 16, PSSD symptom score of 0 vs Otezla (BL ≥1) at Week 16

SELECT STUDY RESULTS6,7

Co-primary end points

  • PASI 75 at Week 16 for SOTYKTU vs placebo: PSO-1: 58% (193/330) vs 13% (21/166), P<0.0001; PSO-2: 53% (271/511) vs 9% (24/255), P<0.0001
  • sPGA 0/1 at Week 16 for SOTYKTU vs placebo: PSO-1: 54% (178/330) vs 7% (12/166), P<0.0001; PSO-2: 50% (253/511) vs 9% (22/255), P<0.0001

BID=twice daily; BL=baseline; BSA=body surface area; PASI=Psoriasis Area and Severity Index; PASI 50=≥50% improvement from baseline in PASI; PASI 75=≥75% improvement from baseline in PASI; PASI 90=≥90% improvement from baseline in PASI; PGA-F=Physician’s Global Assessment of Fingernail Psoriasis; PSSD=Psoriasis Symptoms and Signs Diary; QD=once daily; sPGA=static Physician’s Global Assessment; sPGA 0/1=static Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin; ss-PGA=scalp-specific Physician’s Global Assessment.

POETYK PSO-LTE:

Long-term extension study1-3,8

Phase 3 and long-term extension (LTE) study of SOTYKTU® in POETYK PSO-1 and PSO-2 clinical trials
* Otezla was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing.3
† Upon relapse (≥50% loss of Week 24 PASI percentage improvement from baseline), patients were switched to SOTYKTU 6 mg QD; due to a programming error, however, these patients continued on placebo until Week 52.3
‡ Safety and efficacy data through 256 weeks with a cutoff date of September 2, 2024.3

STUDY DESIGN

  • Patients who completed treatment through Week 52 in either POETYK PSO-1 or PSO-2 were eligible to enroll in an optional LTE and be switched to open-label SOTYKTU 6 mg once daily2
  • A total of 1,519 patients received ≥1 dose of SOTYKTU across the parent trials and the LTE including 1,364 patients in PSO-1/PSO-2 and 1,221 patients in the LTE2
  • Exposure during Weeks 0-52 of PSO-1/PSO-2 was 969.0 PY, with an additional 4,077.7 PY of exposure during the LTE3,8
  • 1,206 (79.4%) patients had ≥12 months of total SOTYKTU exposure and 449 (29.6%) patients had ≥60 months of total SOTYKTU exposure throughout POETYK PSO-1, PSO-2, and PSO-LTE3

LTE=long-term extension; PY=patient-years.

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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, HI.
  4. Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial.  J Am Acad Dermatol. 2023;88(1):29-39. doi:10.1016/j.jaad.2022.07.00.
  5. Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 program for evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88(1):40-51. doi:10.1016/j.jaad.2022.08.061
  6. Data on file. BMS-REF-DEU-0020. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  7. Data on file. BMS-REF-DEU-0021. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  8. ClinicalTrials.gov. NCT04036435. https://clinicaltrials.gov/ct2/show/NCT04036435. Accessed June 8, 2023.

POETYK PSO-1 AND PSO-2, POOLED: SELECT BASELINE DEMOGRAPHICS1,2

Graphic of select baseline demographics in POETYK PSO-1 and POETYK PSO-2 clinical trials (pooled)

In both trials, 13% of patients were Hispanic or Latino.3

SD=standard deviation; y=years.

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References:
  1. Warren RB, Armstrong A, Imafuku S, et al. Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy analysis by prior treatment in the phase 3 POETYK PSO-1 and PSO-2 trials. Oral presentation at: European Academy of Dermatology & Venereology (EADV) Congress; September 29-October 2, 2021; virtual. Presentation FC03.06.
  2. Gooderham M, Kircik L, Spelman L, et al. Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy by prespecified baseline demographics in the phase 3 POETYK PSO-1 and POETYK PSO-2 trials. Poster presented at: European Academy of Dermatology & Venereology (EADV) Congress; September 29-October 2, 2021; virtual. Poster P1393.
  3. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2026. 

POETYK PSO-1 AND PSO-2, POOLED: BASELINE PATIENT CHARACTERISTICS1,2

Graphic of select baseline characteristics in SOTYKTU® POETYK PSO-1 and POETYK PSO-2 clinical trials (pooled)

BSA=body surface area; IL=interleukin; SD=standard deviation; sPGA=static Physician’s Global Assessment; PASI=Psoriasis Area and Severity Index; TNF=tumor necrosis factor.

ARE YOU READY TO EXPLORE MORE? SELECT A TOPIC BELOW.
References:
  1. Warren RB, Armstrong A, Imafuku S, et al. Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy analysis by prior treatment in the phase 3 POETYK PSO-1 and PSO-2 trials. Oral presentation at European Academy of Dermatology & Venereology (EADV) Congress; September 29-October 2, 2021; virtual. Presentation FC03.06.
  2. Gooderham M, Kircik L, Spelman L, et al. Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy by prespecified baseline demographics in the phase 3 POETYK PSO-1 and POETYK PSO-2 trials. Poster presentation at European Academy of Dermatology & Venereology (EADV) Congress; September 29-October 2, 2021; virtual. Poster P1393. 
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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