SOTYKTU WAS STUDIED IN TWO PHASE 3 TRIALS TO ASSESS EFFICACY AND SAFETY

Actor portrayal of SOTYKTU® patient with psoriatic arthritis carrying backpack

POETYK PSA-1 AND PSA-2: PHASE 3 STUDY DESIGNS1,2

Study designs of SOTYKTU® POETYK PSA-1 and PSA-2 phase 3 clinical trials for psoriatic arthritis

Enthesitis resolution (LEI) did not meet statistical significance. The following endpoints fell out of the pre-specified multiplicity hierarchy: CfB mSvdH (radiographic progression), CfB in FACIT-Fatigue, dactylitis resolution, ACR50, ACR70, and enthesitis resolution (SPARCC). Data were analyzed descriptively; therefore, statistical significance has not been established.1,2

Otezla was included in the PSA-2 study design as a safety reference arm and titrated from 10 mg QD to 30 mg BID in the first 5 days of dosing; no comparisons for efficacy were planned or made with the Otezla arm.2

* After the Week 16 database lock, BMS was unblinded to treatment conditions. Investigative site staff, Cardiovascular and Infection Adjudication Committees, and patients and their families remained blinded to initial treatment assignments through Week 52.1
† Patients who completed treatment through Week 52 were eligible to enroll in an optional OLE period and be switched to open-label SOTYKTU 6 mg once daily. There was an additional safety follow-up period for 30 days after the last dose of SOTYKTU.1,2

PSA-11,3-5:

Key eligibility criteria

  • Met the CASPAR classification criteria for PsA
  • Active or documented history of PsO
  • Adults with active PsA
    • ≥3 swollen joints
    • ≥3 tender joints
    • hsCRP ≥3 mg/L
    • ≥1 PsA-related hand or foot erosion on radiographs
  • No prior use of bDMARDs

Endpoints

  • Primary (W16)
    • ACR20 vs placebo
  • Secondary (W16) vs placebo
    • CfB in HAQ-DI
    • PASI 75
    • CfB in SF-36 PCS
    • MDA
    • Enthesitis (LEI) resolution (pooled analysis)
    • CfB in mSvdH (radiographic progression)
    • CfB in FACIT-Fatigue
    • Dactylitis resolution (pooled analysis)
  • Nonhierarchical prespecified analyses (W16)
    • ACR50
    • ACR70
    • Enthesitis (SPARCC) resolution (pooled analysis)
    • BASDAI50

Randomization stratification factors:

  • Screening hsCRP concentration (<10 mg/L vs ≥10 mg/L)
  • csDMARD use at baseline (yes/no)

PSA-22,3,6,7: 

Key eligibility critieria

  • Met the CASPAR classification criteria for PsA
  • Active or documented history of PsO
  • Adults with active PsA
    • ≥3 swollen joints
    • ≥3 tender joints
    • hsCRP ≥3 mg/L
  • bDMARD naïve or TNF-IR

Endpoints

  • Primary (W16)
    • ACR20 vs placebo
  • Secondary (W16) vs placebo
    • CfB in HAQ-DI
    • PASI 75
    • CfB in SF-36 PCS
    • MDA
    • Enthesitis (LEI) resolution (pooled analysis)
    • CfB in FACIT-Fatigue
    • Dactylitis resolution (pooled analysis)
  • Nonhierarchical prespecified analyses (W16)
    • ACR50
    • ACR70
    • Enthesitis (SPARCC) resolution (pooled analysis)
    • BASDAI50

Randomization stratification factors:

  • TNF inhibitor exposure (yes/no)
  • Screening hsCRP concentration (<10 mg/L vs ≥10 mg/L)
  • csDMARD use at baseline (yes/no)

POETYK PSA-1 AND PSA-2, POOLED:

BASELINE PATIENT DEMOGRAPHICS AND CLINICAL CHARACTERISTICS8,9

Baseline characteristics of patient demographics in SOTYKTU® POETYK PSA-1 and PSA-2 clinical trials for psoriatic arthritis
* In patients with ≥3% BSA and sPGA ≥2 at baseline.8
† In patients with an enthesitis (LEI) score ≥1 at baseline (SOTYKTU: n=318, 49.1%; placebo: n=317; 49.1%).8
‡ In patients with an enthesitis (SPARCC) score ≥1 at baseline (SOTYKTU: n=393, 60.6%; placebo: n=407; 63.0%).8
§ In PSA-1 only for modified mSvdH, study populations were 336 for SOTYKTU and 334 for placebo.9

BMI=body mass index; BSA=body surface area; csDMARD=conventional synthetic disease-modifying antirheumatic drug; DAS28-CRP=28-joint Disease Activity Score-C-reactive protein; FACIT-Fatigue=Functional Assessment of Chronic Illness Therapy–Fatigue; HAQ-DI=Health Assessment Questionnaire–Disability Index; hsCRP=high-sensitivity C-reactive protein; LEI=Leeds Enthesitis Index; PASI=Psoriasis Area and Severity Index; PCS=physical component score; QD=once daily; SD=standard deviation; SF-36=36-item Short Form Survey; SPARCC=Spondyloarthritis Research Consortium of Canada; sPGA=static Physician's Global Assessment; TNFi=tumor necrosis factor inhibitor.

ACR=American College of Rheumatology; ACR20/50/70=American College of Rheumatology 20%/50%/70% improvement criteria; bDMARD=biological disease-modifying antirheumatic drug; BID=twice daily; CASPAR=Classification Criteria for Psoriatic Arthritis; CfB=change from baseline; csDMARD=conventional synthetic disease-modifying antirheumatic drug; FACIT-Fatigue=Functional Assessment of Chronic Illness Therapy–Fatigue; HAQ-DI=Health Assessment Questionnaire–Disability Index; hsCRP=high-sensitivity C-reactive protein; LEI=Leeds Enthesitis Index; MDA=minimal disease activity; mSvdH=modified Sharp/van der Heijde score; OLE=open-label extension; PASI 75=≥75% improvement in the Psoriasis Area and Severity Index; PCS=physical component score; PsA=psoriatic arthritis; PsO=psoriasis; QD=once daily; SPARCC=Spondyloarthritis Research Consortium of Canada; TNF=tumor necrosis factor; TNF-IR=tumor necrosis factor inadequate responder; W=week.

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References:
  1. van der Heijde D, Mease PJ, Paul C, et al. Efficacy and safety of deucravacitinib up to week 52: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drugs. Paper presented at the American College of Rheumatology (ACR) Convergence 2025; October 24-29, 2025; Chicago, IL.
  2. Mease PJ, Chandran V, Armstrong AW, et al. Efficacy and safety of deucravacitinib up to week 52 from POETYK PsA-2: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with psoriatic arthritis. Paper presented at the EULAR 2025 European Congress of Rheumatology; June 11-14, 2025; Barcelona, Spain.
  3. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  4. Data on file. REF-02251-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  5. Data on file. REF-02263-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  6. Data on file. REF-02252-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  7. Data on file. REF-02264-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  8. Deodhar A, Blanco R, Kavanaugh A, et al. Impact of deucravacitinib on disease activity in patients with psoriatic arthritis (PsA): results from the pivotal phase 3 PsA studies. Paper presented at the ACR Convergence 2025; October 24-29, 2025; Chicago, IL.
  9. van der Heijde D, Mease PJ, Paul C, et al. Efficacy and safety of deucravacitinib up to week 16 from POETYK PsA-1: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with active psoriatic arthritis. Presented at the EULAR 2025 European Congress of Rheumatology; June 11-14, 2025; Barcelona, Spain.
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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