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SOTYKTU RESULTS: RADIOGRAPHIC PROGRESSION DATA THROUGH WEEK 52

Actor portrayal of SOTYKTU® patient with psoriatic arthritis carrying backpack

POETYK PSA-1, POST HOC ANALYSIS:

RADIOGRAPHIC PROGRESSION, mSvdH (AS OBSERVED)1*

Graph of inhibition of structural joint damage over 52 weeks in the POETYK PSA-1 clinical trial

As-observed analysis for the total number of patients with non-missing baseline, Week 16, and Week 52 values. Patients with missing data are not included, which may enrich the population and increase the response rates. Data were analyzed descriptively; therefore, statistical significance has not been established.1

Pre-specified analysis at Week 16: Adjusted mean CfB in mSvdH total score was 0.64 in the placebo group (n=334) and 0.78 in the SOTYKTU group (n=336). Outcomes were analyzed descriptively; therefore, statistical significance has not been established.2

Limitations1,2: Radiographic analyses beyond the prespecified Week 16 analysis were post hoc, exploratory, and descriptively evaluated without hypothesis testing for establishment of statistical significance. The prespecified analysis included randomized patients with Week 16 scans obtained within Days 100–127 and prior to active treatment, was analyzed using parametric ANCOVA, and applied control‑based multiple imputation for missing data (N=670). Post hoc analyses included a broader population with data collected at screening and Week 16 nominal visits; were conducted as observed (non‑imputed); and used rank ANCOVA due to non‑normal data distribution. Post hoc radiographic assessments included scans performed within (N=496) and outside (N=611) the prespecified visit window; therefore, sample sizes varied. Not all participants had radiographs at all timepoints.

  There was no placebo comparator after Week 16 because patients were switched to SOTYKTU.1
  Data includes scans collected before the data cutoff date of 10/10/2024.1
* In the post hoc population, baseline mSvdH scores were 20.54 for SOTYKTU and 28.98 for placebo.3

ANCOVA=analysis of covariance; CfB=change from baseline; mSvdH=modified Sharp/van der Heijde score; PsA=psoriatic arthritis; QD=once daily.

 

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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. 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.
  3. Data on file. REF-02266-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
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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