HIGHLIGHTING PATIENT OUTCOMES

SOTYKTU RESULTS FOR PAIN, FATIGUE, AND PHYSICAL FUNCTIONING AT WEEKS 16 AND 52

Actor portrayal of SOTYKTU® patient with psoriatic arthritis carrying backpack

POETYK PSA-2, EXPLORATORY ENDPOINTS:

GLOBAL ASSESSMENT OF PAIN (COMPONENT OF ACR, AS OBSERVED)1*

Graph of the global assessment of pain in the POETYK PSA-2 clinical trial for psoriatic arthritis comparing SOTYKTU to a placebo at week 16

Global Assessment of Pain was a component of the ACR composite score and was an exploratory endpoint at Week 16 and Week 52. Outcomes were analyzed descriptively; therefore, statistical significance has not been established. As-observed analysis: patients with missing data at a specific time are not included, which may enrich the population and increase response rates.3,4

In PSA-1 (exploratory endpoint)2*:
Change in Global Assessment of Pain from baseline at Week 16 was -23.5 for SOTYKTU (n=336) vs -12.6 for placebo (n=334); at Week 52: -30.5 for SOTYKTU (n=336).

  There was no placebo comparator after Week 16 because patients were switched to SOTYKTU.3,4
* As a patient-reported outcome, Global Assessment of Pain results reflect subjective perception and should be interpreted in conjunction with clinical and objective assessments.
Graph of FACIT-fatigue (MI) change in baseline in the POETYK PSA-1 and PSA-2 clinical trial for SOTYKTU®

FACIT-Fatigue outcomes were analyzed descriptively; therefore, statistical significance has not been established.3,4

* The Functional Assessment of Chronic Illness Therapy–Fatigue Scale (FACIT-Fatigue) is a 13-item patient questionnaire assessing fatigue and its impact on function. Scores range from 0-52 with higher scores indicating less fatigue.5 As a patient-reported outcome, FACIT-Fatigue results reflect subjective perception and should be interpreted in conjunction with clinical and objective assessments.
† Missing data were addressed using a control-based statistical method (multiple imputation). This approach estimates outcomes based on patterns observed in the control group.5
  FACIT-Fatigue=Functional Assessment of Chronic Illness Therapy–Fatigue; MI=multiple imputation; QD=once daily.

POETYK PSA-2:

IMPROVEMENT IN PHYSICAL FUNCTIONING, HAQ-DI (MI)4*†

Graph of physical functioning HAQ-DI (MI) in the SOTYKTU PSA-2 clinical trial for psoriatic arthritis

Exploratory endpoints were analyzed descriptively; therefore, statistical significance has not been established.3,4

In PSA-13:
Change from baseline in HAQ-DI at Week 16 (secondary endpoint) was -0.4 for SOTYKTU (n=336) vs -0.2 for placebo (n=334); P<0.0001. At Week 52 (exploratory endpoint), change from baseline in HAQ-DI was -0.5 for SOTYKTU (n=336).

  There was no placebo comparator after Week 16 because patients were switched to SOTYKTU.3,4
* The HAQ-DI encompasses 8 key domains of daily activities, including dressing, arising, eating, walking, hygiene, reach, grip, and activities. Participants answer 20 questions about their ability to perform these activities of daily living, with each item rated from 0 to 3, with “3” indicating inability to complete the task. As a patient-reported outcome, HAQ-DI results reflect subjective perception and should be interpreted in conjunction with clinical and objective assessments.6
† Missing data were addressed using a control-based statistical method (multiple imputation). This approach estimates outcomes based on patterns observed in the control group.3
‡ P=0.0013.4
  HAQ-DI=Health Assessment Questionnaire–Disability Index; MI=multiple imputation; QD=once daily.

SF-36 Physical Component Summary (PCS) score was a secondary endpoint at Week 16 (change from baseline): PSA-1: 6.1 for SOTYKTU vs 3.7 for placebo. PSA-2: 5.8 for SOTYKTU vs 3.8 for placebo. As a patient‑reported outcome, SF‑36 PCS results reflect subjective perception and should be interpreted in conjunction with clinical findings and objective assessments.3,4

ACR=American College of Rheumatology; FACIT-Fatigue=Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI=Health Assessment Questionaire-Disability Index; PsA=psoriatic arthritis; QD=once daily; SF-36=36-item Short Form Survey.

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References:
  1. Data on File. REF-02230-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  2. Data on File. REF-02232-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  3. 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.
  4. 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.
  5. Chandran V, Bhella S, Schentag C, et al. Functional assessment of chronic illness therapy-fatigue scale is valid in patients with psoriatic arthritis. Ann Rheum Dis. 2007;66(7):936–939.
  6. Fairley JL, Hansen D, Proudman S, et al. Clinical associations of worsening physical function as measured by HAQ-DI scores in systemic sclerosis. J Scleroderma Relat Disord. 2025;10(3):545-555.
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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