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See the SUPERIOR Key secondary endpoints for SOTYKTU vs apremilast in studies

IN POETYK PSO-1

~7 out of 10 psoriasis patients achieved PASI 75 with SOTYKTU1,2

Graphic showing key secondary endpoints PASI 75 Response Rates (NRI), Week 16 and 24 Graphic showing key secondary endpoints PASI 75 Response Rates (NRI), Week 16 and 24

Data shown is from PSO-1 (NRI)

  • PASI 75 vs apremilast at Week 16 and Week 24 were key secondary endpoints1
VIEW STUDY DESIGN AND CO-PRIMARY ENDPOINTS
  • P<0.0001 vs apremilast.2
  • BID=twice daily; H2H=head-to-head; NRI=non-responder imputation; PASI=Psoriasis Area and Severity Index; PASI 75=≥75% improvement from baseline in PASI score; QD=once daily; sPGA=static Physician’s Global Assessment. sPGA response defined as PGA score of 0 or 1 with ≥2-point improvement from baseline.

Demonstrated superior response rates vs apremilast1,3

PASI 75 response rates in POETYK PSO-2 (key secondary endpoints)1,3

  • In POETYK PSO-2, PASI 75 response rates at Week 16 were 53% for SOTYKTU (n=511) vs 40% for apremilast (n=254); P=0.0004. At Week 24, PASI 75 response rates were 58% for SOTYKTU (n=511) vs 38% for apremilast (n=254): P<0.0001

Maintenance of response for those on SOTYKTU

In PSO-1, PASI 75 responders at Week 24 who maintained response at week 52 (additional endpoint)1

of patients on SOTYKTU who achieved PASI 75 at Week 24 maintained it at 1 year
(n=187/228)

Maintenance of response in POETYK PSO-2 (additional endpoints)1

  • To evaluate maintenance and durability of response, patients in PSO-2 who were originally randomized to SOTYKTU and were PASI 75 responders at Week 24 were re-randomized to either continue treatment on SOTYKTU or be withdrawn from therapy (ie, receive placebo)
  • At 1 year, 80% (n=119/148) of patients who continued on SOTYKTU maintained PASI 75 compared to 31% (n=47/150) of patients who were withdrawn from treatment with SOTYKTU

PASI 75 Response Rate at Week 52 (additional endpoint)2

  • In PSO-1, 65% of patients receiving continuous SOTYKTU (n=330) achieved PASI 75 at Week 52
  • PASI 75 at Week 52 was not a ranked primary or key secondary endpoint and was analyzed descriptively. In POETYK PSO-2, the same analysis at Week 52 for patients receiving continuous SOTYKTU is not available due to the trial design and forced re-randomization.

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See the PASI 90
results VS apremilast
Learn more about SOTYKTU scalp results
REVIEW SAFETY
DATA

IN POETYK PSO-1

SOTYKTU patients saw ~2x the PASI 90 response rate vs apremilast1,2

Graphic showing POETYK PSO-1 PASI 90 Response Rates (NRI) Graphic showing POETYK PSO-1 PASI 90 Response Rates (NRI)

Data shown is from PSO-1 (NRI)

  • PASI 90 at Week 16 and Week 24 were key secondary endpoints1
VIEW STUDY DESIGN AND CO-PRIMARY ENDPOINTS
  • P=0.0002 vs apremilast.2
  • P<0.0001 vs apremilast.2
  • BID=twice daily; NRI=non-responder imputation; PASI=Psoriasis Area and Severity Index; PASI 90=≥90% improvement from baseline in PASI score; QD=once daily.

SOTYKTU showed superior PASI 90 response rates vs apremilast1,3

PASI 90 response rates vs apremilast in POETYK PSO-2 (key secondary endpoints)1,3

  • In POETYK PSO-2, PASI 90 response rates at Week 16 were 27% for SOTYKTU (n=511) and 18% for apremilast (n=254); P=0.0046. At Week 24, PASI 90 response rates were 32% for SOTYKTU (n=511) and 20% for apremilast (n=254); P=0.0002

Maintenance of response for those on SOTYKTU

PASI 90 responders at Week 24 who maintained response at Week 52 (additional endpoint)1

of patients on SOTYKTU who achieved PASI 90 at Week 24 maintained it at 1 year
(n=103/140)

PASI 90 Response Rate at Week 52 (additional endpoint)2

  • In PSO-1, 44% of patients receiving continuous SOTYKTU (n=330) achieved PASI 90 at Week 52
  • PASI 90 at Week 52 was not a ranked primary or key secondary endpoint and was analyzed descriptively. In POETYK PSO-2, the same analysis at Week 52 for continuous SOTYKTU use is not available due to the trial design and forced re-randomization.

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Learn more about SOTYKTU scalp results
Results througH
4 years
REVIEW SAFETY
DATA

IN POETYK PSO-1

7 out of 10 SOTYKTU patients achieved a clear or almost clear scalp1,2

Graphic of key secondary endpoint SS-PGA p/1 response rates at week 16 Graphic of key secondary endpoint SS-PGA p/1 response rates at week 16
  • ss-PGA 0/1 at Week 16 was a key secondary endpoint1
  • In POETYK PSO-1, ss-PGA 0/1 at Week 16 was 17% for placebo (n=121)1,2

ss-PGA 0/1 response rates in PSO-21,3*

  • In PSO-2, ss-PGA 0/1 response at Week 16 was 60% for SOTYKTU (n=305), 37% for apremilast (n=166), and 17% for placebo (n=173); P<0.0001 for both
VIEW STUDY DESIGN AND CO-PRIMARY ENDPOINTS
  • Included only patients with baseline ss-PGA score of ≥3.1
  • P<0.0001 vs apremilast.2
  • P<0.0001 vs placebo.2
  • BID=twice daily; NRI=non-responder imputation; QD=once daily; ss-PGA 0/1=scalp-specific Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin.

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Results through
4 years
SEE POTENTIAL
SOTYKTU CANDIDATES
REVIEW SAFETY
DATA

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: 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 with psoriasis 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 treatment prior to initiating SOTYKTU 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 initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. 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. Through Week 16, 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. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is 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 clinical trials, 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 when on 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 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. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related 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, consider completion of 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 (≥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.

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.

INDICATION

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.

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

References:

  1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  2. Data on file. BMS-REF-DEU-0020. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  3. Data on file. BMS-REF-DEU-0021. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  2. 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.
  3. 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.
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References:

  1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  2. Data on file. BMS-REF-DEU-0020. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  3. Data on file. BMS-REF-DEU-0021. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  2. 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.
  3. 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.
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