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  • US Full Prescribing Information |
  • Medication Guide |
  • Indication

    Indication

    SOTYKTU 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.

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See efficacy results from 2 pivotal Phase 3 trIAls1

Co-primary

Superior PASI 75 and sPGA 0/1 response rates vs placebo1-3

In POETYK PSO-1 and POETYK PSO-2, superior PASI 75 response rates vs placebo at Week 16

In POETYK PSO-1 and POETYK PSO-2, superior PASI 75 response rates vs placebo at Week 16 In POETYK PSO-1 and POETYK PSO-2, superior PASI 75 response rates vs placebo at Week 16

sPGA response of 0/1 at Week 16 vs placebo (co-primary endpoint)1-3

  • In POETYK PSO-1, 54% for SOTYKTU vs 7% for placebo, P<0.0001
  • In POETYK PSO-2, 50% for SOTYKTU vs 9% for placebo, P<0.0001

Study design1

POETYK PSO-1 (N=664) and POETYK PSO-2 (N=1020) were two, 52-week, multicenter, randomized, double-blind, placebo- and active (apremilast 30 mg twice daily)-controlled, Phase 3 studies to evaluate the safety and efficacy of SOTYKTU (6 mg once daily) in adult patients with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Patients had a body surface area (BSA) involvement of ≥10%, a Psoriasis Area and Severity Index (PASI) score ≥12, and a static Physician’s Global Assessment (sPGA) ≥3 (moderate or severe).

Both studies assessed the responses at Week 16 compared with placebo for the two co-primary endpoints:

  • The proportion of patients who achieved at least a 75% improvement in PASI scores from baseline (PASI 75)
  • The proportion of patients who achieved an sPGA score of 0 (clear) or 1 (almost clear)

There were multiple ranked secondary endpoints, including:

  • The proportion of patients who achieved PASI 75 at Week 16 and Week 24 vs apremilast
  • The proportion of patients who achieved at least a 90% improvement in PASI scores from baseline (PASI 90) at Week 16 and Week 24 vs apremilast
  • The proportion of patients who achieved a scalp-specific PGA (ss-PGA) score of 0 (clear) or 1 (almost clear) at Week 16 vs placebo and vs apremilast

PASI 75

Demonstrated superior response rates vs apremilast1,3,4

In POETYK PSO-1, superior PASI 75 response rate vs apremilast at Weeks 16 and 24 (secondary endpoints)1,2

POETYK PSO-1 PASI 75 Response Rates (NRI)1,2 POETYK PSO-1 PASI 75 Response Rates (NRI)1,2
PASI 75 response rates in POETYK PSO-2 PASI 75 response rates in POETYK PSO-2

SELECT 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.

Please see additional Important Safety Information below.

Maintenance of response1

PASI 75 responders at Week 24 who maintained response at Week 521

POETYK PSO-1 PASI 75 MAINTENANCE IN PATIENTS TAKING SOTYKTU (NRI)1

82% of patients who achieved PASI 75 at week 24 maintained it through Year 1 82% of patients who achieved PASI 75 at week 24 maintained it through Year 1
  • In POETYK PSO-1, 69% of patients taking SOTYKTU (n=330) achieved PASI 75 at Week 241
  • PASI 75 maintenance rate in POETYK PSO-21

  • In POETYK PSO-2, 58% of patients taking SOTYKTU (n=511) achieved PASI 75 at Week 24
  • In POETYK PSO-2, to evaluate maintenance and durability of response, patients 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 Week 52, 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 SOTYKTU

NRI=non-responder imputation; PASI=Psoriasis Area and Severity Index; PASI 75=75% improvement from baseline in PASI score.

Study design1

POETYK PSO-1 (N=664) and POETYK PSO-2 (N=1020) were two, 52-week, multicenter, randomized, double-blind, placebo- and active (apremilast 30 mg twice daily)-controlled, Phase 3 studies to evaluate the safety and efficacy of SOTYKTU (6 mg once daily) in adult patients with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Patients had a body surface area (BSA) involvement of ≥10%, a Psoriasis Area and Severity Index (PASI) score ≥12, and a static Physician’s Global Assessment (sPGA) ≥3 (moderate or severe).

Both studies assessed the responses at Week 16 compared with placebo for the two co-primary endpoints:

  • The proportion of patients who achieved at least a 75% improvement in PASI scores from baseline (PASI 75)
  • The proportion of patients who achieved an sPGA score of 0 (clear) or 1 (almost clear)

There were multiple ranked secondary endpoints, including:

  • The proportion of patients who achieved PASI 75 at Week 16 and Week 24 vs apremilast
  • The proportion of patients who achieved at least a 90% improvement in PASI scores from baseline (PASI 90) at Week 16 and Week 24 vs apremilast
  • The proportion of patients who achieved a scalp-specific PGA (ss-PGA) score of 0 (clear) or 1 (almost clear) at Week 16 vs placebo and vs apremilast

PASI 90

Superior PASI 90 response rates vs apremilast1,2,4,5

In POETYK PSO-1, nearly twice the PASI 90 response rate with SOTYKTU vs apremilast at Week 24 (secondary endpoint)1,2

POETYK PSO-1 PASI 90 Response Rates (NRI)1* POETYK PSO-1 PASI 90 Response Rates (NRI)1*

Superior PASI 90 response rates vs apremilast at Week 16 and Week 24 (secondary endpoints) were also seen in POETYK PSO-21,4

PASI 90 at Week 16 and Week 24 were secondary endpoints PASI 90 at Week 16 and Week 24 were secondary endpoints

SELECT IMPORTANT SAFETY INFORMATION:

Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.

Please see additional Important Safety Information below.

POETYK PSO-1 PASI 90 maintenance (NRI)1

PASI 90 responders at Week 24 who maintained response at Week 521

74% of patients on SOTYKTU who achieved PASI 90 at Year 1 74% of patients on SOTYKTU who achieved PASI 90 at Year 1
  • In POETYK PSO-1, 42% of patients taking SOTYKTU (n=330) achieved PASI 90 at Week 241

Study design1

POETYK PSO-1 (N=664) and POETYK PSO-2 (N=1020) were two, 52-week, multicenter, randomized, double-blind, placebo- and active (apremilast 30 mg twice daily)-controlled, Phase 3 studies to evaluate the safety and efficacy of SOTYKTU (6 mg once daily) in adult patients with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Patients had a body surface area (BSA) involvement of ≥10%, a Psoriasis Area and Severity Index (PASI) score ≥12, and a static Physician’s Global Assessment (sPGA) ≥3 (moderate or severe).

Both studies assessed the responses at Week 16 compared with placebo for the two co-primary endpoints:

  • The proportion of patients who achieved at least a 75% improvement in PASI scores from baseline (PASI 75)
  • The proportion of patients who achieved an sPGA score of 0 (clear) or 1 (almost clear)

There were multiple ranked secondary endpoints, including:

  • The proportion of patients who achieved PASI 75 at Week 16 and Week 24 vs apremilast
  • The proportion of patients who achieved at least a 90% improvement in PASI scores from baseline (PASI 90) at Week 16 and Week 24 vs apremilast
  • The proportion of patients who achieved a scalp-specific PGA (ss-PGA) score of 0 (clear) or 1 (almost clear) at Week 16 vs placebo and vs apremilast

Scalp

Superior scalp response ss-PGA 0/1 at Week 16 vs apremilast1,3,5

In POETYK PSO-1, a greater proportion of patients achieved clear or almost clear scalp at Week 16 (secondary endpoint)1,5

POETYK PSO-1 SS-PGA 0/1 Response Rates (NRI)2* POETYK PSO-1 SS-PGA 0/1 Response Rates (NRI)2*

  • ss-PGA 0/1 at Week 16 was a secondary endpoint1
  • In POETYK PSO-1, ss-PGA 0/1 at Week 16 was 17% for placebo (n=121)1,5

ss-PGA 0/1 response rates in POETYK PSO-2 (secondary endpoints)1,3

  • In POETYK 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

*Include only subjects with baseline ss-PGA score of ≥3.

P<0.0001 vs apremilast.5

P<0.0001 vs placebo.5

BID=twice daily; NRI=non-responder imputation; ss-PGA 0/1=scalp-specific Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin; QD=once daily.

Study design1

POETYK PSO-1 (N=664) and POETYK PSO-2 (N=1020) were two, 52-week, multicenter, randomized, double-blind, placebo- and active (apremilast 30 mg twice daily)-controlled, Phase 3 studies to evaluate the safety and efficacy of SOTYKTU (6 mg once daily) in adult patients with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Patients had a body surface area (BSA) involvement of ≥10%, a Psoriasis Area and Severity Index (PASI) score ≥12, and a static Physician’s Global Assessment (sPGA) ≥3 (moderate or severe).

Both studies assessed the responses at Week 16 compared with placebo for the two co-primary endpoints:

  • The proportion of patients who achieved at least a 75% improvement in PASI scores from baseline (PASI 75)
  • The proportion of patients who achieved an sPGA score of 0 (clear) or 1 (almost clear)

There were multiple ranked secondary endpoints, including:

  • The proportion of patients who achieved PASI 75 at Week 16 and Week 24 vs apremilast
  • The proportion of patients who achieved at least a 90% improvement in PASI scores from baseline (PASI 90) at Week 16 and Week 24 vs apremilast
  • The proportion of patients who achieved a scalp-specific PGA (ss-PGA) score of 0 (clear) or 1 (almost clear) at Week 16 vs placebo and vs apremilast

SELECT IMPORTANT SAFETY INFORMATION:

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.

Please see additional Important Safety Information below

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1787-US-2300121 02/23

1787-US-2200110 09/22