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  • 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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Study Designs

Efficacy

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MOA

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Study Designs

Efficacy

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Dosing

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Study DesignsDemographicsBaseline characteristics

Study Designs

Demographics

Baseline characteristics

Study Designs

The efficacy and safety of SOTYKTU were studied in 2 pivotal Phase 3 trials1-3

POETYK PSO-12 and POETYK PSO-22 Clinical Trials
POETYK PSO-12 and POETYK PSO-22 Clinical Trials

*Apremilast was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing as per its label.2,3

†Upon relapse (≥50% loss of Week 24 PASI percentage improvement from baseline), patients were to be switched to SOTYKTU 6 mg QD; due to a programming error, however, these patients continued on placebo until Week 52.3,5
BID=twice daily; BSA=body surface area; PASI=psoriasis area and severity index; PASI 50=50% reduction from baseline in PASI; PASI 75=75% reduction from baseline in PASI; QD=once daily; sPGA 0/1=static Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin.

STUDY DESIGNS1

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.

Both studies assessed the responses at Week 16 compared to placebo for the 2 co-primary endpoints1:

  • 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)

Other comparisons between SOTYKTU and placebo that were secondary endpoints at Week 161:

  • The proportion of patients who achieved PASI 90, PASI 100, sPGA 0, scalp severity PGA (ss-PGA) score of 0 (clear) or 1 (almost clear), and Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 (symptom-free)

Comparisons between SOTYKTU and apremilast were made for the following secondary endpoints at these time points1:

  • Week 16 and 24 (POETYK PSO-1 and POETYK PSO-2): the proportion of patients who achieved PASI 75, PASI 90, and sPGA 0/1
  • Week 16 (POETYK PSO-1 and POETYK PSO-2): the proportion of patients who achieved sPGA 0 and ss-PGA 0/1 (scalp)

Key eligibility criteria1

  • Adults with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy
  • PASI ≥12, sPGA ≥3, BSA involvement ≥10%

Demographics

Select baseline demographics for POETYK PSO-1 and POETYK PSO-2 pooled5,6

Select baseline demographics for POETYK PSO-1 and POETYK PSO-23
Select baseline demographics for POETYK PSO-1 and POETYK PSO-23

SD=standard deviation.

Baseline characteristics

Select baseline characteristics for POETYK PSO-1 and POETYK PSO-2 (pooled)5

Select baseline characteristics for POETYK PSO-1 and POETYK PSO-23
Select baseline characteristics for POETYK PSO-1 and POETYK PSO-23

BSA=body surface area; IL=interleukin; sPGA=static Physicians Global Assessment; PASI=Psoriasis Area and Severity Index; TNF=tumor necrosis factor.

See efficacy

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. Chimalakonda A, Burke J, Cheng L, et al. Selectivity profile of the tyrosine kinase 2 inhibitor deucravacitinib compared with Janus kinase 1/2/3 inhibitors. Dermatol Ther (Heidelb). 2021:11(5);1763-1776.

References:

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 [published online ahead of print, 2022 Jul 9]. J Am Acad Dermatol. 2022; https://doi.org/10.1016/j.jaad.2022.07.002.

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 POETYK PSO-2 trial. J Am Acad Dermatol. 2022;S0190-9622(22)02643-3. doi: 10.1016/j.jaad.2022.08.061

4. Warren RB, Sofen H, Imafuku S, et al. Deucravacitinib long-term efficacy and safety in plaque psoriasis: 2-year results from the phase 3 POETYK PSO program. Presented at: European Academy of Dermatology and Venereology (EADV) Spring Symposium; May 12-May 14, 2022; Ljubljana, Slovenia.

5. Warren RB, Armstrong A, Imafuku S, et al. Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy analysis by prior treatment in the phase 3 POETYK PSO-1 and POETYK PSO-2 trials. Oral presentation at: European Academy of Dermatology and Venereology (EADV) 30th Congress; September 29-October 2, 2021; Virtual Meeting.

6. Gooderman M, Kircik L, Spelman L, et al. Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy by prespecified baseline demographics in the phase 3 POETYK PSO-1 and POETYK PSO-2 trials. Presented at: European Academy of Dermatology and Venereology (EADV) 30th Congress; September 29-October 2, 2021; Virtual Meeting.

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. 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 POETYK PSO-2 trial. J Am Acad Dermatol. 2022;S0190-9622(22)02643-3. doi: 10.1016/j.jaad.2022.08.061

4. Data on file. BMS-REF-DEU-0021. Princeton, NJ: Bristol-Myers Squibb Company; 2022.

5. 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 [published online ahead of print, 2022 Jul 9]. J Am Acad Dermatol. 2022; https://doi.org/10.1016/j.jaad.2022.07.002.

References:

1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.

2. Armstrong A, Gooderham M, Warren RB, et al. Efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor compared with placebo and apremilast in moderate to severe plaque psoriasis: results from the POETYK PSO-1 study. Oral presentation at: American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX); April 23-25, 2021; Virtual Meeting.

3. Warren RB, Sofen H, lmafuku S, et al. Deucravacitinib long-term efficacy and safety in plaque psoriasis: 2-year results from the phase 3 POETYK PSO program. Presented at: European Academy of Dermatology and Venereology (EADV) Spring Symposium; May 12-May 14, 2022; Ljubljana, Slovenia.

References:

1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.

2. Chimalakonda A, Burke J, Cheng L, et al. Selectivity profile of the tyrosine kinase 2 inhibitor deucravacitinib compared with Janus kinase 1/2/3 inhibitors. Dermatol Ther (Heidelb). 2021;11(5):1763-1776.

3. Di Cesare A, Di Meglio P. Nestle FO. The IL-23/Th17 axis in the immunopathogenesis of psoriasis. J Invest Dermatol. 2009;129(6):1339-1350.

Reference:

1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.

SOTYKTU, SOTYKTU 360 SUPPORT, and SOTYKTU
logo
are trademarks of Bristol-Myers Squibb Company.

© 2023 Bristol-Myers Squibb Company.

Otezla is a registered trademark of Amgen Inc

1787-US-2200576 09/22

1787-US-2200110 09/22

Legal Notice|Privacy Policy|Sitemap
Bristol Myers Squibb™ Logo

SOTYKTU, SOTYKTU 360 SUPPORT, and SOTYKTU
logo
are trademarks of Bristol-Myers Squibb Company.

© 2023 Bristol-Myers Squibb Company.

Otezla is a registered trademark of Amgen Inc

1787-US-2200720 12/22

1787-US-2200110 09/22

Legal Notice|Privacy Policy|Sitemap
Bristol Myers Squibb™ Logo

SOTYKTU, SOTYKTU 360 SUPPORT, and SOTYKTU
logo
are trademarks of Bristol-Myers Squibb Company.

© 2023 Bristol-Myers Squibb Company.

Otezla is a registered trademark of Amgen Inc

1787-US-2200720 12/22

1787-US-2200110 09/22

Legal Notice|Privacy Policy|Sitemap