SEE REAL SOTYKTU PATIENT PHOTOS

Solymarye is a real patient on SOTYKTU and was compensated for her time. Your results may vary.

SOTYKTU® patient Solymarye

The photos below are actual photos of patients with moderate-to-severe plaque psoriasis treated with SOTYKTU outside of the pivotal clinical trials. Individual results may vary.

Please click here to learn more about the pivotal trials.

 

Patient 1

Scalp

Photos of a patient with moderate-to-severe plaque psoriasis treated with SOTYKTU in a non-registrational clinical trial (NCT05478499).9

Plaque Psoriasis on Scalp at baseline of SOTYKTU® treatment

Baseline

Plaque Psoriasis on Scalp by Week 16 of SOTYKTU® Treatment

By Week 16

Plaque Psoriasis on Scalp by Week 24 of SOTYKTU® Treatment

By Week 24

Patient 2

Lower leg

HCP-submitted photos depict patient treated with SOTYKTU outside of clinical trials

Plaque Psoriasis on Lower Legs at baseline of SOTYKTU® treatment

Baseline

Plaque Psoriasis on Lower Legs by Week 24 of SOTYKTU® Treatment

By Week 24

Patient 4

Lower leg

HCP-submitted photos depict patient treated with SOTYKTU outside of clinical trials

Plaque Psoriasis on Lower Leg at baseline of SOTYKTU® treatment

Baseline

Plaque Psoriasis on Lower Leg by Week 24 of SOTYKTU® Treatment

By Week 24

Plaque Psoriasis on Lower Leg by Week 52 of SOTYKTU® Treatment

By Week 24

Patient 2

Abdomen

HCP-submitted photos depict patient treated with SOTYKTU outside of clinical trials. Identifying characteristics have been obscured to protect patient privacy.

Plaque Psoriasis on Abdomen at baseline of SOTYKTU® treatment

Baseline

Plaque Psoriasis on Abdomen by Week 24 of SOTYKTU® Treatment

By Week 24

Patient 2

Back

HCP-submitted photos depict patient treated with SOTYKTU outside of clinical trials. Identifying characteristics have been obscured to protect patient privacy.

Plaque Psoriasis on Back at baseline of SOTYKTU® treatment

Baseline

Plaque Psoriasis on Back by Week 24 of SOTYKTU® Treatment

By Week 24

Patient 3

Palm

Patient-submitted photos depict patient treated with SOTYKTU outside of clinical trials

Plaque Psoriasis on Palm at baseline of SOTYKTU® treatment

Baseline

Plaque Psoriasis on Palm by Week 24 of SOTYKTU® Treatment

By Week 24

Plaque Psoriasis on Palm by Week 52 of SOTYKTU® Treatment

By Week 52

Patient 5

Elbow

HCP-submitted photos depict patient treated with SOTYKTU outside of clinical trials

Plaque Psoriasis on Elbow at baseline of SOTYKTU® treatment

Baseline

Plaque Psoriasis on Elbow by Week 24 of SOTYKTU® Treatment

By Week 24

PIVOTAL TRIAL INFORMATION

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 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 2 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 key secondary endpoints, including:

  • The proportion of patients who achieved PASI 75 and PASI 90 at Week 24 vs apremilast
  • The proportion of patients who achieved PASI 100 at Week 16 vs placebo
  • The proportion of patients who achieved ss-PGA 0/1 at Week 16 vs apremilast

STUDY RESULTS

Co-primary endpoints1-3:

  • PASI 75 at Week 16 for SOTYKTU vs placebo: PSO-1: 58% (193/330) vs 13% (21/166), P<0.0001; PSO-2: 53% (271/511) vs 9% (24/255), P<0.0001
  • sPGA 0/1 at Week 16 for SOTYKTU vs placebo: PSO-1: 54% (178/330) vs 7% (12/166), P<0.0001; PSO-2: 50% (253/511) vs 9% (22/255), P<0.0001

Select key secondary endpoints1-5:

  • PASI 75 at Week 24 for SOTYKTU vs apremilast: PSO-1: 69% (228/330) vs 38% (64/168), P<0.0001; PSO-2: 58% (296/511) vs 38% (96/254), P<0.0001
  • PASI 90 at Week 24 for SOTYKTU vs apremilast: PSO-1: 42% (140/330) vs 22% (37/168), P<0.0001; PSO-2: 32% (164/511) vs 20% (50/254), P=0.0002
  • PASI 100 at Week 16 for SOTYKTU vs placebo: PSO-1: 14% (47/330) vs 1% (1/166), P<0.0001; PSO-2: 10% (52/511) vs 1% (3/255), P<0.0001
  • ss-PGA 0/1 at Week 16 for SOTYKTU vs apremilast†: PSO-1: 70% (147/209) vs 39% (43/110), P<0.0001; PSO-2: 60% (182/305) vs 37% (61/166), P<0.0001

Scalp response rates at Week 24 (additional endpoint)4,5†:

  • In PSO-1, ss-PGA 0/1 was 72% at Week 24 for SOTYKTU (n=209) and 43% for apremilast (n=110)
  • In PSO-2, ss-PGA 0/1 was 59% at Week 24 for SOTYKTU (n=305) and 42% for apremilast (n=166)

ss-PGA 0/1 at Week 24 was not a ranked primary or key secondary endpoint and was analyzed descriptively.

PASI 100 response rates at Week 24 (additional endpoint)2,4:

  • PASI 100 at Week 24 for SOTYKTU and apremilast: PSO-1: 18% (58/330) and 7% (11/168); PSO-2: 13% (66/504) and 7% (17/254)

PASI 100 at Week 24 was not a ranked primary or key secondary endpoint and was analyzed descriptively.

PASI 90 response rate at Week 52 (additional endpoint)2:

  • In PSO-1, PASI 90 response rate was 44% for SOTYKTU (n=330) at Week 52*

PASI 90 at Week 52 was not a ranked primary or key secondary endpoint and was analyzed descriptively.

pp-PGA 0/1 response rates (additional endpoints and post-hoc analysis).6-8‡

  • In PSO-1, pp-PGA 0/1 response rates were 56% (10/18) for SOTYKTU and 0% (0/8) for placebo at Week 16, 67% (12/18) for SOTYKTU at Week 24, and 56% (10/18) for SOTYKTU at Week 52*§
  • In PSO-2, pp-PGA 0/1 response rates were 46% (18/39) for SOTYKTU and 24% (4/17) for placebo at Week 16, and 51% (20/39) for SOTYKTU at Week 24*§

pp-PGA 0/1 was not a ranked primary or key secondary endpoint and was analyzed descriptively. Analysis limited by small sample size.

*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.
†Included patients with a baseline ss-PGA score of ≥3.
‡Included patients with a baseline pp-PGA score of ≥3.
§At Week 24 and Week 52, post-hoc analysis not predefined in the protocol. Placebo data not available after Week 16 due to the trial design.
PASI 75=≥75% improvement from baseline in PASI; PASI 90=≥90% improvement from baseline in PASI; PASI 100=100% improvement from baseline in PASI; pp-PGA=palmoplantar-psoriasis Physician's Global Assessment; pp-PGA 0/1=palmoplantar-psoriasis Physician's Global Assessment, patients achieving clear (0) or almost clear (1) skin; sPGA=static Physician's Global Assessment; ss-PGA=scalp-specific Physician's Global Assessment; ss-PGA 0/1=scalp-specific Physician's Global Assessment, patients achieving clear (0) or almost clear (1) skin.

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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.
  4. 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. doi:10.1016/j.jaad.2022.08.061
  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. J Am Acad Dermatol. 2023;88(1):29-39. doi:10.1016/j.jaad.2022.07.002
  6. Data on file. BMS-REF-DEU-0075. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  7. Data on file. BMS-REF-DEU-0076. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  8. Blauvelt A, Rich P, Sofen H, et al. Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, versus placebo in scalp, nail, and palmoplantar psoriasis: subset analyses of the phase 3 POETYK PSO-1 and POETYK PSO-2 trials. Poster presented at: Maui Derm for Dermatologists; January 24-28, 2022; Maui, HI.
  9. Data on file. BMS-REF-DEU-0148. Princeton, NJ: Bristol-Myers Squibb Company; 2024.

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.

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