PASI 90 and Scalp Data – POCN Peercast Plus

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U.S. Full Prescribing Information | Important Safety Information

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.

SOTYKTU showed superior skin clearance vs Otezla® (apremilast)1*†

Comparison between SOTYKTU and Otezla® was a secondary endpoint.1

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 SOTKYTU.

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.

Please see below for additional Important Safety Information for SOTYKTU.

As a fellow healthcare professional working in the field of dermatology, I wanted to share some results from the POETYK PSO-1 and POETYK PSO-2 trials that have impacted my approach to treating adult patients with moderate-to-severe plaque psoriasis. These studies demonstrated that adult patients treated with SOTYKTU® (deucravacitinib) showed superior scalp and PASI 90 response rates respectively, compared with Otezla (apremilast). This outcome marks an important step in moderate-to-severe plaque psoriasis treatment and management.

In addition to reviewing information on PASI 90 and scalp response rates, below I’ve included a link for you to dive deeper into efficacy results and additional secondary endpoints. I encourage you to read the full prescribing information and detailed study results for a comprehensive understanding of how SOTYKTU may fit into your treatment regimen for your adult patients.

Joe Gorelick, MSN, FNP-C

Compensated for his time

Study Designs1-3

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 vs apremilast
•	The proportion of patients who achieved PASI 90 at Week 16 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

†Study Results1,4,5

Co-primary endpoints:

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

Select secondary endpoints:

•	PASI 75 at Week 16 for SOTYKTU vs apremilast: PSO-1: 58% (n=193/330) vs 35% (n=59/168), P<0.0001; PSO-2: 53% (n=271/511) vs 40% (n=101/254), P=0.0004

PASI 90≥90% improvement from baseline in PASI score.

SELECT IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

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.

Please see below for additional Important Safety Information for SOTYKTU.

See additional study design information.

SOTYKTU: Superior PASI 90 response rates vs apremilast (secondary endpoints)1,4,5

PASI 90 WEEK 16

36% SOTYKTU (n=118/330) | VS (P=0.0002)4 | 20% Apremilast (n=33/168)

PASI 90 WEEK 24

42% SOTYKTU (n=140/330) | VS (P<0.0001)4 | 22% Apremilast (n=37/168)

Results shown above are from POETYK PSO-1

Results for POETYK PSO-2 were:

•	In POETYK PSO-2, PASI 90 response rates at Week 16 were 27% for SOTYKTU (n=511), 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=0.00021,5

PASI 90=90% improvement from baseline in PASI score.

SOTYKTU: Superior scalp response ss-PGA 0/1 at Week 16 vs apremilast (secondary endpoint)1-3

In POETYK PSO-1, a greater proportion of patients achieved clear or almost clear scalp at Week 16 (secondary endpoint)1,2:

POETYK PSO-1 ss-PGA 0/1 response rates (NRI)1,2* | • 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)1,2 | * Includes 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; ss-PGA 0/1=scalp-specific Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin; QD=once daily

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

Ready to take a deeper look at the studies?

Review efficacy results for additional secondary endpoints

Learn More

ADVERSE REACTIONS THAT OCCURRED IN ≥1% OF PATIENTS TREATED WITH SOTYKTU AND MORE FREQUENTLY THAN PLACEBO THROUGH WEEK 16 FROM POOLED CLINICAL TRIALS1*

* In PSO-1 and PSO-2. | † Includes upper respiratory tract infection (viral, bacterial, and unspecified), nasopharyngitis, pharyngitis (including viral, streptococcal, and unspecified), sinusitis (includes acute, viral, bacterial), rhinitis, rhinotracheitis, tracheitis, laryngitis, and tonsillitis (including bacterial, streptococcal). | ‡ Includes oral herpes, genital herpes, herpes simplex, and herpes virus infection. | § Includes mouth ulceration, aphthous ulcer, tongue ulceration, and stomatitis. | ¶ Includes acne, acne cystic, and dermatitis acneiform.

Adverse reactions that occurred in <1% of patients in the SOTYKTU group were herpes zoster.1

Infections1

In the first 16 weeks, infections occurred in 29% of the SOTYKTU group (116 events per 100 person-years) compared to 22% of the placebo group (83.7 events per 100 person-years). The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of SOTYKTU. The incidence of serious infections were reported in 5 patients (2.0 per 100 patient-years) treated with SOTYKTU, and 2 patients (1.6 per 100 patient-years) treated with placebo. The most common serious infections reported during the 52-week treatment period were pneumonia and COVID-19.

Malignancies1

Malignancies (excluding non-melanoma skin cancer) through Week 52 (total exposure of 986 patient-years with SOTYKTU) were reported in 3 patients treated with SOTYKTU (0.3/100 patient-years). During POETYK PSO-1, POETYK PSO-2, and the open-label extension trial, 3 patients (0.1/100 patient-years) developed lymphoma while receiving SOTYKTU.

Safety through Week 521

In PSO-1 and PSO-2, the exposure adjusted incidence rate of adverse reactions in patients treated with SOTYKTU from Week 0 through Week 52 without switching treatment did not increase compared to the rate observed during the first 16 weeks of treatment.

Please see below for more resources.

EXPLORE INFORMATIVE RESOURCES

Committed to patient support:
SOTYKTU 360 SUPPORT

Resources are available for your practice to support patients who begin treatment on SOTYKTU.

See Available Resources

IMPORTANT SAFETY INFORMATION and indication

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

•	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.

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

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. 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. 4. Data on file. BMS-REF-DEU-0020. Princeton, NJ: Bristol-Myers Squibb Company; 2022. 5. Data on file. BMS-REF-DEU-0021. Princeton, NJ: Bristol-Myers Squibb Company; 2022.

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