Demonstrated PsA safety profile through Week 161,2
POETYK PSA-1 and PSA-2: POOLED SAFETY
The Warnings and Precautions for SOTYKTU include: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.3
In PsA, 2.3% of SOTYKTU patients and 1.6% on placebo discontinued treatment due to adverse events through Week 161
The overall safety profile in patients with active PsA was generally consistent with the safety profile observed in patients with PsO through Week 163
| * | Otezla was included in PSA-2 as a safety reference arm. No comparisons for efficacy were planned or made with the Otezla arm.3 |
| AE=adverse event; CPK=creatine phosphokinase; DC=discontinuation; JAK=Janus kinase; PsA=psoriatic arthritis; PsO=psoriasis; SAE=serious adverse event; W=week. |
NO NEW SAFETY SIGNALS OBSERVED WITH SOTYKTU THROUGH 52 WEEKS IN PsA4,5
POETYK PSA-1 AND PSA-2, POOLED THROUGH WEEK 526
The Warnings and Precautions for SOTYKTU include: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.3
In PsA, 2.3% of SOTYKTU patients and 1.6% on placebo discontinued treatment due to adverse events through Week 161
No new safety signals observed through Week 524,5
The overall safety profile in patients with active PsA was generally consistent with the safety profile observed in patients with PsO through Week 163
| AEs are treatment-emergent AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose. Safety cutoff dates for PSA-1 and PSA-2 were 10/10/2024 and 7/11/2024, respectively.6 |
| * | Placebo arm includes all patients initially randomized to placebo. All of these patients were blindly switched to SOTYKTU at Week 16.3 |
| † | Otezla was included in PSA-2 as a safety reference arm. No comparisons for efficacy were planned or made with the Otezla arm.3 |
| AE=adverse event; CPK=creatine phosphokinase; DC=discontinuation; IR=incidence rate; JAK=Janus kinase; PsA=psoriatic arthritis; PsO=psoriasis; PY=patient-years; SAE=serious adverse event; W=week. |
NO BOXED WARNING WITH SOTYKTU3
The Warnings and Precautions for SOTYKTU include: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.
POETYK PSA-1 AND PSA-2, POOLED: AEs OF INTEREST THROUGH 52 WEEKS6
| * | Placebo arm includes all patients initially randomized to placebo. All of these patients were blindly switched to SOTYKTU at Week 16.3 |
| † | Otezla was included in PSA-2 as a safety reference arm. No comparisons for efficacy were planned or made with the Otezla arm.3 |
| ‡ | Serious infections and infestations is defined as appendicitis, pneumonia, cellulitis, erysipelas, respiratory tract infection, salpingitis, urinary tract infection, vulval cellulitis, and bronchitis, COVID-19 pneumonia, diverticulitis intestinal perforated, gastroenteritis, hepatitis infectious mononucleosis, herpes zoster disseminated, oral candidiasis, otitis media, peritonitis.6 |
| § | MACE is defined as non-fatal cardiovascular-related event, stroke hemorrhagic, stroke ischemic, myocardial infarction (non-ST elevation).6 |
| || | VTE is defined as deep vein thrombosis.6 |
| ¶ | Neoplasms benign, malignant, and unspecified (including cysts and polyps) is defined as glioblastoma, lung adenocarcinoma, prostate cancer, adenocarcinoma, endometrial cancer stage 0, and papillary thyroid cancer.6 |
| AE=adverse event; CPK=creatine phosphokinase; IR=incidence rate; JAK=Janus kinase; MACE=major adverse cardiovascular event; PsA=psoriatic arthritis; PY=patient-years; ST=segment; VTE=venous thromboembolism; W=week. |
DEMONSTRATED PsO SAFETY PROFILE THROUGH WEEK 163
- ARs that occurred in <1% of patients in the SOTYKTU group were herpes zoster3
- Serious infections through Week 16 were reported in 5 patients (2.0/100 PY) treated with SOTYKTU and 2 patients (1.6/100 PY) treated with placebo3
| * | 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).3 | |
| † | Includes oral herpes, genital herpes, herpes simplex, and herpes virus infection.3 | |
| ‡ | Includes mouth ulceration, aphthous ulcer, tongue ulceration, and stomatitis.3 | |
| § | Includes acne, acne cystic, and dermatitis acneiform.3 |
POETYK PSO-1 and PSO-2 STUDY DESIGNS8,9
POETYK PSO-1 and PSO-2 STUDY DESIGN3
Key eligibility criteria
- Adults with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy
- PASI ≥12, sPGA ≥3, BSA involvement ≥10%
Co-primary endpoints
- Proportion of patients who achieved the following responses vs placebo at Week 16:
- At least a 75% improvement in PASI scores from baseline (PASI 75)
- sPGA score of 0 (clear) or 1 (almost clear)
AR=adverse reaction; BID=twice daily; BSA=body surface area; CPK=creatine phosphokinase; PASI=Psoriasis Area and Severity Index; PASI 50=≥50% improvement from baseline PASI; PASI 75=≥75% improvement from baseline PASI; PsO=psoriasis; QD=once daily; sPGA=static Physician’s Global Assessment.
THE SOTYKTU SAFETY PROFILE WAS DEMONSTRATED ACROSS 5 YEARS IN PsO
POETYK PSO-LTE: OVERALL SAFETY SUMMARY (AS-TREATED POPULATION)*†
The Warnings and Precautions for SOTYKTU include: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.3
In PsO, 2.4% of SOTYKTU patients and 3.8% on placebo discontinued treatment due to adverse events through Week 163
No new safety signals observed through 5 years8
The overall safety profile in patients with active PsA was generally consistent with the safety profile observed in patients with PsO through Week 163
Exposure Adjusted Incidence Rates (EAIRs) for COVID-19 increased from Year 1 to Year 5.
There were 2 deaths in the SOTYKTU arm through 1 year. An additional 9 deaths were reported in the LTE up to the cutoff date8,9
- Seven of these deaths were attributed to COVID-19, 1 was attributed to a ruptured aortic aneurysm, and 1 was due to sudden death
| * | Patients had varying lengths of treatment exposure.10,11 |
| † | Analysis includes 2 patients in the SOTYKTU arm who were excluded from primary and secondary endpoint analyses.9 |
| ‡ | The LTE safety analysis represents the pooled PSO-1 and PSO-2 populations and patients enrolled in the LTE who were blindly switched from SOTYKTU, Otezla, or placebo to open-label SOTYKTU. All patients in the parent trials were eligible to enter the LTE after 52 weeks, regardless of initial treatment.3,9 |
| § | Data cutoff date of September 2, 2024. 79.4% of patients had total SOTYKTU exposure for ≥12 months and 29.6% for ≥60 months.7 |
| || | Clinical studies were conducted during the COVID pandemic. COVID-19 through Year 2: n=124/1,519. COVID-19 through Year 3: n=242/1,519; EAIR/100 PY=8.0 (total PY=3,294.3). COVID-19 through Year 4: n=321/1,519; EAIR/100 PY=8.3 (Total PY=4,392.8).8,9 |
| ¶ | Serious AEs through Year 2: n=145/1,519; EAIR/100 PY=6.1 (total PY=2,482.0). Serious AEs through Year 3: n=167/1,519; EAIR/100 PY=5.5 (total PY=3,294.3). Serious AEs through Year 4: n=205/1,519; EAIR/100 PY=5.0 (total PY=4,392.8).8,10,11 |
| AE=adverse event; CPK=creatine phosphokinase; EAIR=exposure-adjusted incidence rate; JAK=Janus kinase; LTE=long-term extension; PsA=psoriatic arthritis; PsO=psoriasis; PY=patient-years. |
POETYK PSO-LTE: Long-term extension study8,9,12
| * | Otezla was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing.9 |
| † | Upon relapse (≥ 50% loss of Week 24 PASI percentage improvement from baseline), patients were switched to SOTYKTU 6 mg QD; due to a programming error, however, these patients continued on placebo until Week 52.9 |
| ‡ | Safety and efficacy data through 256 weeks with a cutoff date of September 2, 2024.9 |
LTE STUDY DESIGN
- Patients who completed treatment through Week 52 in either POETYK PSO-1 or PSO-2 were eligible to enroll in an optional LTE and be switched to open-label SOTYKTU 6 mg once daily8
- A total of 1,519 patients received ≥1 dose of SOTYKTU across the parent trials and the LTE including 1,364 patients in PSO-1/PSO-2 and 1,221 patients in the LTE8
- Exposure during Weeks 0-52 of PSO-1/PSO-2 was 969.0 PY, with an additional 4,077.7 PY of exposure during the LTE9,12
- 1,206 (79.4%) patients had ≥12 months of total SOTYKTU exposure and 449 (29.6%) patients had ≥60 months of total SOTYKTU exposure throughout POETYK PSO-1, PSO-2, and PSO-LTE9
BID=twice daily; LTE=long-term extension; PASI=Psoriasis Area and Severity Index; PASI 50=≥50% improvement from baseline in PASI; PASI 75=≥75% improvement from baseline in PASI; PsO=psoriasis; QD=once daily; sPGA=static Physician’s Global Assessment.
NO BOXED WARNING WITH SOTYKTU3
The Warnings and Precautions for SOTYKTU include: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.
POETYK PSO-LTE: AEs OF INTEREST (AS-TREATED POPULATION)*†
| * | Patients had varying lengths of treatment exposure.9 |
| † | Analysis includes 2 patients in the SOTYKTU arm who were excluded from primary and secondary endpoint analyses.3,9 |
| ‡ | The LTE safety analysis represents the pooled PSO-1 and PSO-2 populations and patients enrolled in the LTE who were blindly switched from SOTYKTU, Otezla® (apremilast), or placebo to open-label SOTYKTU. All patients in the parent trials were eligible to enter the LTE after 52 weeks, regardless of initial treatment.8 |
| § | Data cutoff date of September 2, 2024. 79.4% of patients had total SOTYKTU exposure for ≥12 months and 29.6% for ≥60 months.9 |
| || | MACE is defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.14 |
| ¶ | VTE is defined as pulmonary embolism and deep vein thrombosis.14 |
| # | Includes acne, acne cystic, and dermatitis acneiform.14 |
| ** | Includes mouth ulceration, aphthous ulcers, tongue ulceration, and stomatitis.14 |
| AE=adverse event; CPK=creatine phosphokinase; JAK=Janus kinase; LTE=long-term extension; MACE=major adverse cardiovascular event; NMSC=non-melanoma skin cancer; PsO=psoriasis; PY=patient-years; QD=once daily; VTE=venous thromboembolism. |
POETYK PSO-LTE: Long-term extension study8,9,12
| * | Otezla was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing.9 |
| † | Upon relapse (≥ 50% loss of Week 24 PASI percentage improvement from baseline), patients were switched to SOTYKTU 6 mg QD; due to a programming error, however, these patients continued on placebo until Week 52.9 |
| ‡ | Safety and efficacy data through 256 weeks with a cutoff date of September 2, 2024.9 |
LTE STUDY DESIGN
- Patients who completed treatment through Week 52 in either POETYK PSO-1 or PSO-2 were eligible to enroll in an optional LTE and be switched to open-label SOTYKTU 6 mg once daily8
- A total of 1,519 patients received ≥1 dose of SOTYKTU across the parent trials and the LTE including 1,364 patients in PSO-1/PSO-2 and 1,221 patients in the LTE8
- Exposure during Weeks 0-52 of PSO-1/PSO-2 was 969.0 PY, with an additional 4,077.7 PY of exposure during the LTE9,12
- 1,206 (79.4%) patients had ≥12 months of total SOTYKTU exposure and 449 (29.6%) patients had ≥60 months of total SOTYKTU exposure throughout POETYK PSO-1, PSO-2, and PSO-LTE9
BID=twice daily; LTE=long-term extension; PASI=Psoriasis Area and Severity Index; PASI 50=≥50% improvement from baseline in PASI; PASI 75=≥75% improvement from baseline in PASI; PsO=psoriasis; PY=patient years; QD=once daily; sPGA=static Physician’s Global Assessment; W=week.
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References:
- Data on File. REF-02248-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
- Data on File. REF-02261-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
- SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
- van der Heijde D, Mease PJ, Paul C, et al. Efficacy and safety of deucravacitinib up to week 52: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drugs. Paper presented at the American College of Rheumatology (ACR) Convergence 2025; October 24-29, 2025; Chicago, IL.
- Mease PJ, Chandran V, Armstrong AW, et al. Efficacy and safety of deucravacitinib up to week 52 from POETYK PsA-2: a multicenter, randomized, double-blind, placebo-controlled, phase 3 study in patients with psoriatic arthritis. Paper presented at the EULAR 2025 European Congress of Rheumatology; June 11-14, 2025; Barcelona, Spain.
- Data on File. REF-02229-1787. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
- Armstrong AW, Gooderham M, Warren RB, et at. 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 AAD 2021. Session S033. August 5-8, 2021.
- Lebwohl M, Warren RB, Sofen H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase III POETYK trials. Br J Dermatol. 2024;190(5):668-679.
- Armstrong AW, Warren RB, Strober B, et al. Deucravacitinib in moderate to severe plaque psoriasis: 5-year, long-term safety and efficacy results from the phase 3 POETYK PSO-1, PSO-2, and LTE trials. Presented at: Winter Clinical Dermatology Conference; February 14-19, 2025; Waikoloa, Hawaii.
- Armstrong AW, Lebwohl M, Warren RB, et al. Deucravacitinib in plaque psoriasis: 3-year safety and efficacy results from the phase 3 POETYK PSO-1 and PSO-2 trials. Paper presented at the 32nd European Academy of Dermatology & Venereology Congress; October 11-14, 2023; Berlin, Germany.
- Armstrong AW, Lebwohl M, Warren RB, et al. Deucravacitinib in plaque psoriasis: 4-year safety and efficacy results from the phase 3 POETYK PSO-1, PSO-2, and LTE trials. Paper presented at the 32nd European Academy of Dermatology & Venereology Symposium; May 16-18, 2024; St. Julian’s, Malta.
- ClinicalTrials.gov. NCT04036435. https://clinicaltrials.gov/ct2/show/NCT04036435. Accessed June 8, 2023.
- Data on File. BMS-REF-DEU-0102. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
- Data on File. BMS-REF-DEU-0164. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
ACR=American College of Rheumatology; AE=adverse event; MOA=mechanism of action; PsA=psoriatic arthritis; PsO=psoriasis.