LONG-TERM EXTENSION SAFETY PROFILE

SOTYKTU has a well-established safety profile across ~5,050 patient years1,2

Possible plaque psoriasis female patient with arms crossed

Safety profile through 5 years1,2*

IN POETYK PSO-LTE

No increase in EAIRs of most common AEs from year 1 to year 5, except for COVID-19

OVERALL SAFETY SUMMARY (AS-TREATED POPULATION)

Table showing overall safety summary (AS-Treated Population) of Sotyktu in POETYK PSO-1 and PSO-2 clinical trials

IN POETYK PSO-LTE

No new safety signals observed through Year 51,2

AEs OF INTEREST (AS TREATED POPULATION)

Adverse events of special interest in POETYK PSO-1, PSO-2, and LTE clinical trials
* Patients had varying lengths of treatment exposure.1,2
COVID-19 through Year 3: n=242/1519; EAIR/100 PY=8.0 (Total PY=3294.3) COVID-19 through Year 4: n=321/1519; EAIR/100 PY=8.3 (Total PY=4392.8).4,6
Analysis includes 2 patients in the SOTYKTU arm who were excluded from primary and secondary endpoint analyses.7
§ The LTE safety analysis represents the pooled POETYK PSO-1 and PSO-2 populations and patients enrolled in the LTE who were blindly switched from SOTYKTU, 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.1
Data cutoff date of October 1, 2021. 79.0% of patients had total SOTYKTU exposure for ≥12 months and 39.9% for ≥24 months.1
# 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
|| Serious AEs through Year 3: n=167/1519; EAIR/100 PY=5.5 (Total PY=3294.3). Serious AEs through Year 4: n=205/1519); EAIR/100 PY=5.0 (Total PY=4392.8).4,6
** MACE is defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.2
†† VTE is defined as pulmonary embolism and deep vein thrombosis.2
‡‡ Includes acne, acne cystic, and dermatitis acneiform.5
§§ Includes mouth ulceration, aphthous ulcers, tongue ulceration, and stomatitis.5
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References:
  1. Lebwohl M, Warren RB, Soren H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase 3 POETYK trials. Br J Dermatologist. 2024; 190:668-679.
  2. Armstrong AW, Warren R, Strober B, et al. Deucravacitinib in moderate to severe plaque psoriasis: 5-year, long-term safety and clinical and patient-reported efficacy results from the phase 3 POETYK PSO-1, PSO-2, and LTE trials. Presented at the Winter Clinical Dermatology Conference; February 14-19, 2025; Waikoloa, HI.
  3. Data on file. BMS REF DEU 0102. Princeton, NJ: Bristol-Myers Squibb Company, 2024.
  4. 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. Poster presented at: Winter Clinical Dermatology Conference - Hawaii; January 12-17, 2024; Honolulu, HI.
  5. Data on file. BMS REF DEU 0164. Princeton, NJ: Bristol-Myers Squibb Company, 2025.
  6. 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. Oral presentation at: European Academy of Dermatology & Venereology (EADV) Spring Symposium; May 16-18, 2024; St. Julian’s Malta.
  7. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.


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