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Safety profile through 3 years*

Table showing overall safety summary (AS-Treated Population)
Table showing overall safety summary (AS-Treated Population)
Adverse events of special interest: POETYK PSO-1, PSO-2, and LTE Trial
Adverse events of special interest: POETYK PSO-1, PSO-2, and LTE Trial
  • There were 2 deaths in the SOTYKTU arm through 1 year.1,2 An additional 8 deaths were reported in the LTE up to the cutoff date1
    • Six of these deaths were attributed to COVID-19. One was attributed to a ruptured thoracic aortic aneurysm (not deemed to be drug-related), and 1 was attributed to an unknown cause
  • Patients had varying lengths of treatment exposure.2
  • Analysis includes 2 patients in the SOTYKTU arm who were excluded from primary and secondary endpoint analysis.
  • 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.1,2
  • Data cutoff date of October 1, 2021. 79.0% of patients had total SOTYKTU exposure for ≥1 year and 39.9% for ≥2 years.1
  • Data cutoff date of June 15, 2022. 77.6% of patients had total SOTYKTU exposure for >12 months and 22.4% for >36 months.2
  • MACE is defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
  • VTE is defined as pulmonary embolism and deep vein thrombosis.
  • Includes acne, acne cystic, and dermatitis acneiform.
  • Mouth ulcers include mouth ulcerations, aphthous ulcers, tongue ulcerations, and stomatitis.
  • AE=adverse event; AIR=exposure-adjusted incidence rate; LTE=long-term extension; PY=patient-years; QD=once daily; SAE=serious adverse event.

References:

  1. 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. Poster presented at: European Academy of Dermatology & Venereology (EADV) Spring Symposium; May 12-14, 2022; Ljubljana, Slovenia. Poster P465.
  2. 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. Oral presentation at: European Academy of Dermatology & Venereology (EADV) Congress; October 11-14, 2023; Berlin, Germany.
  3. Data on file. BMS-REF-DEU-0096. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
  4. Data on file. BMS-REF-DEU-0102. Princeton, NJ: Bristol-Myers Squibb Company; 2023.
  5. 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 the Winter Clinical Dermatology Conference - Hawaii; January 12-17, 2024; Honolulu, HI.

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