LONG-TERM EXTENSION SAFETY PROFILE
SOTYKTU has a well-established safety profile across ~5,050 patient years1,2
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)‡
IN POETYK PSO-LTE
No new safety signals observed through Year 51,2
AEs OF INTEREST (AS TREATED POPULATION)‡
* | 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:
- 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.
- 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.
- Data on file. BMS REF DEU 0102. Princeton, NJ: Bristol-Myers Squibb Company, 2024.
- 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.
- Data on file. BMS REF DEU 0164. Princeton, NJ: Bristol-Myers Squibb Company, 2025.
- 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.
- SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.