Durable response rates through 5 years for PASI 75 and PASI 90¹

In POETYK PSO-LTE

Durable PASI response rates through 5 years¹

Post-hoc sub-analysis

PASI RESPONSE RATES WITH CONTINUOUS SOTYKTU TREATMENT IN PATIENTS ENTERING PSO-LTE¹

LTE LIMITATION: In open-label LTEs, patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may raise the proportion of responders in the overall population.

• Data are derived from post-hoc sub-analysis of PSO-LTE and includes only patients from PSO-1 and PSO-2 who received continuous SOTYKTU from Day 1 (Week 0) and entered the LTE (n=513, entered; n=485, mNRI).¹
Outcomes were analyzed descriptively
• Note that the SOTYKTU arm of PSO-2 had forced re-randomization of half of the PASI 75 responders at Week 24; these patients are not included in this analysis, as they were no longer under continuous treatment^1,2,5

LTE STUDY DESIGN^1,5,6

POETYK PSO-LTE is an ongoing, open-label, long-term extension trial that enrolled participants from the Phase 3 POETYK PSO-1 and PSO-2 trials. All patients in PSO-1 and PSO-2 were eligible to enter the LTE trial after 52 weeks of treatment, regardless of initial treatment. At the start of the LTE (Week 52), 1221 patients were blindly switched from SOTYKTU, apremilast, or placebo to open-label SOTYKTU 6 mg once daily. Primary endpoints are incidence of adverse events and serious adverse events. Key secondary endpoints are sPGA 0/1 and PASI 75.

Data is presented as an interim analysis with a data cutoff of September 2, 2024. Outcomes were analyzed descriptively.

SEE ADDITIONAL LTE STUDY DESIGN INFORMATION ❯

ADDITIONAL PIVOTAL TRIAL DATA^1-3

Select key secondary endpoints:

PASI 75

• PASI 75 at Week 24 for SOTYKTU vs apremilast: PSO-1: 69% (n=228/330) vs 38% (n=64/168), P<0.0001; PSO-2: 58% (n=296/511) vs 38% (n=96/254), P<0.0001

PASI 90

• PASI 90 at Week 16 for SOTYKTU vs apremilast: PSO-1: 36% (n=118/330) vs 20% (n=33/168), P=0.0002; PSO-2: 27% (n=138/511) and 18% for apremilast (n=46/254); P=0.0046. PASI 90 at Week 24 for SOTYKTU vs apremilast: PSO-1: 42% (n=140/330) vs 22% (n=37/168), P<0.0001; PSO-2: 32% (n=164/511) vs 20% (n=50/254), P=0.0002

LTE=long-term extension; mNRI=modified non-responder imputation; PASI=Psoriasis Area and Severity Index; PASI 75=≥75% reduction from baseline in PASI score; PASI 90=≥90% reduction in baseline PASI score.

1. 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, Hawaii.
2. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
3. Data on file. BMS-REF-DEU-0020. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
4. Data on file. BMS-REF-DEU-0021. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
5. Lebwohl M, Warren RB, Sofen H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase 3 POETYK trials. Br J Dermatol. 2024;190:668-679.
6. ClinicalTrials.gov. NCT04036435. https://clinicaltrials.gov/ct2/show/NCT040364‌35‌. Accessed June 8, 2023.