Durable response rates through 4 years for PASI 75 and PASI 90¹

In POETYK PSO-LTE

Durable PASI response rates through 4 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=508, 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^1,6,7

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 November 1, 2023. Outcomes were analyzed descriptively.

SEE ADDITIONAL LTE STUDY DESIGN INFORMATION ❯

ADDITIONAL PIVOTAL TRIAL DATA^1-3

Maintenance of response (additional endpoints)

PASI 75

• In PSO-1, 82% (n=187/228) of SOTYKTU patients who achieved PASI 75 at Week 24 maintained it at 1 year²
• In PSO-2, 80% (n=119/148) of SOTYKTU patients who achieved PASI 75 at Week 24 (and continued on SOTYKTU after re-randomization) maintained it at 1 year²

PASI 90

• In PSO-1, 74% (n=103/140) of SOTYKTU patients who achieved PASI 90 at Week 24 maintained it at 1 year³

PASI response rates at 1 year (additional endpoints)

• In PSO-1, response rates at 1 year for SOTYKTU patients (n=330) were 65% for PASI 75 and 44% for PASI 90³
  • PASI 75 and PASI 90 at Week 52 were not ranked primary or secondary endpoints and were analyzed descriptively¹
  • In PSO-2, the same analysis at Week 52 for patients receiving continuous SOTYKTU is not available due to the trial design and forced re-randomization²

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, 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.
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. Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88(1):40-51.
6. 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.
7. ClinicalTrials.gov. NCT04036435. https://clinicaltrials.gov/ct2/show/NCT040364‌35‌. Accessed June 8, 2023.