Efficacy outcomes from PSO-2

SOTYKTU was studied in two global, Phase 3, randomised, multi-arm clinical studies1,2

Key eligibility criteria1,3

Adults with moderate-to-severe plaque psoriasis + PASI ≥12, sPGA ≥3, BSA ≥10%
Stratified by geographic region, body weight, and prior biologic use

Selected exclusion criteria1,3

Prior treatment with SOTYKTU or apremilast
History or evidence of active infection, including latent or active TB
Other forms of psoriasis

POETYK PSO-21

A graph showing the outcome of the POETYK PSO-2 clinical trial

Adapted from Strober B et al. 2023.

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Co-primary endpoints at Week 16 (vs. placebo)1,3

  • PASI 75
  • sPGA 0/1

Selected secondary endpoints1,3

  • sPGA 0/1 at Week 16 and 24
  • sPGA 0 at Week 16
  • PASI 75 at Week 16, 24 and 52
  • PASI 90 at Week 16 and 24
  • PASI 100 at Week 16
  • Scalp-specific PGA 0/1 at Week 16
  • PSSD symptom score at Week 16
  • DLQI 0/1 at Week 16

This is a selection of secondary endpoints from PSO-2

baseline characteristics

*Apremilast was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing1
BID, twice daily; BSA, Body Surface Area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PSSD, Psoriasis Symptoms and Signs Diary; QD, once daily; sPGA, static Physician’s Global Assessment; ssPGA, scalp-specific Physician's Global Assessment.

SOTYKTU demonstrated superior efficacy vs. placebo (at 16 weeks) and across key secondary
endpoints in the PSO-2 study1,4

A table showing Sotyktu efficacy vs. placebo (at 16 weeks) and across key secondary endpoints in the PSO-2 study

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Co-primary endpoints1

  • PASI 75 at Week 16 vs. placebo
  • sPGA 0/1 at Week 16 vs. placebo
A table breaking down the data generated through the POETYK PSO-2 study

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Selected secondary endpoints1,3

  • sPGA 0/1 at Week 16 and 24
  • sPGA 0 at Week 16
  • PASI 75 at Week 16, 24 and 52
  • PASI 90 at Week 16 and 24
  • PASI 100 at Week 16
  • Scalp-specific PGA 0/1 at Week 16
  • PSSD symptom score at Week 16
  • DLQI 0/1 at Week 16

*p≤0.0001 for comparison between SOTYKTU and placebo or SOTYKTU and apremilast.1,4
†p<0.001 for comparison between SOTYKTU and apremilast.1,4
‡p<0.01 for comparison between SOTYKTU and apremilast.1,4
§N=504 accounting for missed assessments due to COVID-19 pandemic.
Missing data were imputed using NRI method; patients who discontinued treatment or the study prior to the endpoint or had missing data were counted as non-responders.
NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index; PGA, Physician’s Global Assessment; sPGA, static Physician’s Global Assessment.

SOTYKTU demonstrated superior efficacy vs. placebo at Week 16 (co-primary endpoint)1,4

PSO-2 co-primary endpoints: PASI 75 response and sPGA 0/1 response rates were superior vs. placebo at Week 161

PASI 75

A chart comparing Sotyktu vs. placebo at Week 16 of the POETYK PSO-2 study

sPGA 0/1

A chart comparing Sotyktu vs. placebo at Week 16 of the POETYK PSO-2 study

Adapted from Strober B et al. 2023.
PSO-2: SOTYKTU (n=511), apremilast (n=254), placebo (n=255)1

Missing data were imputed using NRI method.
PASI 75 and sPGA were co-primary endpoints in the Phase 3 POETYK study. PASI 75 was defined as ≥75% reduction from baseline PASI.
NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index; QD, once daily; sPGA, static Physician’s Global Assessment.

SOTYKTU demonstrated superior efficacy vs. apremilast at Week 24 (secondary endpoint)1,4

PSO-2 secondary endpoints: PASI 75 response and sPGA 0/1 response rates were significantly improved vs. apremilast at Week 241

PASI 75

A chart comparing Sotyktu vs. apremilast at Week 24 of the POETYK PSO-2 study

sPGA 0/1

A chart comparing Sotyktu vs. apremilast at Week 24 of the POETYK PSO-2 study

Adapted from Strober B et al. 2023.
PSO-2: SOTYKTU (n=504), apremilast (n=254), placebo (n=255)1

Missing data were imputed using NRI method.
PASI 75 and sPGA were co-primary endpoints in the Phase 3 POETYK study. PASI 75 was defined as ≥75% reduction from baseline PASI.
BID, twice daily; NRI, no-responder imputation; PASI, Psoriasis Area and Severity Index; QD, once daily; sPGA, static Physician’s Global Assessment.

References

  1. Strober B et al. J Am Acad Dermatol. 2023;88(1):40–51. Plus supplementary material.
  2. Armstrong A et al. J Am Acad Dermatol. 2023;88(1):29–39. Plus supplementary material.
  3. Clinicaltrials.gov. An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis (POETYK-PSO-2). NCT03611751. Available at https://clinicaltrials.gov/ct2/show/NCT03611751?term=NCT03611751&draw=2&rank=1 (Accessed August 2023).
  4. SOTYKTU. Summary of Product Characteristics
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© 2023 Bristol-Myers Squibb Company. All rights reserved.

Date of preparation: September 2023 | Job code: 1787-GB-2200015

© 2023 Bristol-Myers Squibb Company. All rights reserved.

Job code: 1787-GB-2200015 Date of preparation: September 2023

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