Efficacy outcomes from PSO-1

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-11

A chart comparing Sotyktu vs. placebo at Week 16 of the POETYK PSO-1 study

Adapted from Armstrong A 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, 24 and 52
  • sPGA 0 at Week 16
  • PASI 75 at Week 16, 24 and 52
  • PASI 90 at Week 16, 24 and 52
  • PASI 100 at Week 16
  • ss-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-1

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-1 study1,4

A graph showing Sotyktu vs. placebo (at 16 weeks) and across key secondary endpoints in the PSO-1 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, 24 and 52
  • sPGA 0 at Week 16
  • PASI 75 at Week 16, 24 and 52
  • PASI 90 at Week 16, 24 and 52
  • 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
‡Includes patients with baseline Scalp Specific PGA score of ≥3.1,4
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.
DLQI, Dermatology Life Quality Index; NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index; PGA, Physician’s Global Assessment; PSSD, Psoriasis Symptoms and Signs; SE, standard error; sPGA, static Physician’s Global Assessment.

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

PSO-1 co-primary endpoints: PASI 75 response and sPGA 0/1 response rates were superior vs. placebo at Week 161,4,5

PASI 75

A chart comparing Sotyktu vs. placebo at Week 16 of the POETYK PSO-1 study

sPGA 0/1

A chart comparing Sotyktu vs. placebo at Week 16 of the POETYK PSO-1 study

Adapted from Armstrong A et al. 2023, SOTYKTU SmPC & SOTYKTU EPAR.
PSO-1: SOTYKTU (n=332), apremilast (n=168), placebo (n=166)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, no-responder imputation; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

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

PSO-1 secondary endpoint: PASI 75 response and sPGA 0/1 response rates were significantly improved vs. apremilast at Week 241,4,5

PASI 75

A graph showing Sotyktu efficacy vs. apremilast at Week 24 of the trial (secondary endpoint)

sPGA 0/1

A graph showing Sotyktu efficacy vs. apremilast at Week 24 of the trial (secondary endpoint)

Adapted from Armstrong A et al. 2023, SOTYKTU SmPC & SOTYKTU EPAR.
PSO-1: SOTYKTU (n=332), apremilast (n=168), placebo (n=166)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, no-responder imputation; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

SOTYKTU demonstrated superior efficacy vs. placebo at Week 16 (co-primary endpoint),
and vs. apremilast at Week 24 (secondary endpoint)1,4

PSO-1: maximum PASI 75 response was achieved by Week 24 and maintained through Week 521,4,5

PASI 75

A graph showing Sotyktu efficacy vs. placebo at Week 16 (co-primary endpoint), and vs. apremilast at Week 24 (secondary endpoint)

Adapted from Armstrong A et al. 2023, SOTYKTU SmPC & SOTYKTU EPAR.
PSO-1: SOTYKTU (n=332), apremilast (n=168), placebo (n=166)1

An icon representing pinch to zoomPinch & zoom to explore

PSO-1: sPGA 0/1 respones rates continued to improve through Week 24 and were maintained through to Week 521,4,5

sPGA 0/1

A graph showing PSO-1: sPGA 0/1 respones rates through weeks 24-52 of the trial

Adapted from Armstrong A et al. 2023, SOTYKTU SmPC & SOTYKTU EPAR.
PSO-1: SOTYKTU (n=332), apremilast (n=168), placebo (n=166)1

An icon representing pinch to zoomPinch & zoom to explore

*p≤0.001 for comparison between SOTYKTU and placebo or SOTYKTU and apremilast.1,4
†p<0.001 for comparison between SOTYKTU and apremilast.1,4
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, no-responder imputation; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

References

  1. Armstrong A et al. J Am Acad Dermatol. 2023;88(1):29–39. Plus supplementary material.
  2. Strober B et al. J Am Acad Dermatol. 2023;88(1):40–51. Plus supplementary material.
  3. Clinicaltrials.gov. Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants with Psoriasis (POETYK-PSO-1). NCT03624127. Available at
    https://clinicaltrials.gov/ct2/show/NCT03624127?term=poetyk&draw=2&rank=2 (Accessed August 2023).
  4. SOTYKTU. Summary of Product Characteristics
  5. SOTYKTU. European Product Assessment Report (EPAR). 26 January 2023. Available at https://www.ema.europa.eu/en/documents/assessment-report/sotyktu-epar-public-assessment-report_en.pdf (Accessed August 2023).
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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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