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  • U.S. Full Prescribing Information |
  • Medication Guide |
  • Indication

    Indication

    SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

    Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

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Study Designs

The efficacy and safety of SOTYKTU were studied in 2 pivotal Phase 3 trials1-4

POETYK PSO-1 and POETYK PSO-2 Clinical Trials
POETYK PSO-1 and POETYK PSO-2 Clinical Trials

*Apremilast was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing as per its label.2,3

Upon relapse (≥50% loss of Week 24 PASI percentage improvement from baseline), patients were to be switched to SOTYKTU 6 mg QD; due to a programming error, however, these patients continued on placebo until Week 52.5
BID=twice daily; BSA=body surface area; PASI=psoriasis area and severity index; PASI 50≥50% reduction from baseline PASI; PASI 75≥75% reduction from baseline PASI; PASI 90≥90% reduction from baseline PASI; PASI 100=100% reduction from baseline PASI, QD=once-daily; sPGA 0/1=static Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin.

STUDY DESIGNS1

Key eligibility criteria1

  • Adults with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy
  • PASI ≥12, sPGA ≥3, BSA involvement ≥10%

Co-primary endpoints1

  • Proportion of patients who achieved the following responses vs placebo at Week 16:
    • At least a 75% improvement in PASI scores from baseline (PASI 75)
    • sPGA score of 0 (clear)
      or 1 (almost clear)

Select secondary endpoints1

  • Proportion of patients who achieved the following responses vs apremilast:
    • At Week 16 and Week 24: PASI 75, PASI 90, sPGA 0/1
    • At Week 16: ss-PGA score of 0 (clear)
      or 1 (almost clear)
  • Proportion of patients who achieved the following responses vs placebo
    • At Week 16: ss-PGA score of 0 (clear)
      or 1 (almost clear), and PASI 100
  • Statistical significance was not met for the following secondary endpoints2,3
    • PGA-F 0/1 (PGA-F score of clear or minimal disease) vs placebo (BL ≥3) at Week 16, PSSD symptom score of 0 vs apremilast (BL ≥1) at Week 16

BL=baseline; PGA-f=Physician's Global Assessment of Fingernail; PSSD= Psoriasis Symptoms and Signs Diary

POETYK PSO-LTE: Long-term extension study5,6

Phase 3 trials and long-term extension (LTE) study
Phase 3 trials and long-term extension (LTE) study

*Apremilast was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing.5

Upon relapse (≥50% loss of Week 24 PASI percentage improvement from baseline), patients were switched to SOTYKTU 6 mg QD; due to a programming error, however, these patients continued on placebo until Week 52.5

Data reported through the cutoff date of October 1, 2021.5

§1179 patients had ≥1 year (52 weeks) of continuous exposure, 584 had ≥2 years (104 weeks) of continuous exposure, and 1056 patients were enrolled in the LTE trial as of data cutoff.5,8

LTE Study Design5

  • All patients in PSO-1 and PSO-2 were eligible to enter the LTE trial after 52 weeks of treatment, regardless of initial treatment. Patients were blindly switched to open-label SOTYKTU.

Exposure to SOTYKTU5

  • At 2 years, 1179 patients had ≥1 year (52 weeks) of continuous exposure and 584 had ≥2 years (104 weeks) of continuous exposure
  • The median exposure to SOTYKTU was 682 days
  • Exposure during Weeks 0-52 of PSO-1/PSO-2 was 969.0 PY, with an additional 1513.0 PY of exposure during the LTE

LTE=long-term extension; PY=patient-years

Demographics

Select baseline demographics for POETYK PSO-1 and POETYK PSO-2 (pooled)9,10

Select baseline demographics for POETYK PSO-1  and POETYK PSO-23
Select baseline demographics for POETYK PSO-1  and POETYK PSO-23
  • In both trials, 13% of patients were Hispanic or Latino1

SD=standard deviation.

Baseline characteristics

Select baseline characteristics for POETYK PSO-1 and POETYK PSO-2 (pooled)9

Select baseline characteristics for POETYK PSO-1  and POETYK PSO-23
Select baseline characteristics for POETYK PSO-1  and POETYK PSO-23

BSA=body surface area; IL=interleukin; sPGA=static Physicians Global Assessment; PASI=Psoriasis Area and Severity Index; TNF=tumor necrosis factor.

Peer Perspectives: Study Design and Co-primary Endpoints

Study Design And Co-primary Endpoints Thumbnail
Efficacy Thumbnail
Safety (week 16 and 52) Thumbnail
MOA And Selectivity Thumbnail
Dosing And Laboratory Evaluation Thumbnail
Important Safety Information Thumbnail
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1787-US-2300483 07/23