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A REP

Week 16 safety profile

ADVERSE REACTIONS THAT OCCURRED IN 1% OF PATIENTS TREATED WITH SOTYKTU AND MORE FREQUENTLY THAN PLACEBO THROUGH WEEK 16 FROM PSO-1 AND PSO-21

Adverse reactions through week 16 Adverse reactions through week 16

Serious infections through Week 16 were reported in 5 patients (2.0/100 PY) treated with SOTYKTU and 2 patients (1.6/100 PY) treated with placebo1

  • AR=adverse reaction; CPK=creatine phosphokinase; PY=patient-years.
  • Includes upper respiratory tract infection (viral, bacterial, and unspecified), nasopharyngitis, pharyngitis (including viral, streptococcal, and unspecified), sinusitis (includes acute, viral, bacterial), rhinitis, rhinotracheitis, tracheitis, laryngitis, and tonsillitis (including bacterial, streptococcal).1
  • Includes oral herpes, genital herpes, herpes simplex, and herpes virus infection.1
  • Includes mouth ulceration, aphthous ulcer, tongue ulceration, and stomatitis.1
  • Includes acne, acne cystic, and dermatitis acneiform.1
  • Adverse reactions that occurred in <1% of patients in the SOTYKTU group were herpes zoster1

Safety profile through Week 16 (≥5%)2

AES OCCURRING IN 5% OF PATIENTS IN ANY ACTIVE TREATMENT GROUP WEEKS 0-16 FROM POOLED CLINICAL TRIALS (PSO-1 AND PSO-2)2

Adverse reactions through week 16
Adverse reactions through week 16
  • Studies were not designed to compare the safety of apremilast to SOTYKTU. Some of the observed safety rates for apremilast may differ from those previously reported. Please refer to the apremilast Full Prescribing Information
  • AE=adverse event.
  • Includes 2 patients in the SOTYKTU arm that were excluded from primary and secondary endpoint analyses.

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References:

  1. SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  2. Armstrong A, Gooderham M, Warren RB, et al. Efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, compared with placebo and apremilast in moderate to severe plaque psoriasis: results from the POETYK PSO-1 study. Oral presentation at American Academy of Dermatology Virtual Meeting Experience (VMX); April 23-25, 2021; Virtual Meeting. Session S033.

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