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Safety Profile1
Week 16 Safety Profile1
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
AR=adverse reaction;
CPK=creatine phosphokinase.
*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
PY=patient year.
Week 16 Safety Profile (≥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
AE=adverse event
*Includes 2 patients in SOTYKTU arm that were excluded from primary and secondary endpoint analyses.1
SAFETY PROFILE THROUGH
WEEK 521,2
Adverse events for SOTYKTU, apremilast, and placebo2
PSO-1 AND PSO-2 POOLED SAFETY, WEEKS 0-522*
*Includes AEs between first dose and 30 days following last dose or rollover to long-term extension study.2
†Includes 2 patients in SOTYKTU arm that were excluded from primary and secondary endpoint analyses.1
AE=adverse event; AR=adverse reaction; EAIR=exposure-adjusted incidence rate; PY=patient years.
HCV=hepatitis C virus
SAFETY PROFILE THROUGH
2 YEARS3
Demonstrated safety profile through 2 years in clinical trials3
ADVERSE EVENTS OF SPECIAL INTEREST: POETYK PSO-1, PSO-2, AND LTE TRIAL3*
*Includes 2 patients in SOTYKTU arm that were excluded from primary and secondary endpoint analyses.1
§MACE is defined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.3
||VTE is defined as pulmonary embolism and deep vein thrombosis.3
AE=adverse event; COVID-19=coronavirus disease 2019; EAIR=exposure-adjusted incidence rate; LTE=long-term extension; NMSC=nonmelanoma skin cancer; PY=patient-years.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION BELOW.