title: Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up.
abstract: BACKGROUND
  Long-term safety evaluations of biologics are needed to inform patient management decisions.
  
  
  OBJECTIVE
  To evaluate the safety of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years.
  
  
  METHODS
  Safety data were pooled from four studies of ustekinumab for psoriasis. Rates of adverse events (AEs), serious AEs (SAEs) and AEs of interest [infections, nonmelanoma skin cancers (NMSCs), other malignancies and major adverse cardiovascular events (MACE)] per 100 patient-years (PY) of follow-up were analysed by ustekinumab dose (45 or 90 mg) and by year of follow-up (years 1-5) to evaluate the dose response and impact of cumulative exposure. Observed rates of overall mortality and other malignancies were compared with those expected in the general U.S. population.
  
  
  RESULTS
  Analyses included 3117 patients (8998 PY) who received one or more doses of ustekinumab, with 1482 patients treated for ≥4 years (including 838 patients ≥5 years). At year 5, event rates (45 mg, 90 mg, respectively) for overall AEs (242·6, 225·3), SAEs (7·0, 7·2), serious infections (0·98, 1·19), NMSCs (0·64, 0·44), other malignancies (0·59, 0·61) and MACE (0·56, 0·36) were comparable between dose groups. Year-to-year variability was observed, but no increasing trend was evident. Rates of overall mortality and other malignancies were comparable with those expected in the general U.S. population.
  
  
  CONCLUSIONS
  No dose-related or cumulative toxicity was observed with increasing duration of ustekinumab exposure for up to 5 years. Rates of AEs reported in ustekinumab psoriasis trials are generally comparable with those reported for other biologics approved for the treatment of moderate-to-severe psoriasis.
authors.affiliation: Probity Medical Research, 135 Union Street East, Waterloo, ON N2J1C4, Canada. kapapp@probitymedical.com
authors.forename: K A
authors.initials: KA
authors.lastname: Papp
authors.forename: C E M
authors.initials: CE
authors.lastname: Griffiths
authors.forename: K
authors.initials: K
authors.lastname: Gordon
authors.forename: M
authors.initials: M
authors.lastname: Lebwohl
authors.forename: P O
authors.initials: PO
authors.lastname: Szapary
authors.forename: Y
authors.initials: Y
authors.lastname: Wasfi
authors.forename: D
authors.initials: D
authors.lastname: Chan
authors.forename: M-C
authors.initials: MC
authors.lastname: Hsu
authors.forename: V
authors.initials: V
authors.lastname: Ho
authors.forename: P D
authors.initials: PD
authors.lastname: Ghislain
authors.forename: B
authors.initials: B
authors.lastname: Strober
authors.forename: K
authors.initials: K
authors.lastname: Reich
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D002318:Cardiovascular Diseases / Q000139:chemically induced; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007239:Infections / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced; D011565:Psoriasis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D000069549:Ustekinumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D000069549:Ustekinumab