title: Long-term safety experience of ustekinumab in patients with moderate to severe psoriasis (Part II of II): results from analyses of infections and malignancy from pooled phase II and III clinical trials.
abstract: BACKGROUND
  Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of moderate to severe psoriasis.
  
  
  OBJECTIVE
  We sought to evaluate the impact of ustekinumab on infections and malignancies, both theoretical risks of blocking IL-12 and IL-23, in patients exposed up to 3 years.
  
  
  METHODS
  Rates of infections and malignancies were evaluated in cumulative safety data from 3117 ustekinumab-treated patients across 4 studies.
  
  
  RESULTS
  During the placebo-controlled periods, rates of overall infections per 100 patient-years were similar among placebo (121.0), ustekinumab 45-mg (145.7), and ustekinumab 90-mg (132.2) groups, with overlapping confidence intervals, and remained stable through 3 years in ustekinumab groups. Rates of serious infections during the placebo-controlled periods were similar between placebo (1.70) and 90-mg (1.97) groups, yet lower in the 45-mg group (0.49). Rates remained stable (90 mg) or decreased (45 mg) over time, and were comparable with those for the US psoriasis population based on a managed care database. Rates of malignancies during the placebo-controlled periods were comparable among groups (placebo: 1.70; 45 mg: 0.99; 90 mg: 0.98) and remained stable over time in ustekinumab groups. Rates of malignancies, excluding nonmelanoma skin cancer, were comparable with rates expected in the general US population based on the Surveillance, Epidemiology, and End Results database.
  
  
  CONCLUSIONS
  Controlled periods do not extend beyond 12 to 20 weeks. Only 1247 patients were treated for at least 2 years, to date. Comparator database populations may not fully represent the clinical trial population.
  
  
  CONCLUSIONS
  The emerging safety profile of ustekinumab remains favorable and does not suggest increased rates of infection or malignancy through 3 years.
authors: NorthShore University Health System and University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA. Kenneth-gordon@northwestern.edu
authors: Kenneth B
authors: KB
authors: Gordon
authors: Kim A
authors: KA
authors: Papp
authors: Richard G
authors: RG
authors: Langley
authors: Vincent
authors: V
authors: Ho
authors: Alexa B
authors: AB
authors: Kimball
authors: Cynthia
authors: C
authors: Guzzo
authors: Newman
authors: N
authors: Yeilding
authors: Philippe O
authors: PO
authors: Szapary
authors: Steven
authors: S
authors: Fakharzadeh
authors: Shu
authors: S
authors: Li
authors: Ming-Chun
authors: MC
authors: Hsu
authors: Kristian
authors: K
authors: Reich
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007239:Infections / Q000453:epidemiology / Q000209:etiology; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology / Q000209:etiology; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D018570:Risk Assessment; D017751:Safety Management; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D000069549:Ustekinumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069549:Ustekinumab