title: Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): experience with infliximab and other systemic and biologic therapies.
abstract: BACKGROUND
  Long-term data are essential to assess the safety of biologic agents for the treatment of psoriasis.
  
  
  OBJECTIVE
  To evaluate the incidence of adverse events of interest (AEIs), including all-cause mortality, major adverse cardiovascular events (MACE), malignancy (excluding nonmelanoma skin cancer), and serious infections (SI), in patients treated for psoriasis in clinical practice settings.
  
  
  METHODS
  PSOLAR is a large, ongoing, observational study of patients receiving, or eligible to receive, biologic or systemic therapy for psoriasis. Cumulative incidence rates of AEIs per 100 patient-years (PY) are reported across treatment cohorts: (1) infliximab, (2) ustekinumab, (3) other biologics (eg, adalimumab and etanercept), and (4) non-biologic agents. Significant predictors of each AEI were identified using Cox proportional hazards regression methodology.
  
  
  RESULTS
  PSOLAR is now fully enrolled at 12095 patients followed for 31818PY. The cumulative rate was 0.46/100PY for death, 0.36/100PY for MACE, 0.68/100PY for malignancy, and 1.50/100PY for SI. Increasing age was a significant predictor of all AEIs. A history of cardiovascular disease, malignancy, and significant infection was associated with a higher risk of developing MACE, malignancy, and SI, respectively. Exposure to infliximab (Hazard Ratio [HR]=3.101, P<0.001) and exposure to other biologics (HR=1.736, P<0.001) were significant predictors of SI. Use of immunomodulators (HR=1.954, P=0.005) was a significant predictor of MACE. Compared with non-biologic therapy, the use of biologic agents was not a significant predictor of death, MACE, or malignancy.
  
  
  CONCLUSIONS
  Based on PSOLAR data through 2013, no new safety concerns were observed with infliximab for all-cause mortality, MACE, or malignancy; the data suggest that infliximab was associated with serious infections.
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: Robert E
authors.initials: RE
authors.lastname: Kalb
authors.forename: Richard G
authors.initials: RG
authors.lastname: Langley
authors.forename: Gerald G
authors.initials: GG
authors.lastname: Krueger
authors.forename: Elke M G J
authors.initials: EM
authors.lastname: de Jong
authors.forename: Lynn
authors.initials: L
authors.lastname: Guenther
authors.forename: Kavitha
authors.initials: K
authors.lastname: Goyal
authors.forename: Steven
authors.initials: S
authors.lastname: Fakharzadeh
authors.forename: Marc
authors.initials: M
authors.lastname: Chevrier
authors.forename: Stephen
authors.initials: S
authors.lastname: Calabro
authors.forename: Wayne
authors.initials: W
authors.lastname: Langholff
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use; D001691:Biological Therapy / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects* / Q000627:therapeutic use; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011565:Psoriasis / Q000188:drug therapy*; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D000069549:Ustekinumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069285:Infliximab; D000069549:Ustekinumab; D000068879:Adalimumab