title: Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR).
abstract: OBJECTIVE
  The efficacy of treatment for psoriasis must be balanced against potential adverse events.
  
  
  OBJECTIVE
  To determine the effect of treatment on the risk of serious infections in patients with psoriasis.
  
  
  METHODS
  A multicenter, longitudinal, disease-based registry (Psoriasis Longitudinal Assessment and Registry [PSOLAR]) at dermatology centers. Participants were adult patients with psoriasis who were receiving or were eligible to receive conventional systemic or biologic agents. The registry opened on June 20, 2007, and data included herein were collected through August 23, 2013.
  
  
  METHODS
  Patients were prescribed psoriasis therapies as in standard clinical practice. Patients will be followed for up to 8 years. Data were collected and serious adverse events (including serious infections) were assessed at regular intervals.
  
  
  METHODS
  Cohort characteristics are described based on evaluation at entry into the registry. The cumulative incidence rates of serious infections are reported across treatment cohorts, including ustekinumab, infliximab, adalimumab, etanercept, and nonbiologics (with or without methotrexate). A multivariate analysis using a Cox proportional hazards regression model was used to identify predictors of the time to the first serious infection using the nonmethotrexate/nonbiologics cohort as the reference.
  
  
  RESULTS
  Data were analyzed from 11,466 patients with psoriasis (22,311 patient-years). Differences in patient characteristics were found between the biologics and nonmethotrexate/nonbiologics cohorts (eg, age, sex, body mass index, and disease characteristics), as well as among the individual biologic groups (eg, a higher prevalence of psoriatic arthritis in the infliximab cohort). The cumulative incidence rate of serious infections was 1.45 per 100 patient-years (n = 323) across treatment cohorts, and the rates were 0.83, 1.47, 1.97, and 2.49 per 100 patient-years in the ustekinumab, etanercept, adalimumab, and infliximab cohorts, respectively, and 1.05 and 1.28 per 100 patient-years in the nonmethotrexate/nonbiologics and methotrexate/nonbiologics cohorts, respectively. The most commonly reported types of serious infections across the registry were pneumonia and cellulitis. Increasing age, diabetes mellitus, smoking, significant infection history, infliximab exposure, and adalimumab exposure were each associated with an increased risk of serious infection.
  
  
  CONCLUSIONS
  Results from PSOLAR suggest a higher risk of serious infections with adalimumab and infliximab compared with nonmethotrexate and nonbiologic therapies. No increased risk was observed with ustekinumab or etanercept.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00508547.
authors.affiliation: Department of Dermatology, School of Medicine and Biological Sciences, State University of New York at Buffalo.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Kalb
authors.affiliation: Department of Dermatology, Stanford University School of Medicine, Stanford, California.
authors.forename: David F
authors.initials: DF
authors.lastname: Fiorentino
authors.affiliation: Department of Dermatology, Mount Sinai Medical Center, New York, New York.
authors.forename: Mark G
authors.initials: MG
authors.lastname: Lebwohl
authors.affiliation: Dermadvances Research, University of Manitoba, Winnipeg, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Toole
authors.affiliation: Laval University and Centre de Dermatologique du Quebec Metropolitain, Quebec City, Quebec, Canada.
authors.forename: Yves
authors.initials: Y
authors.lastname: Poulin
authors.affiliation: Siaal Research Center for Family Medicine and Primary Care, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: Arnon D
authors.initials: AD
authors.lastname: Cohen
authors.affiliation: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
authors.forename: Kavitha
authors.initials: K
authors.lastname: Goyal
authors.affiliation: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
authors.forename: Steven
authors.initials: S
authors.lastname: Fakharzadeh
authors.affiliation: Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
authors.forename: Stephen
authors.initials: S
authors.lastname: Calabro
authors.affiliation: Janssen Research & Development, LLC, Horsham and Spring House, Pennsylvania.
authors.forename: Marc
authors.initials: M
authors.lastname: Chevrier
authors.affiliation: Janssen Research & Development, LLC, Horsham and Spring House, Pennsylvania.
authors.forename: Wayne
authors.initials: W
authors.lastname: Langholff
authors.affiliation: Janssen Research & Development, LLC, Horsham and Spring House, Pennsylvania.
authors.forename: Yin
authors.initials: Y
authors.lastname: You
authors.affiliation: Department of Dermatology, Saint Louis University School of Medicine, St Louis, Missouri.
authors.forename: Craig L
authors.initials: CL
authors.lastname: Leonardi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001688:Biological Products / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015994:Incidence; D007239:Infections / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D007843:Latin America / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D008877:Middle East / Q000453:epidemiology; D009656:North America / Q000453:epidemiology; D015995:Prevalence; D011565:Psoriasis / Q000188:drug therapy*; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment / Q000379:methods*; D012720:Severity of Illness Index; D013997:Time Factors
chemical_list: D001688:Biological Products; D007166:Immunosuppressive Agents