Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR])

J Am Acad Dermatol. 2016 May;74(5):851-61.e4. doi: 10.1016/j.jaad.2015.12.017. Epub 2016 Feb 4.

Abstract

Background: Comparing effectiveness of biologics in real-world settings will help inform treatment decisions.

Objectives: We sought to compare therapeutic responses among patients initiating infliximab, adalimumab, or etanercept versus ustekinumab during the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

Methods: Proportions of patients achieving a Physician Global Assessment score of clear (0)/minimal (1) and mean decrease in percentage of body surface area with psoriasis were evaluated at 6 and 12 months. Adjusted logistic regression (Physician Global Assessment score 0/1) and analysis of covariance (percentage of body surface area with psoriasis) were performed to determine treatment factors associated with effectiveness.

Results: Of 2541 new users on registry, 2076 had efficacy data: ustekinumab (n = 1041), infliximab (n = 116), adalimumab (n = 662), and etanercept (n = 257). Patients receiving tumor necrosis factor-alpha(-α) inhibitors were significantly less likely to achieve Physician Global Assessment score 0/1 versus ustekinumab (infliximab [odds ratio {OR} 0.396, P < .0001], adalimumab [OR 0.686, P = .0012], etanercept [OR 0.554, P = .0003] at 6 months and infliximab [OR 0.449, P = .0040] at 12 months). Mean decrease in percentage of body surface area with psoriasis was significantly greater for ustekinumab versus adalimumab (point estimate 1.833, P = .0020) and etanercept (point estimate 3.419, P < .0001) at 6 months and versus infliximab (point estimate 3.945, P = .0005) and etanercept (point estimate 2.778, P = .0007) at 12 months.

Limitations: Treatment selection bias and limited data for doing adjustments are limitations.

Conclusions: In PSOLAR, effectiveness of ustekinumab was significantly better versus all 3 tumor necrosis factor-α inhibitors studied for the majority of comparisons at 6 and 12 months.

Trial registration: ClinicalTrials.gov NCT00508547.

Keywords: BSA; DLQI; PGA; PSOLAR; Psoriasis Longitudinal Assessment and Registry; adalimumab; biologic; effectiveness; efficacy; etanercept; infliximab; ustekinumab.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab / administration & dosage
  • Adult
  • Biological Products / administration & dosage*
  • Biological Products / pharmacology
  • Confidence Intervals
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Etanercept / administration & dosage
  • Female
  • Follow-Up Studies
  • Global Health
  • Humans
  • Infliximab / administration & dosage
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Odds Ratio
  • Patient Satisfaction / statistics & numerical data
  • Prospective Studies
  • Psoriasis / diagnosis*
  • Psoriasis / drug therapy*
  • Quality of Life*
  • Registries*
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Ustekinumab / administration & dosage

Substances

  • Biological Products
  • Infliximab
  • Ustekinumab
  • Adalimumab
  • Etanercept

Associated data

  • ClinicalTrials.gov/NCT00508547