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])
Bruce E Strober, Robert Bissonnette, David Fiorentino, Alexa B Kimball, Luigi Naldi, Neil H Shear, Kavitha Goyal, Steven Fakharzadeh, Stephen Calabro, Wayne Langholff, Yin You, Claudia Galindo, Seina Lee, Mark G Lebwohl, Bruce E Strober, Robert Bissonnette, David Fiorentino, Alexa B Kimball, Luigi Naldi, Neil H Shear, Kavitha Goyal, Steven Fakharzadeh, Stephen Calabro, Wayne Langholff, Yin You, Claudia Galindo, Seina Lee, Mark G Lebwohl
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.
Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
Source: PubMed