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

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]).

Author information

1
University of Connecticut Health Center, Farmington, Connecticut; Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: strober@uchc.edu.
2
Innovaderm Research Inc, Montreal, Quebec, Canada.
3
Department of Dermatology, Stanford University, Stanford, California.
4
Department of Dermatology, Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts.
5
Centro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED), Azienda Ospedaliera Papa Giovanni XIII, Bergamo, Italy.
6
University of Toronto, Toronto, Ontario, Canada.
7
Janssen Scientific Affairs LLC, Horsham, Pennsylvania.
8
Janssen Research and Development LLC, Horsham, Pennsylvania.
9
Janssen Health Economics and Outcomes Research, Horsham, Pennsylvania.
10
Icahn School of Medicine at Mount Sinai, New York, New York.

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

PMID:
26853180
DOI:
10.1016/j.jaad.2015.12.017
[Indexed for MEDLINE]
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