A Comparison of Psoriasis Drug Failure Rates and Reasons for Discontinuation in Biologics vs Conventional Systemic Therapies
July 2014 | Volume 13 | Issue 7 | Original Article | 848 | Copyright © July 2014
Adriane A. Levin BA,a,b Alice B. Gottlieb MD PhD,b,c and Shiu-chung Au MDb
aBoston University School of Medicine, Boston, MA
bDepartment of Dermatology, Tufts Medical Center, Boston, MA
cTufts University School of Medicine, Boston, MA
Abstract
BACKGROUND: Although biologic therapies have been shown to be more effective than traditional systemic therapies in clinical trials for
the treatment of psoriasis, the drug survival time and reasons for discontinuation of biologics in clinical practice have not been compared
with those of conventional systemic therapies.
DESIGN: Retrospective, cross-sectional.
METHODS: All patient visits coded for psoriasis (ICD-0 696.1) in the clinical practice of 2 dermatologists from January 1 2008 through
January 4 2012 were included in this retrospective data analysis. The practice is a comprehensive psoriasis care center in the northeastern
United States serving a metropolitan population of over 4 million people. Patients were divided by treatment type: biologic or
traditional systemic. Treatment failure was defined as discontinuation of treatment course for any reason. Patient time to failure for each
therapy was calculated, as were previous treatments and reasons for treatment discontinuation.
RESULTS: One hundred and fifty-nine patients who underwent 284 courses of treatment were studied. Forty-eight percent of biologics
failed in an average of 242 days, compared with 75% of traditional systemics (
P<.0001), which failed in an average of 143 days
(
P<.0001). Infliximab had the longest survival time (292 days), and ustekinumab had the smallest failure rate (39%). Reasons for discontinuation
differed significantly between biologics and systemics, with biologics being discontinued more often due to loss of efficacy
(
P=.0014), and systemics failing significantly more frequently due to adverse events (
P<.001). Adverse events were observed most
frequently with methotrexate and infliximab, while golimumab had the highest rates of both loss and lack of efficacy.
CONCLUSION: Biologics had longer survival times and lower failure rates than traditional systemics in the treatment of psoriasis. Biologics
were more likely to be discontinued due to loss of efficacy, and systemics were more likely to fail due to adverse events.
J Drugs Dermatol. 2014;13(7):848-853.
INTRODUCTION
Psoriasis is a chronic immune-mediated disorder that
has been reported at rates of up to 6.5% in certain areas
of the world.1,2 Traditionally, psoriasis has been treated
with oral or topical immunosuppressant therapies or phototherapy.
More recently, biologic agents have emerged as an
effective alternative to traditional systemic therapies such as
methotrexate in the treatment of psoriasis. Biologics target
more specific factors in the inflammatory cascade in order to
more safely and effectively treat autoimmune disease. One of
these targets, tumor necrosis factor-α (TNF-α), is inhibited by
such agents as adalimumab, infliximab, etanercept, and golimumab.
3-7 More recently, ustekinumab has emerged, targeting
both interleukin (IL)-12 and (IL)-23.
Although only a few studies have compared biologics with traditional
systemics,8 biologic therapies have been shown in clinical
trials to have similar or superior efficacy to those reported for
conventional treatment options, such as methotrexate, acitretin,
cyclosporine, and phototherapy.9 Although biologics have integrated into the mainstream, data regarding their efficacy are
derived mostly from clinical trials rather than the clinic setting.10,11
In addition, there is little literature documenting the survival time
(the average length of time patients remain on a given treatment),
rate of failure, or reason for discontinuation of these medications.
Here we retrospectively evaluate agents used in the treatment
of psoriasis during a 4-year period at our medical center.
We hypothesized that biologics would have a longer time
until failure and would be less likely to fail than traditional
systemic agents. The goal of our study was to compare survival
time and rate of failure between the following individual
treatments: infliximab, adalimumab, golimumab, etanercept,
ustekinumab, and methotrexate.
MATERIALS AND METHODS
We designed a retrospective cross-sectional study using the database
of psoriasis patients at the department of dermatology
at Tufts Medical Center, Boston, which is a tertiary care center