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 © 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
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.
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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