Adverse Medical Conditions Across Treatment Options in Patients With Psoriasis: A Claims-Based Analysis
November 2018 | Volume 17 | Issue 11 | Original Article | 1211 | Copyright © November 2018
Jashin J. Wu MD,a April Armstrong MD MPH,b Rakesh Singh PhD,c Martin Cloutier MSc,d Marjolaine Gauthier-Loiselle PhD,d Patrick Gagnon-Sanschagrin MSc,d Dilek Arikan MD,c Alan Fleischer MD,e Annie Guérin MSc,d Arijit Ganguli PhDc
aDermatology Research and Education Foundation, Irvine, CA bKeck School of Medicine, University of Southern California, Los Angeles, CA cHealth Economics and Outcomes Research, AbbVie Inc., North Chicago, IL dAnalysis Group, Inc., Montreal, Québec, Canada eFormerly AbbVie Inc., North Chicago, IL
OBJECTIVE: To assess the real-world risk of developing adverse medical conditions (AMCs) among patients with psoriasis treated with biologic therapies or conventional systemic/topical therapies (CST/topical).
METHODS: Adult patients with psoriasis were identified from the Truven MarketScan US claims database (2008 Q3–2015 Q3) and classified into cohorts based on treatment initiated on the index date (adalimumab [ADA], etanercept [ETN], ustekinumab [UST], infliximab [IFX], or CST/topical). Incident AMCs were identified while on treatment from diagnoses recorded in medical claims and included abnormal test results, infections, mental disorders, cardiovascular disease, malignancies (skin and non-skin), and respiratory disease. Cox proportional hazards models were used to compare AMC risk for (1) ADA, ETN, and UST (separately) vs CST/topical, and (2) ADA vs other biologic therapies (ETN, UST, and IFX combined). Regressions were adjusted for age, gender, region, insurance plan type, year, Charlson comorbidity index, and prior AMCs; and based on stepwise selection, comorbidities, specialist encounters, and frequently prescribed treatments.
RESULTS: A total of 42,981 patients were identified (ADA: 5,197; ETN: 3,311; UST: 1,370; IFX: 187; CST/topical: 32,916). Across cohorts, median age was 46–50 years, 46.2%–53.1% were female, and median follow-up duration was 3.3–7.9 months. For all cohorts, infection was the most frequent AMC (28.7%–41.8%). Compared with CST/topical, ADA, ETN, and UST were associated with a lower risk of infections (adjusted hazard ratio [aHR]: 0.93, 0.92, and 0.86, respectively, all P less than 0.05). ADA was associated with a lower risk of malignancies (aHR: 0.71, P less than 0.05), and ETN was associated with a lower risk of respiratory disease (aHR: 0.80, P less than 0.05). Compared with biologic therapies, ADA was not associated with higher risk of AMCs.
CONCLUSIONS: Compared to CST/topical, biologic therapies were associated with similar or lower risk of AMCs. Comparison between ADA and other biologic therapies suggests a similar safety profile with respect to the studied AMCs.
J Drugs Dermatol. 2018;17(11):1211-1218.
Psoriasis (Ps) is a common chronic immune-mediated inflammatory disease that typically manifests as scaling, itchy, or burning erythematous plaques.1 Topical therapy is recommended for milder forms of Ps, while systemic therapy including phototherapy, conventional systemic therapies (CST), and biologic therapies are recommended for moderate-to-severe Ps.1,2 Previous studies have reported that biologic therapies are associated with superior Ps symptom management compared with CSTs for the treatment of moderate-to-severe Ps.3-6 With respect to safety, clinical trials have shown no difference in the safety of biologic therapies – specifically adalimumab (ADA) and infliximab (IFX) – compared to methotrexate (MTX), the most commonly used CST, in the treatment of patients with moderate-to-severe Ps.4,7In real-world settings, recent studies,8-13 notably those based on data from the Psoriasis Longitudinal Assessment and Registry (PSOLAR),8,12,13 have evaluated the risk of certain adverse medical conditions (AMCs) in patients treated with biologic therapies. In these studies biologic therapies were not associated with increased risk of mortality or cardiovascular disease compared with non-biologic therapies,13 but an association between certain tumor necrosis factor-alpha inhibitors (TNFIs) and serious infections and between long-term exposure to TNFIs and malignancies other than non-melanoma skin cancer was suggested.8,12 However, these findings were based on a mix of biologic-naïve and biologic-experienced patients which resulted in heterogeneous cohorts; when more homogenous biologic-naïve cohorts were studied, these