Safety Observations in 12095 Patients With Psoriasis Enrolled in an International Registry (PSOLAR): Experience With Infliximab and Other Systemic and Biologic Therapies
December 2014 | Volume 13 | Issue 12 | Original Article | 1441 | Copyright © 2014
Alice B. Gottlieb MD PhD,1 Robert E. Kalb MD,2 Richard G. Langley MD,3 Gerald G. Krueger MD,4
Elke M.G.J. de Jong MD PhD,5 Lynn Guenther MD,6 Kavitha Goyal MD,7 Steven Fakharzadeh MD PhD,7
Marc Chevrier MD PhD,7 Stephen Calabro MS,7 Wayne Langholff PhD,8 Alan Menter MD9
1Tufts Medical Center, Tufts University School of Medicine, Boston, MA
2Department of Dermatology, SUNY at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY
3Division of Dermatology, Dalhousie University, Halifax, NS, Canada
4University of Utah Health Sciences Center, University of Utah, Salt Lake City, UT
5Department of Dermatology, Radboud University Medical Centre, Nijmegen, The Netherlands
6The Guenther Dermatology Research Centre, London, ON, Canada
7Janssen Scientific Affairs, LLC, Horsham, PA
8Janssen Research & Development, LLC, Horsham, PA
9Baylor University Medical Center, Dallas, TX
BACKGROUND: Long-term data are essential to assess the safety of biologic agents for the treatment of psoriasis.
OBJECTIVE: To evaluate the incidence of adverse events of interest (AEIs), including all-cause mortality, major adverse cardiovascular events (MACE), malignancy (excluding nonmelanoma skin cancer), and serious infections (SI), in patients treated for psoriasis in clinical practice settings.
METHODS: PSOLAR is a large, ongoing, observational study of patients receiving, or eligible to receive, biologic or systemic therapy for psoriasis. Cumulative incidence rates of AEIs per 100 patient-years (PY) are reported across treatment cohorts: (1) infliximab, (2) ustekinumab, (3) other biologics (eg, adalimumab and etanercept), and (4) non-biologic agents. Significant predictors of each AEI were identified using Cox proportional hazards regression methodology.
RESULTS: PSOLAR is now fully enrolled at 12095 patients followed for 31818PY. The cumulative rate was 0.46/100PY for death, 0.36/100PY for MACE, 0.68/100PY for malignancy, and 1.50/100PY for SI. Increasing age was a significant predictor of all AEIs. A history of cardiovascular disease, malignancy, and significant infection was associated with a higher risk of developing MACE, malignancy, and SI, respectively. Exposure to infliximab (Hazard Ratio [HR]=3.101, P<0.001) and exposure to other biologics (HR=1.736, P<0.001) were significant predictors of SI. Use of immunomodulators (HR=1.954, P=0.005) was a significant predictor of MACE. Compared with non-biologic therapy, the use of biologic agents was not a significant predictor of death, MACE, or malignancy.
CONCLUSIONS: Based on PSOLAR data through 2013, no new safety concerns were observed with infliximab for all-cause mortality, MACE, or malignancy; the data suggest that infliximab was associated with serious infections.
J Drugs Dermatol. 2014;13(12):1441-1448.
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Psoriasis is a chronic skin disorder driven by inflammatory and immune-mediators, affecting 1-3% of people worldwide. 1 Biologic agents have proven to be effective and well tolerated for the treatment of psoriasis in clinical trials.2-7 It is also important to evaluate treatments in patients within a real world setting via observational studies that allow for long-term safety monitoring of therapeutic agents in a wider range of patients who may have co-morbidities and may have received multiple treatments.8,9 In addition, registries can follow a larger number of patients for longer periods of time.
As the largest, intercontinental, disease-based observational study of psoriasis to date, Psoriasis Longitudinal Assessment and Registry (PSOLAR) is now fully enrolled, with over 12000 patients at multiple clinical sites worldwide. PSOLAR is a prospective registry designed to track the long-term safety experience and clinical status of patients receiving, or eligible to receive, systemic therapies for the treatment of psoriasis.10 PSOLAR was designed to satisfy postmarketing commitments to the United States Federal Food and Drug Administration and European counterpart to which annual safety reports for bio-