Journal
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Volume 80, Issue 6, Pages 1630-1639Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2019.01.008
Keywords
biologics; FDG PET/CT; incidental findings; psoriasis; randomized controlled trials
Categories
Funding
- National Institutes of Health [5P30AR069589-03]
- National Institutes of Health/National Heart, Lung, and Blood Institute [R01-HL111293]
- AbbVie
- Novartis Pharmaceuticals
- Janssen Scientific Affairs
- National Psoriasis Foundation
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Background: There has been an increase in the number of psoriasis treatments being investigated in clinical trials. Patients may have undiagnosed issues at the start of a study which may become identified during follow-up as incident medicinal conditions. The prevalence of incidental findings in patients with moderate-to-severe psoriasis presenting for clinical trials is unknown. Objective: Determine the prevalence of incidentalomas and rate of malignancy identified by fludeox-yglucose F 18 (FDG) positron emission tomography/computed tomography (PET/CT) imaging in clinical trial patients with moderate-to-severe psoriasis. Methods: A cross-sectional secondary analysis of patients with moderate-to-severe psoriasis who underwent FDG PET/CT scans at the baseline visit, before randomization, for 3 phase 4 clinical trials on vascular inflammation in psoriasis. Only patients without active infection, malignancy, or uncontrolled comorbidities were eligible for the clinical trials. Results: A total of 259 healthy patients with moderate-to-severe psoriasis underwent an FDG PET/CT scan as part of the study procedures. In all, 31 patients (11.97%) (95% confidence interval [CI], 8.28-16.56) had clinically significant incidentalomas on the baseline FDG PET/CT scan. Univariate logistic regression demonstrated that with every increase of 10 years of age, there was an approximate 30% increased risk of discovery of an incidentaloma (odds ratio, 1.30; 95% CI, 1.01-1.68). Of those patients with findings suggestive of malignancy (n = 28), 6 were confirmed to have cancer, resulting in a 2.31% (95% CI, 0.9-5.0) prevalence of malignancy. The positive predictive value of a true cancer was 31.58% (range, 21%-54%). Limitations: Generalizability and lost to follow-up. Conclusion: Incidentalomas on FDG PET/CT imaging are common in otherwise healthy, asymptomatic patients with moderate-to-severe psoriasis in clinical trials. Our results can help inform interpretation of clinical trial safety data and emphasize the importance of compliance with cancer screening recommendations.
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