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.
Determine the prevalence of incidentalomas and rate of malignancy identified by fludeoxyglucose F 18 (FDG) positron emission tomography/computed tomography (PET/CT) imaging in clinical trial patients with moderate-to-severe psoriasis.
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.
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%).
Generalizability and lost to follow-up.
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.Le texte complet de cet article est disponible en PDF.
Key words : biologics, FDG PET/CT, incidental findings, psoriasis, randomized controlled trials
Abbreviations used : CI, CT, FDG, PASI, PET, SD, VIP
| Funding sources: Supported in part by the National Institutes of Health (grant 5P30AR069589-03), the National Institutes of Health/National Heart, Lung, and Blood Institute (grant R01- HL111293 [to Dr Gelfand]), a grant from AbbVie for the Vascular Inflammation in Psoriasis trial [to Dr Gelfand]), a grant from Novartis Pharmaceuticals for the Vascular Inflammation in Psoriasis–Secukinumab trial (to Dr Gelfand), a grant from Janssen Scientific Affairs for the Vascular Inflammation in Psoriasis–Ustekinumab trial (to Dr Gelfand), and a medical dermatology fellowship from the National Psoriasis Foundation (to Dr Wan and Dr Noe).
| Disclosure: Dr. Gelfand served as a consultant for Bristol-Myers Squibb, Boehringer Ingelheim, GlaxoSmithKline, Janssen Biologics, Novartis Corp, Union Chimique Belge Data and Safety Monitoring Board, Sanofi, and Pfizer Inc, receiving honoraria; in addition, he receives research grants (to the Trustees of the University of Pennsylvania) from Abbvie, Janssen, Novartis Corp, Celgene, Ortho Dermatologics, and Pfizer Inc and has received payment for CME work related to psoriasis that was supported indirectly by Eli Lilly and Company, Ortho Dermatologic, and Novartis. Dr Gelfand is a copatent holder of resiquimod for treatment of cutaneous T-cell lymphoma, and he is also a deputy editor for the Journal of Investigative Dermatology, receiving honoraria from the Society for Investigative Dermatology. Dr Mehta is a full-time US government employee and receives research grants to the National Heart, Lung, and Blood Institute from AbbVie, Janssen, Celgene, and Novartis. Dr Takeshita receives a research grant from Pfizer Inc (to the Trustees of the University of Pennsylvania) and has received payment for CME work related to psoriasis that was supported indirectly by Eli Lilly and Company. Dr Torigian is a cofounder of Quantitative Radiology Solutions LLC. Dr Alavi, Ms Alvarez, Dr Chiesa Fuxench, Dr Noe, Ms Papadopoulos, Dr Shin, Mr Werner, and Dr Wan have no conflicts of interest to disclosure.
| Reprints not available from the authors.