Psoriasis Clinical Trial
Official title:
On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection
In this prospective, open, controlled, cross-sectional observational study patients with
psoriasis or IBD, who received either anti-TNF-alpha inhibitors or alternates (purine-,
folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease
were included.
Anogenital HPV-induced lesions, mucosal HPV DNA and serological status of mucosal low-risk
(HPV6) and high-risk HPV (HPV16, HPV18) were determined.
In this prospective, open, controlled, cross-sectional observational study patients with
psoriasis or inflammatory bowel diseases (IBD), who received either Tumor necrosis
factor-alpha (TNF-Alpha) inhibitors or alternates (purine-, folic acid analogues,
phototherapy, fumaric ester, mesalazine) for their underlying disease were included.
Patients were assigned to the following subgroups according to their current therapy for ≥ 6
months: i) TNF-alpha inhibitor monotherapy; ii) monotherapy with purine or folic acid
analogues, such as azathioprin, 6-mercaptopurine, or methotrexate iii) combination therapy
with TNF-alpha blocker plus purine or folic acid analogues; iv) alternate therapy, such as
phototherapy, fumaric acid, mesalazine. The last group additionally included patients that
were without any therapy.
Information about duration and severity of illness, current and former disease-related
medical treatment, smoking habits and sexual history with emphasis on preexisting human
papillomavirus (HPV) infection, including anogenital warts or previous abnormal cervical
cytology, and HPV vaccination status were obtained for each patient.
Swab samples were taken at one time point from the penile shaft and glans of men, the vulva
and cervix in women, and the perianal region of both genders.
Detection of mucosal human papillomavirus DNA in the samples was performed using the
FDA-approved Digene Hybrid Capture 2 kit.
Cervical Papanicolaou (PAP) smears were collected by cytobrush from female patients at the
same time.
Blood for determination of serological status was drawn from each patient and peripheral
blood mononuclear cells and serum obtained.
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Observational Model: Case Control, Time Perspective: Prospective
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