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On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection

On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02376478
Enrollment
222
Registered
2015-03-03
Start date
2009-12-31
Completion date
2011-01-31
Last updated
2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Psoriasis

Brief summary

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.

Detailed description

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.

Interventions

DRUGTNF-alpha inhibitors

therapy for at least 6 months

DRUGAlternative/no medication

therapy for at least 6 months or no therapy

DRUGPurine/folic acid analogues

therapy for at least 6 months

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Participants between 18-80 years of age with a history of psoriasis or inflammatory bowel diseases, namely Crohn's disease and ulcerative colitis, and * at least 6 month of continuous treatment regimen.

Exclusion criteria

* Pregnant or nursing patients and * patients with inherited immune disorders, human immunodeficiency virus infection, invasive malignancies or psychomotor retardation and * patients with psoriasis or inflammatory bowel diseases who had received high-dose corticosteroids during the past 6 months.

Design outcomes

Primary

MeasureTime frame
Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026