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

Completed

• Conditions: Psoriasis; Inflammatory Bowel Diseases
• Interventions: Drug: TNF-alpha inhibitors; Drug: Purine/folic acid analogues; Other: Alternative/no medication

• Registration Number: NCT02376478
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TNF-alpha inhibitors	TNF-alpha inhibitors	TNF-alpha Inhibitors: patients with psoriasis or inflammatory bowel diseases under TNF-alpha inhibitor monotherapy
Combination therapy	Purine/folic acid analogues	Combination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues
Purine/folic acid analogues	Purine/folic acid analogues	Purine/folic acid analogues: patients with psoriasis or inflammatory bowel diseases receiving monotherapy with purine or folic acid analogues, such as azathioprin, 6-mercaptopurine, or methotrexate
Combination therapy	TNF-alpha inhibitors	Combination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues
Alternative/no medication	Alternative/no medication	Alternative/no medication: patients with psoriasis or inflammatory bowel diseases receiving alternate therapy, such as phototherapy, fumaric acid, mesalazine, or no medication

Primary Outcome Measures

Name	Time	Method
Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity	1 year