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

NCT ID: NCT02376478

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 222 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-01-31

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.

Conditions

Psoriasis; Inflammatory Bowel Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

TNF-alpha inhibitors

TNF-alpha Inhibitors: patients with psoriasis or inflammatory bowel diseases under TNF-alpha inhibitor monotherapy

TNF-alpha inhibitors

Intervention Type: DRUG

therapy for at least 6 months

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

Purine/folic acid analogues

Intervention Type: DRUG

therapy for at least 6 months

Combination therapy

Combination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues

TNF-alpha inhibitors

Intervention Type: DRUG

therapy for at least 6 months

Purine/folic acid analogues

Intervention Type: DRUG

therapy for at least 6 months

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

Alternative/no medication

Intervention Type: DRUG

therapy for at least 6 months or no therapy

Alternative/no medication

Intervention Type: OTHER

phototherapy for at least 6 months

Interventions

TNF-alpha inhibitors

therapy for at least 6 months

Intervention Type: DRUG

Alternative/no medication

therapy for at least 6 months or no therapy

Intervention Type: DRUG

Alternative/no medication

phototherapy for at least 6 months

Intervention Type: OTHER

Purine/folic acid analogues

therapy for at least 6 months

Intervention Type: DRUG

Other Intervention Names

Infliximab, adalimumab, etanercept; fumaric acid, mesalazine, sulfasalazine; azathioprin, 6-mercaptopurine, methotrexate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Reinhard Kirnbauer

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reinhard Kirnbauer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Other Identifiers

EK208/2009

Identifier Type: -

Identifier Source: org_study_id