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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02376478

Collaborator

(none)

222

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Inflammatory Bowel Diseases	Drug: TNF-alpha inhibitors Drug: Alternative/no medication Other: Alternative/no medication Drug: Purine/folic acid analogues

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 Design

Study Type:

Observational

Actual Enrollment :

222 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
TNF-alpha inhibitors TNF-alpha Inhibitors: patients with psoriasis or inflammatory bowel diseases under TNF-alpha inhibitor monotherapy	Drug: TNF-alpha inhibitors therapy for at least 6 months Other Names: Infliximab, adalimumab, etanercept
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	Drug: Purine/folic acid analogues therapy for at least 6 months Other Names: azathioprin, 6-mercaptopurine, methotrexate
Combination therapy Combination therapy: patients with psoriasis or inflammatory bowel diseases receiving combination therapy with TNF-alpha blocker plus purine or folic acid analogues	Drug: TNF-alpha inhibitors therapy for at least 6 months Other Names: Infliximab, adalimumab, etanercept Drug: Purine/folic acid analogues therapy for at least 6 months Other Names: azathioprin, 6-mercaptopurine, methotrexate
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	Drug: Alternative/no medication therapy for at least 6 months or no therapy Other Names: fumaric acid, mesalazine, sulfasalazine Other: Alternative/no medication phototherapy for at least 6 months

Outcome Measures

Primary Outcome Measures

Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.