On the Impact of Therapeutic Tumor Necrosis Factor-alpha Inhibition on Anogenital Human Papillomavirus Infection
Condition: Psoriasis; Inflammatory Bowel Diseases
MeSH terms: Papillomavirus Infections; Inflammatory Bowel Diseases; Psoriasis; Necrosis
Study type: Observational

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.
    

Intervention name(s): TNF-alpha inhibitors; Alternative/no medication; Alternative/no medication; Purine/folic acid analogues
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): therapy for at least 6 months; therapy for at least 6 months or no therapy; phototherapy for at least 6 months; therapy for at least 6 months
Other intervention name(s): Infliximab, adalimumab, etanercept; fumaric acid, mesalazine, sulfasalazine; azathioprin, 6-mercaptopurine, methotrexate
Intervention MeSH terms: Folic Acid; Sulfasalazine; Adalimumab; Infliximab; Etanercept; Methotrexate; Mercaptopurine; Folic Acid Antagonists
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with psoriasis or inflammatory bowel diseases
      
Biospecimen description: 
      Swab samples to detect mucosal HPV DNA using a FDA-approved Assay (Digene Hybrid Capture 2
      kit).

      Cervical PAP smears were collected by cytobrush. Whole blood to obtain peripheral blood
      mononuclear cells and serum