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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNF-alpha inhibitors | TNF-alpha Inhibitors: patients with psoriasis or inflammatory bowel diseases under TNF-alpha inhibitor monotherapy |
| |
| 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 | 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: patients with psoriasis or inflammatory bowel diseases receiving alternate therapy, such as phototherapy, fumaric acid, mesalazine, or no medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNF-alpha inhibitors | Drug | therapy for at least 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of anogenital warts, anogenital HPV DNA positivity and mucosal HPV seropositivity | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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patients with psoriasis or inflammatory bowel diseases
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| Name | Affiliation | Role |
|---|---|---|
| Reinhard Kirnbauer, MD | Medical University of Vienna | Principal Investigator |
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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
| Alternative/no medication | Drug | therapy for at least 6 months or no therapy |
|
|
| Alternative/no medication | Other | phototherapy for at least 6 months |
|
| Purine/folic acid analogues | Drug | therapy for at least 6 months |
|
|
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D000068879 | Adalimumab |
| D000068800 | Etanercept |
| C032005 | fumaric acid |
| D019804 | Mesalamine |
| D012460 | Sulfasalazine |
| C030985 | purine |
| D015122 | Mercaptopurine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D013438 | Sulfhydryl Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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