How biologic treatments for psoriasis affect risk of anogenital warts
Influence of Anti-Psoriatic Biologic Therapies Targeting TNF-α and Interleukins 17 and 23 on the Risk of Development and Recurrence of Anogenital Warts: A Retrospective and Prospective Study With an Exploratory Component on HPV Vaccination Acceptability (CONDYPSO)
We will see if biologic medicines for moderate-to-severe psoriasis change the chance of developing or having recurrent anogenital warts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Saint Pierre Academic / other |
| Drugs / interventions | ustekinumab, risankizumab, guselkumab, tildrakizumab, deucravacitinib, methotrexate |
| Locations | 3 sites (Brussels, Brussels Capital and 2 other locations) |
| Trial ID | NCT07234838 on ClinicalTrials.gov |
What this trial studies
This observational project combines retrospective chart review with prospective, routine follow-up to compare new and recurrent anogenital wart rates in patients treated with anti-TNF-α, anti-IL-17, or anti-IL-23 therapies for moderate-to-severe psoriasis. Clinical data, treatment histories, and wart diagnoses/recurrences will be collected from medical records and during planned dermatology visits over about 24 months without extra study visits. The underlying rationale is that inhibiting Th1 and Th17 pathways could reduce local antiviral responses to HPV at the genital mucosa and thus alter wart persistence or recurrence. Analyses will estimate incidence and recurrence risks by biologic class while adjusting for relevant confounders.
Who should consider this trial
Good fit: Adults (≥18 years) with moderate-to-severe psoriasis who are receiving or starting anti-TNF-α, anti-IL-17, or anti-IL-23 biologics and who have planned dermatology follow-up and can provide informed consent are ideal candidates.
Not a fit: People with severe immunosuppression from other causes, children, or patients not receiving biologic therapy for psoriasis are unlikely to get directly relevant information from this project.
Why it matters
Potential benefit: If successful, the results could help clinicians choose or monitor biologic therapies with lower risk of anogenital warts and guide HPV-related prevention or screening in psoriasis patients.
How similar studies have performed: Previous data are limited and mixed: small or cross-sectional analyses have not consistently shown increased anogenital HPV or wart rates in biologic-treated patients, so definitive evidence is still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Moderate to severe psoriasis (BSA \> 10% or PASI \> 10), prior to initiation of the current therapy at the time of inclusion * Planned dermatological follow-up for approximately 24 months, with no additional visits required by the study * Signed informed consent Exclusion Criteria: * Severe immunosuppression not related to psoriasis or its therapy (concomitant treatment with major immunosuppressants, uncontrolled HIV infection, or other conditions inducing significant immunosuppression)
Where this trial is running
Brussels, Brussels Capital and 2 other locations
- CHU Saint-Pierre — Brussels, Brussels Capital, Belgium (Recruiting)
- CHU Brugmann — Brussels, Brussels Capital, Belgium (Recruiting)
- Hôpital Erasme — Brussels, Brussels Capital, Belgium (Recruiting)
Study contacts
- Principal investigator: Jonathan Krygier, MD — Chu Saint-Pierre Bruxelles
- Study coordinator: Jonathan Krygier, MD
- Email: jonathan.krygier@stpierre-bru.be
- Phone: 025358385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.