Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Recruiting · NCT07234838 · Observational (researchers observe without assigning treatment) · Lead sponsor: Jonathan Krygier
View the official record on ClinicalTrials.gov →What this trial is about
This study aims to assess the impact of anti-TNF-α, anti-IL-17, and anti-IL-23 biologic therapies on the risk of development or recurrence of anogenital warts (AGW) in patients with moderate to severe psoriasis. By modulating systemic and mucosal immunity, these treatments may alter host defenses against human papillomavirus (HPV) infections, which are responsible for AGW. In particular, inhibition of Th1 pathways (by anti-TNF-α) and Th17 pathways (by anti-IL-17 and anti-IL-23), both central to the antiviral response, may reduce local production of pro-inflammatory cytokines (such as IFN-γ, IL-17, and IL-22), decrease the activity of CD8+ cytotoxic T lymphocytes, and impair dendritic cell function, thereby compromising viral clearance at the genital mucosa. AGW are a frequent and recurrent manifestation of HPV infection, and their incidence may be influenced by these immunomodulatory treatments. The retrospective component will review cases already documented in medical records and analyze, to the extent permitted by available data, the same risk factors as in the prospective component, including history of sexually transmitted infections (STIs), risk behaviors, treatments used (systemic or topical), and time to onset or recurrence of AGW. This analysis will be conducted as a retrospective case-control study, matching each patient who developed AGW with one or more controls receiving biologics who did not develop AGW, in order to identify factors associated with their occurrence. The prospective follow-up will assess, over 24 months, risk factors for occurrence or recurrence of AGW in patients with moderate to severe psoriasis, according to the treatment received: no treatment, topical treatment, systemic non-immunomodulatory treatment, or immunomodulatory treatment, including biologics. Acceptability of HPV vaccination will also be evaluated, at enrollment, in a subset of prospectively included adult patients without a known history or current clinical lesion of condyloma, HSIL, or HPV-induced carcinoma.
Who can take part
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 it is running
3 locations listed.
- CHU Saint-Pierre - Brussels, Brussels Capital, Belgium
- CHU Brugmann - Brussels, Brussels Capital, Belgium
- Hôpital Erasme - Brussels, Brussels Capital, Belgium