Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)

NCT07234838 | Recruiting

• 2 other identifiers: HUB20254941st Medical Council Grant
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Psoriasis; Condyloma Acuminata; Biotherapies

Keywords

psoriasis; Influence of Anti-Psoriatic Biologic Therapies; Risk of Development and Recurrence of Anogenital Warts

Outcome Measures

Primary Outcomes (1)

• Incidence of anogenital warts

  To evaluate the incidence of anogenital warts (AW), including both new cases and recurrences, in patients with moderate-to-severe psoriasis, by comparing major therapeutic groups: biologic therapies (anti-TNF-α, anti-IL-17, anti-IL-23, ustekinumab), other immunomodulators (methotrexate, cyclosporine, deucravacitinib, dimethyl fumarate), non-immunomodulatory systemic therapies (apremilast, acitretin), topical therapies alone (topical corticosteroids, calcineurin inhibitors, phototherapy), or no treatment.

  From enrollment until the end of the 2-year follow-up

Secondary Outcomes (6)

• Characterization of AW cases under biologics

  From enrollment until the end of the 2-year follow-up

• Comparison of incidence and recurrence across treatments

  From enrollment until the end of the 2-year follow-up

• Risk factors for AW incidence and recurrence

  From enrollment until the end of the 2-year follow-up

• Impact of topical genital therapies

  From enrollment until the end of the 2-year follow-up

• HPV vaccination acceptability

  At enrollment

Study Arms (5)

Biologic therapies (Anti-TNF, Anti-IL-17, Anti-IL-23, including ustekinumab)

Psoriasis patients receiving biologic therapies. Observational follow-up of anogenital HPV-related outcomes (warts, recurrences, cytology, vaccination acceptability).

Other immunomodulators (methotrexate, cyclosporine, deucravacitinib, dimethyl fumarate)

Psoriasis patients receiving systemic immunomodulators other than biologics. Observational follow-up of anogenital HPV-related outcomes.

Other systemic non-immunomodulators (apremilast, acitretin)

Psoriasis patients receiving systemic therapies not primarily immunomodulatory. Observational follow-up of anogenital HPV-related outcomes.

Topical therapy only (topical corticosteroids, calcineurin inhibitors, phototherapy)

Psoriasis patients managed with topical therapy and/or phototherapy only. Observational follow-up of anogenital HPV-related outcomes.

Untreated psoriasis patients

Psoriasis patients currently not receiving any systemic or topical therapy. Observational follow-up of anogenital HPV-related outcomes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with moderate to severe psoriasis, not severely immunosuppressed, recruited from dermatology clinics

You may qualify if:

• Age ≥ 18 years
• Planned dermatological follow-up for approximately 24 months, with no additional visits required by the study
• Signed informed consent

You may not qualify if:

• Severe immunosuppression not related to psoriasis or its therapy (concomitant treatment with major immunosuppressants, uncontrolled HIV infection, or other conditions inducing significant immunosuppression)

Sponsors & Collaborators

• Jonathan Krygier: lead

Study Sites (3)

CHU Saint-Pierre

Brussels, Brussels Capital, 1000, Belgium

RECRUITING

CHU Brugmann

Brussels, Brussels Capital, 1020, Belgium

RECRUITING

Hôpital Erasme

Brussels, Brussels Capital, 1070, Belgium

RECRUITING

Related Publications (20)

• Karakusevic A, Foss AM. Acceptability of human papillomavirus vaccination in the United Kingdom: a systematic review of the literature on uptake of, and barriers and facilitators to HPV vaccination. Ther Adv Vaccines Immunother. 2024 Dec 25;12:25151355241308313. doi: 10.1177/25151355241308313. eCollection 2024.

  PMID: 39737330 BACKGROUND

• Korecka K, Wisniewska-Szymanska A, Mikiel D. The impact of systemic psoriasis treatments on human papillomavirus activation and propagation. Australas J Dermatol. 2022 Aug;63(3):293-302. doi: 10.1111/ajd.13865. Epub 2022 May 4.

  PMID: 35510323 BACKGROUND

• Burlando M, Molle MF, Cozzani E, Parodi A. Bulky Condyloma Acuminata following Ustekinumab Treatment for Plaque Psoriasis: A Case Report. Case Rep Dermatol. 2021 Apr 21;13(1):244-247. doi: 10.1159/000509178. eCollection 2021 Jan-Apr.

  PMID: 34054460 BACKGROUND

• Avallone G, Dapavo P, Cabutti F, Preti M, Cavallo F, Roccuzzo G, Mastorino L, Rubatto M, Quaglino P, Ribero S. Regression of human papillomavirus-associated high-grade vaginal intraepithelial neoplasia after switching from ustekinumab to risankizumab in a psoriasis patient. Ital J Dermatol Venerol. 2023 Feb;158(1):61-62. doi: 10.23736/S2784-8671.22.07297-8. No abstract available.

  PMID: 36939503 BACKGROUND

• Gosmann C, Mattarollo SR, Bridge JA, Frazer IH, Blumenthal A. IL-17 suppresses immune effector functions in human papillomavirus-associated epithelial hyperplasia. J Immunol. 2014 Sep 1;193(5):2248-57. doi: 10.4049/jimmunol.1400216. Epub 2014 Jul 25.

  PMID: 25063870 BACKGROUND

• Walch-Ruckheim B, Stroder R, Theobald L, Pahne-Zeppenfeld J, Hegde S, Kim YJ, Bohle RM, Juhasz-Boss I, Solomayer EF, Smola S. Cervical Cancer-Instructed Stromal Fibroblasts Enhance IL23 Expression in Dendritic Cells to Support Expansion of Th17 Cells. Cancer Res. 2019 Apr 1;79(7):1573-1586. doi: 10.1158/0008-5472.CAN-18-1913. Epub 2019 Jan 29.

  PMID: 30696656 BACKGROUND

• Sun F, Yu Z. Rapid progression of condyloma acuminatum caused by IL-17A antibody treatment: a case report. Front Med (Lausanne). 2024 May 15;11:1387620. doi: 10.3389/fmed.2024.1387620. eCollection 2024.

  PMID: 38813385 BACKGROUND

• Kucukhemek F, Aypek Y, Ogut B, Adisen E. IL-17 Monoclonal Antibody Related HPV Exacerbation: A Case Report. Indian J Dermatol. 2024 Nov-Dec;69(6):487. doi: 10.4103/ijd.ijd_390_24. Epub 2024 Oct 29. No abstract available.

  PMID: 39678756 BACKGROUND

• Wu DC, Salopek TG. Eruptive condyloma accuminata after initiation of infliximab treatment for folliculitis decalvans. Case Rep Dermatol Med. 2013;2013:762035. doi: 10.1155/2013/762035. Epub 2013 Dec 4.

  PMID: 24368947 BACKGROUND

• Ferreira Torres TC, Vasconcelos Sanches M, Manuela Selores M. Development of Multiple Viral Warts in a Patient Receiving the TNF-α Inhibitor Etanercept. Psoriasis Forum. 2009;15a(2):15-6.

  BACKGROUND

• Rob F, Hugo J, Salakova M, Smahelova J, Gkalpakiotis S, Bohac P, Tachezy R. Prevalence of genital and oral human papillomavirus infection among psoriasis patients on biologic therapy. Dermatol Ther. 2022 Oct;35(10):e15735. doi: 10.1111/dth.15735. Epub 2022 Aug 8.

  PMID: 35883191 BACKGROUND

• Handisurya A, Lazar S, Papay P, Primas C, Haitel A, Horvat R, Tanew A, Vogelsang H, Kirnbauer R. Anogenital Human Papillomavirus Prevalence is Unaffected by Therapeutic Tumour Necrosis Factor-alpha Inhibition. Acta Derm Venereol. 2016 May;96(4):494-8. doi: 10.2340/00015555-2298.

  PMID: 26581127 BACKGROUND

• Hewavisenti RV, Arena J, Ahlenstiel CL, Sasson SC. Human papillomavirus in the setting of immunodeficiency: Pathogenesis and the emergence of next-generation therapies to reduce the high associated cancer risk. Front Immunol. 2023 Mar 7;14:1112513. doi: 10.3389/fimmu.2023.1112513. eCollection 2023.

  PMID: 36960048 BACKGROUND

• Gaffen SL, Jain R, Garg AV, Cua DJ. The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing. Nat Rev Immunol. 2014 Sep;14(9):585-600. doi: 10.1038/nri3707.

  PMID: 25145755 BACKGROUND

• Navarro-Compan V, Puig L, Vidal S, Ramirez J, Llamas-Velasco M, Fernandez-Carballido C, Almodovar R, Pinto JA, Galindez-Aguirregoikoa E, Zarco P, Joven B, Gratacos J, Juanola X, Blanco R, Arias-Santiago S, Sanz Sanz J, Queiro R, Canete JD. The paradigm of IL-23-independent production of IL-17F and IL-17A and their role in chronic inflammatory diseases. Front Immunol. 2023 Aug 4;14:1191782. doi: 10.3389/fimmu.2023.1191782. eCollection 2023.

  PMID: 37600764 BACKGROUND

• Damiani G, Bragazzi NL, Karimkhani Aksut C, Wu D, Alicandro G, McGonagle D, Guo C, Dellavalle R, Grada A, Wong P, La Vecchia C, Tam LS, Cooper KD, Naghavi M. The Global, Regional, and National Burden of Psoriasis: Results and Insights From the Global Burden of Disease 2019 Study. Front Med (Lausanne). 2021 Dec 16;8:743180. doi: 10.3389/fmed.2021.743180. eCollection 2021.

  PMID: 34977058 BACKGROUND

• Patel H, Wagner M, Singhal P, Kothari S. Systematic review of the incidence and prevalence of genital warts. BMC Infect Dis. 2013 Jan 25;13:39. doi: 10.1186/1471-2334-13-39.

  PMID: 23347441 BACKGROUND

• Offidani A, Radi G, Bianchi L, Cannavo SP, Conti A, Gesuita R, Salaffi F, Talamonti M, Campanati A. Prevalence of HPV genital infection in patients with moderate-to-severe psoriasis undergoing systemic treatment with immunosuppressive agents or biologics. Eur J Dermatol. 2021 Aug 1;31(4):493-498. doi: 10.1684/ejd.2021.4121.

  PMID: 34642139 BACKGROUND

• Al-Janabi A, Yiu ZZN. Biologics in Psoriasis: Updated Perspectives on Long-Term Safety and Risk Management. Psoriasis (Auckl). 2022 Jan 6;12:1-14. doi: 10.2147/PTT.S328575. eCollection 2022.

  PMID: 35024352 BACKGROUND

• Ferrara F, Verduci C, Laconi E, Mangione A, Dondi C, Del Vecchio M, Carlevatti V, Zovi A, Capuozzo M, Langella R. Therapeutic Advances in Psoriasis: From Biologics to Emerging Oral Small Molecules. Antibodies (Basel). 2024 Sep 14;13(3):76. doi: 10.3390/antib13030076.

  PMID: 39311381 BACKGROUND

Related Links

• HAS 2024 Guidelines on the Management of Anogenital Warts

Biospecimen

Retention: SAMPLES WITH DNA

curettage specimen of anogenital warts

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jonathan Krygier, MD

  CHU SAINT-PIERRE BRUXELLES

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Krygier, MD

CONTACT

025358385; jonathan.krygier@stpierre-bru.be

Pauline Lecerf, MD, PhD

CONTACT

02 477 21 11; jokrygier@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 18, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)