Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

NCT07448402 | Not Yet Recruiting FDA Drug

• 1 other identifier: CEC HCG 13-2025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:

• Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
• What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
• Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.

Conditions

Psoriasis; Psoriasis Arthritis; Psoriasis (PsO)

Keywords

Psoriasis; IL-23; Registry; Costa Rica

Outcome Measures

Primary Outcomes (2)

• Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease

  Proportion of patients achieving: 1. Psoriasis Area and Severity Index 75, 90, and 100 response 2. Dermatology Life Quality Index score of 0 or 1 3. Disease Activity in Psoriatic Arthritis.

  5 years

• Safety of Interleukin-23 Inhibitors

  Incidence rate of adverse events and serious adverse events, including: * Serious infections * Hospitalizations * New malignancy * Thrombotic events * Injection-site reactions * Treatment discontinuation due to adverse events

  5 years

Secondary Outcomes (5)

• Change in Psoriasis Severity

  5 years

• Articular Disease Activity

  5 years

• Treatment Persistence

  5 years

• Laboratory Safety Parameters

  5 years

• Factors Associated With Clinical Response

  5 years

Interventions

Guselkumab (GUS) BIOLOGICAL

Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic immune-mediated inflammatory condition with substantial clinical and quality-of-life impact. Several biologic classes are available for moderate-to-severe disease, including TNF-α inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors. IL-23-specific inhibitors (guselkumab and risankizumab) selectively block the p19 subunit of IL-23, providing targeted suppression of the Th17 pathway while preserving IL-12-dependent immune responses. This mechanism distinguishes them from IL-12/23 inhibitors (p40 blockade) and IL-17 inhibitors (downstream cytokine inhibition). IL-23 inhibitors also differ in dosing interval (every 8-12 weeks) and safety profile, with lower candidiasis risk than IL-17 blockade and different infection patterns than TNF-α inhibitors. This national registry specifically evaluates real-world effectiveness, safety, and treatment persistence of IL-23 inhibitors.

Risankizumab (RISA) BIOLOGICAL

Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic immune-mediated inflammatory condition with substantial clinical and quality-of-life impact. Several biologic classes are available for moderate-to-severe disease, including TNF-α inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors. IL-23-specific inhibitors (guselkumab and risankizumab) selectively block the p19 subunit of IL-23, providing targeted suppression of the Th17 pathway while preserving IL-12-dependent immune responses. This mechanism distinguishes them from IL-12/23 inhibitors (p40 blockade) and IL-17 inhibitors (downstream cytokine inhibition). IL-23 inhibitors also differ in dosing interval (every 8-12 weeks) and safety profile, with lower candidiasis risk than IL-17 blockade and different infection patterns than TNF-α inhibitors. This national registry specifically evaluates real-world effectiveness, safety, and treatment persistence of IL-23 inhibitors.

Eligibility Criteria

• Age: 12 Years+
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adolescents and adults (≥12 years) with psoriatic disease receiving IL-23 inhibitors within the Costa Rican public health system. This real-world national cohort includes patients with both cutaneous psoriasis and psoriatic arthritis across participating centers. The registry aims to capture the full treated population over time to describe clinical evolution, treatment response, safety, persistence, and associated comorbidities in the national context.

You may qualify if:

• Confirmed diagnosis of psoriatic disease, including psoriasis (any clinical variant) and/or psoriatic arthritis based on rheumatologic criteria.
• Receiving IL-23 inhibitor therapy (guselkumab or risankizumab).
• Treated within participating Costa Rican public health centers.
• Availability of sufficient clinical records to complete registry data (history, follow-up, labs).
• Age ≥12 years, any sex.

Sponsors & Collaborators

• Caja Costarricense de Seguro Social: lead

Study Sites (1)

Caja Costarricense del Seguro Social

San José, Provincia de San José, 40901, Costa Rica

Location

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab; risankizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Daniel E Barquero-Orias, Dermatologist

CONTACT

+506 8341026; debarque@ccss.sa.cr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)