Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis; Psoriasis (PsO); Psoriasis Arthritis
• Intervention / Treatment: Biological: Guselkumab (GUS); Biological: Risankizumab (RISA)

Detailed Description

Psoriatic disease, including psoriasis and psoriatic arthritis, is a chronic inflammatory condition with substantial clinical and functional impact. Although IL-23 inhibitors such as guselkumab and risankizumab have shown high efficacy and favorable safety in international trials, real-world evidence in Latin America-and particularly Costa Rica-is limited. Differences in comorbidities, population genetics, access to therapy, and health-system factors may influence treatment response and safety outcomes.

This national observational registry is designed to generate standardized real-world data on patients with psoriatic disease treated with IL-23 inhibitors within the Costa Rican public health system. The registry will collect demographic and clinical characteristics, dermatologic and rheumatologic disease activity scores, treatment patterns, persistence, and adverse events over time. The resulting evidence will support clinical decision-making, optimize therapeutic strategies, and inform national health policy regarding biologic therapies for psoriatic disease.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Daniel E Barquero-Orias, Dermatologist; Phone Number: +506 8341026; Email: debarque@ccss.sa.cr

Study Locations

• Costa Rica
  • Provincia de San José
    • San José, Provincia de San José, Costa Rica, 40901
      • Caja Costarricense del Seguro Social
      • Contact: Daniel E Barquero-Orias, Dermatologist; Phone Number: +506 83411026; Email: debarque@ccss.sa.cr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• None specified (all patients meeting inclusion criteria are eligible).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease	Proportion of patients achieving: Psoriasis Area and Severity Index 75, 90, and 100 response; Dermatology Life Quality Index score of 0 or 1; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psoriasis Severity	Absolute and relative change in: Psoriasis Area and Severity Index; Body Surface Area affected; Dermatology Life Quality Index score	5 years
Treatment Persistence	Time in months from initiation of guselkumab or risankizumab to treatment discontinuation for any reason. Persistence will be evaluated using survival analysis methods.	5 years
Laboratory Safety Parameters	Continuous values and proportion of abnormal results in: C-reactive protein; Erythrocyte sedimentation rate; Aspartate aminotransferase; Alanine aminotransferase; Serum creatinine; Lipid profile	5 years
Factors Associated With Clinical Response	Association between demographic and clinical factors (age, sex, body mass index, baseline disease severity, prior biologic exposure, comorbidities, smoking status, disease duration) and achievement of clinical response (Psoriasis Area and Severity Index 90 or remission in psoriatic arthritis).	5 years
Articular Disease Activity	Change from baseline in articular disease activity assessed by Tender Joint Count, Swollen Joint Count, and Disease Activity in Psoriatic Arthritis Score. Resolution of dactylitis and improvement in enthesitis will also be recorded when present.	5 years

Collaborators and Investigators

• Sponsor: Caja Costarricense de Seguro Social

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Psoriasis; Registry; Costa Rica; IL-23
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; guselkumab; risankizumab
• Other Study ID Numbers: CEC HCG 13-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Accordingly to protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes