Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Guselkumab (GUS), Risankizumab (RISA).
- Who it may be relevant to
- Registry conditions: Psoriasis, Psoriasis Arthritis, Psoriasis (PsO). Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Costa Rica
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System
Overview
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.
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.
Interventions
- Biological Guselkumab (GUS)
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 immu - Biological Risankizumab (RISA)
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 immu
Primary outcome measures
- Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease [Time frame: 5 years]
- Safety of Interleukin-23 Inhibitors [Time frame: 5 years]
Secondary outcome measures (5)
- Change in Psoriasis Severity [Time frame: 5 years]
- Articular Disease Activity [Time frame: 5 years]
- Treatment Persistence [Time frame: 5 years]
- Laboratory Safety Parameters [Time frame: 5 years]
- Factors Associated With Clinical Response [Time frame: 5 years]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Costa Rica · 1 center
- Caja Costarricense del Seguro Social — San José
Identifiers
NCT: NCT07448402 · CEC HCG 13-2025