Health Trials

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

ConditionsPsoriasisPsoriasis ArthritisPsoriasis (PsO)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorCaja Costarricense de Seguro Social

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Guselkumab (GUS)

    Biological/Vaccine

    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/Vaccine

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years
2

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

Time frame
5 years

Secondary outcomes

1

Change in Psoriasis Severity

Absolute and relative change in: * Psoriasis Area and Severity Index * Body Surface Area affected * Dermatology Life Quality Index score

Time frame
5 years
2

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.

Time frame
5 years
3

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.

Time frame
5 years
4

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Caja Costarricense de Seguro Social

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: