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NCT Number: NCT07448402

Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease

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.

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Key information

Conditions

Psoriasis Psoriasis (PsO) Psoriasis Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caja Costarricense del Seguro Social

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

Location contact

Daniel E Barquero-Orias, Dermatologist

CONTACT

[email protected]

+506 83411026

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Clinical Effectiveness of Interleukin-23 Inhibitors in Psoriatic Disease

    Time frame: 5 years

    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.

  2. Safety of Interleukin-23 Inhibitors

    Time frame: 5 years

    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

Secondary outcomes

  1. Change in Psoriasis Severity

    Time frame: 5 years

    Absolute and relative change in:

    • Psoriasis Area and Severity Index
    • Body Surface Area affected
    • Dermatology Life Quality Index score

  2. Articular Disease Activity

    Time frame: 5 years

    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.

  3. Treatment Persistence

    Time frame: 5 years

    Time in months from initiation of guselkumab or risankizumab to treatment discontinuation for any reason. Persistence will be evaluated using survival analysis methods.

  4. Laboratory Safety Parameters

    Time frame: 5 years

    Continuous values and proportion of abnormal results in:

    • C-reactive protein
    • Erythrocyte sedimentation rate
    • Aspartate aminotransferase
    • Alanine aminotransferase
    • Serum creatinine
    • Lipid profile

  5. Factors Associated With Clinical Response

    Time frame: 5 years

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel E Barquero-Orias, Dermatologist

CONTACT

[email protected]

+506 8341026

Sponsors and collaborators

Lead sponsor

Caja Costarricense de Seguro Social

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 4, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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