GLADEL 2.0 Cohort 10-Year Follow-Up
Real life data

Introduction
The Latin American Lupus Study Group (GLADEL) is a multicenter network with more than 25 years of experience, bringing together more than 50 centers in 15 countries. Over this time, it has generated pioneering evidence on the epidemiology, treatment, and clinical evolution of systemic lupus erythematosus (SLE) in one of the most diverse regions in the world.

The current proposal seeks to extend the clinical follow-up of an already established prospective cohort, currently with 5 years of follow-up, to 10 years.
This real-life study will provide insight into how clinical and social factors and access to healthcare influence the progression of lupus in Latin America.

As an added value, a possible genomic sub-study (DNA from patients and controls) is proposed as an option, which will open up the possibility of identifying genetic variants associated with relapses, cumulative damage, and therapeutic response.

Background
Lupus in Latin America is characterized by:

• Increased clinical severity and early mortality.
• Diagnostic delays and limitations in access to innovative therapies.
• Fragmented healthcare systems, with significant gaps in coverage.
• High genetic and ethnic diversity, which impacts disease progression and response to treatment.

Long-term clinical follow-up integrating clinical and social factors will generate unique and valuable evidence for the region and the world.

Objectives

• Describe the clinical evolution of SLE over 10 years.
• Identify factors associated with cumulative damage (SDI), serious complications, and mortality.
• Analyze the use and efficacy of conventional and biological therapies.
• Evaluate quality of life, adherence, and patient experience.
• Integrate clinical, molecular, and social data to characterize subtypes of SLE.

Expected results

• World-leading multicenter database.
• High-impact international publications.
• Risk maps and social determinants associated with injury and mortality.
• Evidence to support health policies and access to innovative drugs.

Delay in Medical Care for SLE Patients in Latin America

Introduction
Lupus is a complex disease associated with high early morbidity and mortality. Up to 30% of patients experience a diagnostic delay of 3-5 years, which translates into more complications, greater disability, and higher costs.

In Latin America, social conditions and access to the healthcare system exacerbate this problem. Currently, no validated tool allows for standardized measurement of diagnostic delay in the region.

GLADEL is leading a project in 18 Latin American countries, which has already completed phases 1 and 2 and is now moving on to phases 3 and 4. The objective is to develop and validate a specific questionnaire and apply it to more than 16,000 patients to obtain the first regional estimate of diagnostic delay and prevalence of lupus.

Objectives

• Phase 3: Design and validate a questionnaire to measure diagnostic delay and associated factors.
• Phase 4: Apply the validated questionnaire to a sample of approximately 16,693 patients with SLE from 18 Latin American countries.
• Estimate the prevalence, sociodemographic characteristics, and clinical features of SLE in Latin America.

Methodology

• Multicenter, cross-sectional, multistage study.
• Validation of the questionnaire in Spanish and Portuguese (Phase 3).
• Multicenter epidemiological study with ≈ 16,693 patients (Phase 4).

Expected results

• First validated questionnaire to measure diagnostic delay in SLE.
• Regional database > 16,000 patients.
• Scientific publications in high-impact journals and conferences (EULAR, ACR, PANLAR, LUPUS).
• National and regional reports for decision makers.
• First multicenter and multinational estimate of the prevalence and clinical characterization of lupus in Latin America.

Project strategic value
Strategic value and potential impact of the information generated by this study:

1. Value for negotiations with authorities and decision-makers:

The information derived from the estimated prevalence and impact of SLE will offer a solid tool for making presentations and projections to health authorities. This type of evidence will support negotiations and persuade decision-makers about the importance of including early treatment—especially in the insured population—as a cost-effective strategy. In many Latin American countries, sales to the government sector account for a significant share of the pharmaceutical industry's profits, so evidence of economic and social impact is key to strengthening these negotiations.

2. Design of sales strategies and institutional relations:

Having an estimate of the impact of diagnostic and therapeutic delays at the regional level will allow companies to design and plan more effective sales strategies both locally and regionally. In particular, this information will be very useful to Public and Government Affairs teams, facilitating the identification of collaboration opportunities and the development of evidence-based arguments for engaging government and public policy stakeholders.

3. Strengthening scientific and commercial communication:

Having information supported by a solid methodology will not only strengthen the study's credibility but also allow the industry to use these findings in different contexts: presentations to authorities, training materials for the sales force, and scientific promotion campaigns that highlight the importance of early interventions. In this way, commercial teams will be able to support their messages with robust evidence on the benefits of treatments that help reduce the impact of SLE.

4. Social responsibility and support for evidence generation:

The pharmaceutical industry's commitment to generating quality scientific evidence is an essential component of its social responsibility. In some countries, such as Colombia, this collaboration is even formally established as a state obligation. In others, such as Mexico, it represents a goodwill practice that reinforces the sector's credibility and ethical commitment. Promoting these initiatives at the regional level reinforces the industry's positive image among the medical community and regulatory authorities.

5. Unique value of the study at the regional level:

To date, there is no representative data on the prevalence and impact of SLE by country or region. This knowledge gap gives this study significant differential value, positioning it as a unique and benchmark source of evidence for Latin America. Its potential to guide public policies and regional health strategies is undoubtedly one of its main contributions.

Direct Medical Costs Among Latin American Patients With SLE
Real life data

Introduction
Knowledge of direct costs in lupus care is limited and fragmented in Latin America. This lack of data hinders the design of health policies and the evaluation of new therapies, especially biological ones.

GLADEL proposes a multicenter study of direct medical costs, taking advantage of its ongoing cohort. This will generate unprecedented evidence on the economic impact of lupus in the region.

Objectives

• Retrospectively estimate the direct medical costs of patients with SLE (consultations, hospitalizations, medications, complementary studies).
• Compare direct costs between health systems (public, private, university) and between countries.
• Analyze clinical and social determinants associated with higher costs.
• Generate the basis for prospective studies of large-scale economic evaluations.

Methodology

• Initial phase: retrospective study linked to the GLADEL cohort.
• Second stage: a prospective study linking the population registry of > 16,000 patients.
• Descriptive and comparative analysis of costs, standardized in dollars.

Expected results

• Regional database on direct costs of SLE
• Comparative evidence to support regulatory and coverage decisions.
• High-impact publications with real-world data.
• Methodological platform for prospective studies across the region.