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Pre-proof, online 18 November 2024
Real-world clinical characteristics and therapeutic strategies in patients with moderate-to-severe inflammatory bowel disease in Argentina: Data from the RISE-AR study
Características clínicas y estrategias terapéuticas en pacientes con enfermedad inflamatoria intestinal de moderada a grave en Argentina: Datos del estudio RISE-AR
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PA Olivera1,#,
Corresponding author
poliverasendra@gmail.com

Address for correspondence: Gastroenterology Section, Department of Internal Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Buenos Aires, Argentina
, DC Balderramo2,#, JS Lasa3, I Zubiaurre4, G Correa5, P Lubrano6, O Ruffinengo7, M Yantorno8, A Rausch9, G Piñero10, A Bolomo11, C Amigo12, J El-Hakeh12, DB Leonardi12, L Brion12, A Sambuelli13
1 Gastroenterology Section, Department of Internal Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Buenos Aires, Argentina and Gastroenterology Department, Sanatorio Mater Dei, Buenos Aires, Argentina
2 Gastroenterology Department, Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina and Instituto Universitario de Ciencias Biomédicas de Córdoba, Córdoba, Argentina
3 Gastroenterology Section, Department of Internal Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Buenos Aires, Argentina and Gastroenterology Department, Hospital Británico de Buenos Aires, Buenos Aires, Argentina
4 Gastroenterology Department, Hospital Británico de Buenos Aires, Buenos Aires, Argentina
5 Gastroenterology Department, Hospital Interzonal General de Agudos General José de San Martin, La Plata, Buenos Aires, Argentina
6 Gastroenterology Department, Sanatorio Mater Dei, Buenos Aires, Argentina
7 Gastroenterology and Hepathology Service, Hospital Provincial del Centenario, Rosario, Santa Fé, Argentina
8 Gastroenterology Department, Hospital Interzonal General de Agudos General José de San Martin, La Plata, Buenos Aires, Argentina
9 Gastroenterology Department, Hospital Británico de Buenos Aires, Buenos Aires, Argentina
10 Gastroenterology and Hepathology Service, Hospital Provincial del Centenario, Rosario, Santa Fé, Argentina
11 Gastroenterology Department, Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina
12 Medical Affairs, Takeda Pharma S.A., Buenos Aires, Argentina
13 Inflammatory Diseases Section, Hospital de Gastroenterología Dr. Bonorino Udaondo, Buenos Aires, Argentina
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Abstract

Objective: Real-world evidence on the adoption of different pharmacological strategies in inflammatory bowel disease (IBD) in Latin America is scarce. Herein, we describe real-world sociodemographic, clinical characteristics, and different therapeutic approaches used in patients with IBD in Argentina.

Methods: RISE AR (NCT03488030) was a multicenter, non-interventional study with a cross-sectional evaluation and a 3-year retrospective chart review conducted in Argentina. Adult patients with a previous diagnosis of moderate-to-severe ulcerative colitis (UC) or Crohn´s disease (CD) at least 6 months prior to enrollment were included.

Results: This study included 246 patients with IBD (CD: 41%; UC: 59%), with a median age of 39.5 years (IQR 30.7-51.7) for CD and 41.9 years (33.3-55.3) for UC. Overall, 51.5% of CD patients had colonic disease involvement, while 45.5% of UC patients had extensive colitis. At enrollment, the overall use of biologics was high, especially in CD patients (CD: 73.2% vs. UC: 30.3%, p<0.001), while the use of immunosuppressants was similar (∼41%, p=1.000) for both diseases. IBD treatments ever prescribed and healthcare resources utilization during the retrospective period were (CD, UC): biologics: 79.2%, 33.8% (p<0.001); immunosuppressants: 65.3%, 58.6% (p=0.352); aminosalicylates: 62.4%, 97.9% (p<0.001); corticosteroids: 55.4%, 69.7% (p=0.031); surgery: 17.8%, 1.4% (p<0.001); and hospitalizations: 33.7%, 21.4% (p=0.039).

Conclusion: In this cohort of IBD patients, overall prescription patterns of conventional therapy were similar to reports elsewhere; however, biologic therapy use was high, especially in CD, consistent with disease behavior and possibly reflecting better access to care in referral centers. Interestingly, over half of CD patients presented colonic involvement.

Keywords (max. 6):
clinical characteristics
treatment patterns
Crohn’s disease
inflammatory bowel disease
real-world evidence
ulcerative colitis
Resumen

Objetivo: Existe limitada evidencia sobre el uso de terapias farmacológicas en colitis ulcerosa (CU) o enfermedad de Crohn (EC) en el mundo real en América Latina. Aquí, describimos las características sociodemográficas, clínicas y los tratamientos utilizados en Argentina.

Métodos: RISE-AR (NCT03488030) fue un estudio multicéntrico, no intervencional, transversal y retrospectivo (3 años) de historias clínicas realizado en Argentina. Incluyó pacientes adultos con CU o EC de moderada a grave de ≥6 meses a la fecha de enrolamiento.

Resultados: Se incluyeron 246 pacientes (EC:41%; CU:59%), con una mediana de edad de 39.5 años (IQR 30.7-51.7) para EC y 41.9 años (33.3-55.3) para CU. El 51.5% de los pacientes con EC presentaron afectación colónica, mientras que el 45.5% de los pacientes con CU tenían colitis extensa. Al enrolamiento, el uso de biológicos fue alto, especialmente en pacientes con EC (EC: 73.2% vs. CU: 30.3%, p<0.001), mientras que el uso de inmunosupresores fue similar (∼41%, p=1.000) para ambas enfermedades. Los tratamientos recibidos y la utilización de recursos de salud durante el período retrospectivo fueron (EC, CU): biológicos: 79.2%, 33.8% (p<0.001); inmunosupresores: 65.3%, 58.6% (p=0.352); aminosalicilatos: 62.4%, 97.9% (p<0.001); corticosteroides: 55.4%, 69.7% (p=0.031); cirugía: 17.8%, 1.4% (p<0.001); y hospitalizaciones: 33.7%, 21.4% (p=0.039).

Conclusión: El uso de terapia convencional fue similar a lo reportado previamente; sin embargo, el uso de terapia biológica fue alto, especialmente en EC, consistente con el comportamiento de la enfermedad y posiblemente un mejor acceso al tratamiento en centros de referencia. Interesantemente, más de la mitad de los pacientes con EC presentaron afectación colónica.

Mot cles (max. 6):
características clínicas
patrones de tratamiento
enfermedad de Crohn
enfermedad inflamatoria intestinal
evidencia en vida real
colitis ulcerosa

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