P426 Health-Related Quality of Life and Work Productivity in patients with moderate-to-severe Inflammatory Bowel Disease in Argentina: Data from the RISE AR study
Correa, G.J.(1);Yantorno, M.(1);Olivera Sendra, P.(2,3);Lasa, J.S.(2,4);Lubrano, P.(3);Balderramo, D.C.(5,6);Zubiaurre, I.(4);Ruffinengo, O.(7);Brion, L.(8);Leonardi, D.B.(8);El-Hakeh, J.(8);Guimaraens, P.N.(8);Sambuelli, A.(9);
(1)Hospital Interzonal General de Agudos General José de San Martin, Gastroenterology Department, La Plata- Buenos Aires, Argentina;(2)Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC, Gastroenterology Section- Department of Internal Medicine, Buenos Aires, Argentina;(3)Sanatorio Mater Dei, Gastroenterology Department, Buenos Aires, Argentina;(4)Hospital Británico de Buenos Aires, Gastroenterology Department, Buenos Aires, Argentina;(5)Hospital Privado Centro Médico de Córdoba, Gastroenterology Department, Córdoba, Argentina;(6)Instituto Universitario de Ciencias Biomédicas de Córdoba, Department of Internal Medicine, Córdoba, Argentina;(7)Hospital Provincial del Centenario, Gastroenterology and Hepatology Service, Rosario- Santa Fé, Argentina;(8)Takeda Pharma S.A., Medical Affairs, Buenos Aires, Argentina;(9)Hospital de Gastroenterología Dr. Bonorino Udaondo, IBD Section, Buenos Aires, Argentina
Patient-reported outcomes (PROs) are increasingly recognized as complementary to objective markers of disease activity, yet evidence on PROs in inflammatory bowel disease (IBD) in the real-world setting in Latin America is limited. Herein, we describe health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) of IBD patients (pts) in Argentina.
RISE-AR (NCT03488030) was a non-interventional study with a cross-sectional evaluation and a 3-year retrospective chart review conducted in 7 centres in Argentina (12/2018-05/2019) to assess healthcare resource utilisation, HRQoL and WPAI. Adult pts (≥18 yr old) with a previous diagnosis of moderate-to-severe (Mod/Sev) ulcerative colitis (UC) or Crohn´s disease (CD) based on clinical, endoscopic or imaging criteria ≥6 months prior to enrolment, were included. HRQoL (IBD Questionnaire [IBDQ], 5-dimensional EuroQoL measure [EQ5D]) and WPAI instruments were administered at screening. Disease activity at enrolment was classified as Mod/Sev (Harvey Bradshaw Index ≥8 or partial Mayo Score ≥5) vs. “no-or-mild” (No/Mild). A p-value ≤0.05 was considered statistically significant (Mann-Whitney U test).
Overall, 246 pts were included (41.1% CD; 58.9% UC). At enrolment, median (range) age (years) was 39.5 (18.2-74.0) for CD (51.2% female) and 41.9 (18.0-80.4) for UC (55.2% female) pts; 20 pts (9.3% CD; 7.7% UC; excluding 4 ostomized pts) had Mod/Sev disease activity. During the previous 3 years, 17.8% (CD) and 1.4% (UC) of pts required ≥1 surgery, and 33.7% (CD) and 21.4% (UC) were hospitalized. No/Mild pts showed significantly higher overall HRQoL scores (mean±SD) vs. Mod/Sev pts in CD (IBDQ: 178.1±35.4 vs. 140.0±43.5, p<0.05; EQ5D [visual analogue scale]: 75.7±1.8 vs. 64.4±5.5, p<0.05) and UC (180.2±32.9 vs. 132.9±43.8, p<0.001; 77.1±1.3 vs. 57.7±5.3, p<0.001), respectively. Activity impairment was reported by 55.4% and 58.6% of CD and UC pts, respectively, while 37.9% and 43.9% of CD and UC employed pts (67 CD, 92 UC; Mod/Sev: 5 CD, 6 UC) reported work impairment. Mod/Sev IBD pts had higher absenteeism (30.8% vs. 6.3%, p<0.05) and presenteeism (20.0% vs. 7.5%, p=0.149) vs. No/Mild pts. Female gender, surgeries and hospitalizations were associated with lower QoL in the overall IBD population.
This is the first study to evaluate QoL and WPAI in IBD pts in Argentina. Pts with Mod/Sev activity showed impaired QoL and WPAI compared to No/Mild pts. Whilst, less than 10% of IBD pts had Mod/Sev disease activity at enrolment, nearly 60% of the overall IBD population reported either work or activity impairment. Thus, disease activity scores alone may fail to assess the real burden of IBD, suggesting a relevant role for PROs in disease management.