Economic and Clinical Impact of Advanced Therapies in Moderate-to-Severe Rheumatoid Arthritis in Spain: CIARA Study
Author(s)
Alejandro Balsa, MD PhD1, Lucía Silva-Fernández, MD PhD2, Raimon Sanmartí, MD PhD3, Javier Rejas, MSc, PhD, MD4, Miguel A. Ruiz, BA, PhD5, María Montoro, MD, PhD6, ALFONSO DE LOSSADA JUSTE, PharmD7.
1Rheumatology Unit, Hospital Universitario La Paz. Universidad Autónoma de Madrid, Madrid, Spain, 2Rheumatology Department, Complexo Hospitalario Universitario de A Coruña, Spain, A Coruña, Spain, Spain, 3Rheumatology Service, Hospital Clinic de Barcelona, Barcelona, Spain, 4EACCOS Research Group, Universidad Autónoma de Madrid, Spain, Universidad Autónoma de Madrid, Madrid, Spain, 5School of Psychology, Universidad Autónoma de Madrid, Spain, Universidad Autónoma de Madrid, Spain, MADRID, Spain, 6Pfizer S.L.U., Madrid, Spain, 7HEOR, Pfizer, Madrid, Spain.
1Rheumatology Unit, Hospital Universitario La Paz. Universidad Autónoma de Madrid, Madrid, Spain, 2Rheumatology Department, Complexo Hospitalario Universitario de A Coruña, Spain, A Coruña, Spain, Spain, 3Rheumatology Service, Hospital Clinic de Barcelona, Barcelona, Spain, 4EACCOS Research Group, Universidad Autónoma de Madrid, Spain, Universidad Autónoma de Madrid, Madrid, Spain, 5School of Psychology, Universidad Autónoma de Madrid, Spain, Universidad Autónoma de Madrid, Spain, MADRID, Spain, 6Pfizer S.L.U., Madrid, Spain, 7HEOR, Pfizer, Madrid, Spain.
OBJECTIVES: To assess the economic, clinical, and work-related impact of advanced therapies (biologic or targeted synthetic DMARDs) in patients with moderate-to-severe rheumatoid arthritis (RA) refractory to cs (conventional synthetic) or first-line b (biologic) DMARDs (Disease-Modifying Antirheumatic Drugs), from the perspectives of the Spanish National Health System (NHS), patients, and society.
METHODS: CIARA is a 12-month, prospective, multicenter, observational cohort study. Direct and indirect costs, quality of life (EQ-5D-3L), work productivity (WPAI), and clinical outcomes (DAS28, CDAI, SDAI) were evaluated. Cost-utility analyses (CUA) were conducted using both deterministic and probabilistic models, including sensitivity analyses.
RESULTS: Total annual costs increased significantly after initiating advanced therapies [Mean (SD) 6,882 (595) basal visit vs 9,927 (598) at month 12; p < 0,001)], primarily due to pharmacological expenses [Mean (SD) 2,215 (280) basal visit vs 6,445 (142); p < 0,001)]. However, significant reductions were observed in out-of-pocket [Mean(SD) 1,107 (208) basal visit vs 498 (131) at month 12; p < 0,001)] and a reduction also in labor-related costs [Mean(SD) 2,876 (402) basal visit vs 2,156 (423) at month 12; p = 0,394)], particularly among patients switching from a csDMARD (reduction of 59.3% in pocket expenses and of 30,6% in labor-related cost). The CUA showed that switching from a csDMARD was cost-effective in over 95% of simulations, with favorable ICERs across all perspectives. At 12 months, 42% of 118 patients achieved remission and 71% achieved remission or low disease activity, with significant improvements in pain, function, fatigue, sleep, anxiety, productivity, and quality of life.
CONCLUSIONS: Advanced therapies in patients with active RA refractory to prior treatments not only improve clinical outcomes and quality of life but are also cost-effective, reducing the economic burden on patients and society. The CIARA study provides robust evidence to support healthcare decision-making and resource allocation in RA management in Spain.
METHODS: CIARA is a 12-month, prospective, multicenter, observational cohort study. Direct and indirect costs, quality of life (EQ-5D-3L), work productivity (WPAI), and clinical outcomes (DAS28, CDAI, SDAI) were evaluated. Cost-utility analyses (CUA) were conducted using both deterministic and probabilistic models, including sensitivity analyses.
RESULTS: Total annual costs increased significantly after initiating advanced therapies [Mean (SD) 6,882 (595) basal visit vs 9,927 (598) at month 12; p < 0,001)], primarily due to pharmacological expenses [Mean (SD) 2,215 (280) basal visit vs 6,445 (142); p < 0,001)]. However, significant reductions were observed in out-of-pocket [Mean(SD) 1,107 (208) basal visit vs 498 (131) at month 12; p < 0,001)] and a reduction also in labor-related costs [Mean(SD) 2,876 (402) basal visit vs 2,156 (423) at month 12; p = 0,394)], particularly among patients switching from a csDMARD (reduction of 59.3% in pocket expenses and of 30,6% in labor-related cost). The CUA showed that switching from a csDMARD was cost-effective in over 95% of simulations, with favorable ICERs across all perspectives. At 12 months, 42% of 118 patients achieved remission and 71% achieved remission or low disease activity, with significant improvements in pain, function, fatigue, sleep, anxiety, productivity, and quality of life.
CONCLUSIONS: Advanced therapies in patients with active RA refractory to prior treatments not only improve clinical outcomes and quality of life but are also cost-effective, reducing the economic burden on patients and society. The CIARA study provides robust evidence to support healthcare decision-making and resource allocation in RA management in Spain.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO82
Topic
Clinical Outcomes, Economic Evaluation, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment
Disease
Biologics & Biosimilars, Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)