Health-related quality of life measures in spondyloarthropaty patients under biological therapies in real life

Grau García, E.; De La Rubia Navarro, M.; Pávez Perales, C.; Leal Rodriguez, S.; Riesco Barcena, C.; Huaylla Quispe, A. V.; Vicens Bernabeu, E.; Negueroles Albuixech, R.; Ivorra Cortés, J.; Ortiz Sanjuan, F. M.; Martínez Cordellat, I.; Chalmeta Verdejo, I.; Fragío Gil, J. J.; Gonzalez Puig, L.; Oller Rodríguez, J. E.; Alcañiz Escandell, C.; Cánovas Olmos, I.; Nájera Herranz, C.; Cañada Martinez, A. J.; Román Ivorra, J. A.

Background: Spondyloarthropathy patients have reduced health-related quality of life (HRQL) compared to general population. Biological treatment strategies in real life aim to reduce patients' symptoms and different HRQL parameters would share the same behavior as patients' symptoms and disease activity. Objectives: We aim to assess the differences in HRQL reported by spondyloarthropathy patients during the first six months of biological therapy according to the treatment effectiveness. Methods: We performed a prospective observational study of six months of follow-up in spondyloarthropathy patients who are newly on biological therapy. A basal visit and 1, 3 and 6 months follow-up visits were conducted. We analyzed changes during follow-up in the HRQL parameters reported by patients through AsqoL and ASAS-health-index questionnaires. Moreover we measured functional disability through HAQ and BASFI index, disease activity by BASDAI, ASDAS-CRP and ASDAS-ESR index. Statistical analyses were achieved using R software, through multivariate linear regression models for continuous data and Bayesian mixed ordinal regression models with monotonic effect for ordinal data. The corresponding odd ratios (OR) were calculated with their confidence intervals (CI 95%). Results: We included 53 patients (71.77% male), the 73.58% diagnosed with ankylosing spondylitis (AS) and the 26.42% with axial spondyloarthritis. Mean age at the beginning of treatment was 48.74 (11.21) years, mean age at diagnosis was 41.57 (11.97) and mean disease evolution was 7.19 (9.24) years. 60.42% of them exhibited HLAb27 positivity. 34 patients started biological therapy with TNF-α inhibitors and 19 with IL-17 inhibitors. The 81.13% of patients were under monotherapy, and the other 18.87% was treated with DMARDs. The 77.36% of the total number of patients was on the biological therapy at 6 months of follow-up, while the 22.64% discontinued at 6 months of follow-up (9 due to inefficacy and 3 due to adverse effects). 42 patients completed the follow-up at 6 months, and 3 patients achieved until visit 3 due to treatment failure. In 1 case visit 1 and in 7 cases visit 3 could not be performed due to COVID19 pandemic situation. We observed a significant correlation among AsqoL and ASAS-hi values with disease activity indexes (BASDAI, ASDAS-CRP, ASDAS-ESR) and functional disability (HAQ, BASFI). The statistical analyses showed a significant association where AsqoL and ASAS-hi values are significantly decreased in treatment failures compared to the successful treatment (, and in patients with previous biological therapy compared to naïve patients. No effect of years of disease evolution and the type of biological treatment in the AsqoL and ASAS-hi values was observed. (See Table 1) These results were consistent with the significant association found among the disease activity and functional disability with the biological therapy efficacy and the previous biological treatment. Conclusion: The AsqoL and ASAS-hi questionnaire results are correlated with disease activity and functional disability and showed the same behaviour as these parameters, being also associated to the biological therapy efficacy as well as to previous biological therapies. The HRQL variables would be additional clinical results that make it possible to achieve a better management of biological therapies in spondyloarthropathy patients.