AB0112 TNF INHIBITOR MONOTHERAPY IN RHEUMATOID ARTHRITIS: IS THERE REALLY A DIFFERENCE IN COMPARISON WITH COMBINATION THERAPY WITH CSDMARDS IN REAL-LIFE?
Authors: B. M. Fernandes, S. Garcia, F. Oliveira Pinheiro, M. Rato, D. Fonseca, D. Santos Oliveira, A. Martins, F. R. Martins, M. Bernardes, L. Costa
Journal: Annals of the Rheumatic Diseases (2021)

Background: In Rheumatoid Arthritis (RA), tumor necrosis factor inhibitors (TNFi) in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) has shown advantages concerning efficacy and immunogenicity in comparison with monotherapy. However, in clinical practice, up to 40% of patients under biological DMARDs (bDMARDs) are on monotherapy. Objectives: To compare the efficacy outcomes of TNFi in monotherapy and in combination therapy in a RA monocentric cohort. Methods: Retrospective, cross-sectional study including all the RA patients under TNFi followed at our Rheumatology Department and registered in the national database. Demographic, clinical and laboratorial data and disease activity measures were collected at the last visit of 2019 from each patient. Mann-Whitney U and chi-square tests were used to the comparison analysis between the two groups (continuous and categorical variables, respectively). Results: A total of 144 patients were included: 84% were females; at the last visit of 2019, the mean age was 56.3±10.9 years and the mean disease duration was 18.3±10.2 years; 73.6% were positive for rheumatoid factor (RF), 81.9% for anti-citrullinated protein autoantibodies (ACPA) and 45.1% had erosive disease. There were no statistically significant differences in these variables between the monotherapy and the combination therapy groups (table 1). Table 1. Demographic and disease-related variables in the monotherapy and the combination therapy group. Monotherapy (n=31) Combination therapy (n=113) Age - mean±SD 59.1±14.0 years 55.5±9.8 years Disease duration - mean±SD 20.5±11.2 years 17.7±9.7 years RF positive - n (%) 20 (60.4%) 86 (76.8%) ACPA positive - n (%) 25 (80.6%) 93 (85.3%) Erosive disease - n (%) 15 (48.4%) 50 (44.6%) Thirty-one patients (21.5%) were under monotherapy with TNFi and etanercept was the most frequent TNFi in both groups (54.8% vs 50.0%; monotherapy and combination therapy groups, respectively). At the start of the first bDMARD, the monotherapy group had a higher disease activity score 28 - 4 variables (DAS 28 4V; 6.083±0.930 vs 5.605±1.043, p=0.039) and a higher simple disease activity score (SDAI; 36.12±11.77 vs 28.76±9.98, p=0.035); also, in the monotherapy group more patients had already started the bDMARD in monotherapy (22.6% vs 2.7%, p&lt;0.001), less patients were under (38.7% vs 73.2%, p=0.001) or had already been treated with (77.4% vs 93.8%, p=0.007) methotrexate, in comparison with the combination group therapy. At the last visit of 2019, the monotherapy group had a higher mean years of duration of iTNF treatment (5.5±5.8 vs 3.4±4.5, p=0.048), a higher mean patient global assessment - visual analogue scale (PGA-VAS; 49±18 vs 39±25, p=0.023), a higher mean prednisolone equivalent dose in mg/day (7.6±6.3 vs 5.6±3.2, p=0.045) and a lower proportion of American College of Rheumatology 50 and 70 responses (ACR 50: 12.9% vs 17.0%, p=0.023; ACR 70: 3.2% vs 10.7%, p=0.045) in comparison with the combination therapy group. Conclusion: In line with the literature, our real-life results demonstrate some direct (higher PGA-VAS and lower ACR 50 and 70 responses) and indirect (higher current prednisolone equivalent dose) data that suggest that patients with TNFi monotherapy may have a worst disease activity control in comparison with combination therapy. Disclosure of Interests: None declared