Ab0202 characteristics of patients with difficult-to-treat rheumatoid arthritis in real life: data from the biobadaser registry

Background In the last decade there have been multiple attempts to characterize patients with refractory rheumatoid arthritis (RA). In 2020, EULAR proposed a definition for difficult-to-treat RA (D2T-RA) to standardize this population. The mechanisms leading to D2T RA are varied and not fully understood. A better understanding of clinical profile of this specific population may be helpful to support rheumatologists in their clinical decisions. Objectives To determine the prevalence of D2T-RA in a multicenter national registry (BIOBADASER) and to investigate the influence of the initial successive lines of treatment (LoT) in the development of D2TRA. Methods Longitudinal and prospective cohort study of patients with RA from BIOBADASER (a multicenter national registry of adverse events of biologics and targeted therapies in rheumatic diseases). Patients were classified as refractory if failure to at least 2 biologics or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs) with different mechanisms of action (MoA) and as D2TRA if refractory RA who presented moderate to high disease activity according to DAS 28-ESR at their last visit. The comparator group included patients with refractory RA but low disease activity/remission. The therapeutics groups were stablished as TNF inhibitors (TNFi), JAK-inhibitors (JAKi) and other biological therapies non-TNFi bDMARD. Demographic, clinical and therapeutical data on the 1st and 2nd LoT were compared between groups. Results A total of 3852 patients with RA with at least one year follow up were included in the analysis, 1612 (42%) had refractory RA and 348 (9%) D2TRA. Patient and therapeutic characteristics are shown in Table 1. No differences were found between D2TRA and non-D2TRA in clinical variables except for age, being patients with D2TRA significantly older. The use of JAKi as their first or second LoT was more frequent in patients with non-D2TRA, although no statistical significance was reached. Conclusion Around 40% of patients were classified as refractory RA in our registry but only 9% as D2T-RA. Earlier treatment with JAKi was more frequent in the non-D2TRA group. Further research should analyse the influence of LoT on the development of D2TRA. Table 1. Demographic, clinical and therapeutic characteristics in the refractory RA, D2TRA and non-D2TRA population Refractory RA (n= 892) D2TRA (n=348) Non-D2TRA (n=544) p-value Age (years), mean ± SD 63.1 (12.8) 64.2 (12.8) 62.5 (12.8) 0.047 Sex (female), n (%) 712 (79.8) 286 (82.18) 426 (78.31) 0.160 FR positivity, n (%) 159 (22.3) 51 (18.3) 108 (24.8) 0.104 aCCP positivity, n (%) 523 (73.6) 207 (74.29 316 (73.29 0.108 Smoking habit, n (%) 0.88 Smoker 565 (63.3) 219 (62.93) 346 (63.6) Non-smoker 159 (17.8) 68 (19.54) 91 (16.73) Former smoker 129 (14.5) 47 (13.51) 82 (15.07) Charlson Index, mean ± SD 0.3 ± 0.8 0.4 ± 0.8 0.3 ± 0.8 0.215 DAS28-ESR, mean ± SD 2.1 ± 0.7 4.3 ± 0.9 3.0 ± 0.8 <0.001 Concomitant csDMARD, n (%) 470 (52.7) 194 (55.8) 276 (50.7) 0.144 Time to first b/tsDMARD (years) 6.6 (7.1) 6.9 (7.3) 6.5 (7.0) 0.374 Lines of treatment 0.145 TNFi -> other bDMARD 583 (65.4) 233 (67.0) 350 (64.3) TNFi -> JAKi 138 (15.5) 46 (13.2) 92 (16.9) Other bDMARD -> TNFi 75 (8.4) 34 (9.8) 41 (7.5) Other bDMARD -> JAKi 23 (2.6) 8 (2.3) 15 (2.8) JAKi -> TNFi 15 (1.7) 2 (0.6) 13 (2.4) JAKi -> other bDMARD 8 (0.9) 5 (1.4) 3 (0.69 other bDMARD-> other bDMARD 50 (5.6) 20 (5.8) 30 (5.5) REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests Pablo Rodríguez-Merlos Speakers bureau: Lilly, Gebro, Amgen, UCB, Gedeon-Richter, Lucía Otero-Varela: None declared, Fernando Montero: None declared, Francisco Javier Manero Ruiz: None declared, Paloma Vela-Casasempere: None declared, Cristina Campos Fernández: None declared, Sara Manrique Arija: None declared, Carlos Rodríguez-Lozano: None declared, Olga Martínez González: None declared, Jerusalem Calvo Gutierrez: None declared, Jose Campos Esteban: None declared, DIANA SUEIRO DELGADO: None declared, Fernando Sánchez-Alonso: None declared, Isabel Castrejon: None declared.