POS0610 EPIDEMIOLOGIC PROFILE AND CHANNELING TO TREATMENT IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH ABATACEPT OVER THE LAST 5 YEARS: DATA FROM THE SPANISH REGISTER BIOBADASER 3.0
Authors: S. C. Rodriguez-García, C. Sánchez-Piedra, R. Castellanos-Moreira, D. Ruiz-Montesinos, M. Pombo, F. Sánchez-Alonso, J. J. Gómez-Reino
Journal: Annals of the Rheumatic Diseases (2021)

Background: Abatacept (ABA) is a selective T-cell co-stimulatory modulator. After its approval, changes in therapeutic recommendations, the arrival of new drugs (e.g., biosimilars or Janus kinase inhibitors) and growing focus on comprehensive patient care may have changed prescription patterns, channeling ABA use towards specific patient subtypes. To date, studies analyzing these aspects in clinical practice settings are scarce. Objectives: We aimed to evaluate the epidemiological profile of ABA users and compare it to other DMARD groups included in the register. Methods: We performed an observational study based on the nationwide Spanish register BIOBADASER, which includes patients with rheumatic diseases receiving biologic disease-modifying antirheumatic drugs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) from 28 tertiary centers. For this analysis, all RA patients included from December 2015 to December 2020 were examined. Baseline features were analyzed descriptively grouping all b/tsDMARDs by mode of action. Clinical effectiveness was assessed through drug survival obtained by the Kaplan-Meier method. Patients were right-censored if data were not available if they were still on treatment at the time of data analysis. The safety profile was assessed by the adverse events (AE) and serious AE incidence rates (IR) expressed as events per 1000 patient-years. Results: There were 628 ABA-treated patients, 471 (75%) using the subcutaneous presentation. Only 142 (23%) were on first-line while 381 (61%) were on third or later-line therapy. ABA users were older and more likely to present certain comorbidities compared to the other b/tsDMARD groups. The biggest relative differences were seen for interstitial lung disease (ILD), chronic obstructive pulmonary disease (COPD), diabetes and ischemic heart disease. (Table 1) Table 1. This 12-month interim analysis includes 496 patients (336 with axSpA, 98 with RA and 62 with PsA) N ABA IL-6 CD20 JAKi TNFi 628 786 181 669 1787 Mean age, years (SD) 64.1 (12.0) 50.7 (12.7) 63.2 (12.3) 59.6 (12.3) 60.7 (13.1) Female sex, n (%) 482 (77) 652 (83) 135 (75) 537 (80) 1418 (79) Median disease duration (p25-p75) 10.1 (5.1-16.5) 9.4 (4.6-15.9) 13.3 (8.3-20.6) 10.4 (5.0-17.2) 7.4 (3.2-13.7) ACPA, n (%) 352 (72) 425 (71) 113 (79) 407 (70) 875 (70) RF, n (%) 380 (77) 454 (75) 124 (86) 411 (70) 915 (72) Current smokers, n (%) 98 (16) 137 (17) 338 (19) 90 (20) 259 (18) ILD, n (%) 64 (13) 21 (3) 25 (2) 8 (2) 19 (2) COPD, n (%) 38 (6) 23(3) 52 (3) 14 (3) 43 (3) Chronic Kidney Disease, n (%) 18 (3) 13 (2) 19 (1) 13 (3) 18 (1) Diabetes 73 (12) 66 (8) 13 (7) 46 (10) 100 (7) Ischemic Heart Disease, n (%) 36 (6) 23 (3) 0 12 (3) 30 (2) Hypertension, n (%) 197 (31) 198 (25) 416 (23) 131 (30) 338 (23) Heart Failure, n (%) 19 (4) 12 (2) 10 (1) 6 (2) 5 (1) Osteoporosis, n (%) 133 (21) 141 (18) 26 (14) 72 (16) 215 (15) IL-6: Tocilizumab and Sarilumab; CD20: Rituximab and biosimilars; JAKi: Janus kinase inhibitors (Tofacitinib and Baricitinib); TNFi: TNF inhibitors and biosimilars; ACPA: anti-citrullinated peptide antibodies; RF: rheumatoid factor; ILD: interstitial lung disease; COPD: chronic obstructive pulmonary disease. Overall, 63% of patients remained on ABA at 1 year, 48% at 2 and 31% at 5 years after drug initiation. The corresponding proportions were 79%, 65% and 52% for bionaïve and 59%, 43% and 30% for those in third or later-line therapy. From 394 total discontinuations, loss of efficacy in 225 (57%) and AE in 98 (25%) were the main reasons. This trend was consistent among all therapy lines. The total IR of AE was 886.5 (837.3-938.5) and 156.4 (136.5-179.2) for SAE. Infections were the most frequent AE overall, IR 44.4 (34.4-57.3), and the highest IR was seen among bionaïve patients (69.6 (44.9-107.9)). Conclusion: ABA-treated RA patients in Spain are older and have more comorbidities (vs other b/tsDMARDs), especially ILD, COPD, ischemic heart disease and diabetes and receive ABA as third or later-line therapy. Although these features are associated with worse response to treatment and a higher risk of infection, ABA presents a good drug survival and infectious AE are not the main cause of discontinuation. Acknowledgements: On behalf of the BIOBADASER Working group Disclosure of Interests: Sebastián C Rodriguez-García Speakers bureau: Sanofi, MSD, UCB-Pharma, Bristol-Myers-Squibb, Novartis, Janssen, Consultant of: Bristol-Myers-Squibb, Galápagos, Carlos Sánchez-Piedra: None declared, Raul Castellanos-Moreira Speakers bureau: Roche, Sanofi, MSD, UCB-Pharma, Bristol-Myers-Squibb, Novartis, Lilly, and Pfizer., Dolores Ruiz-Montesinos: None declared, Manuel Pombo: None declared, Fernando Sánchez-Alonso: None declared, Juan J. Gómez-Reino Consultant of: Pfizer, Grant/research support from: Abbvie, Lilly, MSD, Pfizer, Roche, and UCB.