Ab1358 biologic treatment suspension and associated factors in patients with rheumatic diseases during the covid-19 pandemic: data from mexican adverse registry (biobadamex)

Background The COVID-19 pandemic triggered serious challenges in the treatment of chronic diseases due to the lack of access to medical attention. Patients with rheumatic diseases (RD) must have adequate treatment compliance in order to reach and maintain remission or low activity of their diseases. Treatment suspension because of non-medical reasons might lead to disease activation and organ damage. Objectives Identify the frequency of biologic treatment (bDMARD) suspension in patients with RD during the COVID-19 pandemic and determine the associated factors for suspension. Methods In this study we included all patients registered in the Mexican Biologics Adverse Events Registry (BIOBADAMEX), that started bDMARD before March 2019 and suspended treatment during the COVID-19 pandemic. We used descriptive statistic to analyze baseline characteristics and main treatment suspension causes. We used Chi [2] and Kruskal Wallis tests to analyze differences between groups. Results A total of 832 patients patients registered in BIOBADAMEX were included in this study, 143 (17%) suspended bDMARD during the COVID-19 pandemic. The main causes of suspension were inefficacy in 54 (38%) patients, followed by other motives in 49 (34%) patients from which 7 (5%) was loss of medical coverage. Adverse events and loss of patients to follow up were the motive in 16 (11%) and 15 (11%) patients respectively. When we compared the group that suspended bDMARD with the non-suspenders (Table 1), we found statistical differences in patient gender, with 125 (87%) female patients that suspended bDMARD, with a median age of 52 (42-60) years, and a treatment duration of 3.8 years. Conclusion In our study we found that 17% of patients with RD suspended bDMARD treatment during the COVID-19 pandemic and that non-medical motives such as lack of patients follow up and loss of medical coverage due to unemployment were important motives. These results are related to the effect of the pandemic on other chronic diseases. Table 1. Patients baseline characteristics Patients that did not suspended bDMARD during pandemic (n = 689) Patients that suspended bDMARD during pandemic (n = 143) p Female gender, n(%) 549 (79.7) 125 (87.4) 0.02 Age, median (IQR) 55 (45 – 63) 52 (42 – 60) 0.04 Body mass index, median (IQR) 26.4 (23 – 30.4) 27.23 (24.2 – 30.46) 0.13 Social security, n(%) 589 (85.5) 128 (89.5) 0.2 Diagnosis 0.7 - Rheumatoid arthritis 444 (64.4) 97 (67.8) - Juvenil idiopathic athritis 29 (4.2) 2 (1.4) - Ankyosing sponylitis 93 (13.5) 19 (13.3) - Psoriasic arthritis 43 (6.2) 6 (4.2) - Systemic lupus erithematosus 32 (4.6) 9 (6.3) - Others 48 (6.9) 10 (6.9) Disease duration, median (IQR) 11 (7 – 19.5) 12 (6 - 18) 0.95 Comorbidities, n(%) 305 (44.3) 73 (51) 0.08 Previos biologic, n(%) 249 (36.1) 60 (42) 0.1 Treatment at pandemic iniciation, n(%) 0.8 - Etanercept a 34 (4.9) 5 (3.5) - Infliximab a 24 (3.5) 5 (3.5) - Adalimumab 130 (18.9) 22 (15.4) - Rituximab a 61 (8.9) 25 (17.5) - Abatacept 76 (11) 20 (14) - Tocilizumab 82 (11.9) 18 (12.6) - Certolizumab 92 (13.4) 28 (19.6) - Rituximab b 7 (1) 0 - Golimumab 36 (5.2) 5 (3.5) - Tofacitinib 14 (2) 1 (0.7) - Infliximab b 4 (0.5) 2 (1.4) - Etanercept b 31 (4.5) 6 (4.2) - Baricitinib 12 (1.7) 1 (0.7) - Belimumab 5 (0.7) 1 (0.7) - Secukinumb 8 (1.2) 3 (2.1) Steroids use, n(%): 254 (36.9) 57 (39.9) 0.2 Steroids dose (mg), median (IQR) 6 (5 – 10) 6 (5 – 10) 0.47 DMARD use, n(%): 538 (78.1) 118 (82.5) 0.1 Treatment duration, median (IQR) 5.06 (4.04 – 5.78) 3.82 (3.35 – 4.95) 0.001 Suspension motive, n(%) NA - Inefficacy - 54 (37.8) - Adverse event - 16 (11.2) - Pregnancy - 2 (1.4) - Loss of patient - 15 (10.5) - Remission - 7 (4.9) - Others - 49 (34.2) Adverse events, n(%): 102 (14.8) 24 (16.8) 0.3 - Severe, n(%) 13 (1.9) 5 (3.5) 0.4 a original, b biosimilar REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests Vijaya Rivera Teran: None declared, Daniel Xavier Xibille Friedmann: None declared, David Vega-Morales: None declared, Sandra Sicsik: None declared, Angel Castillo Ortiz: None declared, Fedra Irazoque-Palazuelos: None declared, Dafhne Miranda: None declared, Iris Jazmin Colunga-Pedraza: None declared, Julio Cesar Casasola: None declared, Omar Eloy Muñoz-Monroy: None declared, Sandra Carrilo: None declared, Angélica Peña: None declared, Sergio Duran Barragan: None declared, Luis Francisco Valdés Corona: None declared, Estefanía Torres Valdéz: None declared, Azucena Ramos: None declared, Aleni Paz: None declared, ERICK ADRIAN ZAMORA-TEHOZOL: None declared, Deshire Alpizar-Rodriguez Employee of: Scientific Advisor in GSK México.