Abstract: Decrease treatment persistence in rheumatoid arthritis (RA) patients has been associated with several factors, including number of previous biological DMARDs (bDMARDs), female gender and higher disease activity or lower function at baseline [1]. Objectives Determine if drug discontinuation of bDMARDs differs by disease activity level at baseline in patients with RA in the Mexican Adverse Events Registry (BIOBADAMEX). Methods BIOBADAMEX is a Mexican ongoing cohort of patients using bDMARDs. In this analysis we included all patients with RA registered from 2016 to 2021 with at least two assessments. Survival on bDMARDs was estimated using Kaplan-Meier analysis. Predictors of discontinuation, including high disease activity defined as DAS28-ESR 〉 5.1, were investigated by Cox regression analyses. Results Among 528 RA patients in the registry, 302 had at least two assessments. Of patients analyzed, 276 (91%) were women. At baseline, patients had a median (IQR) age of 52.7 (44-60) years old, median disease duration of 9.3 (4-16) months. A total of 142 (47%) had comorbidities, 34 (11%) had more than 2 morbidities. At baseline DAS28-ESR was 4.8 (4-6), 59 (20%) patients had low (DAS28-ESR 〈 =3.2) and 130 (43%) had high disease activity. The most common bDMARDs received at baseline were abatacept 68 (23%), tocilizumab 59 (20%), adalimumab 50 (17%) and certolizumab 41 (14%). At the time of analysis, the median bDMARDs treatment duration was 17.2 (12-27) months. Overall, 130 (43%) patients had discontinued treatment, the most common causes of discontinuation were inefficacy in 64 patients, 15 for remission, 12 for adverse events and 26 for others. Figure 1 shows discontinuation rate curves in patients by disease activity. Cox proportional hazards demonstrated significant difference in bDMARD discontinuation between patients with baseline high disease activity (HR 1.3, 95% CI 1.1-1.7, p=0.03), but not differences were found regarding baseline age (HR 1.0, 95% CI 0.9-1.0, p=0.16), sex (HR 0.9, 95%CI 0.6-1.4), disease duration (HR 1.0, 95%CI 0.9-1.0, p=0.92), smoking (HR 1.2, 95% CI 0.7-2.1, p=0.44), number of comorbidities (HR 1.0, 95%CI 0.9-1.2, p=0.51) or other factors. The significant association of baseline high disease activity remained after adjusting by baseline age, sex, smoking, disease duration and number of comorbidities (HR 1.3, 95% CI 1.1-1.7, p=0.02). Figure 1. Discontinuation rate curves in RA patients with high disease activity (DAS28 〉 5.1) and DAS28 〈 =5.1 Conclusion In Mexican RA patients registered in BIOBADAMEX, we found that baseline high disease activity is associated with the discontinuation of bDMARDs. Further longitudinal analyses will be performed including more patients to assess retention rate of specific bDMARDs and identify predictive variables of discontinuation in Mexican population. References [1]Lauper K, Finckh A. Predictive factors of treatment persistence in rheumatoid arthritis. Joint Bone Spine. 2020 Dec;87(6):531-534. Disclosure of Interests VIJAYA RIVERA TERAN: None declared, David Vega-Morales: None declared, Sandra Sicsik: None declared, Fedra Irazoque-Palazuelos: None declared, Miguel A Saavedra: None declared, Julio Cesar Casasola: None declared, Sandra Carrilo: None declared, Angélica Peña: None declared, Angel Castillo Ortiz: None declared, Omar Eloy Muñoz-Monroy: None declared, Sergio Duran Barragan: None declared, Azucena Ramos: None declared, Luis Francisco Valdés Corona: None declared, Estefanía Torres Valdéz: None declared, Aleni Paz: None declared, ERICK ADRIAN ZAMORA-TEHOZOL: None declared, Daniel Xavier Xibille Friedmann: None declared, Francisco Guerrero: None declared, Natalia Santana: None declared, Miguel Vazquez: None declared, Claudia Zepeda: None declared, Melanea Rivera: None declared, Kitzia Alvarado: None declared, Deshire Alpizar-Rodriguez Consultant of: Scientific advisor for GSK, unrelated to this study., Employee of: Scientific advisor for GSK, unrelated to this study.

Abstract: Patients with rheumatic diseases (RD) have a higher risk of developing infections due to disease and immunosupressor treatment factors 1 . Biologic disease -modifying antirheumatic drugs (bDMARD) have been associated with the development of opportunistic infections, nevertheless their impact on severe infections has not been consistent 2 . Objectives To describe the sociodemographic and clinical characteristics of patients with RD on bDMARD treatment with and without infections, using data from the Mexican Adverse Events Registry (BIOBADAMEX), as well as to identify factors associated with the presence of infections. Methods BIOBADAMEX is a Mexican ongoing cohort of patients using bDMARDs. In this analysis we included all patients registered in Biobadamex from 2016 to 2021. We compared sociodemographic, clinical and treatment characteristics between patients who developed infections with to those who did not. We used descriptive statistics, Chi square and Kruskal Wallis tests to analyze differences between the groups. Results A total of 780 patients registered in Biobadamex were included in this study, among them 42 (5%) patients presented infections and 738 (95%) did not. At baseline, patients had a median (IQR) age of 50 (40-58) years and median disease duration of 7 (3-15) years. The most common diagnosis was rheumatoid arthritis with 512 (66%) patients, followed by ankylosing spondylitis in 115 (15%), psoriatic arthritis in 44 (6%), systemic lupus erythematosus in 30 (4%) and idiopathic juvenile arthritis in 27 (3%) patients. Comorbidities were present in 351 (45%) of the patients. Conventional DMARD (cDMARD) were used by 626 (80%) patients, and 290 (37%) used steroids. The most frequently used bDMARDs were adalimumab in 166 (21%) patients, certolizumab in 129 (16%), tocilizumab in 103 (13%) and abatacept 94 (12%). Table 1 shows baseline characteristics in the groups with and without infections. Patients with infections presented more severe adverse events 3 (7%) compared to those who did not 11 (2%), p=0.007, with a complete recovery without sequels. Most common infection site was skin (21%) followed by superior airways (12%). Most common infectious agents were gram negative bacteria. Only 2 patients presented bacteremia. Table 1. Patients baseline characteristics Infectionn=42 Without infectionn=738 p Female, n(%) 33 (79) 595 (80) 0.74 Age, median(IQR) 50.9 (43-59) 49.8 (40-58) 0.58 Disease duration (years), median (RIC) 7.5 (2-16) 7.0 (3-15) 0.9 Diagnostic, n(%):  Rheumatoid arthritis 25 (59) 487 (66) 0.42  Idiopathic Juvenile Arthritis 0 (0) 27 (4)  Ankylosing Spondylitis 6 (14) 109 (15)  Others 11 (26) 115 (15) Comorbidities, n(%): 22 (52) 329 (44.6) 0.32 Previous bDMARD, n(%): 15 (36) 271 (37) 0.89 Use of steroids, n(%): 16 (38) 274 (37) 0.9 cDMARD, n(% ) 33 (79) 593 (80) 0.77 Severe Adverse Events, n(% ) 3 (7 ) 11 (2) 0.007   Outcome, n(% ) Recovered without sequels 3 (100) 6 (55) p=0.34* Not recovered 0 3 (27) Unknown 0 2 (18) Infection site, n(% ) Skin 9 (21) Superior airways 5 (12) Urinary tract 4 (10) Agent, n(% ) Gram- bacteria 9 (21) Gram+ bacteria 0 (0) Virus 4 (14) *Chi2 Conclusion The frequency of infections in patients using bDMARD in Biobadamex is low compared to the frequency reported in similar studies in other countries 3 . The presence of infections was associated with more severe adverse events in general, which recovered completely without sequels. References [1]Wallis D. Curr Opin Rheumatol. 2014;26(4):404-9. [2]Singh JA et al. Lancet. 2015;386(9990):258-65. [3]Pérez-Sola MJ, et al. Med Clin (Barc). 2011;137(12):533-40. Disclosure of Interests VIJAYA RIVERA TERAN: None declared, David Vega-Morales: None declared, Sandra Sicsik: None declared, Fedra Irazoque-Palazuelos: None declared, Miguel A Saavedra: None declared, Julio Cesar Casasola: None declared, Sandra Carrilo: None declared, Angélica Peña: None declared, Angel Castillo Ortiz: None declared, Omar Eloy Muñoz-Monroy: None declared, Sergio Duran Barragan: None declared, Azucena Ramos: None declared, Luis Francisco Valdés Corona: None declared, Estefanía Torres Valdéz: None declared, Aleni Paz: None declared, ERICK ADRIAN ZAMORA-TEHOZOL: None declared, Alfonso Torres: None declared, Samara Mendieta: None declared, Daniel Xavier Xibille Friedmann: None declared, Francisco Guerrero: None declared, Natalia Santana: None declared, Miguel Vazquez: None declared, Claudia Zepeda: None declared, Melanea Rivera: None declared, Kitzia Alvarado: None declared, Deshire Alpizar-Rodriguez Consultant of: Scientific advisor for GSK, unrelated to this study., Employee of: Scientific advisor for GSK, unrelated to this study.

Abstract: Rheumatic diseases prevalence and characteristics in Mexico may vary depending on the country´s region 1 . To acknowledge these differences is needed to develop focused strategies for early diagnosis and treatment 2 . Objectives Identify the sociodemographic, clinical and treatment characteristics of the rheumatic diseases in the different regions in Mexico using data from the Mexican Adverse Events Registry (BIOBADAMEX). Methods In this analysis we included all patients registered from 2016 to 2021. We described the prevalence in the northern region of Mexico (NR), central (CR) and southern region (SR). We compared sociodemographic, clinical and treatment characteristics between these three regions. We used descriptive statistics, Chi square and Kruskal Wallis tests to analyze differences between the groups. Results A total of 780 patients were included in this study, 248 patients (32%) were from the NR, 471 (60%) were from the CR and 61 (8%) from the SR. At baseline, patients had a median (IQR) age of 50 (40-58) years and median disease duration of 7 (3-15) years. NR patients had longer disease duration (9.7 years, p 〈 0.001) and SR patients had higher BMI (29, p 0.001). Overall, 351 (45%) had comorbidities. In CR and SR more than the half of the patient had comorbidities, while in NR only 29% (p 0.001). The most common diagnosis was rheumatoid arthritis with 512 (66%) patients, followed by ankylosing spondylitis in 115 (15%), psoriatic arthritis in 44 (6%), systemic lupus erythematosus in 30 (4%) and idiopathic juvenile arthritis in 27 (3%), this proportions were maintained when analyzed by regions. We found SR had higher DAS 28 and higher BASDAI (Table 1). Table 1. Baseline characteristics by region. Northern regionn=248 Central regionn=471 Southern regionn=61 p Age, median(IQR) 49.7 (42-58) 49.9 (38-58) 51.6 (43-61) 0.4 Female, n(%) 193 (78) 383 (81) 52 (85) 0.33 Body Mass Index, median (IQR) 28 (25-32) 26 (22-29) 29 (26-32 ) 0.001 Disease duration (years), median (RIC) 9.7 (5-16 ) 5.9 (2-14) 4.5 (1-10) 0.001 Diagnostic, n(%):  Rheumatoid arthritis 173 (70 ) 300 (64) 39 (64) 0.001  Idiopathic Juvenile Arthritis 3 (1) 23 (5 ) 1 (2)  Ankylosing Spondylitis 47 (19 ) 59 (13) 9 (15) Laboratory studies, n(% ) Rheumatoid factor 97 (39) 274 (58) 38 (62 ) 0.001 ACPA 15 (6) 68 (14) 12 (19 ) 0.001 Disease activity scores, median (IQR )  DAS28 4.8 (3-6) 5.1 (4-6) 5.2 (5-7 ) 0.001  BASDAI 2.8 (0-7) 4.9 (2-7) 8.0 (5-9 ) 0.003 Comorbidities, n(% ) 72 (29) 247 (52 ) 32 (52 ) 0.001 Previous bDMARD, n(%): 136 (55 ) 149 (32) 1 (2) 0.001 Steroids, n(%): 93 (38) 155 (33) 42 (69 ) 0.001 cDMARD, n(% ) 200 (81) 373 (79) 53 (87) 0.4 Cause of bDMARD discontinuation, n(% ) a Lack of efficacy 85 (62 ) 45 (33) 2 (22) 0.001 Adverse Event 4 (3) 25 (18) 3 (33 ) Pregnancy 1 (1) 3 (2 ) 0(0) Loss of patient follow up 10 (7) 0 (0) 2 (22 ) Remission 23 (17 ) 5 (4) 0 (0) Others 14 (10) 59 (43 ) 2(22) a) 238 patients. Glucocorticoids were used by 290 (37%) patients, SR had the highest use rate (69%, p 〈 0.001) and 80% of the patients used conventional DMARDs (cDMARDs) with no differences between regions. Overall, the most used bDMARDs were adalimumab, certolizumab, tocilizumab and abatacept. At the time of the analysis 238 (36%) had discontinued bDMARDs treatment, 132 (47%) due to lack of response, being this the most frequent cause reported overall, with the highest rate in NR (62%, p 〈 0.001). All NR patients have social security compared to 83% in CR and 79% in SR. Conclusion There are regional differences between patients with rheumatic diseases registered in Biobadamex. It was remarkable that all patients form NR had social security, which may impact in the access to treatment. There were differences in the treatments between regions. The data from this analysis may be useful to policy makers, pharmaceutical companies and physicians. Differences in size samples between regions could have influenced in the results, further analyses will be performed in the future including more patients. References [1]Peláez-Ballestas I et al. J Rheumatol 2011;86;3-8. [2]Chopra A et al. Best Pract Res Clin Rheumatol 2008;22:583-604. Disclosure of Interests VIJAYA RIVERA TERAN: None declared, David Vega-Morales: None declared, Sandra Sicsik: None declared, Fedra Irazoque-Palazuelos: None declared, Miguel A Saavedra: None declared, Julio Cesar Casasola: None declared, Sandra Carrilo: None declared, Angélica Peña: None declared, Angel Castillo Ortiz: None declared, Omar Eloy Muñoz-Monroy: None declared, Sergio Duran Barragan: None declared, Azucena Ramos: None declared, Luis Francisco Valdés Corona: None declared, Estefanía Torres Valdéz: None declared, Aleni Paz: None declared, ERICK ADRIAN ZAMORA-TEHOZOL: None declared, Alfonso Torres: None declared, Samara Mendieta: None declared, Daniel Xavier Xibille Friedmann: None declared, Francisco Guerrero: None declared, Natalia Santana: None declared, Miguel Vazquez: None declared, Claudia Zepeda: None declared, Melanea Rivera: None declared, Kitzia Alvarado: None declared, Deshire Alpizar-Rodriguez Consultant of: Scientific advisor for GSK, unrelated to this study., Employee of: Scientific advisor for GSK, unrelated to this study.

Abstract: Rheumatoid arthritis (RA) is the most common autoimmune disease. Older patients treated with biologic DMARDs (bDMARDs) are at a significantly greater risk of adverse effects (AEs) [1]. However, the rate of drug discontinuation because of adverse effects caused by bDMARDs has not differed in elderly compared to younger patients in different registries. Objectives: Determine if drug discontinuation of bDMARDs differs by age in patients with rheumatoid arthritis in the Mexican Adverse Events Registry (BIOBADAMEX). Methods: BIOBADAMEX is a Mexican ongoing cohort of patients using bDMARDs since 2016. In this analysis we included all patients with diagnosis of RA with at least two assessments. Survival on bDMARDs was estimated using Kaplan-Meier analysis. Predictors of discontinuation, including age older than median age in the sample were investigated by Cox regression analyses. Results: Among 743 patients in the registry, 497 had RA diagnosis, from which, 214 had at least two assessments. At baseline, patients had a median (IQR) age of 53.4 (45-61) years old, median disease duration of 10.7 (6-17) months and median DAS28 of 4.7 (3-6). Conventional DMARDS were used by 185 (87%) patients and 94 (44%) patients used corticosteroids. Comorbidities were present in 194 (91%). The most common bDMARDs received at baseline were abatacept 59 (27%), tocilizumab 45(21%), adalimumab 31 (15%) and certolizumab 30 (14%). At the time of analysis, the median bDMARDs treatment duration was 21.0(13-34) months, 128 (59%) had discontinued treatment, 66 for inefficacy, 32 for adverse events and 30 for others. Fig 1 shows discontinuation rate curves in patients younger and older than median age. Cox proportional-hazards demonstrated no significant differences regarding age older than median age (HR 1.1, 95% CI 0.8-1.4, p=0.7), female sex (HR 1.2, 95% CI 0.7-1.9, p=0.44), use of corticosteroids (HR 1.2, 95% CI 0.9-1.6, p=0.20), comorbidities (HR 0.9, 95% 0.6-1.5, p=0.78), DAS28 (HR 0.9, 95% 0.9-1.1, p=0.93) or other factors. Figure 1. Discontinuation rate curves in patients younger and older than median age ( 〈 53.4 and 〉 =53.4 years old) Conclusion: This analysis did not show a role of age on discontinuation of bDMARDs in Mexican RA patients. Further longitudinal analyses will be performed including more patients to assess retention rate of bDMARDs and identify predictive variables of discontinuation in Mexican population. References: [1]Akter R, et al. Can Geriatr J. 2020 May 1;23(2):184-189. [2]Ikari Y, et al. Medicine (Baltimore). 2020 Dec 24;99(52):e23861. Disclosure of Interests: None declared

Abstract: To develop and validate a Patient-Centred Quality of Cancer Care Questionnaire in Spanish (PCQCCQ-S) appropriate to the Mexican context. Design Psychometric validation of a questionnaire. Setting Two public oncology hospitals in Mexico City. Participants 1809 patients with cancer aged ≥18 years. Source of information Cross-sectional survey. Methods The validation procedures comprised (1) content validity through a group of experts and patients; (2) item reduction and evaluation of the factor structure, through an exploratory factor analysis based on the polychoric correlation matrix; (3) internal consistency using Cronbach’s alpha; (4) convergent validity between the PCQCCQ-S and supportive care needs scale; (5) correlation analysis between the PCQCCQ-S and quality of life scale by calculating Spearman’s rank-correlation coefficient; and (6) differentiation by ‘known groups’ through the Wilcoxon rank-sum test. Results The PCQCCQ-S has 30 items with the following five factors accounting for 96.5% of the total variance: (1) timely care; (2) clarity of the information; (3) information for treatment decision-making; (4) activities to address biopsychosocial needs; and (5) respectful and coordinated care. Cronbach’s alpha values ranged from 0.73 to 0.90 among the factors. PCQCCQ-S has moderate convergent validity with supportive care needs scale, revealing that higher quality is correlated with lower patient needs. PCQCCQ-S has acceptable ability to differentiate by ‘known groups’, showing that older patients and those with low levels of education perceived lower total quality of care as compared with their counterparts. Conclusion PCQCCQ-S has acceptable psychometric properties and can be used to measure quality of patient-centred cancer care in Mexico and serve as a reference to develop PCQCCQ-S in other Spanish-speaking countries.