Objectives. To report the prevalence of severe functional difficulties and disability (SFD) in a nationally representative sample of children ages 5 to 17 in Mexico, to identify factors associated with SFD, and population profiles predictive of SFD. Materials and methods. Using data from the National Survey on Children and Women we estimated prevalence and 95% confidence intervals of SFD and risk factors. We fitted bivariate and multivariate logistic regression models. We then examined which combinations of the sociodemographic factors best predicted SFD. Results. The prevalence of SFD was 11.2%. The most prevalent SFD were on the socioemotional dimension (8.3%). The associated risk factors in the three dimensions were: living in a poor household, being a boy, having a mother with basic education or less, and non-indigenous background or living in an urban area. Conclusions. Identifying groups of the population at higher risk for SFD provides useful information for targeted intervention implementation.Keywords: disability; risk factors; population at risk https://doi.org/10.21149/8494Resumen Objetivos. Reportar la prevalencia de dificultades funcionales y discapacidad severa (SFD) en una muestra nacional representativa de niños de 5 a 17 años en México; identificar los factores asociados con SFD; documentar los perfiles poblacionales que predicen SFD. Material y métodos. Se utilizaron los datos de la Encuesta Nacional de Niñas, Niños y Mujeres en México; se estimaron prevalencias e intervalos de confianza al 95%. Se ajustaron modelos bivariados y multivariados. Se examinaron las combinaciones de factores sociodemográficos que mejor predecían la SFD. Resultados. La prevalencia de SFD fue de 11.2%. Las SFD más prevalentes fueron en la dimensión socioemocional (8.3%). Los factores de riesgo asociados en las tres dimensiones fueron pobreza, ser hombre, tener una madre con educación primaria o menor, no ser indígena o vivir en zonas urbanas. Conclusiones. Identificar a los grupos con mayor riesgo de SFD dentro de la población proporciona información útil para el desarrollo de intervenciones.Palabras clave: discapacidad; factores de riesgo; población en riesgo
Background: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
Background:Access to biosimilar drugs in Mexico started on 2014. Although biosimilar drugs safety has proved comparability to originator drugs on trials, information about its safety on real-life data is limited.Objectives:To compare safety in terms of adverse events of biosimilar etanercept (BEt) to originator etanercept (OEt) using information from the Mexican Adverse Events Registry (BIOBADAMEX).Methods:BIOBADAMEX is a Mexican cohort that collects the information of biologic and biosimilar drugs used in patients with rheumatic diseases in public and private practice since 2016. Patients enrolled are followed- up yearly. For this study we included patients from 18 to 65 years old who were or are currently in treatment with OEt or BEt and analyzed the frequency of adverse events (AE), the severity and the outcome of these. Baseline time was considered at enrolment to the cohort. We used logistic regression to analyze univariable and multivariable associations.Results:At the time of analysis a total of 119 have received treatment with OEt, 38 with BEt. Mean follow up time was 1.35 years. Rheumatoid arthritis (RA) was the most common disease for all the groups followed by ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Both groups had similar baseline characteristics (Table 1). AE occurred in 4 (3.4%) patients with OEt and in 6 (15.8%) with BEt (OR 0.2, 95% CI 0.04-0.7). The most frequent AE in OEt group was allergic reaction, (2(2.5%) of patients), and infections were the most frequent AE in BEt group (2 (5.3%)). Of patients with BEt, 2(5.3%) had severe AE compared to none in the OEt (p=0.012). In the multivariable adjusted analysis comparing development of AE vs no AE including BEt, comorbidities and glucocorticoids, we found that use of BEt (OR 4.6, 95%CI 1.1-19.5) and presence of comorbidities (OR 4.6, 95%CI 1.01-20.5), were associated with AE. Use of glucocorticoids was not significantly associated.Table 1.Baseline characteristicsOriginator etanercept (n=119)Biosimilar Etanercept(n=38)UnivariableAnalysisaOR(95%CI)Sex (female), n(%)98 (82.4)27 (71.0)1.9 (0.8-4.4)Age, median (IQR)53.6 (45-61)51.3 (43-58)1.0 (0.9-1.0)Body Mass Index, median (IQR)27.5 (23.4-32.5)26.7 (24-29)1.0 (0.9-1.1)Diagnosis, n(%): Rheumatoid arthritis98 (82.4)26 (68)1 Ankylosing spondylitis13 (10.9)9 (24.0)0.3 (0.1-0.9) Psoriatic arthritis8 (6.9)3 (8.0)0.7 (0.1-2.8)Comorbidities, n(%):41 (34.5)14 (40.0)0.3 (0.3-1.5)Use of previous biologic, n(%):95 (79.8)16 (42.1)5.4 (2.5-11.9)Use of steroids, n(%):45 (37.8)22 (57.8)0.4 (0.2-0.9)Use of DMARD, n(%):94 (78.9)35 (92.1)0.3 (0.1-1.1)Adverse eventsb, n(%):4 (3.4)6 (15.8)0.2 (0.04-0.7)Infectionsb, n(%):1 (0.8)2 (5.3)0.15 (0.1-1.7)Allergic reactionsb, n(%):3 (2.5)1 (2.6)0.9 (0.1-9.5)Severeb, n(%):0 (0)2 (5.3)p=0.012caUnivariable logistic regression analysis.bCumulative at time of analyses,cChi-square test.Conclusion:This preliminary study showed that AE with BEt were more frequent as well as more severe compared to AE presented with OEt in patients with rheumatic diseases using BIOBADAMEX data. Our study suggests that use of BEt and comorbidities are associated with the development of AE. Follow up and inclusion of more participants is going on and will allow us to perform further analyses.References:[1]Rugo HS et al. Future Oncol. 2019;15(7):777-790[2]Moots RJ BioDrugs. 2018;32(3):193-199Disclosure of Interests:Vijaya Rivera Teran: None declared, Marcela Pérez Rodríguez: None declared, Deshire Alpizar-Rodriguez: None declared, Fedra Irazoque-Palazuelos Consultant of: Bristol-Myers Squibb, Janssen, Pfizer Inc, Roche and UCB, Sandra Carrilo: None declared, Sandra Sicsik: None declared, David Vega-Morales: None declared, Dafhne Miranda: None declared, angel castillo: None declared, Julio Cesar Casasola: None declared, Cesar Francisco Pacheco Tena: None declared, José Francisco Moctezuma: None declared, Francisco Aceves: None declared, Aleni Paz: None declared, Sergio Duran Barragan: None declared, Leonor Barile: None declared, Natalia Santana: None declared, Daniel Xavier Xibille Friedmann Consultant of: Lilly, Abbvie, Speakers bureau: Lilly, Abbvie
BackgroundPatients with rheumatic diseases (RD) have a higher risk of developing infections due to disease and immunosupressor treatment factors1. Biologic disease -modifying antirheumatic drugs (bDMARD) have been associated with the development of opportunistic infections, nevertheless their impact on severe infections has not been consistent2.ObjectivesTo 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.MethodsBIOBADAMEX 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.ResultsA 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 characteristicsInfectionn=42Without infectionn=738pFemale, n(%)33 (79)595 (80)0.74Age, median(IQR)50.9 (43-59)49.8 (40-58)0.58Disease duration (years), median (RIC)7.5 (2-16)7.0 (3-15)0.9Diagnostic, n(%): Rheumatoid arthritis25 (59)487 (66)0.42 Idiopathic Juvenile Arthritis0 (0)27 (4) Ankylosing Spondylitis6 (14)109 (15) Others11 (26)115 (15)Comorbidities, n(%):22 (52)329 (44.6)0.32Previous bDMARD, n(%):15 (36)271 (37)0.89Use of steroids, n(%):16 (38)274 (37)0.9cDMARD, n(%)33 (79)593 (80)0.77Severe Adverse Events, n(%)3 (7)11 (2)0.007 Outcome, n(%)Recovered without sequels3 (100)6 (55)p=0.34*Not recovered03 (27)Unknown02 (18)Infection site, n(%)Skin9 (21)Superior airways5 (12)Urinary tract4 (10)Agent, n(%)Gram- bacteria9 (21)Gram+ bacteria0 (0)Virus4 (14)*Chi2ConclusionThe frequency of infections in patients using bDMARD in Biobadamex is low compared to the frequency reported in similar studies in other countries3. 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 InterestsVIJAYA 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.
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