Adherencia al tratamiento con tofacitinib en pacientes con artritis reumatoide en la práctica clínica diaria / Adherence to Treatment with Tofacitinib in Patients with Rheumatoid Arthritis in Daily Clinical Practice

Objetivos: Evaluar la adherencia al tratamiento con tofacitinib en pacientes con artritis reumatoide (AR) mediante las dos versiones del autocuestionario Compliance Questionnaire Rheumatology, CQR19 y CQR5, determinar las variables asociadas a la adherencia a tofacitinib y comparar el rendimiento de ambos cuestionarios. Material y métodos: Estudio de corte transversal. Se incluyeron pacientes ≥18años de edad con AR (ACR/EULAR 2010) en tratamiento con tofacitinib. Se consignaron datos sociodemográficos, características clínicas de la enfermedad, tratamientos y datos sobre la evaluación de los pacientes. Todos los pacientes completaron los autocuestionarios CQR19 y CQR5. Análisis estadístico: Estadística descriptiva. T-test o Mann Whitney para variables continuas y test de chi cuadrado o test exacto de Fisher para las categóricas. Índice de concordancia kappa. Regresión logística múltiple. Resultados: Se incluyeron 52 pacientes, 82,7% mujeres, con una edad mediana (m) de 57,7años, tiempo de evolución de la enfermedad m 16años. El 63,5% presentaban comorbilidades. El 86,5% de los pacientes estaban tratados con tofacitinib (5mg dos veces/día) y el 48% recibía tofacitinib en monoterapia. El tiempo m de tratamiento con tofacitinib fue de 13meses. El 42,3% suspendieron el tratamiento y un solo paciente suspendió definitivamente por falta de provisión. La m de CQR19 fue del 89,5%, y el 84,6% de los pacientes presentaron una adherencia ≥80%. Las variables significativamente asociadas con adherencia ≥80% fueron la presencia de comorbilidades (p=0,014) y mayor edad (p=0,033). Considerando el CQR5, un porcentaje similar de pacientes (82,7%) fueron adherentes al tratamiento, aunque la concordancia con CQR19 fue baja (??: 0,227). En el análisis multivariado, mayor edad fue la única variable independientemente asociada a buena adherencia al tratamiento (p=0,037).(AU)

Objectives: To evaluate the adherence to treatment with tofacitinib in patients with rheumatoid arthritis (RA) using two versions of the self-questionnaire Compliance Questionnaire Rheumatology, CQR19 and CQR5, to determine the variables associated with adherence to tofacitinib and to compare the performance of both questionnaires. Material and methods: A cross-sectional study was carried out. We included patients ≥18years old, with RA (ACR/EULAR criteria 2010) under treatment with tofacitinib. Sociodemographic data, clinical characteristics, treatment and data on patient evaluation. All the patients completed self-questionnaires CQR19 and CQR5. Statistical analysis: Descriptive statistics. T-test or Mann Whitney to compare the continuous variables, chi2 test or Fisher's exact test for the categorical ones. Kappa concordance index. Multiple logistic regression. Results: We included 52 patients, 82.7% women, with a median (m) age of 57.7years, disease duration m 16years, 63.5% had comorbidities. Of the patients, 86.5% were treated with tofacitinib (5mg BID) and 48% received tofacitinib as monotherapy. The median time of tofacitinib treatment was 13months, 42.3% suspended treatment, and only one patient permanently stopped treatment due to lack of provision. Median CQR19 was 89.5%, and 84.6% had an adherence ≥80%. The variables significantly associated with adherence ≥80% were the presence of comorbidities (P=.014) and older age (P=.033). Considering the CQR5, a similar percentage of patients (82.7%) were adherents to treatment, however, the concordance with CQR19 was low. In the multivariate analysis, older age was the only variable independently associated with good adherence to treatment. Conclusions: Treatment adherence to tofacitinib was very good for both presentations. Older age was associated with higher adherence. The agreement between the questionnaires CQR19 and CQR5 was low.(AU)

Adherence to treatment with tofacitinib in patients with rheumatoid arthritis in daily clinical practice.

OBJECTIVES: To evaluate the adherence to treatment with Tofacitinib in patients with Rheumatoid Arthritis (RA) using two versions of the self-questionnaire Compliance Questionnaire Rheumatology, CQR19 and CQR5, to determine the variables associated with adherence to Tofacitinib and to compare the performance of both questionnaires. MATERIAL AND METHODS: A cross-sectional study was carried out. We included patients ≥18 years old, with RA (ACR/EULAR criteria 2010) under treatment with Tofacitinib. Sociodemographic data, clinical characteristics, treatment and data on patient evaluation. All the patients completed self-questionnaires CQR19 and CQR5. STATISTICAL ANALYSIS: Descriptive statistics. t-Test or Mann Whitney to compare the continuous variables, Chi2 test or Fisher's exact test for the categorical ones. Kappa concordance index. Multiple logistic regression. RESULTS: We included 52 patients, 82.7% women, with a median (m) age of 57.7 years, disease duration m 16 years, 63.5% had comorbidities. Of the patients, 86.5% were treated with Tofacitinib (5 mg BID) and 48% received Tofacitinib as monotherapy. The median time of Tofacitinib treatment was 13 months, 42.3% suspended treatment, and only one patient permanently stopped treatment due to lack of provision. Median CQR19 was 89.5% and 84.6% had an adherence ≥ 80%. The variables significantly associated with adherence ≥ 80% were the presence of comorbidities (p = .014) and older age (p = .033). Considering the CQR5, a similar percentage of patients (82.7%) were adherents to treatment, however, the concordance with CQR19 was low. In the multivariate analysis, older age was the only variable independently associated with good adherence to treatment. CONCLUSIONS: Treatment adherence to Tofacitinib was very good for both presentations. Older age was associated with higher adherence. The agreement between the questionnaires CQR19 and CQR5 was low.

Adherence to Treatment with Tofacitinib in Patients with Rheumatoid Arthritis in Daily Clinical Practice. / Adherencia al tratamiento con tofacitinib en pacientes con artritis reumatoide en la práctica clínica diaria.

OBJECTIVES: To evaluate the adherence to treatment with tofacitinib in patients with rheumatoid arthritis (RA) using two versions of the self-questionnaire Compliance Questionnaire Rheumatology, CQR19 and CQR5, to determine the variables associated with adherence to tofacitinib and to compare the performance of both questionnaires. MATERIAL AND METHODS: A cross-sectional study was carried out. We included patients ≥18years old, with RA (ACR/EULAR criteria 2010) under treatment with tofacitinib. Sociodemographic data, clinical characteristics, treatment and data on patient evaluation. All the patients completed self-questionnaires CQR19 and CQR5. STATISTICAL ANALYSIS: Descriptive statistics. T-test or Mann Whitney to compare the continuous variables, chi2 test or Fisher's exact test for the categorical ones. Kappa concordance index. Multiple logistic regression. RESULTS: We included 52 patients, 82.7% women, with a median (m) age of 57.7years, disease duration m 16years, 63.5% had comorbidities. Of the patients, 86.5% were treated with tofacitinib (5mg BID) and 48% received tofacitinib as monotherapy. The median time of tofacitinib treatment was 13months, 42.3% suspended treatment, and only one patient permanently stopped treatment due to lack of provision. Median CQR19 was 89.5%, and 84.6% had an adherence ≥80%. The variables significantly associated with adherence ≥80% were the presence of comorbidities (P=.014) and older age (P=.033). Considering the CQR5, a similar percentage of patients (82.7%) were adherents to treatment, however, the concordance with CQR19 was low. In the multivariate analysis, older age was the only variable independently associated with good adherence to treatment. CONCLUSIONS: Treatment adherence to tofacitinib was very good for both presentations. Older age was associated with higher adherence. The agreement between the questionnaires CQR19 and CQR5 was low.

Changing rate of serious infections in biologic-exposed rheumatoid arthritis patients. Data from South American registries BIOBADABRASIL and BIOBADASAR.

OBJECTIVE: Most reports on serious infections (SI) in rheumatoid arthritis (RA) patients treated with biological disease-modifying antirheumatic drugs (bDMARDs) are from the USA and Western Europe. Data from other regions are largely missing. We report data from South American countries with different backgrounds and health-care systems but similar registries. METHODS: We merged 2010-2016 data from two registries, BIOBADABRASIL (Brazil) and BIOBADASAR (Argentina), which share the same protocol, online platform and data monitoring process. Patients with active RA were included when they began the first bDMARD or a conventional synthetic DMARD (csDMARD, control group). The SI incidence rate (IR) per 1000 patient/years and adjusted IR ratio (aIRR) were estimated for bDMARDs and csDMARDs. RESULTS: Data were analysed for 3717 RA patients with an exposure of 13,380 patient/years. The 2591 patients treated with bDMARDs (64% tumour necrosis factor-α inhibitors (TNFi)) had a follow-up of 9300 years, and the 1126 treated with csDMARDs had an exposure of 4081 patient/years. The SI IR was 30.54 (CI 27.18-34.30) for all bDMARDs and 5.15 (CI 3.36-7.89) for csDMARDs. The aIRR between the two groups was 2.03 ([1.05, 3.9] p = 0.034) for the first 6 months of treatment but subsequently increased to 8.26 ([4.32, 15.76] p < 0.001). The SI IR for bDMARDs decreased over time in both registries, dropping from 36.59 (28.41-47.12) in 2012 to 7.27 (4.79-11.05) in 2016. CONCLUSION: While SI remains a major concern in South American patients with RA treated with bDMARDs, a favourable trend toward a reduction was observed in the last years.Key Points• New comprehensive data on biologic drugs safety from international collaboration in South America.• First proposal for national registries data merging in South America.• Serious infections remain a major concern in RA patients treated with biologics.• A significant reduction of serious infections in RA patients exposed to biologics was observed over a 7 years period.

Tuberculin test conversion in patients with chronic inflammatory arthritis receiving biological therapy.

OBJECTIVE: The blockade of inflammatory mediators produced by biological therapies is associated with an increased risk of opportunistic infections, as for example Mycobacterium tuberculosis (MT). Given the endemic situation of tuberculosis (TB) in some countries and immunosuppression/anergy of patients with chronic inflammatory arthritis, we wonder whether it is necessary to monitor the MT infection after starting the biological treatment. To evaluate the frequency of the tuberculin skin test (TST) conversion and its association with an active TB infection and other disease variables. METHODS: Patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), and spondyloarthritis (SpA) receiving treatment with anti-TNF, tocilizumab, and/or abatacept agents were included into the study. Patients had to have a negative TST (<5 mm) at the baseline, and a second TST was performed 2-22 months after the initiation of biologic therapy. The TST conversion was considered as a variation ≥5 mm between the two TSTs performed within an interval between 2 months and 2 years. RESULTS: A total of 85 patients were included into the study, and 78.8% were women, with a median schooling duration of 12 years. A total of 74.1% of patients had RA, 16.5% psoriatic arthritis, and 4.7% AIJ and ankylosing spondylitis. Regarding treatment, 75.3% received anti-TNF therapy (31.8% etanercept, 21.2% adalimumab, 17.6% infliximab, 3.5% golimumab, and 1.2% certolizumab), 15.3% tocilizumab, and 9.4% abatacept. Eight patients (9.4%) developed a TST conversion. The shift was more frequent in men (62.5%) than in women (37.5%) (p=0.009), and in those with a prolonged disease duration (X 226±109 vs X130±105 [p=0.017]). This association remained after adjusting for other variables. All patients who developed a TST conversion received prophylactic isoniazid, and only one patient with other risk factors developed active TB. CONCLUSION: The frequency of a TST conversion in patients with chronic inflammatory arthritis was low and was associated with male gender and longer disease duration.

Viraje tuberculínico en pacientes con artritis inflamatorias crónicas y terapia biológica / Tuberculin test conversión in patients with chronic inflammatory arthritis and biological therapy

Introducción: El bloqueo de los mediadores inflamatorios producido por las terapias biológicas se asocia a un aumento de las infecciones oportunistas, como infección por Mycobacterium tuberculosis (MT), por lo que se recomienda realizar intradermorreacción de derivado proteico purificado (PPD) antes de iniciar dicho tratamiento. Teniendo en cuenta la situación endémica de tuberculosis (TBC) en nuestro país y la inmunosupresión/anergia de los pacientes con artritis inflamatorias crónicas, nos planteamos si es necesario monitorear la infección de MT luego de iniciado el tratamiento biológico. Objetivos: Evaluar la frecuencia de viraje de PPD y la asociación del viraje con infección activa por MT u otras variables. Materiales y métodos: Se incluyeron pacientes con Artritis Reumatoidea (AR), Artritis Idiopática Juvenil (AIJ) y Espondiloartritis (EsP) en tratamiento con agentes Anti-TNFα, Tocilizumab y/o Abatacept. Los pacientes debían tener una PPD negativa (<5 mm) basal y una segunda PPD realizada entre los 2 y 22 meses posteriores. Se consignaron datos sociodemográficos (edad, género, estatus social, hacinamiento), antecedentes patológicos (desnutrición, alcoholismo, tuberculosis y sus contactos), tipo de enfermedad reumática y tiempo de evolución, índices de actividad (RAPID-3, BASDAI), de función (BASFI, HAQ-II) y tratamiento concomitante con corticoides (CT), drogas modificadoras de la enfermedad (DME) y terapia biológica (TB). Se consideró viraje de PPD a una variación ≥ a 5 mm entre dos pruebas realizadas con intervalo entre 2 meses y 2 años. En caso de viraje se recomendó seguimiento por Neumonología e Infectología. Análisis estadístico: las variables categóricas se compararon por Chi2 y test exacto de Fisher y las continuas por T-test o Mann-Whitney. Regresión logística múltiple. Resultados: Se incluyeron 85 pacientes, 78,8% eran mujeres, con una escolaridad mediana de 12 años. El 98,8% tenía residencia urbana, 12,9% tenía criterios de hacinamiento y 8,2% ingresos inferiores a la línea de pobreza. 5,9% de los pacientes había padecido TBC con cumplimiento de tratamiento completo y 2,4% reportó contactos con TBC. En cuanto al tipo de artropatía inflamatoria crónica, el 74,1% de los pacientes tenían AR, el 16,5% Artritis Psoriásica (APs) y 4,7% tanto AIJ como Espondilitis Anquilosante. Con respecto al tratamiento, 18,8% recibía más de 10 mg diarios de esteroides orales, el 91,8% DME, (84,7% Metotrexato y 21,2% Leflunomida). El 75,3% recibía terapia Anti-TNFα (31,8% Etanercept, 21,2% Adalimumab, 17,6% Infliximab, 3,5% Golimumab y 1,2% Certolizumab), el 15,3% Tocilizumab y el 9,4% Abatacept. De los 85 pacientes, 8 viraron (9,4%). El viraje fue más frecuente en varones 62,5% vs mujeres 37,5% (p=0,009) y en aquellos con mayor tiempo de evolución de enfermedad en meses [X226±109 vs X130±105 (p=0,017)]. Esta asociación se mantuvo luego de ajustar para otras variables. Todos los pacientes que presentaron viraje recibieron isoniacida (INH) profiláctica y sólo un paciente, con factores de riesgo, desarrolló tuberculosis activa. Conclusión: La frecuencia del viraje tuberculínico en pacientes con artritis inflamatorias crónicas fue baja y se asoció a sexo masculino y mayor tiempo de evolución de la enfermedad