Clinical relevance of monitoring serum adalimumab levels in axial spondyloarthritis.

Our aim was to assess the relationship between serum adalimumab levels, anti-drug antibodies (ADA) and disease activity in patients with axial spondylarthritis (SpA). We have carried out a single-centre cross-sectional study. adalimumab and ADA levels were analysed with ELISA and correlated with SpA activity using BASDAI and ASDAS scores. Adalimumab cut-off value was calculated to discriminate inactive disease/low disease activity (BASDAI < 4; ASDAS < 2.1) from moderate/high disease activity (BASDAI ≥ 4; ASDAS ≥ 2.1), using a receiver operating characteristic (ROC) curve. Up to January 2016, 51 consecutive patients were included. The median (range) age was 46.6 (18-68) and 47.1% were women. ADA prevalence was 27.5%, with none detected in the 21.6% receiving concomitant disease-modifying antirheumatic drugs (DMARDs) (p = 0.021). Adalimumab level was normal (> 3 mg/l) in 36 patients (70.6%), all without ADA. Fifteen patients (29.4%) had subtherapeutic adalimumab levels (< 3 mg/l), with ADA in 14 (93%). Median adalimumab (mg/l) was significantly higher in patients with inactive disease/low disease activity: BASDAI < 4 vs ≥ 4: 9.5 vs 2.6 (p < 0.01); ASDAS-CRP < 2.1 vs ≥ 2.1: 9.3 vs 0.3 (p < 0.001); ASDAS-ESR < 2.1 vs ≥ 2.1: 9.9 vs 3.0 (p < 0.001), and this finding was consistent with the result of the multivariate model. Patients with inactive disease/low disease activity presented significantly lower ADA levels. The adalimumab level cut-offs and area under the curve (AUC) obtained in the ROC curves were: ASDAS-CRP (< 2.1) 4.6 mg/l (AUC 81.2%; 95% CI 67.5-94.9; p < 0.001); ASDAS-ESR (< 2.1) 7.7 mg/l (AUC 82.4%; 95% CI 69.3-95.5; p < 0.001); BASDAI (< 4) 6.4 mg/l (AUC 73.5%; 95% CI 58.6-88.3; p < 0.01). In conclusion, presence of ADA in axial SpA patients treated with adalimumab was associated with lower serum drug levels. ADA levels were lower and adalimumab levels were higher in patients with inactive disease/low disease activity based on BASDAI and ASDAS indices. Concomitant treatment with MTX reduces de likelihood of finding ADA. Serum adalimumab levels above 4.6 mg/l are recommended to avoid compromising efficacy.

[The balanced scorecard used as a management tool in a clinical laboratory: internal business processes indicators]. / Cuadro de mando integral en el laboratorio clínico: indicadores de perspectiva interna del negocio.

OBJECTIVE: to propose a set of indicators as a management tool for a clinical laboratory, by using the balanced scorecard internal business processes perspective. MATERIAL AND METHODS: indicators proposed are obtained from different sources; external proficiency testing of the Valencia Community Government, by means of internal surveys and laboratory information system registers. One year testing process proportion indicators results are showed. RESULTS: internal management indicators are proposed (process, appropriateness and proficiency testing). The process indicators results show gradual improvement since its establishment. CONCLUSION: after one years of using a conceptually solid Balanced Scorecard Internal business processes perspective indicators, the obtained results validate the usefulness as a laboratory management tool.

Cuadro de mando integral en el laboratorio clínico: indicadores de perspectiva interna del negocio / The balanced scorecard used as a management tool in a clinical laboratory: internal business processes indicators

Objetivo: proponer un sistema de indicadores como instrumento de dirección para el laboratorio clínico, desde la perspectiva de gestión interna de un cuadro de mando integral. Material y métodos: los indicadores se obtienen de distintas fuentes, a través de registros internos del sistema informático del laboratorio, control externo de calidad de la Generalitat Valenciana. Se muestran los resultados de los indicadores de proceso analítico (proporción) de un año. Resultados: se proponen indicadores de gestión interna (divididos en proceso, adecuación y control de calidad). Los indicadores de proceso muestran una progresiva mejora desde su establecimiento. Conclusión: tras un año de utilización de los indicadores de proceso analítico de un cuadro de mando integral en el laboratorio, los resultados obtenidos validan su utilidad como instrumento para la gestión del laboratorio (AU)

Objective: to propose a set of indicators as a management tool for a clinical laboratory, by using the balanced scorecard internal business processes perspective. Material and methods: indicators proposed are obtained from different sources; external proficiency testing of the Valencia Community Government, by means of internal surveys and laboratory information system registers. One year testing process proportion indicators results are showed. Results: internal management indicators are proposed (process, appropriateness and proficiency testing). The process indicators results show gradual improvement since its establishment. Conclusion: after one years of using a conceptually solid Balanced Scorecard Internal business processes perspective indicators, the obtained results validate the usefulness as a laboratory management tool (AU)

Disminución de la demanda de laboratorio tras la modificación del formato de solicitud / No disponible

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