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Performance of classification criteria for Sjögren’s disease in clinical practice
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Introdução: Os critérios de classificação da Doença de Sjögren (DSj) demostraram alta sensibilidade e especificidade em estudos de validação na prática clínica. No entanto, estes estudos foram realizados em coortes bem controladas, o que não reflete o dia a dia clínico.
Objetivos: Avaliar o desempenho dos critérios de classificação ACR/EULAR de 2016 para a DSj na prática clínica e identificar subgrupos de doentes nos quais o preenchimento dos critérios poderá ser mais desafiante.
Métodos: Estudo de coorte retrospetivo multicêntrico, incluindo doentes com diagnóstico clínico de DSj, registados no PORTRESS – Registro Português de DSj – até Novembro de 2023. Foram colhidos dados demográficos, clínicos, laboratoriais e anátomo-patológicos. A análise univariada foi realizada com os testes Chi-quadrado e Mann-Whitney. Os preditores para o preenchimento dos critérios de classificação foram determinados através de regressão logística binominal.
Resultados: Foram incluídos um total de 1375 doentes. A sensibilidade dos critérios de classificação ACR/EULAR de 2016 foi de 48% (n=663). Mais de metade dos doentes (52%, n=772) da coorte PORTRESS, não preencheram os critérios de classificação e não podem ser incluídos em ensaios clínicos. Os doentes com DSj que preenchem os critérios de classificação ACR/EUALR de 2016 apresentam uma doença mais prolongada (11.7 (7.0-18.0) vs. 11.0 (6.0-17.0) anos, p=0.049), e um maior atraso no diagnóstico (2.5 (1.0-6.0) vs. 2.0 (1.0-6.0) anos, p=0.038), do que os doentes que não preenchem os critérios. O preenchimento dos critérios de classificação foi menos frequente num subgrupo de doentes caracterizado pela maior prevalência de envolvimento sistémico, principalmente nos domínios biológico, hematológico e articular do ESSDAI. Na análise multivariada, os preditores mais importantes para o preenchimento dos critérios incluem um focus score 1 na biópsia (OR: 48,76 [CI: 13,4-177,8]), na presença de anti-SSA (OR:36,5 [CI:9,4-140,8]), e um teste de Schirmer positivo (OR:8,75 [CI: 2,9-26,7]), Nagelkerke R2=0.67. Entre os itens minor dos critérios, o teste de Schirmer demostrou ser o item mais importante na predição do preenchimento dos critérios com 2% de aumento na classificação dos doentes (11% aumento no Nagelkerke R2). Conclusão: Um número considerável de doentes diagnosticados com DSj da coorte PORTRESS não preenchem os critérios de classificação ACR/EULAR de 2016, sendo assim excluídos da participação em ensaios clínicos.
Introduction: The 2016 ACR/EULAR classification criteria for Sjögren’s disease (SjD) have demonstrated high sensitivity and specificity in clinical practice validation studies. However, these studies were conducted in well-controlled cohorts, which do not reflect everyday clinical practice. Objectives: To evaluate the performance of 2016 ACR/EULAR classification criteria for SjD in real-life clinical practice and to identify subgroups of patients in which classification criteria fulfillment may be more challenging. Methods: Multicentre retrospective cohort study, including patients with a clinical diagnosis of SjD, registered in PORTRESS — the Portuguese Registry of SjD — up to November 2023. Demographic, clinical, laboratory and pathological data were collected. Univariate analysis was performed using Chi-square or Mann-Whitney test. Predictors of classification criteria fulfillment were identified through binominal logistic regression modeling. Results: A total of 1375 patients were included. The sensitivity of the 2016 ACR/EULAR criteria was 48% (n=663). Over half of the patients (52%, n=772) within the PORTRESS cohort, did not meet classification criteria and cannot be included in research studies or recruited for clinical trials. Patients with SjD that fulfill the 2016 ACR/EULAR classification criteria exhibit a longer disease duration (11.7 (7.0-18.0) vs. 11.0 (6.0-17.0) years, p=0.049), and a greater delay in diagnosis (2.5 (1.0-6.0) vs 2.0 (1.0-6.0) years, p=0.038), than patients who do not fulfill the criteria. Classification criteria fulfillment was less common in a subgroup of patients characterized by higher prevalence of systemic involvement, mainly in biological, hematological and articular ESSDAI domains. On multivariate analysis, the most important predictors for fulfillment of the criteria include a focus score 1 on biopsy (OR: 48,76 [CI: 13,4-177,8]), the presence of anti-SSA antibodies (OR:36,5 [CI:9,4-140,8]), and a positive Schirmer’s test (OR:8,75 [CI: 2,9-26,7]), Nagelkerke R2=0.67. Among minor items from the criteria, Schirmer’s test revealed to be the most important predictor for criteria fulfillment with 2% increase in patient classification (11% increase in Nagelkerke R2). Conclusion: A considerable number of patients diagnosed with SjD from the PORTRESS cohort do not meet 2016 ACR/EULAR classification criteria, which consequently excludes them from participation in clinical trials. Harmonization of diagnosis and classification of SjD remains a significant unmet need.
Introduction: The 2016 ACR/EULAR classification criteria for Sjögren’s disease (SjD) have demonstrated high sensitivity and specificity in clinical practice validation studies. However, these studies were conducted in well-controlled cohorts, which do not reflect everyday clinical practice. Objectives: To evaluate the performance of 2016 ACR/EULAR classification criteria for SjD in real-life clinical practice and to identify subgroups of patients in which classification criteria fulfillment may be more challenging. Methods: Multicentre retrospective cohort study, including patients with a clinical diagnosis of SjD, registered in PORTRESS — the Portuguese Registry of SjD — up to November 2023. Demographic, clinical, laboratory and pathological data were collected. Univariate analysis was performed using Chi-square or Mann-Whitney test. Predictors of classification criteria fulfillment were identified through binominal logistic regression modeling. Results: A total of 1375 patients were included. The sensitivity of the 2016 ACR/EULAR criteria was 48% (n=663). Over half of the patients (52%, n=772) within the PORTRESS cohort, did not meet classification criteria and cannot be included in research studies or recruited for clinical trials. Patients with SjD that fulfill the 2016 ACR/EULAR classification criteria exhibit a longer disease duration (11.7 (7.0-18.0) vs. 11.0 (6.0-17.0) years, p=0.049), and a greater delay in diagnosis (2.5 (1.0-6.0) vs 2.0 (1.0-6.0) years, p=0.038), than patients who do not fulfill the criteria. Classification criteria fulfillment was less common in a subgroup of patients characterized by higher prevalence of systemic involvement, mainly in biological, hematological and articular ESSDAI domains. On multivariate analysis, the most important predictors for fulfillment of the criteria include a focus score 1 on biopsy (OR: 48,76 [CI: 13,4-177,8]), the presence of anti-SSA antibodies (OR:36,5 [CI:9,4-140,8]), and a positive Schirmer’s test (OR:8,75 [CI: 2,9-26,7]), Nagelkerke R2=0.67. Among minor items from the criteria, Schirmer’s test revealed to be the most important predictor for criteria fulfillment with 2% increase in patient classification (11% increase in Nagelkerke R2). Conclusion: A considerable number of patients diagnosed with SjD from the PORTRESS cohort do not meet 2016 ACR/EULAR classification criteria, which consequently excludes them from participation in clinical trials. Harmonization of diagnosis and classification of SjD remains a significant unmet need.
Descrição
Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2024
Palavras-chave
Doença de Sjögren Critérios de classificação Envolvimento sistémico Reumatologia