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- OP0147 THE SLE-DAS REMISSION AND LOW DISEASE ACTIVITY STATES DISCRIMINATE DRUG FROM PLACEBO AND BETTER HEALTH-RELATED QUALITY OF LIFE: POST-HOC ANALYSIS OF THE BLISS-52 AND BLISS-76 PHASE III TRIALS.Publication . Jesus, D.; Henriques, Carla; Matos, A.; Doria, A.; Inês, L.Background Accurate and practical outcome measures for clinical trials in systemic lupus erythematosus (SLE) are lacking. The SLE Disease Activity Score (SLE-DAS) is a recently validated 17-item instrument, with high accuracy and sensitivity to changes in SLE disease activity. The SLE-DAS definitions of remission and low disease activity (LDA) were newly validated in the clinical setting1,2. These definitions may constitute accurate and easy to apply endpoints for SLE trials. Objectives (1) To evaluate the ability of SLE-DAS remission and LDA definitions to discriminate drug from placebo in SLE phase 3 trials; (2) To determine if attainment of these SLE-DAS targets are associated with better health-related quality of life (HR-QoL). Methods Post-hoc analysis of the merged study population in the BLISS-52 and -76 trials (NCT00424476; NCT00410384) of intravenous belimumab versus placebo for moderate to severe SLE disease activity. We analyzed the British Isles Lupus Assessment Group (BILAG), Physician Global Assessment (PGA), Functional Assessment of Chronic Illness Therapy (FACIT) and 36-Item Short Form Survey (SF-36) trial data. The fulfillment of SLE-DAS remission and LDA definitions were retrospectively assessed from the individual participants’ data. Proportion of patients attaining SLE-DAS Boolean remission (defined as absence of all SLE-DAS clinical items and prednisone ≤5mg/day) and LDA (defined as SLE-DAS≤2.48 and prednisone ≤7.5mg/day), at week 52, was compared between belimumab and placebo arms, using likelihood ratio chi-square test. We further compared the SF-36 physical component summary (PCS) and mental component summary (MCS) and domain scores and the FACIT score between patients attaining SLE-DAS remission vs non-remission and SLE-DAS LDA vs non-LDA, using t-test and Mann-Whitney test. Results A total of 1684 SLE patients were included: 562 on placebo, 559 on belimumab 1mg/Kg and 563 on belimumab 10mg/Kg. At week 52, significantly more patients attained SLE-DAS LDA on belimumab 1mg/Kg and 10mg/Kg as compared with placebo (13.0% vs 17.9%, OR=1.459, p=0.023, and 13.0% vs 21.7%, OR=1.853, p<0.001, respectively). Likewise, more patients attained SLE-DAS remission on belimumab 10mg/Kg as compared with placebo (10.1% vs 14.7%, OR= 1.532, p=0.019) (Table 1). Importantly, none of the patients achieving SLE-DAS remission or LDA presented a new BILAG A or more than 1 new B domain score, neither a worsening in PGA≥0.3. Conclusion The SLE-DAS remission and LDA showed discriminant validity for identifying patients receiving active drug in clinical trials. These treatment targets are associated with better HR-QoL and lower fatigue.
- POS0119 SLE-DAS REMISSION AND LOW DISEASE ACTIVITY STATES ARE ASSOCIATED WITH IMPROVED HEALTH-RELATED QUALITY OF LIFE AND FATIGUE: POST-HOC ANALYSIS OF THE BLISS-52 AND BLISS-76 PHASE III TRIALS.Publication . Jesus, D.; Matos, A.; Henriques, Carla; Doria, A.; Inês, L.Background Accurate and practical outcome measures for clinical trials in systemic lupus erythematosus (SLE) are lacking. The SLE Disease Activity Score (SLE-DAS) is a recently validated 17-item instrument, with high accuracy and sensitivity to changes in SLE disease activity. The SLE-DAS definitions of remission and low disease activity (LDA) were newly validated against disease activity physician-applied measures in the clinical setting [1, 2]. Criterion validity of SLE-DAS for Patient Reported Outcomes, namely health-related quality of life (HR-QoL) and fatigue needs to be assessed. Objectives To evaluate if the attainment of SLE-DAS remission and LDA states is associated with improvements in HR-QoL and fatigue. Methods Post-hoc analysis of the merged study population in the BLISS-52 and -76 trials (NCT00424476; NCT00410384) of intravenous belimumab versus placebo for moderate to severe SLE disease activity. We analysed the Functional Assessment of Chronic Illness Therapy (FACIT) and 36-Item Short Form Survey (SF-36) trial data. Fulfillment of SLE-DAS remission (defined as absence of all SLE-DAS clinical items and prednisone ≤5mg/day) and LDA (defined as SLE-DAS≤2.48 and prednisone ≤7.5mg/day) definitions were retrospectively assessed from the individual participants’ data. Mean changes from study baseline to week 52 in FACIT and SF-36 physical component summary (PCS) and mental component summary (MCS) and domain scores were compared between patients attaining at week 52 the SLE-DAS remission vs non-remission and the SLE-DAS LDA vs non-LDA using multivariate regression analysis adjusted for baseline scores. Results A total of 1684 SLE patients were included. Few patients were in SLE-DAS remission (0.5%) and LDA (0.8%) at study entry. At week 52, 12.5% patients attained SLE-DAS remission and 17.5% attained SLE-DAS LDA. Mean improvements in SF-36 PCS and MCS scores were greater in patients that attained SLE-DAS remission vs non-remission (5.4 vs 3.4, and 4.6 vs 2.7, respectively; multivariate p<0.005 for both) and SLE-DAS LDA vs non-LDA (5.0 vs 3.4 and 4.6 vs 2.6, respectively; multivariate p<0.005 for both), at week 52 (Figure 1). Similarly, improvements in all individual domain scores were greater in SLE-DAS remission vs non-remission patients (all multivariate p<0.005) and SLE-DAS LDA vs non-LDA patients (all multivariate p<0.005) (Figure 1). Importantly, improvements in the summary scores and in all the individual domain scores largely exceeded the minimum clinically important differences (MCIDs) of 2.5 and 5 points, respectively, in those patients attaining SLE-DAS remission or LDA. Additionally, mean improvements in FACIT scores were higher in SLE-DAS remission than non-remission (6.3 vs 3.6, multivariate p<0.001) and in SLE-DAS LDA than non-LDA (5.9 vs 3.6, multivariate p<0.001), and exceeded the MCID of 4 points. Conclusion Attainment of SLE-DAS remission and LDA is associated with meaningful improvement in HR-QoL and fatigue.
- O envolvimento da família na motivação para a leituraPublication . Pereira, Patrick Fernandes; Melão, Dulce; Menezes, LuísO presente Relatório Final de Estágio (RFE) encontra-se dividido em duas partes: a primeira é uma reflexão crítica sobre a Prática de Ensino Supervisionada (PES) no 1.º Ciclo do Ensino Básico (CEB) e na Educação Pré-Escolar (EPE), e a segunda parte é relativa ao projeto de investigação desenvolvido em contexto de estágio no âmbito da PES na EPE. A primeira parte do RFE, contempla uma retrospetiva do percurso no 1.º CEB e na EPE, realizados na PES I e II, e uma reflexão sobre os contextos e as aprendizagens realizadas. Esta parte foi baseada nos elementos dos dossiês semestrais elaborados. A segunda parte do RFE inclui um estudo empírico, que resulta de um trabalho de investigação, visando conhecer o envolvimento da família na motivação para a leitura. O estudo de caráter qualitativo aplicado em EPE, foi realizado com recurso à observação, recolha documental, atividades de leitura, vídeos e inquéritos por questionário. Esta investigação possibilitou-nos concluir que os Pais/Encarregados de Educação (EE) se envolviam na vida escolar dos seus educandos, e constatar a importância de tal envolvimento.