Publication
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.
| dc.contributor.author | Jesus, D. | |
| dc.contributor.author | Matos, A. | |
| dc.contributor.author | Henriques, Carla | |
| dc.contributor.author | Doria, A. | |
| dc.contributor.author | Inês, L. | |
| dc.date.accessioned | 2022-11-17T14:04:24Z | |
| dc.date.available | 2022-11-17T14:04:24Z | |
| dc.date.issued | 2022-05-23 | |
| dc.date.updated | 2022-11-16T19:44:52Z | |
| dc.description.abstract | 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. | pt_PT |
| dc.description.version | info:eu-repo/semantics/publishedVersion | pt_PT |
| dc.identifier.doi | 10.1136/annrheumdis-2022-eular.3634 | pt_PT |
| dc.identifier.issn | 0003-4967 | |
| dc.identifier.issn | 1468-2060 | |
| dc.identifier.slug | cv-prod-3080324 | |
| dc.identifier.uri | http://hdl.handle.net/10400.19/7401 | |
| dc.language.iso | eng | pt_PT |
| dc.peerreviewed | yes | pt_PT |
| dc.subject | Systemic lupus erythematosus | |
| dc.subject | Sjogren's syndrome and anti-phospholipid syndrome | |
| dc.title | 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. | pt_PT |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.citation.endPage | 285 | pt_PT |
| oaire.citation.issue | Suppl 1 | pt_PT |
| oaire.citation.startPage | 284.2 | pt_PT |
| oaire.citation.title | Annals of the Rheumatic Diseases | pt_PT |
| oaire.citation.volume | 81 | pt_PT |
| person.familyName | Henriques | |
| person.givenName | Carla | |
| person.identifier.ciencia-id | F91C-B000-9ED8 | |
| person.identifier.orcid | 0000-0002-2142-2849 | |
| person.identifier.scopus-author-id | 8955187400 | |
| rcaap.cv.cienciaid | 961C-1FBD-5555 | Ana Cristina Bico Rodrigues de Matos | |
| rcaap.rights | openAccess | pt_PT |
| rcaap.type | article | pt_PT |
| relation.isAuthorOfPublication | 9138da60-0a34-4302-b547-864d612c30b8 | |
| relation.isAuthorOfPublication.latestForDiscovery | 9138da60-0a34-4302-b547-864d612c30b8 |