Abstract

BackgroundTreat to Target strategies are necessary in Systemic Lupus Erythematosus (SLE). They are difficult to establish due to the heterogeneity of the disease. The current definitions of Lupus Low Disease Activity State (LLDAS) according to the Asia Pacific Lupus Collaboration (APLC) and remission according to Definition of Remission in SLE (DORIS) 2021 are difficult to achieve and maintain over time.ObjectivesTo evaluate the concordance between the LLDAS and the clinical status according to the rheumatologist opinion and reasons of disagreement. To explore modifications in LLDAS definition that best fit with the expert´s opinion.MethodsProspective multicenter study of SLE patients (ACR 1997 Classification Criteria or clinical diagnosis by the physician) from seven Spanish Rheumatology Departments. Statistical analysis: descriptive cross-sectional (at the time of recruitment) analysis of the demographic and clinical characteristics, treatments; remission and LLDAS and the subjective evaluations of SLE activity by the rheumatologist. Analysis of the level of agreement between expert opinion and the definition of LLDAS and its modification were evaluated using Cohen’s kappa.ResultsDEMOGRAPHIC, DISEASE CHARACTERISTICS AND TREATMENTS. Five hundred and eight were included (92% women; mean age (±SD): 50.4 years (±13.7)). Mean SLEDAI-2K (±SD) was 2.84 (±3.31). A total of 406 (79.9%) patients presented SLEDAI-2K≤4. A total of 317 (74.1%) patients were on antimalarial treatment. Two hundred and twenty-two (43.7%) patients were on some type of immunosuppressive or biological therapy. More than half of patients were not taking glucocorticoids (n=310, 61%). A total of 38 patients (7.5%) were taking doses of prednisone higher than 7.5mg/day.REMISSION/LLDAS 267 (54.4%) patients were in remission and 304 (62.7%) patients were in LLDAS. According to the expert opinion of the rheumatologist, remission was the most frequent state considered (n=206, 41.6%); followed by low activity (n=153, 30.9%); serologically active (n=71, 14.3%); moderate activity (n=55, 11.1%) and high activity (n=10, 2%).AGREEMENT Overall agreement between expert opinion and the definition of LLDAS was 71.4 % with a Cohen’s kappa of 0.3. The majority of the cases (96.1%) that fulfilled the definition of LLDAS, were classified by the expert as remission, serologically active or low activity. Only 12 (3,9%) patients were classified by the expert as moderate or high activity. Of the patients that did not fulfill the definition of LLDAS, 126 out of 179 (70.4%) patients were classified by the expert as remission/low disease activity (Figure 1). The main reasons for discordance in the group that did not fulfill the definition of LLDAS were the presence of new clinical features compared to previous visit and a SLEDAI 2-K >4, in 74 (58.7%) and 59 (46.8%) patients, respectively. The LLDAS adjustment that meant a significant increase in the agreement was the exclusion of the comparative features with the previous visit, with an increase in the agreement to 82.6% (95% CI: 81.61-83.96%). The modification of prednisone to 5mg/daily dose, did not represent a significant change in agreement from the original definition.Figure 1.Comparison of LLDAS and expert opinionConclusionAt a given point in time, almost two thirds of SLE patients were in remission or in LLDAS. There is a good correlation between LLDAS and the physician’s opinion, particularly for those patients who fulfill LLDAS definition. However, the agreement is not so good for patients who don’t, these being excessively classified by the physician as remission or low activity. The main LLDAS items causing this disagreement were a SLEDAI-2K >4 and the appearance of different clinical manifestations from the previous evaluation. On the contrary, physician assessment by the PGA adequately fits the LLDAS definition. The modification of the LLDAS definition excluding the comparison with previous assessment increases the agreement with the expert opinion to 82.6%.Disclosure of InterestsNone declared

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