Quality evaluation of the underlying evidence in the updated treatment recommendations for systemic lupus erythematosus

Abstract

Objective Systemic lupus erythematosus (SLE) is a multisystem autoimmune disorder known for its broad clinical spectrum. Recently, the European, British and Latin American rheumatology professional societies (EULAR, BSR and PANLAR) published updated recommendations for SLE management. The objective of this study was to characterize the data supporting the updated recommendations, with the goal of highlighting areas which could benefit from additional high-quality research. Methods References were compiled from the recently published EULAR, BSR and PANLAR SLE treatment recommendations. Data collected from each study included publication year, treatment regimen, study design, sample size, inclusion and exclusion criteria and relevant SLE diagnostic criteria. Studies with less than 10 patients and those which did not specify the SLE diagnostic criteria used were excluded. Results Altogether 250 studies were included in this study. The majority were prospective and retrospective cohorts (72%), with only a small percentage of randomized controlled trials (28%). The median number of patients included was 37 (IQR 19-86). The revised American College of Rheumatology (ACR) 1982 criteria were the most commonly used criteria for SLE diagnosis (52%), followed by the revised ACR criteria from 1997 (27%). Only a small proportion of studies included the use of disease activity scores when defining study population (15%). Conclusions Our study has indicated a scarcity of sufficiently powered high-quality research referenced in the recently published SLE treatment guidelines. Well-designed large-scale studies utilizing the updated 2019 SLE diagnostic criteria are needed to better inform healthcare professionals caring for patients with SLE.

Systemic lupus erythematosus: history and modernity

“…Наконец, в рекомендациях по лечению АФС подчеркивается неэффективность прямых антикоагулянтов в отношении профилактики рецидивирования тромбозов [52,54]. В то же время анализ материалов клинических исследований, послуживших основой для разработки рекомендаций по лечению СКВ, показал, что подавляющее большинство из них включало проспективные или ретроспективные когорты пациентов (только около трети представляли собой рандомизированные плацебо-контролируемые исследования (РПКИ)), а для диагностики СКВ и оценки эффективности терапии редко использовались современные классификационные критерии и индексы активности СКВ [55]. Таким образом, даже современные рекомендации по лечению СКВ имеют недостаточно высокий уровень доказательности (часто основаны на мнении экспертов) и не всегда соответствуют критериям «медицины, основанной на доказательствах».…”