Residual disease activity and treatment intensification in systemic lupus erythematosus: A cross-sectional study to quantify the need for new therapies

Abstract

Objective The proportion of SLE patients with residual disease activity in routine settings is variable. We assessed disease activity state in patients during their most recent visit, and whether patients with residual activity were offered therapy intensification. Methods Cross-sectional study of consecutive lupus patients in three tertiary centers. Patients were categorized as: i) remission off-therapy, ii) remission on-therapy, iii) low disease activity, and iv) non-optimally controlled disease. Multivariable regression identified factors associated with treatment intensification and ROC analysis calculated the accuracy of SLEDAI-2K to predict this intensification. Results Three hundred and thirty-two patients were included [93.1% female, mean (SD) age 48.5 (14.7) years, median (IQR) disease duration 6.5 (12.4) years]. Mean (SD) total and clinical SLEDAI at last visit were 3.7 (3.0) and 3.0 (2.9), respectively. Although 23.2% of patients were in remission, 40.1% were categorized as non-optimally controlled disease (79.2% due to SLEDAI-2K > 4), but less than 50% of them were offered therapy intensification. Proteinuria (OR 6.78, 95% CI 2.06–22.25), arthritis (OR 5.48, 95% CI 3.20–9.40), and rash (OR 3.23, 95% CI 1.81–5.75) were associated with intensification of therapy, but the accuracy of either total or clinical SLEDAI to predict it was moderate (ROC area under the curve 0.761 and 0.779, respectively). Conclusions About 40% of patients have evidence of residual disease activity and could qualify for novel treatments. Most treatment changes were triggered by active renal, joint, and skin disease, whereas the predictive value of SLEDAI-2K as a metric of disease activity was modest.

Glucocorticoids in systemic lupus erythematosus: future of steroid-sparing therapy

“…В многоцентровом 2-летнем исследовании, проводившемся в нескольких странах Европы, обострения СКВ были зарегистрированы более чем у половины из 412 пациентов [51]. В другом исследовании признаки воспалительной активности несмотря на иммуносупрессивную терапию были выявлены у 40% из 332 больных СКВ [52]. Приведенные данные свидетельствуют о том, что для улучшения результатов лечения многие пациенты с СКВ нуждаются в новых препаратах, обладающих стероидосберегающей активностью и позволяющих ограничить применение ГКС, в том числе за счет профилактики обострений заболева-ний, которые обычно предполагают необходимость в увеличении дозы ГКС или возобновлении их приема.…”