Approximately 40% of patients with systemic lupus erythematosus (SLE) have residual disease activity and could qualify for novel treatments,” according to study results published in Lupus.
The percentage of patients with SLE with residual activity in routine settings is variable. Therefore, the researchers of the current study sought to evaluate the state of disease activity in patients with SLE during their most recent visit and whether those who reported residual activity were offered therapy intensification.
Specifically, they aimed to determine rates of remission and low disease activity, as well as residually active disease; current use of glucocorticoids and immunosuppressive agents; and percentage of patients who received treatment intensification for residual disease activity.
The study included consecutive patients with a formal diagnosis of SLE who were evaluated in the rheumatology outpatient departments of 3 tertiary care centers in Greece between June 2020 and 2021. The diagnosis of SLE was based on expert physician evaluation, according to existing classification criteria.
At their most recent visit, patients were categorized into 4 disease activity states, according to the following definitions:
- Remission off-therapy: total SLE Disease Activity Index 2000 (SLEDAI-2K) of 0 without any prednisone or immunosuppression
- Remission on-therapy: total SLEDAI-2K of 0 and prednisone dose of 5 mg/day or lesser and/or immunosuppression (maintenance phase)
- Low disease activity: total SLEDAI-2K of 4 and lesser and prednisone dose of 7.5 mg/day or lesser and/or immunosuppression (maintenance phase)
- Active or nonoptimally controlled disease: total SLEDAI-2K of more than 4 and/or prednisone dose of greater than 7.5 mg/day and/or immunosuppression (induction phase)
A total of 332 participants were included in the study, 93.1% of whom were women. The mean patient age at study visit was 48.5±14.7 years; the median disease duration was 6.5±12.4 years. Overall, 90 (27.1%) participants had mild SLE, 114 (34.3%) had moderate SLE, and 128 (38.6%) had severe SLE. More than 80% of patients were receiving hydroxychloroquine at their last visit, and nearly 70% were receiving treatment with an additional immunosuppressive agent. Nearly half of the patients were not receiving treatment with any glucocorticoid at their last visit.
Results of the study showed that mean and clinical SLEDAI at participants’ last visit were 3.7±3.0 and 3.0±2.9, respectively. In terms of categorization of disease activity states, 23.2% of participants were in remission, either on or off therapy; 40.1% were had nonoptimally controlled disease, with 79.2% due to a total SLEDAI-2K of greater than 4; and fewer than 50% were offered therapy intensification.
Although proteinuria (odds ratio [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) all were associated with intensification of therapy, the accuracy of total or clinical SLEDAI to predict this intensification was moderate (receiver operating characteristics area under the curve [ROC AUC], 0.761 and 0.779, respectively).
Study limitations included the lack of physician global assessment (PGA); the SLEDAI not being able to detect partial improvement or deterioration in manifestations over time; and the cross-sectional design.
The study authors concluded that “the predictive value of SLEDAI-2K as a metric of disease activity was modest.” They added, “These data are useful to inform the lupus community regarding the available ‘room’ for new therapies to be approved in SLE.”
Gioti O, Chavatza K, Nikoloudaki M, et al. Residual disease activity and treatment intensification in systemic lupus erythematosus: a cross-sectional study to quantify the need for new therapies. Lupus. Published online September 28, 2022. doi:10.1177/09612033221129776