Unmet therapeutic needs in patients with systemic lupus erythematosus is a widespread and serious issue that urgently needs to be addressed

Understanding whether patients with systemic lupus erythematosus (SLE) are “doing well” or not is key to helping clinicians use better treatment approaches to improve disease outcomes, explains Eric F. Morand, MD, PhD. “The treatment for active SLE has changed little in the past 50 years,” he says. “This is due to the lack of approved or reimbursed new therapies. Few studies have quantified unmet needs in the management and treatment of SLE. However, the recent classification of treat-to-target endpoints of uncontrolled disease activity gives us the chance to formally define unmet needs in SLE, for patients, clinicians, researchers, and insurers.”

To examine the association of unmet needs with adverse outcomes, Dr. Morand and colleagues conducted a 13-country longitudinal cohort study of 3,384 patients with SLE, which was published in Arthritis Research & Therapy. Patients were followed over 30,313 visits between 2013 and 2019. “The existence of new definitions of ‘doing well,’ such as lupus low disease activity state (LLDAS), enabled us to quantify the number of patients ‘not doing well’ and examine the outcomes,” Dr. Morand says.

Nearly 25% of the Cohort Never Attained Low Disease Activity

With data from the Asia Pacific Lupus Collaboration (APLC), the researchers used “never attaining LLDAS” as a definition of a patient group in need of better treatment. “This defined nearly a quarter of the entire cohort,” Dr. Morand notes. “A similar proportion of patients met the definition for High Disease Activity State (HDAS) at least once, and we know this state of peak activity disease is a poor prognostic marker. Finally, a third of the cohort had a time-adjusted mean disease activity greater than 4 on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) scale, which indicates that these patients effectively always presented with active disease during follow-up.”

It was observed that each of these states was strong associated with a range of worse outcomes, including damage accrual and mortality as well as both physical and mental domains of HRQOL measured with the SF36 (Table). “Not only are these states of unmet needs prevalent, but their association with worse outcomes is very robust,” Dr. Morand says.

Dr. Morand and colleagues were curious whether states of “doing poorly” were due to being undertreated with standard of care medications. “Treatment patterns were similar across the states of unmet need in the cohort as a whole,” Dr. Morand notes. “This suggests that rather than lack of treatment, it is lack of useful treatment that results in these states of poor disease control.”

Better Treatment Strategies for SLE Are Urgently Needed

These findings show that better therapeutic strategies for lupus are urgently needed, Dr. Morand says. “Physicians should focus their attention on strengthening treat-to-target approaches, lobby for clinical trials, and advocate for approval and reimbursement of more effective medications for treating SLE. Patients should also lobby for better treatment from their physicians and consider participation in clinical trials.”

The researchers acknowledge some limitations in this study. First, although the data were collected prospectively, the analysis of the data was conducted retrospectively. Additionally, this study was conducted in the Asia-Pacific region, with the cohort consisting mostly of individuals with Asian ancestry and variations in health systems, including access to biologics, which may affect results.

As new treatments emerge, it is important to examine whether their use improves the current statistics and leads to fewer patients ‘not doing well,’ according to Dr. Morand. “Unmet need in patients with SLE is a widespread and serious issue, which greatly needs to be addressed,” he says.