At this year’s Annual Congress of the European League against Rheumatism (EULAR), researchers from the lupus community endorsed the use of new patient outcome measures for the management of lupus patients.
While some researchers led by Professor Doria advocated the use of remission as measured by his Definition Of Remission In SLE (DORIS), others led by Professor Mitchel use low disease activity (LLDA), whereas other physicians around Professor Schneider preferred the use of patient-reported outcome (PRO) to measure disease improvements.
GlobalData notes that all patient outcome measures have various advantages on their own, but the overall strength of these different outcome targets is the acknowledgement that a reduction in background medication is desired. Together, they represent a considerable improvement over currently used outcome measures such as the Systemic Lupus Erythematosus Responder Index (SRI), BILAG-Based Composite Lupus Assessment (BICLA), and Systemic lupus erythematosus disease activity index (SLEDAI).
Professor Doria presented compelling data from his Italian lupus cohort demonstrating the utility of DORIS to measure achievable disease improvement in patients, which translate to long-term reduction of organ damage in clinical practice. Professor Mitchel's poster presentation also showed that a LLDAS is correlated with long-term reduction in organ damage accrual.
The research community acknowledged the utility of both approaches and demonstrated a significant overlap between both measures in achieving reduced organ damage. However, some physicians expressed a preference for remission measured by DORIS over LLDAS as preferable outcome measure. These physicians were concerned about the low number of patients maintaining a LLDAS and were more compelled by a higher number of patients achieving remission as measures by DORIS.
Other researchers had a clear preference for LLDAS as patient outcome because of utility in both clinical practice and clinical trial research. In a presentation, Professor Morand demonstrated that LLDAS was able to differentiate between placebo (standard of care) and AstraZeneca’s pipeline drug anifrolumab in a post hoc analysis of the MUSE Phase IIb trial. The session concluded with Professor Schneider advocating PRO in lupus patients, arguing that in a heterogeneous disease such as lupus, patients experience of quality of life, pain, and visual impairments are equally important than achieving a measurable disease state. Although all these measures are not mutually exclusive, many patient factors such as pain, depression, and quality of life are not assessed by DORIS, LLDAS, BICLA, SRI, and SLEDAI.
Lupus is a very heterogeneous disease and the lupus community is continuing to work on new approaches to treat the multiple disease manifestations involved. GlobalData believes it is imperative to continuously develop new meaningful patient outcomes, while incorporating new research about the etiology of lupus into clinical practice.