Two New Tools Can Reliably Measure Changes in Disease Activity in SLE, Study Finds

Two comprehensive tools can reliably measure changes in disease activity in people with systemic lupus erythematosus (SLE), a new study suggests.

The findings support the use of these instruments — the SELENA SLEDAI Physician’s Global Assessment, known as the SSPGA, and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus, called the LFA-REAL system — both in standard care and clinical trials, the scientists said.

The study, titled “Scoring systemic lupus erythematosus (SLE) disease activity with simple, rapid outcome measures,” was published in the journal Lupus Science & Medicine.

In the course of managing the disease and designing clinical trials, it is often necessary to find ways to assess the diverse symptoms experienced by people with SLE. Using numeric scores can help monitor changes in disease activity over time.

Currently, the most widely used tools for this purpose are the SLE Disease Activity Index (SLEDAI) and the British Isles Lupus Assessment Group Index (BILAG 2004). However, each of these has drawbacks that limits its usefulness, particularly regarding the tests’ accuracy in measuring symptoms.

The SSPGA was developed to address some of these shortcomings, in large part through the use of visual analogue scales (VAS). Put simply, VAS rate pain and other manifestations across a gradient rather than in discrete categories such as mild, moderate, and severe.

The LFA-REAL system uses additional subscales, allowing for an even more nuanced evaluation of lupus symptoms. It also looks at less common complications, such as gastrointestinal and ophthalmic involvement, and allows for analyses focusing on individual organs.

Researchers at the Oklahoma Medical Research Foundation and their collaborators evaluated the extent to which the two instruments could reflect changes in SLE disease activity. For this purpose, they compared these tools to the previously established SLEDAI and BILAG 2004.

All four assessments were used on data from a previous Phase 2 clinical trial (NCT02270957) in people with SLE, which had tested abatacept for the treatment of lupus arthritis and other manifestations of lupus. That trial, conducted at the Research Foundation, evaluated 50 people (average age 44.6 years) in a total of 528 hospital visits, averaging about 11 visits per person.

The results of the new study showed that both SSPGA and LFA-REAL scores were in line with the commonly used tools at all visits. Changes in scores over time also were correlated across the four instruments.

This suggests that SSPGA and LFA-REAL can be broadly used to provide more nuanced measurements of disease activity, the researchers said.

The team also drew attention to its findings that the LFA-REAL system provides a more precise assessment compared with SSPGA.

“For example, if a person had mild arthritis and moderate rash the expanded scaling [the LFA-REAL] would allow a higher numeric score than a person with only moderate rash, a distinction not captured on the SSPGA,” they said.

However, the investigators added that more studies are needed to enable definitive conclusions regarding whether a given tool outperforms the other: “The potential advantages of the LFA-REAL over other instruments are hypothesised and remain to be proven/validated,” they said.

Still, the results support the utility of both tools. According to the researchers, they “might provide an opportunity for increased discrimination between gradations of active disease and changes in disease activity, especially in individuals with multiple organ involvement.”