More stringent thresholds in the Cutaneous Lupus Activity and Severity Index (CLASI), a common tool to assess disease progression and treatment response in cutaneous lupus erythematosus (CLE), can better identify patients with clinical improvements, a study reports.
Its findings also suggest that people who develop CLE early in life are less likely to benefit from treatments than are those with later-onset disease.
The study, “Robust measurement of clinical improvement in patients with cutaneous lupus erythematosus,” was published in journal Lupus Science & Medicine.
Lupus, as an autoimmune disease, can affect many organs and systems in the body. CLE occurs when abnormal immune system activation specifically affects the skin, but its symptoms and severity can vary. As a consequence, measures assessing clinical improvement in CLE are not well-established, and this complicates the choice of treatments.
“While a variety of treatment options are available for CLE, treatment selection remains largely based on expert opinion rather than objective data,” the researchers wrote.
Reliable tools to assess the range of clinical manifestations and spot meaningful clinical improvements are needed to improve patient care.
CLASI is the most often used clinical tool to evaluate disease activity (CLASI-A), including skin redness and scaling, and skin damage (CLASI-D), including discoloration and scarring. CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease.
Given the lack of consensus regarding how changes in these scores correlate with treatment response, researchers at the University of Texas Southwestern Medical Center (UTSW) investigated different CLASI thresholds in terms that related to changes in CLE .
They analyzed data from 66 CLE patients for improvements in CLASI-A scores, and 74 patients for improvements in CLASI-D. Fifty-two people were included in both assessments. In total, the CLASI-A analysis included 119 visit-pairs (consecutive study visits) and 177 for the CLASI-D group.
The primary outcome measures of skin disease activity and damage improvement were response thresholds based on percent change in CLASI-A and CLASI-D scores in such a visit-pair.
A higher proportion of African-Americans were in the CLASI-D group than in the CLASI-A group (62% vs 49%), with all patients in CLASI-D having chronic CLE lesions compared to 85% in the CLASI-A group.
All had been enrolled in the UTSW Cutaneous Lupus Registry. Most (above 85% in both groups) were women with a median age of 45 to 46. More than half of the patients in each group met diagnostic criteria for systemic lupus erythematosus, this disease’s most common form.
Disease activity, evaluated by CLASI-A, varied greatly among visits, with 29% of visit-pairs showing a 50% or greater relative decrease in the CLASI-A score, and 14% with a 75% or better reduction.
Changes in the damage scores were more subtle: 21% of visit-pairs had a relative decrease in the CLASI-D score of at least 20%, and 10% a minimum reduction of 40%.
Researchers found that factors like smoking, CLE subtype, and age when patients developed CLE were important for improvements on CLASI-A scores. African-Americans were less likely to experience improvements in CLASI-D than patients of other ethnicities.
Importantly, the links between subacute CLE and lower disease activity, and between being African-American and having a lower likelihood of lesser damage were much stronger with more stringent thresholds in both scales — 75% in CLASI-A and 40% in CLASI-D.
Early use of immunosuppressants correlated with a lower likelihood of decreased disease activity. In turn, longer follow-up correlated with a 40% or higher likelihood of experiencing less damage.
Age at CLE development was modestly associated with greater likelihood of lesser disease activity at both the 50% and 75% CLASI-A thresholds.
“This result suggests that patients who develop CLE early in life may be less responsive to treatment than those with later-onset disease,” the researchers wrote.
The analysis also revealed that early CLE activity was linked with a lower chance of lesser damage at both 20% and 40% CLASI-D thresholds.
“Patients with higher initial CLASI-A scores are less likely to experience even modest improvement in CLASI-D scores between visits, “ the scientists added.
“[T]he factors associated with CLE activity and damage improvement identified in this study can inform patient counselling and treatment planning,” they concluded.
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