Gaines E, Bonilla-Martinez Z, Albrecht J, Taylor L, Okawa J, Troxel AB, Werth VP. Quality of Life and Disease Severity in a Cutaneous Lupus Erythematosus Pilot Study. Arch Dermatol. 2008;144(8):1061-1062. doi:10.1001/archderm.144.8.1061
As part of a study to evaluate the clinical responsiveness of the cutaneous lupus area and severity index (CLASI),1 we assessed the relationship between the change in cutaneous lupus erythematosus (CLE) disease severity and quality of life (QOL).
Activity and severity of CLE were assessed by the physician using the CLASI1 and by the patient and physician using a 0 to 10 analog scale to rate global skin health. Quality of life was measured using the Skindex-29.2
We prospectively observed 8 patients with biopsy-proven CLE (6 with discoid lupus erythematosus [DLE] and 2 with subacute cutaneous lupus erythematosus [SCLE]) for 56 days after they started new treatment regimens. At each visit, patients completed the CLE-modified Skindex-29, which included 3 questions beyond the previously validated Skindex-29. Two of the additional questions related to patient concerns about photosensitivity, and 1 related to patient concerns about hair loss.
The results of our study were surprising in that QOL did not easily correlate with improvement or deterioration of the disease. We found a moderate correlation between the change in CLASI1 activity scores and the change in Skindex-292 scores (Spearman r = 0.55). In patients 4 and 6, who had SCLE, the complete resolution of the active disease without significant scarring was associated with only minimal improvement in Skindex-29 scores (Table). In patient 3, there was moderate improvement of the Skindex-29 score even though the skin condition as measured by the CLASI did not significantly improve. Although there was improvement of disease activity in patient 2, there was increased damage and worsening of the Skindex-29 score. The improved disease activity in patients 7 and 8 correlated with an improved Skindex-29 score despite a worsening of the damage score. Only patients 1, 5, and 6 had both the CLASI and Skindex-29 score correlate as expected with parallel improvement of both scores.
This small monocentric study cannot validate or devalue the Skindex-292 as a measure for QOL in CLE. The correlation between what physicians and patients perceive as objective improvement or deterioration of a skin condition may not correlate with the patient's QOL. Our observations may imply that our treatment goals should extend beyond the obvious control of the disease, which is reliably measured by the CLASI.1 Quality of life does not uniformly improve as the activity of the disease wanes. This may mean that attention to cosmetic outcomes may need to become a routine part of our treatment plans for patients with CLE.
For future trials, cosmetic considerations will affect power calculations based on QOL outcomes. In addition, analysis of our additional lupus-oriented questions indicates that patients with SCLE have a persistent concern about photosensitivity after disease activity and damage improve. It is likely that the risk of subsequent flares of their disease in response to outdoor activity reduces their QOL even though disease activity has improved.
Clearly, QOL is tremendously impaired in patients with CLE, and measurements of disease improvement will not always correlate with measures directed at QOL.
Correspondence: Dr Werth, 2 Rhodes Pavilion, 3400 Spruce St, Philadelphia, PA 19104 (firstname.lastname@example.org).
Author Contributions:Study concept and design: Albrecht, Okawa, and Werth. Acquisition of data: Bonilla-Martinez, Albrecht, and Werth. Analysis and interpretation of data: Gaines, Taylor, Troxel, and Werth. Drafting of the manuscript: Gaines, Bonilla-Martinez, Taylor, and Okawa. Critical revision of the manuscript for important intellectual content: Albrecht, Troxel, and Werth. Statistical analysis: Taylor and Troxel. Obtained funding: Werth. Administrative, technical, and material support: Gaines, Bonilla-Martinez, Albrecht, Okawa, and Werth. Study supervision: Werth.
Financial Disclosure: None reported.
Funding/Support: This study was supported by grant K-24-AR 02207 from the National Institutes of Health and a grant from Celgene Inc.