In cutaneous lupus erythematosus (CLE), interventional studies of medications have relied on serial physician assessments of patients’ skin disease to determine whether patients have improved or not. Earlier studies often employed physicians’ subjective grading of skin severity as primary outcome measures. In more recent clinical trials, physicians have been using validated scoring systems that incorporate presence, location, and severity of skin signs of CLE. Using scoring tools with these defined features have improved identification of therapies that can effectively treat CLE.

While there have been improvements in provider assessment tools of skin disease severity in CLE patients, there is a paucity of instruments that sufficiently represent how CLE patients feel about their skin disease. The patient’s perspective is paramount, since it may not always corroborate with the provider’s perception. For example, low CLE skin disease damage scores may not correspond with the patient’s increased distress of their scarring or dyspigmentation. Patient-reported outcome measures have been devised to represent and quantitatively assess the patient’s perspective. They commonly consist of self-administered questionnaires on quality of life, with answers being converted into scores. They have been increasingly used in clinical trials to help determine whether patients felt that medications were providing benefit or not. In CLE, most interventional studies have used patient-reported outcome measures that were generic to skin diseases. However, they leave out important concerns to CLE patients including alopecia, photosensitivity, scarring, and pigmentation changes that can affect their well-being.

To address this gap, we devised the Cutaneous Lupus Erythematous Quality of Life (CLEQoL) questionnaire that would comprehensively address multiple aspects of CLE. We have completed preliminary testing of this questionnaire in a group of 101 patients at University of Texas Southwestern Medical Center. We found that CLEQoL scores correlated well with other patient-reported outcome measure scores and validated skin disease activity and damage scores measured by physicians. However, because this study was limited by its small sample size and location at one medical center, the CLEQoL needs to undergo similar testing with a larger group of CLE patients from different geographic areas for further validation. Furthermore, studying how the CLEQoL scores change over time with disease severity changes is also warranted.

The goals of this proposal are twofold: (1) assess the rigor of the CLEQoL in a larger multi-center group of CLE patients by measuring reliability and validity, and (2) evaluate how CLEQoL scores change with variances in disease severity in CLE patients. CLE patients will be recruited to complete CLEQoL and other quality of life questionnaires and undergo disease severity assessments at two visits spaced 6 months apart.

The grant proposal concentrates on the Lupus Research Program Focus Area on improving quality of life for individuals with lupus. The CLEQoL can serve as a useful tool that represents the patient’s perspective on how CLE affects their daily lives and can ultimately be used to inform which therapies are beneficial to them. Upon conclusion of this grant proposal, we expect that this data will be used toward obtaining approval from the Federal Drug Administration as a patient-oriented outcome measure in the following 2-3 years. This would then result in all clinical trials in CLE using the CLEQoL as a standardized patient-reported outcome measure to gauge whether patients feel that they are experiencing therapeutic benefit.