Cutaneous Lupus Activity Investigator’s Global Assessment–Revised (CLA-IGA-R) Content Validity: Cutaneous Lupus Erythematosus (CLE) Patient Qualitative Study

The Cutaneous Lupus Activity Investigator’s Global Assessment-Revised (CLA-IGA-R) is an emerging clinician-reported outcome measure for severity of Cutaneous Lupus Erythematosus (CLE) disease activity, developed with clinician input. It consists of three separate items (‘Erythema’, ‘Other morphologic characteristics’ [edema, scale, and secondary change], and ‘Follicular activity’).1 Qualitative interviews with patients are an important step in assessing the content validity of a measure. The objectives of this concept elicitation study were to qualitatively explore the lived experience of the condition from the patient’s perspective and to confirm whether all key signs experienced by patients with CLE are captured by the CLA-IGA-R. In total, 15 US participants with a clinical diagnosis of CLE were invited to take part in a qualitative, semi-structured, face-to-face interview. The interview lasted approximately 60 minutes and focused on spontaneously reported signs, symptoms, and impacts of CLE. Key topics not spontaneously discussed were then probed by the interviewer. All interviews were audio recorded and transcribed verbatim; transcripts were then coded and subjected to thematic analysis by two independent researchers. Saturation analysis was performed by dividing the 15 participants into three equal sets. Participants had an average age of 43.8 (range 24–59) years. They included Black/African American (53.3%; n=8), White (26.6%; n=4), Asian/Asian American (6.6%; n=1), and multiracial (13.3%; n=2) individuals, and most were non-Hispanic (73.3%; n=11). Most were women (86.7%; n=13). Half of the participants had been diagnosed with CLE for at least 10 years, and most reported mild or moderate CLE symptom severity. Six participants had a diagnosis of subacute CLE (SCLE) and eight were diagnosed with chronic CLE (CCLE), including five with discoid lupus. Red, pink, or purple skin (erythema) was discussed by all 15 participants; 13 reported this spontaneously. Erythema was described as typically being the first sign of a lupus rash, which was then shortly followed by dry, ashy, or scaly skin (scale: n=13; mentioned spontaneously by 9 participants); this was sometimes followed by swelling, swollen, or bumpy skin (edema) (n=12). Open wounds (n=11) and skin crusting/scabbing (n=8) were associated with more severe rashes and typically occurred at the end of the rash. Little blisters were reported by less than half of participants (n=6). Participants also reported experiencing both current and previous hair loss on the scalp due to CLE (n=14). Saturation was supported as no skin-related lupus signs were introduced within the last group of interviews. The findings from this qualitative analysis reveal the participants with CLE experienced a wide range of skin-related lupus signs. The key signs and symptoms experienced by participants (erythema, scale, edema, open wounds, crusting, and hair loss [hair loss is the downstream effect of follicular activity]) are captured in the CLA-IGA-R. These data support the content validity of the CLA-IGA-R, and thus its use as a measure of CLE disease activity. This study was funded by Biogen (Cambridge, MA, USA) and conducted by Clinical Outcomes Solutions (Folkestone, Kent, UK). Editorial support was provided by Selene Medical Communications (Macclesfield, UK), funded by Biogen.