Quality of Life in Patients with Cutaneous Lupus Erythematosus (CLE)Motolani Ogunsanya, B.Pharm, MS1, Benjamin Chong, MD2, Carolyn Brown, PhD1,

1College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, 2Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, TX 75390

Background• Cutaneous Lupus Erythematosus (CLE) is a chronic dermatologic autoimmune disease marked by photosensitive lesions that can vary in appearance depending on the subtype. 1-3

• CLE is not fully understood, but it is speculated that genetic, hormonal, immunological abnormalities (e.g., cytokine, B-cells and T-cells dysfunction) and environmental factors (especially ultraviolet irradiation) contribute to its pathogenesis.4,5

• While dermatologic diseases, in general, have been shown to have a signi�cant impact on quality of life, there is limited information as to the extent in which CLE a�ects a patient’s quality of life.6-8Studies have reported that patients with dermatologic diseases are not only distressed about the disease itself but also how they are perceived by others as result of their appearance.9-10

• Consequently, dermatologic patients may experience higher rates of mental health conditions, especially anxiety and depression, with a prevalence ranging from approximately 20-40%, compared to 11-30% seen in the general population.11-13

• CLE is generally perceived as being less severe and having a better prognosis than systemic lupus erythematosus; chronic forms of CLE, however, can last for several years and may lead to severe disability and permanent dis�guration.14,15

• Given the impact of CLE on the quality of life of patients and the increasing prominence of patients’ involvement in their own care, it is important to assess outcomes from the patients’ perspectives.

PurposeThe purpose of this study is to better understand the impact of CLE on patients’ lives.

Study Objectives• Describe focus group (FG) participants: - Demographics and personal characteristics

• As part of the initial development of a CLE-speci�c QoL measure, a qualitative approach was utilized to: - Explore, describe and clarify the patients’ perspective of how CLE has impacted their lives, and - Examine patients’ perceptions of unmet needs regarding CLE treatment and care.

Methods• Study was approved by The University of Texas at Austin IRB and the University of Texas Southwestern IRB.• Inclusion Criteria - CLE diagnosis - Adults, age ≥ 18 years - English-speaking - Able to provide informed consent• Study Site - Outpatient, University dermatology clinic in Dallas, TX• Participants - Purposeful sample of patients with CLE • Recruited via a cutaneous lupus registry using emails or phone numbers• Data Collection - Pre-FG Survey • Questions on demographics/personal characteristics, such as age, gender, years since diagnosis, race/ethnicity, smoking status. - Focus group sessions • Three FGs (approx. 1.5 hours long) • Sessions were audio-recorded with notetaking • Moderator guide - Open-ended questions to assess how CLE a�ects overall QoL, including work life, daily activities, social life, personal relationships, and leisure activities as well as the impact on photosensitivity, alopecia, mental health, and treatment outcomes • Recordings were transcribed• After FGs, participants were given pamphlets on lupus information, as well as information on support groups available for lupus.• Incentives - $50 VISA gift cards

Data Analyses• Descriptive Analysis - Demographic/personal characteristics were analyzed using descriptive statistics (e.g., frequencies, means and standard deviations using SPSS).18

• Qualitative Analysis - The transcripts were content-analyzed to identify emerging themes related to overall QoL. - Using Braun and Clarke’s approach for content analysis,16 categories were created and de�ned by counting the frequency of similar words and phrases throughout the transcript. - Inter-coder reliability • Two coders independently pretested the de�nitions of the category by thoroughly reviewing the transcripts. • Compared codes generated and corroborated the frequency of each theme. - Generated themes will be used to populate the CLE-speci�c QoL measure. The data was analyzed using Dedoose.17

ResultsTable 1. Descriptive Statistics for Study Variables (n=19)

Several major themes emerged from the FGs that concentrated on issues that are important to patients iving with CLE.

Discussion/Conclusion• Eleven themes emerged as important to patients with CLE: physical e�ects; mental e�ects; social e�ects; medication e�ects; disease e�ects; coping mechanisms; social dynamics; diagnosis odyssey; cutaneous e�ect/body image; photosensitivity; and unmet needs.• Most patients reported a negative impact of CLE on their lives, however, some patients reported some positive aspects to having CLE.• Results from this study provide pharmacists, physicians and other healthcare practitioners a better understanding of the impact of CLE on patients’ QoL.• Treatments that improve CLE manifestations, as described by participants, may o�er considerable bene�t to patients, physicians, and the society.

Study Limitations • Social desirability bias – this may have impacted patients’ responses to please the moderator and/or other patients.

• It is possible that the universe of issues that are important to patients with CLE were not captured.

• Selection bias – FG participants did so voluntarily. Also, patients who were motivated to show up were more likely to have severe skin disease than those who did not.

References1. Gaines E, Bonilla-Martinez Z, Albrecht J, et al. Quality of life and disease severity in a cutaneous lupus erythematosus pilot study. Archives of dermatology. 2008;144(8):1061-1062.2. Goreshi R, Chock M, Foering K, et al. Quality of life in dermatomyositis. Journal of the American Academy of Dermatology. 2011;65(6):1107-1116. 3. Vasquez R, Wang D, Tran QP, et al. A multicentre, cross-sectional study on quality of life in patients with cutaneous lupus erythematosus. The British journal of dermatology. 2013;168(1):145-153.4. Foering K, Goreshi R, Klein R, et al. Prevalence of self-report photosensitivity in cutaneous lupus erythematosus. Journal of the American Academy of Dermatology. 2012;66(2):220-228.5. Panjwani S. Early diagnosis and treatment of discoid lupus erythematosus. Journal of the American Board of Family Medicine : JABFM. 2009;22(2):206-213.6. Chren MM, Lasek RJ, Quinn LM, Mostow EN, Zyzanski SJ. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. The Journal of investigative dermatology. 1996;107(5):707-713.7. Sontheimer RD. Skin manifestations of systemic autoimmune connective tissue disease: diagnostics and therapeutics. Best practice & research. Clinical rheumatology. 2004;18(3):429-462.8. Verma SM, Okawa J, Propert KJ, Werth VP. The impact of skin damage due to cutaneous lupus on quality of life. The British journal of dermatology. 2014;170(2):315-321.9. Fortune DG, Main CJ, O'Sullivan TM, Gri�ths CE. Quality of life in patients with psoriasis: the contribution of clinical variables and psoriasis-speci�c stress. The British journal of dermatology. 1997;137(5):755-760.10. Richards HL, Fortune DG, Gri�ths CE, Main CJ. The contribution of perceptions of stigmatisation to disability in patients with psoriasis. Journal of psychosomatic research. 2001;50(1):11-15.11. Aktan S, Ozmen E, Sanli B. Psychiatric disorders in patients attending a dermatology outpatient clinic. Dermatology (Basel, Switzerland). 1998;197(3):230-234.12. Attah Johnson FY, Mostaghimi H. Co-morbidity between dermatologic diseases and psychiatric disorders in Papua New Guinea. International journal of dermatology. 1995;34(4):244-248.13. Hughes JE, Barraclough BM, Hamblin LG, White JE. Psychiatric symptoms in dermatology patients. The British journal of psychiatry : the journal of mental science. 1983;143:51-54.14. Tebbe B, Orfanos CE. Epidemiology and socioeconomic impact of skin disease in lupus erythematosus. Lupus. 1997;6(2):96-104.15. O'Quinn SE, Cole J, Many H. Problems of disability and rehabilitation in patients with chronic skin diseases. Archives of dermatology. 1972;105(1):35-41.16. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77-10117. Dedoose Version 6.1.18, web application for managing, analyzing, and presenting qualitative and mixed method research data (2015). Los Angeles, CA: SocioCultural Research Consultants, LLC (www.dedoose.com).18. IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp.

Acknowledgements• The authors would like to express their gratitude to the patients who participated in these focus group

sessions. We would also like to thank Fiona Imarhia and Christina Maxey for helping with the data transcription process, and Danielle Lin, Rose Cannon and Jack O’Brien for assistance with logistics and patient recruitment.

• This project was partially funded in part by a research grant awarded by The University of Texas at Austin, O�ce of the Vice President for Research.