AB1249 ASSESSMENT OF FATIGUE IN ADULTS WITH MODERATE-TO-SEVERE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): A QUALITATIVE STUDY TO EXPLORE WHAT PATIENTS FEEL SHOULD BE MEASURED IN CLINICAL TRIALS

Background: Fatigue is one of the most common symptoms reported by patients with systemic lupus erythematosus (SLE)—it is responsible for considerable loss of work time and greatly impaired quality of life. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) has been used to assess fatigue in SLE clinical trials1; however, assessment of the content validity of the FACIT-F in adults with SLE suggested that closer evaluation may be warranted.2 Objectives: This qualitative study aimed to understand SLE patients’ experience of fatigue and assess the content validity of the FACIT-F. Methods: The evaluation was informed by literature and guided by a project steering committee (PSC; patient advocate, clinical expert, outcomes measure expert). The institutional review board-approved study involved focus groups (Round 1) and cognitive interviews (Round 2) with adults with moderate-to-severely active SLE. All participants provided written informed consent. Round 1 included three focus groups to understand the disease and fatigue-related concepts that were most important to patients; participants also provided high-level feedback on the FACIT-F. Round 2 included 13 one-on-one cognitive interviews on the relevance of content, clarity, and comprehensiveness of the FACIT-F. Interviews were audio-recorded and transcribed and a content analysis was completed. The PSC reviewed results and contributed to decision-making. Specific focus was on determining patient understanding of the FACIT-F, comprehensiveness, and any gaps in concept coverage to evaluate fatigue in the context of a clinical trial. Results: Twenty-eight patients with moderate-to-severely active SLE participated; they were mostly female (n=27), had a mean age of 45.5 ± 12.1 years (range: 18–75), and 23 (82%) had moderate and five (18%) severely active SLE. All participants were receiving SLE treatment, and most (n=23, 82%) reported fatigue among their top three most important SLE-related symptoms. Fatigue was described as having a profound impact on daily life, including ability to perform chores and work-related activities, maintain personal hygiene, exercise, and participate in hobbies. Study participants reported the FACIT-F covered concepts most relevant to their fatigue experience. Participants were able to understand the FACIT-F instructions, items, and response options and felt the recall period of seven days was appropriate. Conclusion: Fatigue was one of the most important symptoms, having a significant impact on adults with moderate-to-severely active SLE, limiting their ability to perform necessary or desired activities. The FACIT-F was found to be an appropriate measure for the assessment of fatigue in this sample.3 Evidence of the content validity of the FACIT-F in adults with SLE was confirmed for use to support endpoints in the Cenerimod Assessing S1P1 Receptor Modulation in SLE (CARE) clinical trial. References: [1]Izadi Z, Gandrup J, Katz PP, Yazdany J. Patient-reported outcome measures for use in clinical trials of SLE: a review. Lupus Sci Med. 2018;5(1):e000279. [2]Kosinski M, Gajria K, Fernandes A, Cella D. Qualitative validation of the FACIT-Fatigue scale in systemic lupus erythematosus. Lupus. 2013;22(5):422-430. [3]Mannix S, Beyer A, Strand V, Hanrahan L, Abel C, Flamion B, Hareendran A. Assessment of Fatigue in Adults with Moderate to Severe Systemic Lupus Erythematosus (SLE): A Qualitative Study to Explore What Patients Feel Should Be Measured in Clinical Trials [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). Acknowledgments: We thank Dr. David Cella, developer of the FACIT-F, for his time discussing the measure, interim findings, and PSC feedback; the site staff for patient recruitment; Andrea Schulz and Rodolfo Matos, who conducted interviews. Disclosure of Interests: Sally Mannix Employee of: Evidera, Andrea Beyer Employee of: Idorsia Pharmaceuticals, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Leslie Hanrahan: None declared, Cristina Abel Employee of: Evidera, Bruno Flamion Shareholder of: Idorsia Pharmaceuticals, Employee of: Idorsia Pharmaceuticals, Asha Hareendran Employee of: Evidera