Background/Purpose: Fatigue is one of the most common symptoms reported by patients with systemic lupus erythematosus (SLE) and is responsible for considerable loss of time at work and greatly impaired quality of life. There is a lack of patient reported outcome (PRO) instruments developed with input from patients with SLE. To collect evidence of content validity required by regulatory agencies for a PRO tool to support label claims, this qualitative study aimed to understand SLE patients’ experience of fatigue and to assess the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire used extensively in health research to evaluate fatigue. Evaluation of the FACIT-F content was informed by a literature review and guided by a project steering committee (PSC; consisting of a patient advocate, a clinical expert, and an outcomes measure expert).

Methods: The study, approved by an institutional review board, involved focus groups (Round 1) and cognitive interviews (Round 2) with adults with moderate to severely active SLE. All participants provided written informed consent. In Round 1, three focus groups were conducted 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 to collect more nuanced feedback on the relevance of content, clarity, and comprehensiveness of the FACIT-F. The qualitative interviews were audio-recorded and transcribed; content analysis methods were used to analyze the transcripts to achieve the study objectives. The PSC reviewed the results and contributed to decision making. Specific attention was given to determine the comprehensiveness and participant understanding of the FACIT-F and any gaps in concept coverage to evaluate fatigue in the context of a clinical trial.

Results: A total of 28 adult patients with moderate to severe SLE, mostly female (n=27) with a mean age of 45.5 ± 12.1 years (range: 18–75 years) participated in the study; 23 (82%) had moderate disease activity and five (18%) severe SLE. All participants were receiving treatment to manage their SLE at the time of the study and most (n=23, 82%) reported fatigue among the top three most important SLE-related symptoms. Fatigue was described as profoundly impacting their daily life, including the ability to perform chores, work-related activities, maintain personal hygiene, exercise, and participate in hobbies. Study participants reported that the FACIT-F covered concepts most relevant to their experience of fatigue. Participants were able to understand the instructions, items, and response options of the instrument and felt that the recall period of 7 days was appropriate.

Conclusion: Fatigue was one of the most important symptoms that had a significant impact on adults with moderate to severely active SLE, limiting their ability to perform activities they needed or wanted to do.  The FACIT-F was found to be an appropriate measure for the assessment of fatigue in this sample. Evidence of content validity of the FACIT-F in adults with SLE was confirmed for its use to support endpoints in Idorsia’s Cenerimod Assessing S1P₁ Receptor Modulation in SLE (CARE) clinical trial.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/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/