Study Supports Patient-reported Tool Measuring Fatigue’s Impact on Daily Activities

Fatigue has a major impact on quality of life in people with systemic lupus erythematosus, and measuring it using a patient-reported tool may prove useful in clinical trials, new research shows.

The findings were presented at the recent 2019 American College of Rheumatology/Association for Rheumatology Professionals Annual Meeting in a session, titled “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.”

Fatigue has a well-known impact on people with SLE, but it has not been measured using self-reported feedback from patients, which poses a challenge for assessing the symptom in clinical studies.

To address this gap, a team at Evidera, Idorsia Pharmaceuticals, Stanford University, and the Lupus Foundation of America studied how people with SLE view their fatigue and whether it could be assessed with the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire, which has been used in medical research.

The study involved 28 adults with moderate to severe SLE (27 women, mean age of 45.5 years). The researchers first conducted focus groups, then 13 one-on-one interviews. Both rounds focused on the role of SLE-related fatigue in participants’ daily lives and their opinions on FACIT-F.

Twenty-three patients (82%) had moderate disease activity and five (18%) had severe SLE. All were being treated for SLE during the study.

Results showed that 23 participants (82%) identified fatigue as one of the top three most impactful symptoms of SLE. They said that fatigue had a profound impact on daily life, “including the ability to perform chores, work-related activities, maintain personal hygiene, exercise, and participate in hobbies,” the researchers wrote.

FACIT-F was generally viewed as a satisfactory tool by the participants, who said that they were able to understand the questionnaire, and it was relevant to their experience of fatigue.

Overall, the study confirmed the significant impact of fatigue in the life of people with SLE and showed that it can be measured using FACIT-F.

The tool is being used by Idorsia in its CARE Phase 2b clinical trial (NCT03742037) of the potential oral therapy cenerimod. This international study is still enrolling adults with SLE; more information about contacts and locations is available here.