OBJECTIVES: Systematic lupus erythematosus (SLE) is a condition linked with high symptom burden and severe quality of life (QoL) impacts. The FDA and EMA SLE guidance recommends inclusion of clinical outcome assessments (COAs), such as those assessing disease activity, fatigue, and quality of life in SLE clinical trials. The objective of this research is to review the landscape of COAs that were included in SLE clinical trials and FDA and EMA drug labels.

METHODS: The PROLABELS database was reviewed to identify COA-related label claims for approved SLE products (FDA and EMA). Researchers also performed a review of the Clinicaltrials.gov website to identify COAs used in active/completed interventional Phase III SLE clinical trials in the past ten years.

RESULTS: Three drug approvals with COAs included in the label were identified. Two approvals were granted by the FDA (2011 and 2022) and one was also approved by the EMA. Fatigue was the only patient reported outcome (PRO) included in one label, while the rest included clinician reported outcomes (ClinROs) assessing flares and disease activity. A total of eleven clinical trials meeting the criteria were identified. Five included PROs and nine included ClinROs. The most frequently utilized PROs (primary and secondary endpoints) in clinical trials were the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) (n=3), and Lupus Quality of Life Questionnaire (LupusQoL) (n=2). The majority of ClinROs used supported primary composite endpoints for disease activity.

CONCLUSIONS: The review of labels for approved SLE drugs indicated only a single drug that included a PRO in the label. PROs in SLE trials were not consistently used and unlikely assessed all meaningful outcomes. Future SLE drug development should focus on improving meaningful outcomes for patients, especially those relating to QoL impacts.