| Summary: | Elvira Bangert,1 Laura Wakani,2 Mehveen Merchant,3 Vibeke Strand,4 Zahi Touma2 1Division of Rheumatology, Department of Medicine, Queen’s University, Kingston, ON, Canada; 2University of Toronto Lupus Clinic, Toronto Western Hospital, Centre for Prognosis Studies in the Rheumatic Diseases, Toronto, ON, Canada; 3Division of Rheumatology, Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada; 4Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA Abstract: Systemic lupus erythematosus (SLE) is a chronic autoimmune, multisystem rheumatic disease with significant impact on health-related quality of life (HRQoL). Patient-reported outcomes (PROs) provide valuable data on patient perceptions across a variety of domains, such as HRQoL, pain, fatigue, and depression. The measurement and results of PROs with respect to HRQoL in randomized controlled trials (RCTs) on belimumab (B-lymphocyte stimulator inhibitor) in SLE are reviewed here, including BLISS-52 and BLISS-76, as well as publications related to belimumab trials that included HRQoL data. Other trials that evaluated belimumab did not include HRQoL data and were therefore not included in the analysis. The BLISS-52 and BLISS-76 RCTs met their primary endpoints and demonstrated improvements in PROs, measured by the 36-item Short Form Health Survey, EuroQol 5 Dimensions, and Functional Assessment of Chronic Illness Therapy-Fatigue Scale. Belimumab was shown overall to improve PROs in adult autoantibody-positive lupus patients. Keywords: quality of life, fatigue, systemic lupus, Benlysta, trials
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