Impact of Belimumab on Patient-Reported Outcomes in Systemic Lupus Erythematosus: Insights from Clinical Trials and Real-World Evidence.
Alvaro GomezYvonne EnmanIoannis ParodisPublished in: Patient related outcome measures (2023)
Systemic lupus erythematosus (SLE) is a chronic, autoimmune disease, characterised by a relapsing-remitting pattern of inflammatory activity, with each relapse contributing to irreversible end-organ damage with detrimental effects on patients' course, adding up to morbidity burden and shortening life-length. Along with several other demographic, socioeconomic, and life-style factors, high inflammatory activity and accrued organ damage have been coupled with adverse health-related quality of life (HRQoL) within physical, mental, and psychosocial aspects. The management of SLE has improved substantially during the last decades, owing to a technological explosion that has advanced drug development towards more targeted options. Being the first drug to be approved for SLE in more than half a century and the first in history biological agent for SLE, the introduction in 2011 of the monoclonal antibody belimumab that specifically binds to the soluble counterpart of B cell activating factor (BAFF) was a breakthrough in SLE drug development. The efficacy and favourable safety profile of belimumab has been demonstrated across several clinical trials and observational studies. Herein, we reviewed the literature and provide a summary on the effects of belimumab on SLE patients' HRQoL based on 23 studies. Belimumab has been shown to induce clinically important improvements in physical aspects of HRQoL and in fatigue, the latter being a common and major complaint within the SLE population. People with SLE overall benefit more from belimumab within physical compared with mental aspects of HRQoL. However, despite improvements of clinical and immunological features upon therapy with belimumab, HRQoL perception remains unsatisfactory for a substantial percentage of the patients. Finally, our review made apparent an urgent need for optimisation of the use of patient-reported outcome measures, both in research and clinical practice.
Keyphrases
- systemic lupus erythematosus
- disease activity
- patient reported outcomes
- end stage renal disease
- clinical trial
- patient reported
- mental health
- newly diagnosed
- chronic kidney disease
- ejection fraction
- multiple sclerosis
- oxidative stress
- systematic review
- clinical practice
- prognostic factors
- physical activity
- peritoneal dialysis
- randomized controlled trial
- mesenchymal stem cells
- rheumatoid arthritis
- magnetic resonance
- drug delivery
- open label
- sleep quality
- magnetic resonance imaging
- smoking cessation
- study protocol
- drug induced
- drug administration
- contrast enhanced