COPD treatment: Belimumab

Belimumab was first approved in 2011; it is the primary and only approved biologic for both systemic lupus erythematosus (SLE) and lupus nephritis (LN). Numerous drugs have been approved for the treatment of COPD which provide patients with optimal bronchodilation and improvements in symptoms. However, there is need to optimize the COPD management to address the co-morbidities such as cardiovascular disease, lung cancer and diabetes and metabolic syndrome.

DelveInsight estimates that the number of diagnosed prevalent population of COPD in the 7MM (the US, EU-5 (Germany, France, Italy, Spain and the UK), and Japan) was approximately 32,259,000 in the year 2021. During 2021, among all 7MM, the US had highest diagnosed prevalent population with approximately 17,798,000 cases.

Belimumab is already approved in indications such as Autoantibody-Positive Systemic Lupus Erythematosus (SLE) and Lupus Erythematosus, as a subcutaneous injection and intravenous infusion form. This monoclonal antibody is also in the trial phase for multiple conditions.

There are some similarities between COPD and autoimmune diseases. Exacerbations occur in autoimmune diseases and COPD and are also associated with an increase in the number of B cells in the tissue. Increased B cell counts in the COPD lung and increased number and size of B cell-rich lymphoid follicles have been shown to directly correlate with the severity of COPD. It also increases lung levels of mediators that promote B cell maturation, activation, and survival in COPD patients. B-cell products such as lung cells, cellular components, and autoantibodies to extracellular matrix proteins are also present in the COPD lung. These autoantibodies may contribute to lung inflammation and damage in COPD patients by forming immune complexes that activate complement components.

The BOTEGA trial has come up with interesting results presented at the American Thoracic Society (ATS) International Conference 2022; a pilot trial for atherosclerosis-associated autoimmunity in COPD patients. This is the first to demonstrate feasibility, validate essays and approaches, and investigate the administration and safety of belimumab in patients with Atherosclerosis associated autoimmunity in COPD patients. The purpose is "proof of concept" research (NCT03244059).

Measurement of plasma anti-GRP78 IgG by ELISA in 37 COPD patients whose Weston coronary calcium calcification (CAC) score was determined by non-gated chest CT. The CAC score is a validated surrogate for cardiovascular disease in COPD. In parallel, a randomized, double-blind, phase IIa study was conducted in a cohort of COPD patients to test the efficacy and safety of belimumab (NCT03865927).

Treatment with belimumab resulted in decreased circulating GRP78 autoantibody levels (19.42% ± 16.24%) compared to small changes in the placebo group (1.48% ± 4.48%) (p = 0, 02). There were no differences in age, gender, or lung function between the groups, and there were no infections or serious side effects associated with belimumab treatment. The result of the study was promising because belimumab treatment appears to be safe and effective in reducing circulating levels of anti-GRP78 IgG, an autoantibody strongly associated with cardiovascular disease in this population. Reducing autoantibodies may be a new aid in reducing cardiac events in COPD patients. The study was sponsored by the University of Alabama at Birmingham in collaboration with GlaxoSmithKline.

Atherosclerosis and COPD are both systemic inflammatory diseases that share common risk factors/pathways and thereby may occur more frequently in the presence of each other and the results of this small initial study support a more prominent and long-term study to more clearly assess the efficacy and safety of belimumab or other targeted autoimmune therapies in COPD.

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