Anti-IL-13 treatment with tralokinumab in moderate to severe asthma
Published online: May 29, 2019
Asthma is a chronic inflammatory disease of the airways affecting approximately 300 million people all around the world. Despite sufficient medical therapy, including high doses of inhaled corticosteroids (ICS) or oral corticosteroids, approximately 20% of patients are unable to control their symptoms and experience asthma exacerbations leading to frequent hospitalization. Asthma is associated with a type-2 (Th2) inflammatory response modulated by the release of cytokines IL-4, IL-5 and IL-13. Tralokinumab (CAT-354) is a fully humanized IgG4 monoclonal antibody that specifically and effectively neutralizes the IL-13 interaction with its receptor (IL-13R). Recently, several clinical studies have evaluated the use of tralokinumab administration in patients with moderate to severe asthma; no consensus of tralokinumab efficacy and safety were reached. Thus, the efficacy and safety of tralokinumab as an asthma biologic requires further analysis and evaluation.
Zhang Y. et al recently published a systematic review and meta-analysis of studies addressing the efficacy and safety of tralokinumab in the treatment of asthma in The Journal of Allergy and Clinical Immunology: In Practice. Clinical trials were identified from MEDLINE, EMBASE, CENTRAL, and ClinicalTrials.gov. The authors comprehensively evaluated randomized, double-blinded, placebo-controlled, parallel-group and multicenter studies published to date that compared the safety and efficacy between tralokinumab and placebo in patients with moderate to severe asthma.
Five studies involved 2,928 adults with moderate to severe asthma were pooled and analyzed in this study. For the efficacy, giving tralokinumab 300mg every 2 weeks and 600mg every 2 weeks significantly improved lung function (including absolute forced expiratory volume in 1 second (FEV1) and absolute forced vital capacity (FVC)) in patients with moderate to severe asthma. However, tralokinumab did not improve asthma control or asthma-related quality of life to a clinically meaningful degree. In addition, tralokinumab did not reduce asthma exacerbations in unselected moderate to severe asthmatic patients, but it decreased the occurrence of asthma exacerbations in severe asthmatic patients with high fractional exhaled nitric oxide (FeNO) levels. Regarding safety, tralokinumab was well-tolerated and it did not increase the incidence of serious adverse events, but it was associated with an increase in mild injection site reactions.
This study suggested that tralokinumab was well tolerated and modestly improved FEV1 and FVC in patients with moderate to severe asthma. It did not render clinically important improvements in asthma-related quality of life, nor did it reduce asthma exacerbations in unselected patients.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.