Safety of humanized monoclonal antibodies against IL-5 in asthma: focus on reslizumab

Introduction: Reslizumab, a humanized mAb against IL-5, reduces the number of eosinophils in the blood and lungs. Based on efficacy and safety data from pivotal RCTs, reslizumab had been approved for use as an add-on maintenance treatment of severe asthma with an eosinophilic phenotype in adults who have a history of exacerbations despite receiving their current asthma medicines. Areas covered: Current literature on reslizumab has been reviewed with a specific focus on its safety profile in the treatment of severe asthma. Expert opinion: Large pivotal and supportive trials reinforce the view that reslizumab is well tolerated, with an acceptable safety profile in patients exposed for longer than 2 years. However, no or few data concerning safety in special populations such as smokers, those with immune- and cellular senescence, patients with comorbidities and those receiving multi-drug treatments are available as yet. Furthermore, we need to fully elucidate some fundamental issues such as the risk of anaphylaxis and the long-term risk-benefit ratio of the impact of depletion of eosinophils and the potential risk of malignancies induced by a treatment with this anti-IL-5 agent.