Asthma Control in Patients with Severe Eosinophilic Asthma Treated with Reslizumab: Spanish Real-Life Data

Abstract

Background Reslizumab is an anti-interleukin 5 monoclonal antibody that has demonstrated to reduce the risk of severe exacerbations and to improve symptoms, lung function, and quality of life in randomized controlled trials that included patients with severe eosinophilic uncontrolled asthma (SEUA) and a history of severe exacerbations. Objective The aim of the present study was to evaluate the effectiveness of add-on reslizumab in a cohort of patients with SEUA under real-life conditions. Methods This was a multi-centre, retrospective, real-life study that included subjects with SEUA treated with reslizumab in 44 asthma units throughout Spain. Eligible patients were those who had received at least one dose of reslizumab as part of normal clinical practice. The primary endpoint was complete asthma control at 52 weeks, defined as absence of severe exacerbations, ACT ≥20 and no maintenance oral corticosteroids (OCS). Demographic, clinical, and functional data were collected at baseline (T0), after four to six months (T1); after 12 months (T2) and beyond 12 months of therapy (T3). Results Treatment with reslizumab achieved complete asthma control in 40% of the 208 included SEUA patients and led to a significant reduction in exacerbations (from 3.0; IQR: 2.0–4.0 at V0 to 0.0; IQR: 0.0–0.0 at V2), maintenance OCS use (from 54.8% (95% CI: 48.0–61.6 at T0 to 18.5% (95% CI: 12.5–24.5 at T2) and a meaningful improvement in symptoms in the entire treated population: ACT increased from 12.8 ± 4.5 at V0 to 20.0 ± 5.1 at V2 (p < 0.001). Most of the improvement achieved at 12 months was obtained at 4–6 months. The retention (continuation) rate of reslizumab was 75% through 2 years (95CI%: 1.9–2.1). Overall, reslizumab showed an adequate safety profile. Conclusion Reslizumab is an effective therapy for SEUA with adequate safety profile in real-life conditions.

Response to monoclonal antibodies in asthma: definitions, potential reasons for failure and therapeutic options for suboptimal response

“…However, there remains a significant discrepancy about the stringency of the criteria required to classify a patient as a "super-responder," "complete responder," or "patient in remission" (Table 1) [7][8][9][10][11][12][13]. From a clinician's point of view, it seems reasonable to require the elimination of severe exacerbations, OCS withdrawal, and achieve symptom control and normal pulmonary function to categorize a patient as a "complete responder."…”

“…Response in terms of symptoms, lung function or corticosteroid reduction can be estimated 4-6 months after starting treatment with a mAb [8]. To assess the effect on J Investig Allergol Clin Immunol 2023; Vol.…”

“…Many recent anti-IL-5 and IL-5R studies have included SA patients previously on omalizumab treatment, showing relevant benefits in clinical outcomes (38.2% in the REDES study with mepolizumab; 35.1% in a Spanish real-life study with reslizumab and 19% in the Italian Registry ANANKE) [8,75,76]. However, very few publications assess the effectiveness of switching to anti-IL-5/IL-5R in non-responders to omalizumab in real-life conditions.…”

“…Pérez de Llano et al [8] Complete response: no chronic OCS use, no severe exacerbations, and ACT ≥ 20.…”

“…Treatment with reslizumab led to a significant reduction in exacerbations (from a median of 3 to 0), use of OCS (from 54.8% to 18.5%), and significant symptom improvement in the entire treated population (ACT increased from 12±4 to 20±5). Seventy-five percent of patients continued treatment for two years [8].…”