Biologics in Severe Eosinophilic Asthma: Three-Year Follow-Up in a SANI Single Center

Abstract

Introduction: Biologic drugs have dramatically improved severe eosinophilic asthma (SEA) outcomes. Our aim was to evaluate the long-term efficacy of biological therapy in SEA in a real-life setting and to identify the predictors for switching to another biological drug in patients with poor asthma control. The outcomes for efficacy were decreased annual exacerbations (AE) and improved asthma control test (ACT). Methods: In 90 SEA patients being treated with a biological drug, clinical examination, ACT, blood eosinophils count and spirometry were assessed before (T0) and after 6 (T1), 12 (T2), 24 (T3) and 36 (T4) months from the start of biological therapy. Patients were considered responders (R) or non-responders (NR) to biologics depending on whether or not they had less than two AE and a 20% increase in the ACT after 12 months of treatment. Results: 75% of the patients were R, 25% NR. In R patients, biological therapy add-on was followed by significant improvement in AE and ACT throughout the whole follow-up period. The percentage of patients on oral corticosteroids (OCS) dropped from 40% to 12%. By contrast, the NR patients were shifted to another biological drug after 12 months of therapy, as they still had high AE and nearly unchanged ACT; 40% of them still needed OCS treatment. The predictors of switching to another biological drug were three or more AE, ACT below 17, nasal polyposis and former smoking (p < 0.05). In NR, the shift to another biological drug was followed by a significant decrease in AE and an increase in the ACT. Discussion: This real-life study confirms the long-term efficacy of biologics in most SEA patients and indicates that even in non-responders to a first biological drug, it is worth trying a second one. It is hoped that the availability of additional biologics with different targets will help improve the personalization of SEA therapy.

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“…In our cohort, only two patients were in therapy with biological drugs, suggesting that most of them had a mild-to-moderate asthma which was likely to be kept under control with a proper adherence to standard therapies [ 30 , 31 ].…”

“…All the patients enrolled in our study had, in fact, a proper prescription as per GINA guidelines [ 8 ]; however, only half of them took their prescription regularly. Adherence to medication regimes with ICS in asthma has always been notoriously low, with estimates showing as little as 30% [ 30 ]. Nevertheless, in the first wave of the pandemic, such a percentage increased by 14% therefore varying between 54 and 61% [ 33 ], mainly due to the fear of worse clinical outcomes, as previously stated.…”

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“…50 Among these patients, the percentage on OCS dropped from 41% to 12% over the course of the study. 50 In total, 43% of non-responders still needed OCS treatment despite shifting to another biologic after 12 months. 50 However, switching treatment resulted in significant improvements in the incidence of AEs, as well as improvements in clinical measures of asthma (asthma control test [ACT] and forced expiratory volume after 1 second).…”

“…49 Analysis from the SANI registry similarly indicates that biologics reduce long-term OCS use. 50 In a 3-year follow-up in a SANI singlecentre study, 75% of 90 patients with severe eosinophilic asthma were found to respond to biologic therapy. 50 Among these patients, the percentage on OCS dropped from 41% to 12% over the course of the study.…”

“…50 In a 3-year follow-up in a SANI singlecentre study, 75% of 90 patients with severe eosinophilic asthma were found to respond to biologic therapy. 50 Among these patients, the percentage on OCS dropped from 41% to 12% over the course of the study. 50 In total, 43% of non-responders still needed OCS treatment despite shifting to another biologic after 12 months.…”