Real-world outcomes of mepolizumab treatment in severe eosinophilic asthma patients - retrospective cohort study in Slovakia.

AIMS: Mepolizumab, a fully-humanized recombinant IgG1 kappa monoclonal antibody directed against IL-5, has shown improved asthma control and lung function in randomised controlled trials. The aim of this study was to evaluate real-world clinical experience in patients with severe eosinophilic asthma treated with mepolizumab in Slovakia. METHODS: A retrospective, non-interventional study based on medical records of all adult asthma patients initiating mepolizumab between November 1, 2017 and January 31, 2019, completing 12 months of treatment. At baseline, general and clinical profile data were recorded 12 months prior to treatment. Primary and secondary endpoints described the results of mepolizumab use at 2, 6, and 12 months after the initiation and compared to baseline. Statistical testing of individual change (in each patient) in selected parameters was performed. RESULTS: The cohort included 17 patients with particularly severe asthma at baseline, with frequent severe exacerbations (SE, median 5 [IQR 4-6]/patient/year), high blood eosinophil counts (median 0.6x109/L), frequent oral corticosteroid (OCS) dependence (82.35%), median dose 15 (IQR 7.5-20) mg/day, impaired lung function, and a spectrum of comorbidities. In a one-year follow-up, the data showed reductions in median SE (0 [IQR 0-1] patient/year, eosinophilia (median 0.175x109/L) and OCS maintenance dose (median 6.25 [IQR 2.5-20] mg/day), all statistically significant after 12 months on mepolizumab. Improved and stabilised lung functions throughout the cohort and a reduced incidence of nasal polyposis were observed. CONCLUSIONS: The results provide clinical evidence of mepolizumab efficacy in a real sample of patients with severe asthma when administered in routine care settings in Slovakia.

The "real-world" effectiveness and safety of omalizumab in patients with uncontrolled persistent allergic asthma in Slovakia: a subgroup analysis of the eXpeRience study.

Introduction: Omalizumab was proven to be effective and safe in patients with moderate-to-severe allergic asthma. However, there is no direct evidence of the benefits of add-on omalizumab in real-life practice in the Slovakian population. Aim: This subgroup analysis assessed the real-life effectiveness and safety of omalizumab in Slovakian patients with severe allergic asthma enrolled in the eXpeRience registry. Material and methods: Patients who commenced omalizumab 15 weeks prior to inclusion were assessed for the physicians' global evaluation of treatment effectiveness (GETE), exacerbation rate, asthma symptoms, lung function, oral corticosteroid (OCS) use, rescue medication, hospitalizations, and school/work absenteeism at 16 weeks and 12 and 24 months. Results: Of 204 patients, 159 (77.9%) completed 2-year follow-up. As per GETE, 69.5% of patients treated with omalizumab achieved excellent/good response at 16 (±1) weeks. The proportion of patients with no severe clinically significant asthma exacerbations increased from 17.3% at pre-treatment to 82.4% and 92.0% at months 12 and 24, respectively. Maintenance OCS use was reduced to 17.0% and 15.3% of patients at 12 and 24 months, respectively, compared with 34.7% at baseline (BL). From BL until month 24, asthma control test scores improved from 11.6 to 20.3; rescue medication use/week decreased from 5.5 to 1.6 days; mean total number of days of asthma-related medical healthcare use decreased from 7.7 to 0.3 days and missed workdays decreased from 16.8 to 0.3 days. No new safety signals were observed. Conclusions: Add-on omalizumab was effective and well-tolerated in Slovakian patients, complementing the results observed in the overall population of eXpeRience.

Comparable long-term safety and efficacy of a novel budesonide/formoterol pressurized metered-dose inhaler versus budesonide/formoterol Turbuhaler in adolescents and adults with asthma.

Budesonide/formoterol in one inhaler is an established therapy for asthma and chronic obstructive pulmonary disease. The long-term safety and efficacy profile of a novel hydrofluoroalkane (HFA) pressurized metered-dose inhaler (pMDI) formulation of budesonide/formoterol was compared with that of budesonide/formoterol in a dry powder inhaler (DPI; Turbuhaler). This multinational, 52-week, randomized, open, parallel-group study included patients aged > or = 12 years with asthma who had a forced expiratory volume in 1s (FEV1)> or = 50% of predicted normal; all patients used inhaled corticosteroids (400-1200 microg/day) and needed additional short-acting beta 2-agonist therapy. Patients were randomized to receive budesonide/formoterol pMDI or DPI 160/4.5 microg, two inhalations twice daily. Safety endpoints included assessment of adverse events and laboratory parameters. Efficacy endpoints included change from baseline in FEV1 and time to first severe asthma exacerbation. Overall, 673 patients (446pMDI, 227DPI) were included. There were no clinically significant differences between treatment groups in the nature, incidence or severity of adverse events or laboratory parameters. The number of patients experiencing adverse events was comparable in the pMDI (332/446 [74%]) and DPI (175/227 [77%]) groups; the most commonly reported adverse event was upper respiratory tract infection. The proportion of patients discontinuing as a result of adverse events was low in both groups (pMDI 12/446 [3%], DPI 2/227 [1%]). Lung function was improved to a similar extent in both groups and there was no detectable difference in time to first severe asthma exacerbation. The novel HFA pMDI formulation of budesonide/formoterol is an equally well tolerated and effective treatment for adults and adolescents with asthma as the budesonide/formoterol DPI.