SABA Overuse in Russia - Burden and Possible Causes: An Analysis of the Russian Population in the SABINA III (SABA use IN Asthma) Study.

Background: Short-acting ß2-agonists (SABA) overuse is associated with asthma morbidity and mortality. The SABA use IN Asthma (SABINA) program aimed to describe the global use of SABA in patients with asthma. SABINA III study was a cross-sectional study covering 24 countries. Methods: We performed statistical analysis of the Russian population (618 patients recruited in 12 centers) from the SABINA III study. In this study in patients aged ≥12 years, data on disease characteristics and asthma treatments were collected using real-time electronic case report forms. Patients were classified by asthma severity and control according to the 2017 GINA. All variables (asthma severity and control, number of severe exacerbations, SABA and other medications use) were analyzed descriptively only, no hypothesis was tested. Results: Majority of the study population consisted of patients with moderate/severe asthma (78.5%), while mild asthma was seen in 21.5%. Asthma was uncontrolled in 36.1% of patients and partly controlled in 33.5%. More than 80% of patients were treated with ICS/LABA fixed-dose combination. Almost half of all patients (47.0%) had at least 1 severe exacerbation in the previous 12 months. SABA over-prescription (≥3 canisters per year) was seen in 37% of patients. The frequency of SABA over-prescription was similar in patients with mild (35%) and moderate/severe (38%) asthma. SABA was purchased over-the-counter (OTC) in the past 12 months by 30.1% of all patients, and 14% purchased ≥3 canisters of SABA per year. About 91% of patients who purchased SABA OTC already received prescriptions for SABA, of whom 59% were prescribed ≥3 canisters per year. Conclusion: Russia is seeing very high level of SABA over-prescription. This is potentially associated with poor asthma control and frequent severe exacerbations. Over-prescription may serve as the main cause for SABA overuse in Russia. To reduce SABA overuse and improve overall asthma control in Russia, it is necessary to educate not just the patients but also the doctors, while actively implementing up-to-date asthma treatments.

Withdrawal of inhaled corticosteroids in COPD patients: rationale and algorithms.

Observational studies indicate that overutilization of inhaled corticosteroids (ICS) is common in patients with chronic obstructive pulmonary disease (COPD). Overprescription and the high risk of serious ICS-related adverse events make withdrawal of this treatment necessary in patients for whom the treatment-related risks outweigh the expected benefits. Elaboration of an optimal, universal, user-friendly algorithm for withdrawal of ICS therapy has been identified as an important clinical need. This article reviews the available evidence on the efficacy, risks, and indications of ICS in COPD, as well as the benefits of ICS treatment withdrawal in patients for whom its use is not recommended by current guidelines. After discussing proposed approaches to ICS withdrawal published by professional associations and individual authors, we present a new algorithm developed by consensus of an international group of experts in the field of COPD. This relatively simple algorithm is based on consideration and integrated assessment of the most relevant factors (markers) influencing decision-making, such a history of exacerbations, peripheral blood eosinophil count, presence of infection, and risk of community-acquired pneumonia.

Russian guidelines for the management of COPD: algorithm of pharmacologic treatment.

The high prevalence of COPD together with its high level of misdiagnosis and late diagnosis dictate the necessity for the development and implementation of clinical practice guidelines (CPGs) in order to improve the management of this disease. High-quality, evidence-based international CPGs need to be adapted to the particular situation of each country or region. A new version of the Russian Respiratory Society guidelines released at the end of 2016 was based on the proposal by Global Initiative for Obstructive Lung Disease but adapted to the characteristics of the Russian health system and included an algorithm of pharmacologic treatment of COPD. The proposed algorithm had to comply with the requirements of the Russian Ministry of Health to be included into the unified electronic rubricator, which required a balance between the level of information and the simplicity of the graphic design. This was achieved by: exclusion of the initial diagnostic process, grouping together the common pharmacologic and nonpharmacologic measures for all patients, and the decision not to use the letters A-D for simplicity and clarity. At all stages of the treatment algorithm, efficacy and safety have to be carefully assessed. Escalation and de-escalation is possible in the case of lack of or insufficient efficacy or safety issues. Bronchodilators should not be discontinued except in the case of significant side effects. At the same time, inhaled corticosteroid (ICS) withdrawal is not represented in the algorithm, because it was agreed that there is insufficient evidence to establish clear criteria for ICSs discontinuation. Finally, based on the Global Initiative for Obstructive Lung Disease statement, the proposed algorithm reflects and summarizes different approaches to the pharmacological treatment of COPD taking into account the reality of health care in the Russian Federation.

Efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma not receiving inhaled corticosteroids.

BACKGROUND: Asthma is a heterogeneous and complex disease in both its clinical course and response to treatment. IL-13 is central to Type 2 inflammation and contributes to many features of asthma. In a previous Phase 2 study, lebrikizumab, an anti-IL-13 monoclonal antibody, did not significantly improve FEV1 in mild-to-moderate asthma patients not receiving ICS therapy. This Phase 3 study was designed to further assess the efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma treated with daily short-acting ß2-agonist therapy alone. METHODS: Adult patients with mild-to-moderate asthma were randomised to receive lebrikizumab 125 mg subcutaneously (SC), placebo SC, or montelukast 10 mg orally for 12 weeks, with an 8-week follow-up period. The primary efficacy endpoint was absolute change in pre-bronchodilator FEV1 from baseline at Week 12. FINDINGS: A total of 310 patients were randomised and dosed in the study. The mean absolute change in FEV1 from baseline at Week 12 was higher in the lebrikizumab-treated arm compared with placebo (150 mL versus 67 mL); however, this improvement did not achieve statistical significance (overall adjusted difference of 83 mL [95% CI: -3, 170]; p = .06). Montelukast did not improve FEV1 as compared with placebo. Lebrikizumab was generally safe and well tolerated during the study. INTERPRETATION: Lebrikizumab did not significantly improve FEV1 in mild-to-moderate asthma patients at a dose expected to inhibit the IL-13 pathway. Inhibiting IL-13 in this patient population was not sufficient to improve lung function. These data support the findings of a previous trial of lebrikizumab in patients not receiving ICS. CLINICAL TRIALS REGISTRY NUMBER: This trial was registered under NCT02104674 at http://www.clinicaltrials.gov.