Sibel Atis Nayci

Assessment of Long-term Omalizumab Treatment in Patients with Severe Allergic Asthma Long-term Omalizumab Treatment in Severe Asthma

Objective. Several clinical studies have demonstrated the effectiveness of omalizumab in patients with severe allergic asthma but the treatment period has always been relatively short (4–12 months). In the literature, there are a few data about the long-term omalizumab therapy. We aimed to assess the long-term clinical and functional effectiveness of omalizumab treatment in severe allergic asthmatic patients, Methods. Medical records describing the patients’ status before the start of treatment, and also having been registered at the end of 4th, 12th, and 36th months from the commencement of treatment, and at the last visit where the patient was evaluated were used for omalizumab effectiveness assessments. Twenty-six patients (female/male: 21/5) with severe allergic asthma, uncontrolled despite GINA 2006 Step 4 therapy, were included in the study. Effectiveness outcomes included spirometry measurements, level of asthma control measured by asthma control test (ACT), systemic glucocorticosteroid (sGCS) use, emergency room (ER) visits, and hospitalizations for severe exacerbations. In addition, the quality of life was assessed using the quality of life questionnaire AQLQ(S) before, 4, and 36 months after treatment, Results. The mean age was 47.6 ± 13.9 and duration of allergic asthma was 22.7 ± 10.1 years. Serum total IgE levels were 322.0 ± 178.1 IU/mL. Mean duration of omalizumab treatment was 40.81 ± 8.2 months. FEV1 improved significantly at all control points versus baseline (p < .05). The level of asthma control as evaluated by ACT improved significantly after treatment (p < .05). We determined significantly reduced numbers of exacerbation, emergency visits, hospitalizations, sGCS, and SABA use by the end of 36 months (p < .05). The proportion of patients with improvements larger than 1.5 points in AQLQ(S) total score was 80.7% at the 4th month and 96.1% at the 36th month of treatment, Conclusions. This study showed that long-term therapy with omalizumab for up to 3 years was well tolerated with significant improvement both in symptoms and lung functions. Accordingly, long-term omalizumab treatment may be recommended for responders.

An integrated index combined by dynamic hyperinflation and exercise capacity in the prediction of morbidity and mortality in COPD.

BACKGROUND: Dynamic hyperinflation (DH) and exercise limitation develop in patients with COPD; however, there is lack of knowledge about their long-term clinical consequences. We aimed to assess the impact of DH and exercise capacity in predicting mortality and also morbidity, as evaluated by emergency visits and hospital admissions in COPD patients during a 4-year period. METHODS: We recruited 73 stable COPD patients. The relationships of different respiratory parameters (FEV1%, body mass index, 6 min walk test distance [6MWD], static hyperinflation as measured by the ratio of inspiratory capacity to total lung capacity (IC/TLC) at rest, DH as measured by the change between the post- and pre-exercise values of IC/TLC [ΔIC/TLC], PaO2, and PaCO2) with emergency visits and hospital admissions because of exacerbations and also with respiratory and all-cause mortality were assessed. RESULTS: The median follow-up period was 47 months (IQR 45–48 months, n = 73). During the follow-up there were 8 (11%) deaths. The ΔIC/TLC value was 3.9 ± 4.6%. The Kaplan-Meier survival curve showed that the cumulative survival rate was significantly lower in the patients with ΔIC/TLC > 4 and with 6MWD ≤ 439.56 m, using these values as thresholds. (The rates for sensitivity were 100% and 87.5%, and for specificity were 56.92% and 87.69%, respectively). The Cox proportional hazards model showed that DH (hazard ratio = 1.4, 95% CI = 1.09–1.84, P = .009) and 6MWD (hazard ratio = 0.98, 95% CI = 0.97–0.99, P = .006) were independent predictors of all-cause and respiratory mortality. 6MWD, FEV1%, IC/TLC, and ΔIC/TLC were found to be significantly related to emergency visits (r = −0.28, r = −0.41, r = −0.24, and r = 0.38, respectively) and hospital admissions (r = −0.41, r = −0.45, r = −0.36, and r = 0.28, respectively). CONCLUSIONS: DH and exercise capacity are reliable and independent predictors for mortality and morbidity in COPD patients. We propose that DH and exercise capacity be considered in the assessment of long-term clinical consequences of COPD patients.

Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial

Background: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. Methods: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. Results: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. Conclusion: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good.

The View of the Turkish Thoracic Society on the Report of the GOLD 2017 Global Strategy for the Diagnosis, Management, and Prevention of COPD

Since the Global Initiative for Obstructive Lung Disease (GOLD) published its first guidelines on chronic obstructive pulmonary disease (COPD) in 2001, much has changed till 2017. Previous versions of GOLD guidelines mentioned the forced expiratory volume in one second (FEV1)-based approach for staging and treatment modalities. Since 2011, a composite multi-dimensional approach has been introduced to cover various aspects of the disease. Unfortunately, this approach was not found to be correlated with mortality as well as the FEV1-based approach, despite the fact that it was better for estimating exacerbation rates. Although this assessment tool has been considered as a big step in personalized medicine, the system was rather complex to use in daily practice. In 2017, GOLD introduced a major revision in many aspects of the disease. This mainly includes a revised assessment tool and treatment algorithm. This new ABCD algorithm has excluded spirometry for guiding pharmacological therapy. Treatment recommendations are mainly based on symptoms and exacerbation rates. Escalation and de-escalation strategies have been proposed for the first time. The spirometric measurement has only been retained to confirm the diagnosis and lead to nonpharmacological therapies. In this report, the Turkish Thoracic Society COPD assembly aimed to summarize and give an insight to the Turkish interpretation of GOLD 2017.

Follow-up of asthma control and quality of life after discontinuation of omalizumab in severe asthmatic patients

Results The mean age was 53.5±9.5 and duration of asthma was 21.2±11.2 years. Serum total IgE level was 380.3±196 IU/mL. Mean duration of omalizumab treatment was 54.6±15 months. Loss of asthma control was documented in 10/16 patients (62.5%). The mean time to the first moderate to severe asthma exacerbation after discontinuation was 2.68±2.2 months. No correlation was found between time to loss of control and duration of omalizumab treatment. The mean score of ACT in the time of discontinuation of omalizumab decreased from 22.13±1.2 to 21.06±1.5 at 3th months (p=0.0001) and to 19.3 ±2.0 at 12th months of discontinuation (p=0.005). The number of exacerbation within the last 12 months increased from 1.3±0.9 to 3.4±3.2 (p=0.006), and the number of hospitalization increased from 0.12±0.26 to 0.6±0.9 within 12 months of discontinuation. The mean score of AQLQ decreased from 4.17±0.8 to 3.26±0.7 at 12th months of discontinuation (p=0.0001).

Updates in Chronic Obstructive Pulmonary Disease for the Year 2014

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality in the world. Research conducted over the past decade has contributed much to our current knowledge of the pathogenesis and treatment of COPD. Additionally, an evolving literature has recently accumulated information about the management of COPD and also about exacerbations. This article reviews a concise summary on the updates in COPD including 1) new pathogenic mechanisms and therapeutic targets, 2) management of patients in Group B, C and D according to GOLD 2014 report; 3) prevention and management of exacerbation; 4) monitoring of natural history; and 5) essential but usually forgotten parts of the management.