Positioning of Tezepelumab in Severe Asthma.

Asthma is one of the most common chronic diseases and is estimated to be severe in 3%-10% of affected patients. There is a need for additional biologic treatments that are highly efficacious across the spectrum of severe uncontrolled asthma. Currently available drugs inhibit 1 or 2 specific cytokines or IgE antibodies and thus only partially suppress the complex type 2 (T2) inflammatory cascade. Biologics targeting more upstream molecules in the pathophysiological pathway of asthma could treat asthma more effectively. Tezepelumab is a human monoclonal immunoglobulin G2λ antibody that targets the cytokine thymic stromal lymphopoietin (TSLP). It is the first marketed biologic against an epithelial cell-derived cytokine, preventing binding of TSLP to its receptor and reducing the immune stimuli that TSLP can trigger in different asthma endotypes. Tezepelumab reduces downstream biomarkers of inflammation, such as blood and airway eosinophils, FeNO, IgE, IL-5, and IL-13. Tezepelumab provides a clinical benefit in severe asthma, reducing the annualized asthma exacerbation rate in patients with either high or low levels of biomarkers of T2 inflammation, although the effect is greater among those with high levels. The drug has been shown to improve asthma control, quality of life, and lung function and reduce airway hyperresponsiveness. Therefore, tezepelumab can be used across the spectrum of patients with severe uncontrolled asthma, especially in T2-high patients. This review includes a positioning statement by the authors, all of whom are members of the SEAIC Asthma Committee.

Asthma Mortality in Spain From 1980 to 2019: Trends and Perspectives in the New Treatment Era.

BACKGROUND AND OBJECTIVE: Previous studies suggest that asthma mortality rates in Spain have been decreasing in recent years. However, this trend is not homogeneous across age groups. Objective: To analyze asthma mortality rates over a 40-year period, focusing on changes associated with the development of new therapeutic approaches. METHODS: Death records and mid-year population data were collected from the National Statistics Institute. Using the direct method, agestandardized mortality rates were calculated for the overall population and for each sex and age group. Significant changes in mortality trends were identified using joinpoint regression analysis. The independent effects of age, period, and cohort and potential years of life lost due to asthma were also analyzed. RESULTS: Age-standardized asthma mortality rates decreased in Spain from 7.38 to 2.03 deaths per 100 000 from the first to the last quinquennium of the study (1980-1984 to 2015-2019) for the whole population. This decrease was more intense among men, where a decrease from 10.37/100 000 to 0.91/100 000 was observed compared with 5.53 to 2.77/100 000 in women. Mortality decreased in all age groups. During the last 3 years, the decrease stabilized in patients aged >64 years but increased in those aged 35-64. Mortality has been decreasing rapidly since the 1990s in patients aged <35 years. CONCLUSION: Asthma mortality rates began to decline in 1980. The decrease was observed among younger cohorts starting in the 1990s, thus confirming earlier trends. Improved diagnosis and development of new therapies for asthma may have played a role in the changes observed. Close monitoring of asthma mortality rates is necessary to confirm these trends.

Referral Criteria for Asthma: Consensus Document.

Asthma is one of the most prevalent chronic diseases in Spain. Current treatments ensure that the disease is controlled in most cases. However, disease is often uncontrolled in daily clinical practice, mainly owing to underdiagnosis, loss to follow-up, and poor adherence to therapy. In order to improve this situation, we must coordinate all those health professionals who intervene in patient care. Therefore, the Spanish Society of Allergology and Clinical Immunology (SEAIC), the Spanish Society of Primary Care Physicians (SEMERGEN), the Spanish Society of Family and Community Medicine (semFYC), the Spanish Society of General and Family Physicians (SEMG), and the Spanish Society of Pneumology and Thoracic Surgery (SEPAR) have drawn up a consensus document in which they establish criteria for referral and guidelines for the diagnosis, control, and follow-up of patients with asthma. The document aims to facilitate continuing and improved care in this area.

Comparison of azelastine nasal spray and oral ebastine in treating seasonal allergic rhinitis.

The efficacy and safety of the nasally administered histamine H1 receptor blocking drug azelastine was investigated in a randomized comparative trial with ebastine. Patients were treated for 14 days and efficacy was assessed by the physician using a rating scale measuring 10 nasal and ocular symptoms of seasonal rhinitis (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Tolerability was measured on the basis of reported adverse events. Data from a total of 59 patients were included in the efficacy analysis. Both treatment groups had dramatic reductions in the physician's total symptom score following treatment. Mean scores in the azelastine group decreased from 12.4 pretreatment to 5.6, while the mean ebastine scores decreased from 13.6 to 6.6. There was no significant difference between the two groups (p = 0.86). Changes in individual rhinitis symptoms showed no differences between the two groups. The majority of patients in both treatment groups reported an initial relief of symptoms within 1 h of dosing. For seven patients treated with azelastine, the initial effect was already seen after 10 min (ebastine: two patients). Eight adverse events were reported in each treatment group; all were mild except one report of sedation in an ebastine patient, which was of moderate severity. Three patients reported somnolence during treatment with ebastine. A bitter taste was mentioned by four patients in the azelastine group, but neither somnolence nor sedation was reported with azelastine. In conclusion, the results of the study suggest that both azelastine and ebastine are effective treatments of the symptoms of seasonal allergic rhinitis. Both drugs were well tolerated.

Investigation on the efficacy and tolerance of azelastine (HCL) nasal spray versus ebastine tablets in patients with seasonal allergic rhinitis.

We compared the efficacy and tolerance of Azelastine nasal spray (0.14 mg in each nostril twice a day) versus Ebastine tablets (10 mg) as a single night dose in a Phase IV open, randomized, parallel-group clinical trial lasting 14 days, conducted with 63 patients diagnosed of seasonal allergic rhinitis. The symptoms assessed before and after the treatment period were: sneezing, nasal pruritus, rhinorrhea, nasal obstruction, conjunctival erythema, eye pruritus, eye watering, photophobia, pharyngeal pruritus and cough. Each symptom was rated by the patients according to a 4-point scale: absent: 0, mild: 1, moderate: 2, and severe: 3. The score required to be included in the study was 8 or above. In addition, the resistance of nasal fossae was assessed, before and after the treatment, by active anterior rhinomanometry, as well as the appearance of adverse events. Both drugs were equally effective both in the control of symptoms and in decreasing the airway resistance and no statistically significant differences were observed in the variables tested in both groups. We concluded that Azelastine nasal spray is a treatment as effective as Ebastine in the relief of symptoms of seasonal allergic rhinitis, with an excellent tolerance and minimum adverse effects.