Efficacy and safety of mepolizumab in a Chinese population with severe asthma: a phase III, randomised, double-blind, placebo-controlled trial.

Background: In China, the prevalence of severe asthma with eosinophilic phenotype is rising, yet treatment options are limited. Mepolizumab is the first targeted biologic therapy for eosinophilic-driven disease in China. This study (clinicaltrials.gov identifier NCT03562195) evaluated efficacy and safety of mepolizumab in Chinese patients with severe asthma. Methods: The phase III, multicentre, randomised, placebo-controlled, double-blind, parallel-group study enrolled patients aged ≥12 years with severe asthma, with two or more exacerbations in the previous year, and on inhaled corticosteroids plus at least one controller medication. Following a 1-4-week run-in, patients were randomised 1:1 to mepolizumab 100 mg or placebo subcutaneously every 4 weeks for 52 weeks. The primary end-point was annualised rate of clinically significant exacerbations (CSEs) through week 52. Secondary end-points were time to first CSE, frequency of CSEs requiring hospitalisation/emergency department visits or hospitalisation over 52 weeks, mean change in St George's Respiratory Questionnaire (SGRQ) total score and pre-bronchodilator forced expiratory volume in 1 s (FEV1) at week 52; safety was evaluated. Results: The modified intention-to-treat population included 300 patients. At week 52 with mepolizumab versus placebo, annualised rate of CSEs was 65% lower (0.45 versus 1.31 events per year; rate ratio 0.35, 95% CI 0.24-0.50; p<0.001); time to first CSE longer (hazard ratio 0.38, 95% CI 0.26-0.56; p<0.001) and number of CSEs requiring hospitalisation/emergency department visit lower (rate ratio 0.30, 95% CI 0.12-0.77; p=0.012). From baseline to week 52, SGRQ score improved (p=0.001) and pre-bronchodilator FEV1 increased (p=0.006). Incidence of adverse events was similar between treatment groups. Conclusion: Mepolizumab provided clinical benefits to patients with severe asthma in China and showed a favourable benefit-risk profile.

A multicenter, prospective, observational study on montelukast monotherapy or montelukast-based combinations treating cough variant asthma.

BACKGROUND: Evidence of treatment against cough variant asthma (CVA) is insufficient for the clinical practice in China. We aimed at evaluating the real-world effectiveness of montelukast (MONT) alone or in combination with low-dose inhaled corticosteroids (ICS) and low-dose ICS plus long-acting beta-2-agonists (LABA) for Chinese CVA patients in a multicentre, prospective, cohort study. METHODS: Adult patients diagnosed with CVA defined as chronic cough >8 weeks with a positive bronchial provocation test and normal chest X-ray findings were enrolled at respiratory clinics. Study treatment followed routine clinical practice. The investigators initiated MONT by 10 mg/day alone or in combination with a low-dose ICS +/- LABA and followed up treatment outcomes for 4 weeks. The primary outcome measure was the change in cough score (CS) from baseline. RESULTS: The study enrolled 247 patients (MONT =146, MONT + ICS =38, MONT + ICS/LABA =63). In the primary analysis, the mean change (95% CI) in CS at the end of the study was -1.2 (-1.6, -0.9), -0.9 (-1.5, -0.4), and -1.3 (-1.7, -0.8) in the three groups, respectively. MONT monotherapy had a satisfactory rate of weekly asthma control at the end of the study (83.5%, 95% CI: 75.1%, 89.4%) in the per-protocol analysis. Rates of weekly asthma control were similar in two MONT-based combination regimens (83.9%, 81.4%). Short-acting beta-2-agonist (SABA) user (≥2 times per week) was 16.8% in the MONT group. CONCLUSIONS: The real-world effectiveness of MONT alone or in combination with ICS or ICS and LABA was acceptable for CVA short-term control.

[Clinical analysis of 252 patients with pulmonary thromboembolism].

OBJECTIVE: To improve the capability of diagnosing and treating for pulmonary thromboembolism (PE) by analyzing the characteristics of PE. METHODS: Retrospective analysis was performed among 252 patients with PE, diagnosed by CT pulmonary angiography (CTPA) without medical history of serious cardiopulmonary disease. And the before-after comparisons in echocardiography cardiovascular parameters and pulmonary artery Qanadli embolism index (PAQI) were launched within 32 patients who finished 3 months follow-up visiting. RESULTS: In 252 patients with final diagnosis of PE, smoking was the most important risk factor, accounted for 44.84%. Dyspnea was the main symptom in patients with PE (84.13%). PE often occurred in the elderly [64.00 (19.75) years old]. Hypotension, shortness of breath and tachycardia were always observed when circulatory collapsed. It could not be excluded for PE when D-dimmer was less than 5000 mg/L. In 32 patients rechecked 3 months after treatment, PAQI was significantly decreased compared with that before treatment [0.05 (0.18) vs. 0.39 (0.44), P < 0.01], but there were no significant differences in cardiovascular parameters before and after treatment. CONCLUSIONS: The clinical manifestations of PE are variable, it could be considered when the elder or smoker were suffered with dyspnea. After 3 months of anticoagulant therapy, cardiac morphology induced by PE didn't get demonstrate improvement.