We present three cases of pseudoaneurysm caused by self-expandable metal stents that formed arteriobiliary fistulas and caused hemobilia. Diagnoses were made on the basis of dynamic computed tomography or angiography. One patient died because of bleeding and cholangitis, whereas the others were successfully treated by transarterial embolization.

Purpose: The Informing the Pathway of COPD Treatment (IMPACT) study demonstrated that single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduces moderate/severe exacerbation rates and improves lung function and health status versus FF/VI or UMEC/VI dual therapy in patients with symptomatic COPD and a history of exacerbations. This analysis evaluated the efficacy and safety of FF/UMEC/VI in patients enrolled in Japan. Patients and methods: IMPACT was a 52-week, randomized, double-blind, multicenter study comparing FF/UMEC/VI 100/62.5/25 µg with FF/VI 100/25 µg or UMEC/VI 62.5/25 µg in patients ≥40 years with symptomatic COPD and ≥1 moderate/severe exacerbation in the previous year. Endpoints included annual rate of on-treatment moderate/severe exacerbations (primary endpoint), time-to-first on-treatment moderate/severe exacerbation and change from baseline at Week 52 in trough FEV 1 , post-bronchodilator FEV 1 , St. George's Respiratory Questionnaire, and COPD Assessment Test score. Safety was also assessed. Results: The Japan subgroup accounted for only 4% (378/10,355) of the overall IMPACT intent-to-treat (ITT) population. In the Japan subgroup, FF/UMEC/VI reduced the annual rate of on-treatment moderate/severe exacerbations by 15% (95% CI: −20, 40) versus FF/VI (compared with 15% [10, 20] in the ITT) and 36% (95% CI: 6, 57) versus UMEC/VI (compared with 25% [19, 30] in the ITT). FF/UMEC/VI reduced moderate/severe exacerbation risk (time-to-first), improved lung function and health status at Week 52 versus both dual therapies. These results were in the same direction and of a generally similar magnitude to those seen in the overall ITT population. No new safety signals were identified in the Japan subgroup compared with the ITT population. Pneumonia incidence was higher with FF/UMEC/VI and FF/VI versus UMEC/VI. Conclusion: These results highlight the favorable benefit-risk profile of FF/UMEC/VI single-inhaler triple therapy compared with FF/VI or UMEC/VI dual therapy in patients in Japan with symptomatic COPD and ≥1 exacerbation in the prior year.

To the Editor, Patients with severe eosinophilic asthma experience frequent exacerbations and may require oral corticosteroids (OCS) to maintain asthma control. 1 In randomized controlled trials (RCTs), the anti-interleukin-5 monoclonal antibody, mepolizumab, reduces exacerbation rates and OCS use in patients with severe eosinophilic asthma versus placebo. 2,3 However, due to strict eligibility criteria, RCT populations often have more homogeneous demographics and clinical characteristics than patients treated in real-world clinical practice. 4 As such, it is important to validate and complement the results of RCTs with effectiveness data from real-world settings, which can provide valuable information for clinical decision-making 5 ; these data are currently limited for Japan. The objective of the current study was to evaluate the effectiveness of mepolizumab in reducing exacerbations and OCS use in patients with severe asthma in Japan.

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